Standard operating procedure to learn how to behave in Quality Control Laboratory in

pharmaceuticals.

Ankur Choudhary | Quality Control | SOP | Print |

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1.0 OBJECTIVE
To clearly lay down the procedure for behavior in quality control
department.

2.0 SCOPE
This procedure is applicable to all persons working in quality control
department.

3.0 RESPONSIBILITY
3.1 Doing
: Technical Assistant/Executive
3.2 Checking : Executive/Manager

4.0 ACCOUNTABILITY
Head of Department

5.0 PROCEDURE
5.1 Keep the working place neat and clean.
5.2 Follow general instruction laid down by department head.
5.3 Wear appropriate clothing as per S.O.P.
5.4 Follow safety guideline as per instruction given by manufacturers on
container label, while performing hazardous test /handling hazardous
chemicals.
5.5 Carry out analysis as per their respective specification.
5.6 Follow all respective S.O.P, M.O.A. during any analysis.
5.7 Follow MSDS of chemicals which is available in chemical analysis room,
before performing analysis of hazardous chemicals /materials.
5.8 Handle the hazardous and toxic chemicals very carefully as per respective
S.O.P. in presence of Q.C. incharge.
5.9 Follow GLP and fill all related records on line while performing analysis,
properly in respective annexures /records .
5.10 Before starting any analysis check the expiry of volumetric
solution/chemicals/reagents/ instrument calibration due date.
5.11 Always place back all reagents/chemicals bottles to its proper place after
use.

5.10 Do not keep used glassware on working platform, but place it properly in
tray labelled as
Glassware for washing
5.11 Always draw attention of incharge in case finding any damaged or
eligible reagent/chemical bottle label during working. Such labels are to be
replaced.
5.12 Always handle sensitive equipment like analytical balance very gently.
5.13 Take care to protect data sheet from any damage/spillage on it during its
use for reporting.
5.16 Do not eat drink, chew, smoke while performing the analysis.
5.17 Do not horse play and chitchat in laboratory.
5.18 Behave decently in laboratory.
5.19 Maintain discipline at all places.

6.0 ABBREVIATIONS
6.1
6.2
6.3
6.4
6.5

MSDS = Material Safety Data Sheet

Q.C. = Quality control
S.O.P.No. = Standard Operating Procedure number
G.L.P = Good Laboratory Practices
MOA = Method of analysis

Standard operating procedure to clean and sanitize the Microbiology laboratory with
disinfectant.

Ankur Choudhary | Microbiology | SOP | Print | Question ForumBe the

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1.0 PURPOSE
To lay down the procedure for Cleaning and Sanitation of Microbiology
laboratory.

2.0 SCOPE
It is applicable to Microbiology laboratory.

3.0 RESPONSIBILITY
Microbiologist

4.0 ACCOUNTABILIY

Head of Department

5.0 PROCEDURE
5.1 Precautions
5.1.1 Perform the area cleaning and sanitation when there is no activity.
5.1.2 Handle the disinfectant carefully to avoid contact with skin and eyes. Use only
validated disinfectants.
5.1.3 Do not use expired disinfectant solutions.
5.1.4 Rotate the disinfectants use to avoid the development of resistance by
microorganisms. For MLT & LAL test area and sterility area cleaning use freshly
prepared 0.45 m filtered disinfectants.
5.1.5 Wherever suitable use vacuum cleaner. Ensure the vacuum cleaners are in
clean and dry condition before use.
5.1.6 Use separate lint free mop and fresh solution for cleaning of different area to
avoid contamination of mop and solution.
5.1.7 Use only dedicated buckets/ containers for preparation and filtration for
different disinfectants.
5.1.8 Rotate the disinfectant once in a week sequentially, with validated
disinfectants.

5.2 Preparation of Disinfectant solution

5.2.1 Take the required amount of disinfectant and add purified water to makeup
desired final volume.
5.2.2 Keep the container containing disinfectant in the pass box.
5.2.3 Filter the disinfectant under the LAF with the help of filtration assembly.
5.2.4 Prepare the volume of disinfectant according to the use and record the
details.

5.3 Cleaning and Sanitization of MLT and LAL test, Media

preparation and decontamination area.
5.3.1 Start cleaning in following sequence with lint free mop soaked with 70% v/v
filtered Iso propyl alcohol.
5.3.1.1 Outer surface of equipments.
5.3.1.2 Cabinet and accessories.

5.3.1.3 View glass windows and doors.

5.3.2 Empty waste bins. (Replace the plastic liner daily.)
5.3.3 Mop the floor with validated disinfectant with non-fibre shedding mop. As per
following sequence as mentioned below.
5.3.3.1 MLT and LAL test room
5.3.3.2 Change room
5.3.3.3 Change room
5.3.3.4 Media preparation room
5.3.3.5 Change room media predation
5.3.3.6 Inspect and ensure the cleanliness of the area and record.
5.3.3.7 Frequency: Twice a day, beginning and at the end of working hours or
whenever required.
5.3.4 The other ancillary areas shall be cleaned once in a day and whenever
required.
5.3.5 Inspect and ensure the cleanliness of the area and record.

5.4 Fogging of MLT, LAL test room and Change rooms

5.4.1 Switch off the air-handling unit (AHU) of MLT, LAL test room and change
rooms.
5.4.2 Perform the fogging of the area with the help of fogger. Operate the fogger
according SOP for operation of fogger.
5.4.3 Record the details.
5.4.4 Put 'ON' air handling unit (AHU) of MLT, LAL test room on next day.
5.4.5 Frequency: Once in a day after completion of work.
5.4.6 Note: Fogging Shall be done in the sequence

5.5 Cleaning and Sanitation of sterility testing area.

5.5.1 Follow the procedure from point no 5.1.1 to 5.2.2
5.5.2 Mop the floor with validated disinfectant with non-fibre shedding mop. As per
following sequence as mentioned below.
5.5.2.1 Buffer room: Autoclave unloading area

5.5.2.2 Sterility testing room

5.5.2.3 Buffer room
5.5.2.4 Garment cubicle room
5.5.2.5 Inspect and ensure the cleanliness of the area and record.
5.5.2.6 Frequency: Twice in a day and whenever required.

5.6 Cleaning and Sanitation of Air lock and Buffer

Mop the floor with validated disinfectant with non-fibre shedding mop.

