21.1.

2 Personnel

7. Organization chart

8. Qualification, experience & responsibilities of key personnel Name,

Designation & signature (send it in a chart)
Designation, Qualification, Experience & Responsibilitys of key persons:

Name Designation Qualification Experience Responsibility

Mr. S.R Rane Partner BAMS 36 years To take the overview of current market
status & new product in the market.
Select the product for marketing & plan
in accordance to upcoming demand of
the same product.
To control & maintain the finance
management of the organization

Mr. Sudeep Rane CEO/Production B.Sc. 16 years To generate the business for domestic
Manager market and to caters overseas buyers for
the export business online. To ensure
that the appropriate process validation
and calibrations of control equipments
are performed and recorded and the
reports made available. To ensure that
the required initial and continuing
training of production and packing
personnel. Handling of labors. Follow up
with loan license parties, purchase,
maintenance & quality control
department for their respective work.
Prepare weekly production planning.
Monitor day to day productivity.

Mr. Bhushan Bodade Production B. Pharm. 1.6 years To ensure that manufacturing and
Chemist packing is carried out as per S.O.P to
monitor production operations and
records in accordance with master card
dockets.

Mr. Lalit Beldar Production B.Sc. 1 Year As above

Chemist
Mrs. Komal Shinde QA Manager M.Tech To initiate actions to resolve non-
(Pharma) conformances. To authorize and
maintain adequate documents pertaining
to the activities for which she is
responsible. All quality assurance
activities. Vendor development activities
prepare master validation plan
preparation, issuing and reviewing of
SOP, BMR & Master Cards. As per master
validation plan work on prospective,
concurrent & retrospective validation
prepare annual product review. Prepare
documents & manuals for stability study,
quality, safety water system etc. Batch
manufacturing, Documentation, New
SOPs, BMR preparation, maintain the
area as per WHO-cGMP.

Mrs. Vaishali Badgujar QA Chemist B.Pharm 2 months Prepare documents & manuals for
stability study, quality, safety water
system etc. Batch manufacturing,
Documentation, New SOPs, BMR
preparation, maintain the area as per
WHO-cGMP.

Mrs. Mrunal Rane QC Manager M.Tech To control & authorize on the testing
(Pharma) activities of raw materials, packing
materials & finish good as per the STP &
SOPs & IPQC.
Ms. Archana Phegade QC Chemist B.Sc. 1.8 year To perform the testing of raw material,
packing material & finish good as per the
STP & SOPs.
Ms. Manisha Chavan QC Chemist M.Sc. 2 months As above

Mr. Rahul Mali QC Chemist B.Sc. To prepare and standardizes the solvents.

Ms. Yogita Mahajan Microbiologist M.Sc. Micro 1 year To study the growth and characteristics
of micro-organisms (viruses, bacteria,
fungi, paracites) and their interactions
with their environment & in the finish
 products & API with reference to STP
&SOP creating aseptic conditions for
working in micro lab. Conducting
experiments to isolate & grow cultures of
specific micro-organisms under
controlled conditions, observing,
identifying and classifying micro-
organisms.
Mr. Devendra Saitwal Store Incharge D.Pharm 3 years To maintain the stock of Raw/Packing
materials. To maintain the records of
Finish goods & records of
invoice/dispatch of finish goods. To verify
Raw/Packing materials and Finish goods.
To keep records of inwards for
Raw/Packing materials.

Mr. Sagar Patil Store Assistant B.Sc. As above

Chart:

2.0 PERSONNEL
CEO HR
SALES
& GM/ QA Manager
MARKETING
Store & Production QC
Accounts Manager Manager
Manager
Production QC Q
Chemist Chemist Che

ORGANOGRAM
Maintenance
 9.Outline of arrangement for training programs:

In-service Training and Method of Record Maintenance:

Training is the key area for updating the skills and cGMP practices of Team engaged in day today activities in
the manufacturing plant.
Training is given to new employees at the site. The CEO & QA managers identify training needs For the new
machineries, sanitation & cleanness training sessions are conducted by qualified trainers of the organization.
Training Evaluation is done through questionnaires.
Manager Q.A. compiles training records in the individual training files of employees. Training records
include attendance sheet, answers to questionnaires, evaluation and trainers Comments. Based on Trainers
assessment, re-training needs are identified.
CEO is responsible for identifying the training needs of the departmental heads & Departmental heads are
responsible for person working under them. Training programme is organized individually or in a group and is
based on the area of operation of the staff.

