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A Review on Qualification of Auto clave, RMG,


FBD, Cone blender, Tablet compression
machine.

Article · January 2014

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Journal of Global Trends in Pharmaceutical Sciences

Review Article
Available online at www.JGTPS.com

ISSN: 2230-7346
Journal of Global Trends in Pharmaceutical Sciences
Volume 5, Issue 1, pp-1450-1459, January-March 2014
A REVIEW ON QUALIFICATION OF AUTOCLAVE, RMG, FBD, CONE BLENDER,
TABLET COMPRESSION MACHINE
B.Venkateswara Reddy*1, ABSTRACT
B.Rasmitha Reddy1,
K.Navaneetha1, Validation is one of the important steps in achieving and
maintaining the quality of the final product batch after batch. Without
K.Venkata Ramana Reddy2
equipment, we cannot manufacture a product. If equipment is validated,
1 we can ensure that our product is of the best quality. Validation of the
St.pauls College of Pharmacy,
equipment is called the Qualification. To manufacture different types of
Turkayamjal, R.R (Dist) -501510 dosage forms, different equipments are used. Here, this article
2
Sree Datta Institute of concentrates on the equipment qualification for RMG, FBD, and
Pharmaceutical sciences, Blender & Compression Machine. It gives in detail, qualification
Sheriguda, R.R (Dist)-501510 steps of the equipment which is used for manufacturing process
through wet granulation
E-mail: basu.pharmacist@gmail.com
Keywords: Validation, Equipment Qualification, RMG, FBD, Blender
Journal of Global Trends in & Compression Machines.
Pharmaceutical Sciences
INTRODUCTION: been made mandatory by the regulatory bodies
In manufacturing facilities, validation to prove the safety, efficacy, purity &
test procedures are used to validate equipment effectiveness of the drug product, medical
and processes that may influence product devices & biologics in the market place &
quality. The tests for validation are used in health system.
accordance with approved written qualification IMPORTANCE OF VALIDATION
procedures. All necessary activities and  Increased throughput
responsibilities for the qualification and  Reduction in rejections and reworking
validation are controlled and specified in this  Reduction in utility costs
Validation Master Plan. Every step of the  Avoidance of capital expenditures
described validation program for facilities,  Fewer complaints about process-related
equipment, processes, process controls, and failures
cleaning is in accordance with the current  Reduced testing in-process and in finished
European Community Guidelines for GMP and goods
FDA, and the cGMP guideline for finished
 More rapid and reliable start-up of new
pharmaceutical manufacturers
equipment
DEFINITION:
 Easier scale-up from development work
Validation may be defined as
 Easier maintenance of equipment
“Establishing documented evidence which
provides a high degree of assurance that a  Improved employee awareness of
specific process will consistently produce a processes
product meeting its pre-determined  More rapid automation
specifications and quality attributes.” It has EQUIPMENT QUALIFICATION
Qualification: Action of proving and
Address for correspondence documenting that equipment or ancillary
B. Venkateswara Reddy* systems are properly installed, work
St.pauls College of Pharmacy, correctly, and actually lead to the expected
Turkayamjal, R.R (Dist) -501510 results. Qualification is part of validation, but
B. Venkateswara Reddy et al/JGTPS/Volume 5, Issue 1, January-March 2014
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Journal of Global Trends in Pharmaceutical Sciences

the individual qualification steps alone do not Operational Qualification (OQ):