5.7 Fogging of Sterility testing area and Sterility cRABS

5.7.1 Switch off the air supply and exhaust system of sterility testing area and
sterility cRABS.
5.7.2 Perform the fogging of the area with the help of fogger. Operate the fogger
according SOP
5.7.3 Record the details.
5.7.4 Put 'ON' air supply and air suction of sterility test area on next day.
5.7.5 Frequency: Once in a day after completion of work.
Note: Fogging Shall be done in the sequence

5.8 Cleaning of Doors, Walls, Glass windows, Riser grill and Ceiling.
5.8.1 Clean the doors, walls, glass windows, riser grill and ceiling with dry non-fibre
shedding mop.
5.8.2 Mop the doors, walls, glass windows, riser grill and ceiling with validated
disinfectant with non-fibre shedding mop.
5.8.3 Inspect and ensure the cleanliness of the area and record.
5.8.4 Frequency: Weekly or when required.

5.9 Sanitation of drain point

5.9.1 Clean and flush the drain with water.
5.9.2 Fill the cup of drain with disinfectant or Flush the drain with disinfectant
available on the day of use.
5.9.3 Cleaning shall be done at the end of working or when required.
5.9.4 Record the details of sanitation.

6.0 ABBREVIATIONS
6.1 SOP - Standard Operating Procedure
6.2 AHU - Air handling unit
6.3 % - Percent

Standard operating procedure for cleaning of double door autoclave.

Ankur Choudhary | Microbiology | SOP | Sterilization | Print | Question ForumBe the

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1.0 OBJECTIVE
To lay down the cleaning procedure of autoclave.

2.0 SCOPE
This procedure is applicable for cleaning of Autoclave

3.0 RESPONSIBILITY
3.1 Doing : Lab Asst./Technical Assistant
3.2 Checking : Technical Assistant/Executive

4.0 ACCOUNTABILITY
Head of the Department

5.0 PROCEDURE
5.1 After the completion of cycle unload the autoclave.
5.2 Then shut the door II of sterile side.
5.3 Open the non sterile side door.
5.4 Check the chamber temperature. It should be below 50.
5.5 Clean the chamber & trays by tap water.
5.6 Keep the chamber drain value open
5.6 Use brush for cleaning if required.
5.7 Remove the strainer from drain hole and clean and put it back in place.
5.8 Rinse the entire chamber and trays with distilled water.

5.9 Clean the outer surface with clean cotton cloth.

5.10 Record the cleaning in Annexure I.

6.0 ABBREVIATIONS:
SOP - Standard Operating Procedure

ANNEXURE-I
MICROBIOLOGY DEPARTMENT
CLEANING RECORDS OF AUTOCLAVE
Date

Inner side

Outer side

Cleaned By

Checked by

Remarks & Sign

Standard operating procedure to evaluate the environmental monitoring results of

different area by trend analysis.

Ankur Choudhary | Microbiology | SOP | Print | Question ForumBe the

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1.0 OBJECTIVE
To ensure the corrective action to be taken for the result exceeding alert & action
level.

2.0 SCOPE

This procedure is applicable to evaluate the environmental monitoring results of

different area by trend analysis.

3.0 RESPONSIBILITY
3.1 Doing

: Technical Assistant (Microbiologist)

3.2 Checking : Executive/Manager

4.0 ACCOUNTABILITY
Head of the Department

5.0 PROCEDURE
5.1 Distinguish the results in three categories as follows.
1. Normal level
2. Alert level
3. Action level
5.2 No action is required for results observed in normal level and below alert level
category.
5.3 Consider the results, observed above normal level and below action level as alert
level category.
5.3.1 On alert trend of results inform to Q.A and Production department.
5.4 Initiate the preventive action for any action level or critical results .
5.4.1 In action level results, a deviation report must be submitted to Production, Q.A
and Quality control (Microbiological testing lab) and to be involved in deciding action
to be taken.
5.5 Evaluate the results and decide that up to what extent and how much
identification is relevant based on comments from production. Identify all micro
organisms found in the critical areas up to a level for determining the origin of the
same.
5.6 Send the trend analysis report to QA dept. for evaluation of trend.
5.7 Frequency of trend analysis
Location

Frequency

Surface samples and air samples in class 100 and 10,000 area
in week

Once

Surface samples and air samples in class 100,000 area

in quarter

Once

Finger print and gown of personnel working in Green Area

quarter
Settling plate in solid dosage area
in quarter

Once in
Once

Settling plate in Raw material dispensing and sampling booth

in quarter

Once

Surface sample and air samples in 100 and 10,000 area

in a month

Once

In sterility room and inoculam room in microbiology laboratory

in a month

Once

Settling plate in sterility testing and inoculation room microbiology lab.

in a month
Finger print and gown of person working in sterility
quarter
Inoculation room and non viable particle count in microbiology lab
in quarter

Twice
Once in
Once

6.0 ABBREVIATIONS
6.1 Q.A = Quality Assurance
6.2 Lab. = Laboratory

Standard operating procedure to evaluate the performance of analyst (Analyst Qualification).

Ankur Choudhary | Quality Control | SOP | Print | Question ForumBe the first to
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1.0 OBJECTIVE
To lay down a procedure for evaluation of analysts performance.

2.0 SCOPE
This procedure is applicable for qualification of analyst in quality control
department.

3.0 RESPONSIBILITY
3.1 Doing
: Executive/Manager
3.2 Checking : Manager

4.0 ACCOUNTABILITY
Head of the Department

5.0 PROCEDURE
5.1 Identify approved raw material and finish product and prepare a list.
5.2 Keep the record of material /product name, B.No., A.R.No., Code no. and
analytical value of sample along with acceptance limit.
5.3 Assign appropriate code no. to each sample identified for qualification.
5.4 Give sample for analysis appropriately coded in poly bags/glass vials to
analyst.
5.5 Provide detail method of analysis to analyst.
5.6 Evaluate the analyst either one or more of in following areas of analysis.
1. Assay (Analysis to be carried out in triplicate)
2. Dissolution
3. Identification by IR spectrophotometer (Analysis to be carried out
in triplicate)
4. Microbiology
5.7 Evaluate the analyst for one or more of the following analytical method
1. HPLC
2. U.V. spectrophotometer
3. Titration
4. I.R. Spectrophotometer
5.7 Evaluate the capability of the analyst in terms of its precision to perform
the tests and GLP followed by the analyst.
5.8 The capability to perform tests by analyst shall be considered
satisfactory if the results reported by the analyst.
a. Are within the acceptable limits
b. The analyst complies with GLP
c. Documents the results as per requirement
5.9 Qualify each new analyst with in three month of the area of work given
to them.
5.10 Keep the details like calculations, chromatograms, strip chart along
with comments of department head in training file to be maintained
separately for each analyst.
5.11 In case of analyst found not qualified, retrain the analyst and do not
allot subjected work until he is qualified.
5.12 Maintain records related to training /retraining and requalification in
training file.
5.13 Prepare the final report.