10. Health Requirements for Personnel engaged in Production (Process):

All persons engaged in production should be free from infections and communicable diseases. In order to
conform to the above requirement, the following precautions are taken Medical examination of all
employees is done at periodic intervals and not less than once annually, by a qualified Medical Practitioner.

11. Personnel Hygiene Requirement Including Clothing:

The following conditions for hygiene are mandatory of the workers engaged in manufacturing:
1. They have to bath daily and wear a fresh set of garments.
2. Nails are to be trimmed regularly.
3. The hair cut of the male worker is as per the military cut (Sikhs Excluded).
4. On reporting to work and before entering the manufacturing dept., they are required to change into their
work attire.
5. Hands are to be cleaned at regular interval using soaps. This is more essential after visiting the toilets.
The following facilities are made by the managements:
Separate Change room for male & female staff with toilet and wash room Protective clothing such as:
Aprons, working garments, face masks; Head covers Slippers, Plastic leg wear Gloves, head caps,
safety goggles, etc.

All garments are laundered every day.

Manufacturing facility is equipped with sufficient area for washing, outfit changing/locker, and
resting. It is required for every personnel to use own-area facility. All employees should change outfit
into locker room. They should wear company dress (Apron, Cap, Mask and Slippers). Then enter to
production area through corridor and proceed to their respective working areas. Employees should
follow the rule of entering before entering.
The employees are required to disinfect their hands first, using provided disinfectant before lay a hand
 on the garment. They should also pass through the air shower before entering into the manufacturing
area.

21.1.3 Premises
12. Site lay out of the manufacturing plan

Size of Industry: Small scale industry (SSI).

Location:
The manufacturing unit is situated at G-19, M.I.D.C, Jalgaon, M.S., India, 425 003. This is an industrial area
near the state highway & National Highway No.6.
Immediate Environment:
The surrounding of the manufacturing facility is away from polluting, Toxic & Hazardous industry or
output. The area is cleaned, neat well planted & eco friendly. There are more than well planned 30-35
huge trees along with 20-25 fruits fertile trees which will help to decorate the plat naturally with its
natural greenery.
Area Statement:
The land area is 20000 sq. feet factory has built up area 6000 sq. feet The connected power capacity is 67
HP. The storage area is well maintained and each manufacturing area is having dedicated HVAC system
For each operations Plant has capacity to produce 150 to 200 Ltr. of purified water per hour.
The raw water 4000 Ltr. Is stored in over head tank along with the continuous supply of raw water by
MIDC.

All the wash rooms are provided with ample of water supply and hand dryers in place.
The whole facility is well maintained at all times with adequate and prompt repairs and paintings and
servicing.
 Authorized qualified engineering drawing with describing all areas:

13. Brief description of ventilation system:

Area Type of Class Temperature RH Fresh Primary Secondary Final

Ventilation of air filter filter filter
air filter
Granulation HVAC 100 23 c 2 55 20 10 05 Terminal
3100 CFM 5 HEPA
0.3
Compression HVAC 100 23 c 2 55 20 10 05 Terminal
I 500 CFM 5 HEPA
0.3
Compression HVAC 100 23 c 2 55 20 10 05 Terminal
II 500 CFM 5 HEPA
0.3
Primary HVAC 100 23 c 2 55 20 10 05 Terminal
Packing I 5 HEPA
900 CFM 0.3

Primary HVAC 100 23 c 2 55 20 10 05 Terminal

 Packing II 5 HEPA
900 CFM 0.3
Primary HVAC 100 23 c 2 55 20 10 05 Terminal
Packing for 5 HEPA
granules 0.3
1000 CFM
Coating 1500 HVAC 100 23 c 2 55 20 10 05 Terminal
CFM 5 HEPA
0.3
Passage HVAC 100 23 c 2 55 20 10 05 Terminal
1000CFM 5 HEPA
0.3
Microbiology HVAC 100 23 c 2 55 20 10 05 Terminal
I 1000 CFM 5 HEPA
0.3
Microbiology HVAC 100 23 c 2 55 20 10 05 Terminal
II 800 CFM 5 HEPA
0.3