constitute process validation. "Operational qualification (OQ) is the
1. Design Qualification (DQ) process of demonstrating that an instrument will
2. Installation Qualification (IQ) function according to its operational
3. Operational Qualification (OQ) specification in the selected environment”. The
4. Performance Qualification (PQ) proper operation of equipment is verified by
5. Maintenance Qualification (MQ) performing the test functions specified in the
Who should do Equipment Validation? : protocol. A conclusion is drawn regarding the
The vendor or the user has the ultimate operation of equipment after the test functions
responsibility for the accuracy of the analysis are checked and all data has been analyzed.
results and also for equipment qualification. DQ Following are the contents of equipment
should always be done by the user. While IQ for operation qualification: 1. Application S.O.P’s,
a small and low cost instrument is usually done 2. Utilization List, 3. Process Description, 4.
by the user, IQ for large, complex and high cost Test Instrument Utilized To Conduct Test, 5.
instruments should be done by the vendor. OQ Test Instrument Calibration, 6. Critical
can be done by either the user or the vendor. PQ Parameters, 7. Test Function (List), 8. Test
should always be done by the user because it is Function Summaries.
very application specific, and the vendor may Performance Qualification (PQ):
not be familiar with these. As PQ should be "Performance Qualification (PQ) is the
done on a daily basis, this practically limits this process of demonstrating that an instrument
task to the user. consistently performs according to a
Design Qualification (DQ): specification appropriate for its routine use ".
"Design qualification (DQ) defines the PQ should always be performed under
functional and operational specifications of the conditions that are similar to routine sample
instrument and details for the conscious analysis. PQ should be performed on a daily
decisions in the selection of the supplier". The basis or whenever the equipment is being used.
steps that should be considered for inclusion in In practice, PQ can mean system suitability
a design qualification. Description of the testing, where critical key system performance
analysis problem, Description of the intended characteristics are measured and compared with
use of the equipment, Description of the documented.
intended environment, RAPID MIXER GRANUALATOR
Preliminary selection of the functional and 1. Homogenous mixing of dry & wet
performance specifications, Preliminary powders, deaglomeration of wet mass
selection of the supplier, Final selection of the and fast dispersion of binding agent.
equipment, Final selection of the supplier, 2. Dust free, high free flowing dosing
Development and documentation of final particles, high uniformity of granule size.
functional and operational specifications, 3. Frequency control for bottom driven
Impeller Mixer with 3 or 4 blades with
Installation Qualification (IQ): exclusive scrape side design and Chopper
“Installation qualification establishes positioned to make granules.
that the instrument is received as designed and
specified, that it is properly installed in the Installation Qualification:
selected environment, and that this environment • An IQ establishes confidence that the
is suitable for the operation and use of the equipment is properly installed. The
instrument.” The qualification involves the installation must meet the manufacturer's
coordinated efforts of – The vendor. The specified guidelines, along with design changes
operating department. The project team (which at installation. Also the supporting electrical
provide input into the purchase, installation, utilities must meet all electrical codes.
operation and maintenance of the equipment).

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Journal of Global Trends in Pharmaceutical Sciences

 Equipment control functions:


 Impeller, timer, bowl on/off & slow/fast
buttons.
 Emergency, discharge port on/off
 Alarm, wash down walls on/off
Equipment operation:
 On empty the impeller should run at low
speed and also check direction and speed.
Performance Qualification:
By using placebo max/min conditions are
verified
FLUIDIZED BED DRYER
Figure 4: Rapid mixer granulator Design Qualification:
Equipment identification:  In FBD, the fluidizing air stream is
 Record the equipment identification introduced by a fan or blower. The air is
number, with equipment manufacturer, heated to the required temperature in an
purchase order, model number, and air heater and flows upward through
equipment number. the wet materials, which contained in a
Required Documentation: drying chamber fitted with a wire mesh
The manufacturers operation and maintenance supported at the bottom.
manual and SOPs that cover the set up.  Capacity : 5-200kg
 Utility requirements  Drying time: 20 to 40 min
 Power
 Water
 Compressed air, spraying, impeller
movement, pneumatic discharge port.
Calibration Requirements:
 Ammeter
 Voltmeter
 Water pressure gauge
 Air pressure gauge
 Equipment major specifications:
 Mixing bowl material of contact, surface
finishing, dimensions, capacity.
 Motors two are required Figure 5: Fluidized bed dryer
 Discharge port Installation Qualification
 Lid • An IQ establishes confidence that the
 Liquid air dispersing system equipment is properly installed. The installation
 Nozzle must meet the manufacturer's specified
 Components coming in contact with guidelines, along with design changes at
product installation. Also the supporting electrical
 Lubrication/ filter utilities must meet all electrical codes.
 Verify approved purchase order.
Equipment Safety Features:  Verify invoice.
 Emergency stop button, barrier guard,  Check manufacturer and supplier.
electrical inter locking system, alarms  Verify model number and serial number.
Control Functions:  Check for any physical damage.
 Regulators, discharge port opening,  Confirm location and installation
spraying button Operational Qualification: requirements per recommendation of
 Calibration requirements for temp, timer, manufacturer.
pressure gauges, ammeter.
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Journal of Global Trends in Pharmaceutical Sciences