6.0 ABBREVIATIONS
6.1 B.No. = Batch No.
6.2 I.R = Infra red spectrophotometer
6.3 U.V = Ultraviolet

6.4 GLP = Good laboratory practise

Standard operating procedure of fumigation process in microbiology lab using
chemicals and precaution taken during the fumigation.

Ankur Choudhary | Microbiology | SOP | Print | Question ForumBe the

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1.0 OBJECTIVE:
To lay down the procedure for fumigation of Microbiology Laboratory.

2.0 SCOPE:
This SOP shall be applicable to Quality Control Dept.

3.0 RESPONSIBILITY:
Microbiologist

4.0 ACCOUNTABILITY:
Head Quality Control Department.

5.0 PROCEDURE:
5.1 Apparatus:
Fumigation machine
5.2 Reagent:
5 % Gramicid Solution
5.3 Fumigation Procedure:
Frequency: Once in a week or if the microbial counts exceed the limits in
Microbiology Testing area .
5.3.1 Connect the machine electric plug to main supply.
5.3.2 Keep the machine 2 feet above the ground level.
5.3.3 Open the lid of tank.

5.3.4 Add 2 ltrs of 5 % Gramicid solution and close the lid.

5.3.5 Adjust the blower at approximately 45 angle.
5.3.6 Put on the MAIN switch.
5.3.7 Switch on the blower.
5.3.8 Fogger starts emitting fine fog.
5.3.9 Keep the fog generator control minimum, to get fine particles of gramicid
solution.
5.3.10 Keep the fogger on till it forms sufficient fog in the area, and then shift to
another area.
5.3.11 Air handling unit should be put OFF before starting fumigation.
5.3.12 After fumigation keep all the doors closed.
5.3.13 After completion of fumigation keep the area closed for not less than 6 hrs.
5.3.14 Switch on the AHU 1 hour before starting the work for defumigation
5.3.15 Maintain fumigation Record.
Related: SOP for Guidelines for Working in Microbiology Laboratory
5.4 Precautions:
5.4.1 Make sure the area to be fumigated cleaned thoroughly.
5.4.2 Cover the electronic equipments with plastic sheet.
5.4.3 AHU should be put OFF 10 minutes before the fumigation starts.
5.4.4 AHU can be put ON 1 hour before starting work.
5.4.5 Use proper safety apparel such as gowns, rubber hand gloves and safety
goggles during fumigation of lab.

6.0 ABBREVIATIONS:
6.1 SOP : Standard Operating Procedure
6.2 Dept. : Department
6.3 AHU : Air Handling Unit

Standard operating procedure to write down the General Test Procedure for analysis.
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1.0 OBJECTIVE
To lay down a procedure for preparation, approval, authorization, control and revision of
general test procedure (GTP) in order to achieve uniformity.

2.0 SCOPE
This procedure is applicable for GTP prepared by the Q.C department.

3.0 RESPONSIBILITY
3.1 Doing
: Technical Assistant./Executive
3.2 Checking : Executive/Manager

4.0 ACCOUNTABILITY
Head of Department

5.0 PROCEDURE
5.1 Prepare general test procedure in the approved format.
5.2 Describe analytical test procedure step wise in general test procedure to simplify the
analytical procedure.
5.3 Write name and type of the test for which the procedure is laid down in
main heading of subject.
5.4 Write general test procedure under following headings as per
requirements of the test contents.
a. Objective
b. Chemical and Reagents
c. Procedure
Related: Analytical Method Validation

6.0 ABBREVIATION:
6.1 GTP = General Test Procedure
6.2 Q.C = Quality Control
Standard operating procedure of Good Laboratory Practice to avoid the errors inherent during
performance of any analysis.
Ankur Choudhary | GLP | Quality Control | SOP | Print | Question Forum 2 Comments

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1.0 OBJECTIVE
Objective of this procedure to avoid the errors inherent during performance of any analysis,
Good laboratory practices shall be followed.

2.0 SCOPE
This SOP is to provide guidelines for Good Laboratory practice.

3.0 RESPONSIBILITY
Officer/ Executive - Quality Control

4.0 ACCOUNTABILITY
Manager Quality Control

5.0 PROCEDURE
5.1 Procedure
5.1.1 While performing any analysis always follow respective standard operating procedure.
5.1.2 Use only pure (AR / GR grade) material for standardization.
5.1.3 Use calibrated volumetric glassware only, when accurate dilutions are
required.
5.1.4 Ensure that the temperature during dilution, at the time of volumetric
measurement and standardization is maintained i. e. at about 25C.
5.1.5 Rinse the burette or other vessel used to collect the volumetric
solution with the solution to be standardized.
5.1.6 While dilution always add concentrated acid slowly to the water, and
never add water to acid.
5.1.7 Handle the chemicals and solvents in a way to avoid spillage on the
working bench and the floor.
5.1.8 In case of any spillage immediately clean the affected area, according
the type of spillage.
5.1.9 Wear a full-seal goggles and safety mask while handling concentrated
acids and bases.
5.1.10 Never try and adjust the pH of a solution in a narrow-neck container.
Always use a beaker.
5.1.11 Never stick a spatula in to a container of a solid reagent. Always roll
the container to deliver the reagent in a controlled manner to the receiving
beaker.
5.1.12 Never return unused reagent to the reagent container. Contamination
of the whole reagent supply is more costly than the small amount of reagent
discarded.
5.1.13 Use water for injection, unless otherwise specified, for preparation
and standardization of solution.
5.1.14 Use water for injection for preparation of buffer solution, indicator
solution, standard solution unless otherwise specified.

5.1.15 Standardize the volumetric solution with that method only which is used for endpoint
determination.
5.1.16 Store the light sensitive solution in the light resistant (amber colored)
containers only.
5.1.17 Label all the reagents for Name, strength, prepared by & on and shelf
life.
5.1.18 While performing titration in case of colorless solutions in the burette,
consider the lower meniscus as the reading. In case of colored solutions
consider upper meniscus.
5.1.19 Always fill burette taking it away from the stand in to the hand and
using a glass funnel. Adjust the reading to zero before starting titration.
5.1.20 Use approximately 0.1 ml of indicator, during titration or
standardization, unless otherwise specified.
5.1.21 Never use broken glass-wares and in case of iodometric titration use
iodine flask.
5.1.22 Store toxic and flammable chemicals in the separate area under lock
and key.
5.1.23 Store all the reference standards and stock of working standards in
their Specified area.
5.1.24 Working standards in use are to be stored in the desiccator provided.
And the bottles are sealed immediately after their use.
5.1.25 Never leave any chemical reaction taking place on the gas i.e.
boiling, distillation, refluxing unattended.
5.1.26 While boiling anything, keep the container opened, if not refluxing.
5.1.27 Check the LPG cylinder and pressure tubing for any damage or
leakage; change the tubing if damage or leakage is found.
5.1.28 Always close LPG valve first and then put off the compressor while
working with them, there is a chance of explosion when compressor is closed
first.
5.1.29 Always keep the burner OFF while mopping the LAF bench.
5.1.30 After completion of any microbiological work, put on the UV light.
5.1.31 Never look directly into the UV light.
5.1.32 For analysis always use calibrated instruments.
5.1.33 If instrument / equipment found damaged, do not use it and consult
Q. C. Manager / executive to get it repaired or changed.
5.1.34 While cleaning any electrode of either pH meter or conductivity
meter, clean them with water for injection and wipe off with the help of a
tissue paper gently.
5.1.35 Never rub the electrode and keep all the electrodes dipped constantly on the water for
injection.