14. Brief description of water system:

Potable Water Making Process:
Potable water is obtained from MIDC supply. The water is injected with chlorine to prevent microorganism
growth. This raw water is pumped to the over head water storage tank.
Potable water is used as the source of purified water.
Purified Water making process:
Potable water is pumped & passed through the carbon & sand filter which reduces the CO2 . concentration &
dissolved solids contains So the conductivity of water is also reduced then this filtered water is pumped
using High Pressure Pump onto RO membrane by passing through 20 and 10 filter. this RO water is
stored in to a closed lid HDPE tank.
This RO water is then pumped to DM water plant the generate DM water is Passed through the UV light &
then stored in jacketed SS 316 tank in which the temperature of water is controlled thermostatically up to
110 C this tank is provided with the SS 316 pump which pushes the water in the SS pipeline with minimal
flow velocity which is functioned to create inside-pipe-turbulence in order to prevent bacterial growth
(bio-film) and circulated continuously inside piping structure designed & return the same water in above
tank which will create a close loop system for water handling.

Pipeline : it is designed & fabricated at the sight with considering the slope level, cleaning of pipeline Every
user point is equipped with zero dead leg diaphragm valve to avoid dead/unused point. Entire pipeline is
mirror finished & welded to become non porous & smooth. There are only two points where water is used.
Sanitation System: utilizes boiled purified-water until 100C and it is circulated in a specific period of time
based on validation data.
Piping and tank sanitation is implemented routinely based on validation data gathered.
Uses of Purified water: Cleaner of particular equipment, Water supply to Tablet production.

The quality control department is having their dedicated small RO water system & distillation assembly for
their daily use.

Schematic Diagram of Water system:

 15. Brief description on maintenance system:
To ensure that all equipments and machines perform effectively, the Maintains Department carries out
planned preventive maintenance.
Detailed procedures for preventive maintenance are available, which define the frequency of preventive
maintenance. The procedure includes a preventive maintenance checklist for each and every equipment
/machine. Records for preventive maintenance carried out are maintained.
If any equipment/machine is not available for preventive maintenance, or preventive maintenance cannot be
carried out for some reason or the other, an alternate date is scheduled and authorized by Utility-In charge.
Few equipments/machines are serviced by external agencies at agreed frequencies. Laboratory equipments
are put under annual service contract with outside agencies or as per the needs.
Records of preventive maintenance by the external agencies are also maintained and reviewed by
Manager -Quality Assurance.
If any equipment/machine needs servicing, the operator of the equipment reports to the Department officer
& the office intimate to the service Engineering Microbiological controls for environmental conditions like
Air, Water and also finished products.

16.Special area for handling of highly toxic, hazardous and sanitizing materials:
Sanitation of water treatment system are implemented based on validation data & periodically and result of
inspection data that conducted daily/ weekly and monthly, with refer to each requirement specification.
Data from validation and routine inspection are evaluated to define period of time sanitation.
Sanitation program for Water are grouped into potable Water Sanitation, Purified Water Sanitation.
Potable water sanitation use Chlorine that injected periodically accompany deep well pump running, dose

chlorine is based on result of routine inspection and requirement for Potable water (maximum Chlorine
compound in Potable water is 0.4 ppm)

Purified Water plant sanitation use Purified Water that heated up to 80 C in purified water tank and
circulation to all pipe line for 1-2 hour (depend on validation data) and afterwards the water is drained via
drain sanitary valve and all user point valve.
Frequency sanitation is based on Validation data and result of routine inspection and condition of Purified
water itself (if the parameter reach action limit, sanitation should be done immediately)

17.Cleaning procedures for manufacturing areas, equipment and machines:

Cleaning and Sanitation activities are done according to Sanitation SOP. These are combined together with
room cleaning and sanitation, machine cleaning and sanitation and processing tool cleaning and
sanitation. The activity begins with recapitulating room cleaning and sanitation master list and machine and
processing tools master list. Recapitulation is designed under consideration of cleaning method ,
sanitation material used, cleaning agent/ disinfectant, cleaning agent/ disinfectant changing frequency,
and inspection item (i.e. acceptance criteria, inspection/ examination frequency, person in charge of
validation implementation). Periphery of building is also daily cleaned. The walls, roof, gates and doors of
building are periodically maintained and cleaned.
Cleaning and Sanitation implementation method recorded in SOP is validated by QC s Microbiology
team.
The validation includes: measuring of residual active material, rinsing cleaning agent, microbiology content
and comparing the measurement to acceptance criteria of the above master list to ensure that sanitation
method is effective.