 Verify that the utilities required are Delay time for achieving constant air
available. conditions
 Installation shall be conducted per
instructions provided in the manual. Procedure
 Ensure that all relevant documentation is Determine, by use of a thermocouple and a
received: hygrometer, the necessary delay time required
 User manual at an adjusted inlet air temperature (in relation
 Maintenance manual to granulating processes) for reaching
 List of change parts constant air conditions. Determine these
figures for first use of the equipment at the
 Electrical drawings
Instruments for measuring temperature, working day, as well as for further use of the
humidity, time, air volume and pressure, as equipment at the same working day.
well as recording devices for these variables, Also calculate from the obtained data the water
should be calibrated. content of the inlet air (g water/kg air) and
Air temperature distribution Place compare to the requirements.
several thermocouples at different locations in Equipment identification:
an empty fluid bed drier, e.g.: Record the
Equipment identification number
 Inlet air channel below product container
Equipment manufacturer
mesh bottom
Purchase order
 Product container
Model number
 Below filter bag Equipment number
 Above filter bag
 Exhaust air channel Required documentation:
Measure the temperatures, letting in air of a The manufacturers operation and maintenance
constant temperature (e.g., 60°C). manual and SOPs that cover the set up.
Inlet air installation
Equipment Utility Requirements:
Delay time for achieving constant air  Compare the manufacturer's specified
conditions Determine, by use of a requirements to their as found conditions
thermocouple and hygrometer, the necessary at the time of qualification testing.
delay time required at an adjusted inlet air  Power
temperature (in relation to drying processes)
 Steam
for reaching constant air conditions. Determine
 Compressed air
these figures for the first use of the equipment
 Calibration
at the working day, as well as for further use of
the equipment at the same working day.  Ammeter
Also calculate from the obtained data the water  Air/ water
content of the inlet air (g water per kg air) and  Pressure gauge
compare with the previously fixed  Temperature gauge
requirements.  Major component specifications:
Microbiological quality of the inlet air  Motor
Determine, by use of a bio test RCS centrifugal  Fan: mfg, location, no of blades, rotation,
air sampler, the microbiological quality of the capacity
inlet air.  Ducting systems : material, type,
Sampling time 5 min = 8:1 air welding, type of welding, no of weld
Requirements spots
200 CFU/m inlet air  Heater: voltage/ capacity
Influence of weather on inlet air conditions  Air heaters: coils
Inlet air installation  Product container: housing, material, type
of discharge port.

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Journal of Global Trends in Pharmaceutical Sciences
Equipment Safety Features: 2. Air flow
 Barrier guard, alarm, emergency stop 3. High temp
button, interlock with housing, positive 4. Filter test
pressure differential with flow regulators 5. feeding inlet/outlet
for fluid air regulation 6. air volume
 Positive high temperature alarm device 7. damper control
 Control functions: 8. humidity control
 Process control like temperature, timer 9. drying time
on/off bath, product discharge port All these parameters are recorded before
buttons, filter bag, cleaning button operation
Operational Qualification Performance Qualification
An OQ evaluation should establish that the  After the equipment proper installation it's
equipment can operate within specified functioning and operating parameters must
tolerances and limits. be verified.
 Verify alarm control.  Calibrated equipment like hydrometer,
 Perform calibration requirements, temp probes, air flow monitors are
identified in the manual or established by required.
the validation team.  Using placebos the PQ is verified
 Operate the equipment at low, medium,  The drying cycle parameters are fed charge
and high speed per operations manual to at min& max load.
verify the operating control. As drying proceeds check temp, RH,
 Verify that all switches and push buttons fluidization pressure, differential air pressure
are functioning properly. parameters, after drying timer is set back to
 Establish procedures for operation, “O” to stop.
maintenance, and calibration. All these parameters are recorded before
 Establish training program for relevant operation.
staff. After drying the product check weight and also
Procedure sampling is done at varied time and location.
Run three batches of each product and analyze
for: Test Functions
1. Perform Installation Qualification. Verify
 Active ingredient homogeneity
equipment identification, required
 Moisture content
documents, utilities, manual, and drawings.
 Particle size distribution 2. Perform general operational controls
 Percentage fines verification testing. pressure, timer
 Tap density operations, circulation air flow, exhaust
Based on these data try to fix a drying end Verify calibration requirements.
point of the process (e.g., correlation between 3. Operate system throughout the range of
moisture content of the product and the product operating design specifications or range of
bed temperature). intended use. Verify switches and push-
Calibration requirements: buttons, open-door leaks, differential air
 All the critical instruments on the flow, and high-temperature limit.
equipment must be calibrated with 4. Verify that all safety devices are operating
calibration procedures. The equipment’s as specified in the manual.
calibrated are temperature probes, pressure 5. Verify that recommended lubricants are
gauges for air/steam, timer, air flow rate used during machine operation.
and volume. 6. Perform controller security challenges to
 Equipment control functions verify that specified parameters cannot
 In this the ON/Off switches and discharge be altered without appropriate supervisory
port are verified and also the LED buttons. control.
Equipment Operation: 7. Perform studies to check the moisture
1. Drying cycle removal on each product as per SOP.
B. Venkateswara Reddy et al/JGTPS/Volume 5, Issue 1, January-March 2014
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Journal of Global Trends in Pharmaceutical Sciences