6.0 ABBREVIATIONS
6.1 SOP - Standard Operating Procedure

Standard operating procedure of Good Laboratory Practices for High Performance

Liquid Chromatography.

Ankur Choudhary | HPLC | Quality Control | SOP | Print | Question

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1.0 OBJECTIVE
To describe the procedure to be followed in HPLC analysis and documentation
and to insure that Good Laboratory Practices are followed in the HPLC analysis.

2.0 SCOPE
This SOP is applicable for the procedure to be followed in HPLC analysis and
documentation and to insure that Good Laboratory Practices are followed in the
HPLC analysis.

3.0 RESPONSIBILITY
Officer/ Executive - Quality Control

4.0 ACCOUNTABILITY
Manager Quality Control.

5.0 PROCEDURE
5.1 There shall be sequence available for the analysis before start up on the
instrument.

5.2 Mobile Phase

5.2.1 The mobile phase shall be prepared as per the composition described in the
standard test procedure (STP) of respective sample.
5.2.2 The mobile phase container shall have labeling details as follows:
Mobile phase :
Product

Analysis of

Prepared by

Use before

Date :

Detail like weight of buffer (s), Balance No., Observed pH, etc. for the mobile phase
shall be recorded in record of analysis.

5.2.3 The mobile phase shall not be use after 7 days of its date of preparation.
5.2.4 The mobile phase shall be discarded if any haziness or precipitation is found
upon visual examination.

5.3 Resolution Solution

5.3.1 In case where the resolution solution required for system suitability is to be
stored for longer duration it shall be assigned a self-life based on the following.
A) The resolution solution required for system suitability parameter as required by
the respective STP on each days of the study.
B) For the main analyze peak the difference in the area count on the day of
preparation and at the end of the self life shall not vary by 20 % with respect to the
limit area count.
C) For the impurities peak the difference in the area count on the day of
preparation and at the end of the self life shall not vary more than 20 % with
respect to the initial area count.

5.4 Standard Preparation

5.4.1 The standard preparation shall be prepared as per the STP, taking in
consideration them stability & storages requirement.

5.5 Analysis

5.5.1 The system suitability shall be established as per the STP, before proceeding
with the analysis.
5.5.2 Injection sequence shall be captured from the system as per the STP of
respective product and shall be recorded.
5.5.3 The injection sequence to be followed shall be as per the respective STP the
following injection sequence may be used as a guidelines:
Blank System suitability (or System Suit Blank) Placebo (if required)
Impurity standard (if applicable) Standard Sample
5.5.4 The system suitability (once established) shall be valid for a maximum period
of 24 hour. After about every 24 hour system suitability (from the time when first
system suitability is established).
5.5.5 The system suitability shall be demonstrated after about every 24 hour in the
following manner:
5.5.6 For assay and related substances analysis after about every 24-hour standard
solution in triplicate shall injected. The RSD of triplicate injection shall be NMT 1%

5.6 Acceptance Criteria

5.6.1 The store resolution solution if used, shall meet the acceptance area on all
the day of its use. Otherwise a freshly prepared resolution solution shall be injected.

5.6.2 Where the sample is required to be injected in duplicate /triplicate the area
ratio between the successive injections shall lie between: 0.99 to 1.01 from the
mean area.
Method where the STP does not specify any RSD limit; the area ratio between the
successive injection of the standard shall lie between 0.99 to 1.01 from the mean
area.
5.6.3 The area ratio of the average area of the intermittent set of standard and
average of initial standard, shall lie between 0.99 to 1.01 from there mean area.
5.6.4 During assay and related substance analysis involving isocratic runs. The flow
rate of mobile phase shall be kept constant for the entire run, after the system
suitability is established. If the flow rate of the system is change for more than 200
minute, fresh system suitability shall be established.
5.6.5 During assay and related substance analysis involving gradient run. If there is
delay (exceeding the run time) in injection the next sample, the blank run with
gradient operation shall be continued. The chromatogram for blank injection shall
be recorded.
5.6.6 In case the above mentioned acceptance criteria are not met, all the data
collected during the suspect time period shall be properly identified and reviewed
by supervisor. The system suitability shall be carried by out all over again, before
injecting any test samples.

5.7 Recording Chromatogram

5.7.1 All chromatogram before establishment of system suitability and up to entire

run, shall be recorded and documented. Appropriate reamer (if required) shall be
recorded by the analyst / supervisor.
5.7.2 In case where the chromatogram needs disregarding, the analyst shall show it
to the supervisor /QAM for review and approval.
5.7.3 The disregarded
supervisor /QAM.

chromatogram

shall

be

checked

and

certified

by

5.7.4 The chromatogram, which is disregarded and not considered for calculation,
shall be stamped as DISREGARDED. The reason for disregarding the
chromatogram could be variation in the area count / inconsistent area, faulty
integration, abnormal drift in baseline. Ghost peak or any other reason.
5.7.5 The analyst performing the analysis shall assign the reason of disregarding a
chromatogram on the chromatogram itself. The disregarded chromatogram shall be
filled along with the test chromatogram.
5.7.6 For the system generated chromatogram, the necessary information shall be
printed on each chromatogram.
5.7.7 The integration parameter such as peak width, peak threshold, minimum
peak area and height shall be recorded, as used for integration of chromatogram.

5.7.8 Reprocessing of chromatogram, if necessary at a letter date /time shall be

documented with reason (s) for reprocessing and certified by the QAM.

5.8 Calculation

5.8.1 The calculation shall be performed as per the respective STP. All calculation
shall be as per the area count / value obtained from the standard injected in the
beginning. Area count of the in between injection of standard shall not be
considered for calculation.