8. Perform the study for establishing the  User manual


drying time as per acceptable moisture  Maintenance manual
level.  List of change parts
Acceptance Criteria  Electrical drawings
1. The system is installed in accordance  Mechanical drawings
with design specifications, manufacturer Calibration of the control and recording
recommendations, and cGMPs. equipment:
Instruments are calibrated, identified, and Instruments for measuring temperature,
entered into the calibration program. pressure, time, mixing chamber slope, and
2. General alarms and controls operate in mixing velocity, as well as recording devices
accordance with design specifications. for these variables, should be calibrated.
3. The system operates in accordance with Operational Qualification:
design specifications throughout the  Verify alarm control.
operating range or range of intended use.
 Perform calibration requirements,
4. The safety devices operate as specified in identified in the manual or established by
the manual.
the validation team.
5. The quality of lubricants is adequate, and
 Operate the equipment at low, medium,
their storage is dry and cool.
and high speed per operations manual to
6. Unauthorized changes to cycle parameters
verify the operating control.
must not be allowed without supervisory
 Verify that all switches and push buttons
control or password.
are functioning properly.
7. The moisture level should meet
specifications.  Establish procedures for operation,
maintenance, and calibration.
VALIDATION OF CONE BLENDER  Establish training program for relevant
staff.
Net capacity of the mixing chamber:
Procedure
Fill the mixing chamber with reweighed
quantities of water. The available net capacity
should be equal to the supplier specification.
Mixing or stirring velocity:
Measure velocity three times at low, medium,
and high speed and compare the average and
deviation from the average of the single
measurements with the supplier specification.
Figure 6: Cone blender Requirements
Installation Qualification: Compliance with the supplier specification
 Verify approved purchase order.
 Verify invoice. Performance Qualification:
 Check manufacturer and supplier. Product homogeneity:
 Verify model number and serial number.
 Check for any physical damage. Mixing process:
 Confirm location and installation Procedure:
requirements per recommendation of Fix the mixing or stirring velocity, load
manufacturer. the mixer with the product and switch the
 Verify that the required utilities are mixer on. After previously fixed intervals, the
available. mixer should be switched off and samples
 Installation shall be conducted per the should be taken from different locations of the
instructions provided in the manual. product surface. The samples should be
 Ensure that all relevant documentation is analyzed for their active content.
received:

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Journal of Global Trends in Pharmaceutical Sciences

Unloading: VALIDATION OF TABLET


Procedure: After determination of the COMPRESSION MACHINE
suitable mixing time to achieve product A 45-STATION TABLET PRESS
homogeneity, the influence of the unloading The press is automatic, high speed
process on the homogeneity should be rotary press. A motor drives the press at speeds
evaluated. Samples should be taken and sent to that vary from 410 to 1630 tablets per minute
QC for analysis. (rpm). The material being tableted is fed from a
Requirements: hopper by gravity through the feed frame into
Homogeneity should remain consistent. dies. Regulating the weight adjusting cam
Water content of the product: controls the weight of material in each tablet
Take samples of the product prior to can be adjusted.
mixing, after mixing, and after unloading
(begin, mid, end). Determine the water content
of all samples.

Test Functions
1. Perform Installation Qualification. Verify
equipment identification, required Figure 7: Components of tableting equipment
documents, utilities, manual, and drawings.
2. Verify components material. Installation Qualification:
3. Verify equipment safety features.
4. Operate the blender throughout the range
of operating design specifications or range
of intended use direction, and motor fixed
speed.
5. Verify equipment switches, push-buttons,
and rotation
6. Perform the assay to check the content Figure 8: IQ elements of a tablet press
uniformity on blended granules at different
locations. The supporting electrical utilities must meet all
electrical codes.
Acceptance Criteria: The information required for an IQ
1. The system is installed in accordance evaluation is equipment identification,
with design specifications, manufacturer required documentation, equipment utility
recommendations, and cGMPs. requirements, major component
Instruments are calibrated, identified, and specifications, component material, lubricants
entered into the calibration program. and equipment safety features.
2. General alarms and controls operate in
accordance with design specifications. Equipment Identification:
3. The system operates in accordance with Record the equipment identification numbers,
design specifications throughout the along with the following information:
operating range or range of intended use.  Model number
4. The safety devices operate as specified in  Serial number
the manual.  Company assigned equipment number and
5. The quality of lubricants is adequate and  Location of the equipment
the lubricants are properly stored.
6. Unauthorized changes to cycle parameters Required Documentation:
are not allowed without supervisory Record the equipment manufacturer's operation
control or password. and maintenance manual and drawings. Record
7. Assay results should be within the the SOP that cover the setup, operation and
specifications. cleaning of the tablet press.