Related: Calculation of Relative Response Factor (RRF)

6.0 ABBREVIATIONS
6.1 SOP - Standard Operating Procedure
6.2 HPLC - High Performance Liquid Chromatography
6.3 STP - Standard testing procedure
6.4 RSD - Related Standard Deviation

Standard operating procedure maintain the desiccant effective in desiccators of Quality Control.
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1.0 OBJECTIVE
To verify and change the desiccant for effective functioning of desiccator.

2.0 SCOPE
This procedure is applicable to maintain all desiccators lying in Quality
Control Laboratory.

3.0 RESPONSIBILITY
Doing
: Technical Assistant
Checking : Executive /

4.0 ACCOUNTABILITY

Head of the department.

5.0 PROCEDURE
5.1 Remove the containers of the desiccator and put them in a Hot Air oven.
5.2 Remove the desiccant and destroy it.
5.3 Clean the desiccator with water, detergent solution and again with
water. Mop it with dry cotton cloth.
5.4 Allow it to dry.
5.5 Fill the new desiccant (calcium chloride) up to the cup height.
5.6 Transfer all the containers back into the desiccator.
5.7 Apply silicone gel to the lid and top circumference of the desiccator.
5.8 Check that all the containers placed in the desiccator are labelled
properly.
5.9 Record it in the format as per annexure.
5.10 Change the desiccant once in a quarter / wherever it seems to be
change.

6.0 ABBREVIATIONS
6.1 SOP - Standard Operating Procedure

Standard operating procedure for checking of viable count on surface of clean

equipment by swab method.

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1.0 OBJECTIVE
To check viable count in to clean equipment from Solid dosage area.

2.0 SCOPE
This SOP is applicable for checking of viable count on surface of clean equipment
by SWAB method.

3.0 RESPONSIBILITY
3.1 Doing

: Technical Assistant ( Q.C) / Executive.

3.2 Checking : Executive / Manager.

4.0 ACCOUNTABILITY

Head of the department.

5.0 PROCEDURE
5.1 Frequency :

Once in a month to cover all equipment in solid dosage area.

5.2 Requirement :

Sterile SWAB Sticks, 10 ml Sterile Normal Saline tube/ 10 ml sterile water, Melted SCD
Agar Medium, 70% filtered IPA. Micropipette, Sterile tips (1ml).
5.3 Take SWAB sample as per point No 5.5 in presence of Q.A & Production
Representative. As per approved list of clean equipment.

5.4 Media Preparation :

Melted SCD Agar Medium

5.4.1 As per the instruction, weigh specified quantity of media powder in a beaker
whose capacity is double the final volume of the media to be prepared.
5.4.2 Add appropriate quantity of Purified water and mix it properly.
5.4.3 Check the pH of the medium and adjust the pH using 0.1 N HCl / 0.1N NaoH, if
required.
5.4.4 Heat and dissolve the medium constituents with constant stirring to avoid
charring.
5.4.5 While in the molten state, distribute the specific volume of the media into the
appropriate glass container.
5.4.6 Seal the mouth of the glass container using cotton plug.
5.4.7 Cover the cotton plugs with wrapping paper.
5.4.8 Sterilize the media at 121C for 20 min as per S.O.P.
5.4.9 After sterilization, media should be kept in to oven / water bath whose
temperature should be between 50C 60C until use so that it should remain in
molten state.

5.5 Sampling Procedure :

5.5.1 On request through requisition slip from Production / Q.A department for viable
count of clean equipment. Take the SWAB sample with the help of sterile SWAB
sticks.
5.5.2 Wear gloves and wash the hand with 70% IPA before sampling.

5.5.3 Take the sterile SWAB stick and moistened in 10 ml sterile Normal saline or 10
ml sterile water for injection.
5.5.4 Apply the SWAB in a controlled fashion as indicated in the figure below and
with uniform pressure, to the pre determined clean equipment. Cover 100-sq. cm.
area for sampling
5.5.5 Put this SWAB in to 10 ml Sterile Normal Saline /10 ml sterile water for
injection.
5.5.6 Label it with equipment ID.No, Location, Cleaning Date, sampling date & time
5.5.7 Send the sample via material entry through microbiology laboratory and swabs
should analyze within 24 hours while stored at 2-8 C.
5.5.8 Put the sample in to LAF of microbiology laboratory.
5.5.9 Testing should be done in duplicate under LAF.
5.5.10 Properly marked two sterile Petridishes with equipment ID.No, Location,
sampling date & time and testing Date & Time.
5.5.11 Take two different aliquot of 1 ml sample aseptically with sterile pipette and
transferred in to two different sterile petridishes, because testing should be done in
duplicate.
5.5.12 Pour Melted SCD Agar medium, whose medium temperature is 50C 60C
into sample containing petridishes, swirl well and close the petridishes.
5.5.13 Wait for some times to solidify the medium and put it into incubator for
incubation at 30C 35C for 5 days.
5.5.14 After incubation, Count the Colony and multiply with 10 ( dilution Factor) and
note down the results in the requisition Slip as colony/100 sq.cm.
5.5.15 Submit the Requisition Slip to requester ( production dept/ QA Dept.for
further action.

6.0 ABBREVIATIONS
IPA : Iso - Propyl alcohol
SCD : Soybean Casein Digest.
LAF : Laminar Air Flow.
Q.C : Quality Control
Q.A : Standard operating procedure to monitor the microbiology laboratory for
microbial load and non viable particle count.

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1.0 PURPOSE
To lay down the procedure for monitoring of microbiology lab to determine
nature and extent of microbiological load and non-viable particles.

2.0 SCOPE
It is applicable to Microbiological lab.

3.0 RESPONSIBILITY
Microbiologist

4.0 ACCOUNTABILITY
Head of Department

5.0 PROCEDURE
5.1 Pre operational checks for area monitoring
5.1.1 Two days pre incubated plates shall be used.
5.1.2 Check the plates for any microbial contamination and physical integrity of
solid media.
5.1.3 Outer surface of the plates should be sanitized with filtered sporocidal agent.
5.1.4 Check the expiry / use before date of the media.
5.1.5 Check the cleaning status of area where plate has to be exposed.
5.1.6 Ensure the temperature, humidity and differential pressure of the area within
the limit or not.

5.2 Precaution to be taken during area monitoring.

5.2.1 Expose and collect the plate in such a way to avoid personnel interference.
5.2.2 Open the lid in such a way that finger does not touch the surface of the media
5.2.3 Do not lean on plate while exposing and collecting the plate.
Note: Monitoring of microbiology lab is carried out by the following methods.

5.3 Passive air sampling (Settle plate method)

5.3.1 Prepare the Soyabean casein digest agar plates as per SOP for storage and
preparation of microbial media. Use the prepared plates after 48 hours of pre
incubation.
5.3.2 Transfer the required number of pre-incubated petriplate into pass box (LAL
test room to Incubator).
5.3.3 Enter the respective area as per the SOP
5.3.4 Aseptically check the pre-incubated plates for any evidence of microbiological
contamination.
5.3.5 Discard the plates having microbiological growth.
5.3.6 Decontaminate the external surface of the petriplates with the help of a
sterile mop soaked in a filtered sporocidal agent.
5.3.7 Mark the petriplates at the base with the following details with marker,
For negative control For all the other
plate
plates
Media lot No

Name of the location

Date of use

Date of Sampling

Used by

Sampled by

5.3.8 Place the petriplates on the plate exposure stands and remove the upper lid
of the petriplates and keep it in inverted position on resting stand. (Note: Inclined
petriplate stand in front of riser and straight petriplates stand at all other location if
there is no stand available expose the plates on floor at the specified location)
5.3.9 Expose the media plates at all the locations for 4 hours at the locations.
5.3.10 After 4 hours of exposure, close the petriplate with lid.
Note: collect the plates in the same sequence in which the plates were exposed.
5.3.11 Collect all petriplates and transfer the plates into the incubator.
5.3.12 Incubate all exposed petriplates in inverted position in the incubator at
22.5 2.5C for 3 day and 32.5 2.5C for 2 day. (Keep each set not more than 10
plates in Stack)
5.3.13 Once in a month (preferably first week of the month) expose the separate
set of plates inside the cRABS and incubate anaerobicaly at 32.5 2.5C for 3 days,
follow the SOP for operating anaerobic jar.

Note: For anaerobic incubation the plates shall be pre incubated under anaerobic
condition for 2 days
5.3.14 After incubation observe and count the number of colonies on the colony
counter or in the light source with the help of marker.
5.3.15 Note down the observation in the format.
5.3.16 If the counts obtained are above the limits specified below investigate the
results and take necessary actions as per SOP
5.3.17 Frequency of Monitoring
Class A: Once in a day whenever there is activity.
Class B: Once in a day
Class C: Once in a day
Class D: Twice in a week
Note: Whenever a sterilitytest is to be performed in a day monitoring shall be done
at the same time.
5.3.18 Acceptance criteria
Alert limit:

Action limit:

Class A: 1 CFU / plate Class A: 1 CFU / plate

Class B: 3 CFU / plate Class B: 5 CFU / plate
Class C: 35 CFU /
plate

Class C: 50 CFU /
plate

Class D: 75 CFU /
plate

Class D: 100 CFU /

plate

5.3.19 Note: For transferring the plates into sterility testing area place the plates in
pass box (Buffer room to LAL test room)

5.4 Active air sampling

5.4.1 Prepare the Soybean casein digest agar plates as per SOP Procedure for
Storage and Preparation of Microbiological Culture Media SOP Use the prepared
plates after 48 hours of pre incubation.
5.4.2 Transfer the required number of media cassette, plate, and accessories into
pass box (LAL test room to Incubator).
5.4.3 Enter the respective area as per the SOP

5.4.4 Aseptically check the pre-incubated plates for any evidence of microbiological
contamination
5.4.5 Discard the plates having microbiological growth.
5.4.6 Sanitize the external surface of the media cassette / plate with filtered
sporocidal agent.
5.4.7 Mark the petriplates at the base with the following details with marker,
For negative control For all the other
plate
plates
Media lot No

Name of the location

Date of use

Date of Sampling

Used by

Sampled by

5.4.8 Perform the air sampling as mentioned.

5.4.9 Place the media cassette / Plate on the Air sampler and operate the
instrument as per SOP for air sampler.
5.4.10 Take the instrument to the locations, where the air is to be sampled, hold it
in such a way plate facing the airflow at the required working height.
5.4.11 After completion of sampling collect all the plates and incubate in inverted
position in the incubator at 22.5 2.5C for 3 day and 32.5 2.5C for 2 day.
5.4.12 After incubation observe and count the number of colonies on the colony
counter or in the light source with the help of marker.
5.4.13 Note down the observation in the format.
5.4.14 If the counts obtained are above the limits specified below investigate the
results and take necessary actions as per SOP.
5.4.14 Frequency of Monitoring
Class A: Once in a day
Class B: Once in a day
Class C: Once in a day
5.4.15 Acceptance criteria
Alert limit

Action limit

Class A: 1 CFU / plate

Class A: 1 CFU / plate

Class B: 7 CFU / plate

Class B: 10 CFU / plate

Class C: 75 CFU / plate

Class C: 100 CFU / plate

Note: Perform the Air sampling after completion of the

activity.
5.4.16 Note: For transferring the plates into Sterility area place the plates in pass
box
5.5 Study the contaminants as per SOP.

5.6 Non Viable sampling

5.6.1 Perform the non viable sampling.
5.6.2 Operate the sampler according to SOP
5.6.3 The sampling should be carried out as mentioned in the table.
5.6.4 Record the details of count.
5.6.5 Perform the non-viable count at specified location for 1 minute per run.
Room
No/

S.n
Clas No. of
o
Locations
Equipme s
nt ID

Acceptance criteria
(particles per cubic
feet)
0.5 m / ft3

5 m / ft3

Frequency

100

Once in fifteen day

100

Daily

100

Once in fifteen day

10,000

57

Once in fifteen day

10,000

57

Once in fifteen day

10,000

57

Once in fifteen day

10,000

57

Once in fifteen day

100,000

571

Once in fifteen day

100,000

571

Once in fifteen day

10

10

Not defined

Not defined

Once in fifteen day

11

11

Not defined

Not defined

Once in fifteen day

12

12

Not defined

Not defined

Once in fifteen day

Note: Perform non-viable count after completion of the activities in case of

equipment. Alert and action limits are defined in case of class A.
5.7 Swab test of surface
5.7.1 For sampling sites refer location chart of site.
5.7.2 Prepare saline peptone solution and dispense 10 ml quantity in test tube and
put one cotton swab in it and sterilize in autoclave at 15 lbs pressure and 121C for
15 minutes.
5.7.3 Sanitize the outer surface of the saline tube with filtered sporocidal agent and
transfer the tube into cRABS through pass box.
5.7.4 Remove excess solution from swab by pressing on side of tube. Swab 5 X 5
cm2 area using parallel overlapping stroke with slow rotation of swab. Repeat the
sampling by stroke at right angle to original stroke. After taking the swab put the
swab stick back into saline peptone solution. Sample according to sampling plan.
After taking swab write the location of swab and date of swab with marker.
5.7.5 Bring the tubes to quality control laboratory and vortex for 1 minute and
perform the Bioburden according to membrane filtration method according to SOP.
5.7.6 Incubate the petridishes at 22.5 2.5o C for 3 days followed by 32.5 2.5o C
for 2 days in upright position.
5.7.7 After incubation count and observe the number of colonies on colony counter
or under light source with the help of marker. Record the results.
5.7.8 Frequency of monitoring
After completion of activities
5.7.9 Acceptance criteria
Class
A