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Journal of Global Trends in Pharmaceutical Sciences

Equipment Utility Requirements: The objective of testing equipment control


Compare the manufacturer's specified volts functions is to verify that the switches and push
(V) and amps (A) requirements to their as- buttons on the tablet press operate per the
found conditions at the time of qualification manufacturer's specifications. The tests will be
testing and record. Also record the location of performed with the tablet press empty. Operate
the power supply source. each control and verify its proper position.
Major Component Specifications: Equipment Operation:
The component specifications section of A) Cam Tracks Test
the protocol verifies that the tablet press The objective of the cam track test is to verify
components purchased were delivered and that the upper and lower cam tracks make
installed. contact with the upper punches according to the
Component material: manufacturer's specification. Use the following
Record the material of each component procedure and record the results.
that contacts the product.  Install the punches and verify that the cams
Lubricants: are contacting the punch head angles on
Record the lubricants used to operate the both the sides of the double-sided
the tablet press and indicate if they make cams.
contact with the product.  Verify that the punches are contacting one
Equipment Safety Features: side of the single-sided came through a full
The objective of testing equipment cam track, upper and lower.
safety features is to verify that the safety
features on the tablet press function B) Upper Punch Test
according to the manufacturer's The objective of the upper punch test is
specifications. This test is performed with the to verify that the upper punch penetration is
tablet press empty. Verify that all of the guards according to the manufacturer's specification. A
are present and record the results. verniercaliper is required for this test, which is
Operational Qualification: performed as follows:
An OQ evaluation should establish that  Attach a piece of tape to mark the depth of
the equipment can operate within specified penetration of an upper punch when it is
tolerances and limits. The mechanical ranges set to a standard depth.
of the tablet press are challenged, along with  Remove the upper punch and use a
the basic tablet press operations. The tablet calibrated vernier caliper to measure the
press will be validated for its operating ability, depth of penetration into the die. Record
not how well it makes tablets. Information the results and instrument used to measure
required for the OQ evaluation is: calibration of the depth.
the instruments used to control the tablet C) Lower Punch Test
press, equipment control functions (switches The objective of the lower punch test is
and push buttons) and equipment operation to verify that the lower punch height is set
(cam tracks, upper punches, lower punches, according to the manufacturer's specification. A
feed frames, take off bars, rotor head direction, dial indicator test is required. Measure the
tablet press speed). height of the lower punch above the die with a
Calibration requirements dial indicator and record the results and the
Verify that all the critical instruments instrument used to measure the height.
on the equipment have been logged into the D) Feed Frame Test
calibration system, have calibration The objective of the feed frame test is to
procedures in place and are in calibration verify that the feed frame distance above the
at the time of qualification testing. Record all rotor head is according to the manufacturer's
information for calibrated instruments used to specification. Feeler gauge test: Measure the
control the tablet press. clearance between the feed frame and the motor
head with a feeler gauge and record the results
Equipment Control Functions and the instrument used to measure the
clearance.
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1457
E) Take Off Bar Test The materials and instruments
The objective of the take-off bar test is required for this test are a placebo and a
to verify that the take-off bars do not make weight, hardness, and thickness gauge.
contact with the lower punches. Turn the tablet Compress tablets using placebo
press by hand and verify that the takeoff bars granulation. Record the placebo used. Obtain
do not make contact with the lower punches. the average weight and hardness of 5 tablets at
Record the results. start up, 10, 20 and 30 min and record the
results and the instrument used to measure the
F) Tablet Press Rotation Direction weight and hardness.
The objective of the rotation direction
test is to verify that the rotor head rotates in the Test Functions:
proper direction. The tests will be performed 1. Perform Installation Qualification.
with the tablet press empty. Press the start 2. Perform general operational controls
switch and observe the direction of the rotation verification testing.
of the rotor head as viewed from front of the 3. Operate system throughout the range of