Action Limits
1 CFU / Plate

5 CFU / Plate

5.8 Personnel fingers dabs and cRABS gloves dab

5.8.1 Prepare the Soyabean casein digest agar plates as per SOP Procedure for
Storage and Preparation of Microbiological Culture Media SOP . Use the prepared
plates after 48 hours of pre incubation.
5.8.2 Mop the plates from outside using filtered sporocidal agent before entering
into aseptic area and label the plates indicating the name of the person, date of
test, LHFD, RHFD.
5.8.3 Open the lid and take the finger impression of left hand finger dabs (LHFD)
and right hand finger dabs (RHFD) by placing the finger and thumb on agar surface.
5.8.4 Incubate the soyabean casein digest agar in inverted position at 22.5 2.5o C
for 3 days followed by 32.5 2.5o C for 2 days.
5.8.5 After incubation count the number of colonies on colony counter or under
light source with the help of marker and record the results in specified format.
5.8.6 In case of sterility cRABS take dab after completion of the activities. Gloves
numbering from left to right
5.8.7 Mop the plates from outside using filtered sporocidal agent and keep the
plates in pass box of sterility cRABS, the plates shall be indicating the gloves No.,
date of test.
5.8.8 First take the gloves dab in pass box, than pass the rest of the plates in
chamber by opening the inner door and take the dab of other gloves
5.8.9 Incubate the soyabean casein digest agar in inverted position at 22.5 2.5o C
for 3 days followed by 32.5 2.5o C for 2 days.
5.8.10 After incubation count the number of colonies on colony counter or under
light source with the help of marker and record the results in specified format..
5.8.11 Frequency of monitoring
After completion of activities
5.8.12 Acceptance criteria
Limits of Personnel fingers dabs.
Action limit: Class A: 1 CFU / 5 fingers
Class B: 5 CFU / 5 fingers

5.9 Contact plates of Personnel gowns

5.9.1 Prepare the Soyabean casein digest agar RODAC (Replicate Organism
Detection and Counting) plates as per SOP Procedure for Storage and Preparation
of Microbiological Culture Media SOP . Pour the media in RODAC plates
completely, make sure convex surface formed after solidification. The plates that
are not having convex surface shall not be taken for monitoring. Use the prepared
plates after 48 hours of preincubation
5.9.2 Decontaminate the external surface of the petriplates with the help of lint
free sterile mop soaked in a filtered sporicidal agent
5.9.3 Mark the petriplates at the base with the following details with marker,
For negative control For all the other
plate
plates
Media lot No

Name of the location

Date of use

Date of Sampling

Used by

Sampled by

5.9.4 Perform the microbial monitoring of gown by touching the convex surface of
the media plate for the locations.
5.9.5 Incubate all the Plates and negative control plate in inverted position at
22.5 2.5 C for 3 days and 32.5 2.5C for 2 days.
5.9.6 After incubation observe and count the number of colonies on the colony
counter or under the light source with the help of marker.
5.9.7 Note down the observation.
Limits:

Class
B

Action limit
5 CFU / Plate

6.0 ABBREVIATIONS
6.1 SOP - Standard Operating Procedure
6.2 C - Degree Centigrade
6.3 CFU - Colony Forming unit
6.4 - Micron
6.5 LHFD - Left hand finger dab
6.6 RHFD - Right hand finger dab

6.7 RODAC - Replicate Organism Detection and Counting

Quality Ass tandard operating procedure to handle the out of specification results
during the analysis of Pharmaceutical products and its investigation report during
different stages.

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Question Forum 2 Comments so far

1.0 PURPOSE
The purpose of this SOP (Standard Operating Procedure) is to describe
the procedure for handling out of specification results obtained during analysis.

2.0 SCOPE
This SOP is applicable to the results, which is out of specification obtained
in Quality Control Laboratory for Raw / packaging materials, finished products for
releasing parameters. This SOP is not applicable for informative parameters.

3.0 RESPONSIBILITY
3.1 Quality Control Analyst:
3.1.1 To inform out of specification results to the quality control incharge.
3.2 Quality control in-charge
3.2.1 To issue out of specification investigation form after entering in the form in
out of specification logbook.
3.2.2 To investigate out of specification results.

4.0 ACCOUNTABILITY
4.1 Quality Head
4.1.1 To verify the investigation form at each and every stage and to give final
conclusion about the status of the material.

5.0 PROCEDURE

5.1 On the receipt of report for the Out of Specification (OOS) of results from the
analyst, Q.C. Incharge shall issue OOS form after duly entering in the out of
specification log book.
5.2 QC In charge or designee shall carry out the investigation and fill in the form
(Stage A).
5.3 If it is found that the parameter of stage A is not satisfactory, any error is
reported, correct the parameter and same sample shall be reanalyzed by another
analyst.
5.4 If the material meets the requirement (passes), release the material; the
analyst shall be re-trained for the error parts.
5.5 If the parameter of stage A is found satisfactory, the Supervisor shall allot the
same material for reanalysis to another senior analyst. (Stage B).
5.6 If (Stage B) result is within specification (passes), the material shall
be reanalyze by first analyst with same sample material and to investigate the first
analysts.
5.7 If investigation of first analysts found satisfactory then release the material.
5.8 If the material fails in Stage B also, by senior analyst, simultaneously analyse
after re-sample with the previously approved material (Stage C).
5.9 Material under investigation (Stage C) should be re-sampled with the
authorization of Head Quality and then proceeds for the further analysis (Stage C)
5.10 If material has been received first time, no previous sample is available, than
stage (C) is not applicable and rejects the material.
5.11 If the previously approved material passes within the specification and the
material under investigation fails to meet the specification, the material shall be
rejected.
5.12 If the previously approved material passes within the specification and the
material under investigation also with the specification than the material shall
be reanalyze by another analyst and investigate the second analysis (Stage B).
5.13 If investigation of second analysis (Stage B) found satisfactory than release
the material.
5.14 The repeat analysis can be carried out in separate sheet allotted by the
supervisor duly authorized or in the particular hard book and all printouts shall be
attached with the document.
5.15 Cross-references of analysis shall be attached with OOS investigation form.

5.16 Final conclusion shall be made in the OOS investigation form for rejection /
approval by Quality Head.
5.17 Cross-reference of OOS investigation form shall be given in the analytical
report.