press and record the results. operating design specifications or range of
intended use.
G) Tablet Press Speed 4. Verify that all safety devices of the tablet
The objective of the speed test is to press are operating as specified in the
verify that the measured speeds are within ± 10 manual.
% of the manufacturer's specification of a 5. Verify that recommended lubricants are
minimum of 9 rpm and a maximum of 36 rpm. used during machine operation.
This test will be performed with the press 6. Perform controller security challenges to
empty. A stop watch is required for this test. verify that specified parameters cannot
Measure the speed of the rotor head with a be altered without appropriate
calibrated stopwatch. Verify that the measured supervisory control.
speeds are within ± 10 % of the manufacturer's 7. Perform capability and consistency studies
specification and record the results and the to check the weight variation of each
instrument used to measure the speed. product as per SOP.
Acceptance Criteria:
Performance Qualification: 1. The system is installed in accordance with
Once the equipment is properly design specifications, manufacturer
installed and functioning within is properly recommendations, and cGMPs.
installed and functioning within specified Instruments are calibrated, identified, and
operating parameters, it must be shown that the entered into the calibration program.
tablet press can operate reliably under routine, 2. General controls and alarms operate in
minimum and maximum operating conditions. accordance with design specifications.
3. The system operates in accordance with
design specifications throughout the
operating range or range of intended use.
4. The safety devices must operate as
specified in the manual.
5. The recommended lubricants must be used
as specified in the manual.
6. The storage location of the lubricants must
be according to manufacturer
recommendations.
Figure 10: PQ elements of a tablet press. 7. Unauthorized changes to cycle parameters
must not be allowed without supervisory
The objective of the weight and hardness test is control or password.
to verify that tablet weight and hardness can be 8. The machine must be in statistical control
maintained consistently throughout the entire as per capability and consistency studies.
weight and hardness setting range.
B. Venkateswara Reddy et al/JGTPS/Volume 5, Issue 1, January-March 2014
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Journal of Global Trends in Pharmaceutical Sciences
CONCLUSION Compliance in the Pharmaceutical
Allot extra time for validation. It Medical Device and Biotech Industry,
always takes longer than we think, particularly CRC press, Florida; 2001
with a new installation. All phases of validation 3) http://www.validation-online.net/process-
successfully completed and final report signed qualification.html
off. Review overall validation process and 4) h t t p : / / www . a n a l y t i k -jena.com
deviations to determine how process could be 5) http://www.chem.agilent.com/Library/ser
handled better in the future. The important vice/Public/Review%20Document_Stand
points are: Carefully write protocols and ard_EQP_LCMS_01.71.pdf
acceptance criteria, try to anticipate 6) http://www.askaboutvalidation.com/foru
problems or issues in advance. Coordination m/showthread.php?1410-Cleaning
with other ongoing activities to ensure validation-quot-Fuid-bed-dryer-quot
required resources will be available when 7) http://xlerator-
needed. Coordination with vendors. Unless handdryer.com/category/fluid-bed-dryer/
equipment qualification has not already been 8) www.validationonline.net
legally mandated today, in the near future it 9) http://www.dipharma.com/Tousey_904T
will have overriding importance, primarily in C.pdf
the pharmaceutical industry and in the food and 10) http://www.labcompliance.com/seminars/
cosmetics sectors. The main goal in qualifying audio155/default.aspx
laboratory equipment is to ensure the validity 11) http://www.ksdp.co.in/cts/tender/d_toolin
of data. The current equipment qualification g_table_compression_machine.pdf
programs and procedures used within the 12) Phil cloud, Pharmaceutical equipment
pharmaceutical industry are based on validation-The ultimate qualification
regulatory requirements, voluntary standards, guidebook, Interpharm/CRC press,
vendor practices, and industry practices. The Florida; 1998
result is considerable variation in the way 13) 13.James P.Agalloco, Frederick
pharmaceutical companies approach the J.Carleton, Validation of Pharmaceutical
qualification of laboratory equipment and the Processes, Third edition, Informal
way they interpret the often vague Healthcare, New York;2007
requirements. 14) Kenneth W. Sigvardson, Joseph A.
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Standard Operating Procedures - A 16) http://www.laboratoryequipment.com
Step-by-Step Guide for Achieving 17) http://www.hachange.pt/countrysite

B. Venkateswara Reddy et al/JGTPS/Volume 5, Issue 1, January-March 2014


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