6.0 ABBREVIATIONS
6.1 SOP - Standard operating procedure
6.2 OOS - Out of Specification
Urance
Standard operating procedure for schedule & frequency for testing, locations for
sampling and type of analysis required to be carried out for the Purified water for
monitoring & assurance of its quality.

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1.0 OBJECTIVE
To define the schedule & frequency for testing, locations for sampling and type
of analysis required to be carried out for the Purified water for monitoring &
assurance of its quality.

2.0 SCOPE
This Procedure is applicable during sampling and analysis of purified water.

3.0 RESPONSIBILITY
3.1 Doing

: Tech.Assistant (Microbiologist)

3.2 Checking : Executive/Manager

4.0 ACCOUNTABILITY
Head of the Department

5.0 PROCEDURE
Remark : Ensure visually that container for sample collection are washed and
dried properly.
5.1 Collection of Purified water sample for chemical analysis.

5.1.1 First collect the sample for chemical analysis.

5.1.2 Flush water from the tap for 30 seconds.
5.1.3 Rinse the sampling bottles three times with actual sample before sampling for
chemical analysis.
5.1.4 Collect approx. 500 ml sample of Purified water in bottle
Note: Sample should be filled up to the neck of sampling bottle for chemical
analysis.
This is to ensure that air in the empty portion of the sampling bottle should not
get dissolved in the water sample.
5.2 Collection of Purified water sample for Total Organic Carbon (TOC) test.
5.2.1 Use airtight container for collection of Purified water sample for TOC analysis.
5.2.2 Wash the container prior to sampling with 2N HCl for 2-3 times.
5.2.3 Follow pt. 5.1.2 & then 5.1.3.
5.2.4 Collect about 60-70 ml of sample & close the sample container tightly.
Note : (1) Take precaution to prevent atmospheric carbon dioxide being dissolved in
sample.
(2) In case if TOC analyser is out of order, the sample can be release on base of
Oxidisable substance test Result.
5.3 Collect the samples of purified water and test accordingly as per Annexure.
5.3.1 Use suitable container for collection of Purified water sample. This to be
sterilized as under.
Fill the sample collection container with PW & keep the cap tightly.
Wrap it with wrapping/butter paper
Sterilise it at 1210C for 30min.
5.3.2 Discard the PW filled in sterilized sample container just before collection of
purified water sample for analysis.
5.3.3 Collect about 15 ml of purified water sample in sterilized container and close
tightly.
5.4 Collection of purified water sample for Bacterial Endotoxin Test (BET)
5.4.1 Use Depyrogenated glass container for collection of purified water sample.
5.4.2 Collect about 15ml purified water sample for BET.

Remark : (1) Send the sample within 1hr. to microbiology Lab for BET &
Microbiological test.
(2) After sampling it is recommended that, the water sample is keep at

2-8 C.

If analysis cannot be performed within 8 hours after sampling, the sample must be
kept at 2-8C.
The microbiological testing of a sample must be performed no later than 24 hours
after sampling and within the time limit test should be started.
5.5 Purified water frequency of testing
Location
Test to be carried out
UF Outlet
User End
Point

Chemical test, pH , Conductivity, TVC, TOC.

Total viable count , pH, Conductivity, TOC

Frequency
Daily
Once in a
week

Note : Complete analysis : As per specification

6.0 ABBREVIATIONS
C

= Degree centigrade

TVC = Total viable count

TOC = Total organic carbon
Q.C = Quality control department
Standard operating procedure of sampling of raw water and purified water for
chemical and microbiological analysis.

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1.0 OBJECTIVE:
To lay down the procedure for sampling and testing of Potable and purified
water for Microbiological and chemical analysis.

2.0 SCOPE:

This SOP shall be applicable to Microbiological and Chemical Section of Quality

Control.

3.0 RESPONSIBILITY:
Quality Control Chemist and Microbiologist.

4.0 ACCOUNTABILITY:
Sr. Manager Quality Assurance.

5.0 PROCEDURE:
5.1 Chemical Analysis:
5.1.1 Take a clean, dry conical flask (500 ml capacity) and plug it with cotton.
5.1.2 Take the flask to the sampling area.
5.1.3 Open the tap/valve of the sampling point and let the water flow for about 30
seconds.
5.1.4 Unplug the flask and rinse it with the running water.
5.1.5 Collect about 500 ml of the water sample in the flask.
5.1.6 Plug the flask immediately and label it, mentioning the sampling point and
date.
Related: Sampling, Preservation and Storage Procedure of Water Sample

5.2 Microbiological Analysis:

5.2.1 Take a clean, dry conical flask of 250 ml capacity and sterilize by autoclaving
at 15 lbs pressure (121 C) for 15 minutes.
5.2.2 Take the sterile, plugged flask to the sampling area.
5.2.3 Open the tap/valve of the sampling point and let the water flow for about 30
seconds.
5.2.4 Unplug the flask and collect about 250 ml of the water sample in the flask.
5.2.5 Plug the flask immediately and label it, mentioning the sampling point and
date.
5.2.6 Carry out microbiological analysis of the sample as per the specifications.

5.3 Purified Water:

5.3.1 Purified water shall be sampled from the following sampling points every day
for chemical analysis and once in a week (first working day of the week) for
microbial analysis.
i. D.M Water Storage Tank
ii. Manufacturing Area
iii. Washing Area
iv. Filling & Sealing Area

v. Granulation
vi. Coating Room
5.3.2 The sampling points of purified water in the production area are marked with
a Yellow colour for the ease of identification.
5.3.3 Purified water shall be analysed as per the available specifications.
5.3.4 The results shall be recorded in format. A copy of the report shall be sent to
the respective departments.
5.3.5 The limit of total microbial count of purified water shall be 100 cfu/ml. The
alert limit shall be 50 cfu/ml and the action limit shall be 75 cfu/ml.
5.3.6 In case the microbial count of a purified water sample exceeds the alert limit,
the maintenance department and the respective department shall be informed
immediately, in writing.

5.4 Raw Water:

5.4.1 Raw water shall be sampled once a month from the raw water storage
tank/raw water sampling point for chemical and microbiological analysis.
5.4.2 Raw water from any one of the following sampling points shall be collected
every month on rotational basis.
i. Manufacturing Area
ii. Washing Area
iii. Filling & Sealing Area
iv. Granulation
v. Coating Room
5.4.3 The sampling points of raw water in the production area are marked with
a green spot for ease of identification.
5.4.4 Raw water shall be analysed as per the specifications available.
5.4.5 The results shall be recorded in format.

6.0 ABBREVIATIONS:
6.1
6.2
6.3
6.4

SOP : Standard Operating Procedure

QA : Quality Assurance
QC : Quality Control
Dept. : Department