21.2. Production

3.Short description of manufacruring activities:

(Are product manufactured routinely or occasionally/Actually manufactured/ contract
manufacturing/loan license)

S.P.Pharmaceuticals
G-19,MIDC,Jalgaon,
M.S.India 425003.
On the above address we are holding the following drug manufacturing license as per the categories shown
against and as issued by the State Food & Drug Control Administration and WHO GMP certification, Maharashtra
State.
Facility is holding following licenses for pharmaceutical products classified under schedule other than schedule C
& schedule C1 of the Drugs and Cosmetics act 1940.
A) Manufacturing license no. NKD/36 in form 25 For Tablets & Granules
License to manufacture for sale, the drugs. Specified in schedule other than C & C1
(excluding those specified in schedule X)
Manufacturing license No. NKD/36
Form No. 25 Dated on 20-11-19996
valid up to 31-12-2016

B) Manufacturing license no. NKD/50 in form 28 For Tablets & Granules

License to manufacture for sale of drugs other than those specified in schedule
C & C1, and schedule X.
Manufacturing license No. NKD/50
Form No. 28 Dated on 18-01-2010
valid up to 17-01-2015
 8.Number of employees engaged in production, storage and distribution
(Pharmacist & others):

FDA Approved tablet manufacturing Chemist - 1 Post.

Production Assistant Production Chemist who is Holding the Bachelor Degree in
Pharmacy- 2 Post
Assistant Q.A. Chemist who is holding Bachelor/Master Degree in Pharmacy
Quality Assurance
2 Post
FDA Approved Chemist in Chemical & instrumentation 1 Post
Quality control Assistant Q.C Chemist who is Holding the Bachelor/Master Degree in
Pharmacy/chemistry 4 Post
1 FDA approved microbiologist
Micro biology
One who is holding the Master Degree in Microbiology 1 Post
Storage &
Account manager - 2
Distribution
Engineering support Maintains in charge having a vast experience in pharmaceuticals industry he
services is an ITI - 2 Post
Expert worker 15 experienced worker
Sweepers 8 daily wages
Security guards 1 contract service
Total No. of employees 30 ~ 35 employees

10. Brief description of equipment and machineries used in production

(Maintenance, Calibration & Validation):

Maintenance:
To ensure that all equipments and machines perform effectively, the Maintains Department carries out
planned preventive maintenance.
Detailed procedures for preventive maintenance are available, which define the frequency of preventive
maintenance. The procedure includes a preventive maintenance checklist for each and every equipment
/machine. Records for preventive maintenance carried out are maintained.
If any equipment/machine is not available for preventive maintenance, or preventive maintenance cannot be
carried out for some reason or the other, an alternate date is scheduled and authorized by Utility-In charge.
Few equipments/machines are serviced by external agencies at agreed frequencies. Laboratory equipments
are put under annual service contract with outside agencies or as per the needs.
Records of preventive maintenance by the external agencies are also maintained and reviewed by
Manager -Quality Assurance.
If any equipment/machine needs servicing, the operator of the equipment reports to the Department officer
& the office intimate to the service Engineering Microbiological controls for environmental conditions like
Air, Water and also finished products.

Calibration & Validation:

The validation performed by validation team, which includes the member from every related department,
i.e.: QC, QA, Production, Product Development & Maintenance Department.
Validation is conducted by in purpose to consistently yield qualified products which comply with the
defined specification.
To organize the activity of validation program, the validation team has designed a master plan
of validation (Validation Master Plan) as the guidance for validation implementation.
Coverage of Validation Master Plan:
1. Validation Team (holding responsible to conduct the validation program).

2. Matrix of Pre Validation.

3. Schedule of Pre Validation Program.
4. Matrix and Schedule of Validation.
5. List of Validation Protocol.
The purpose is to establish consistency in product quality through validated processes, using qualified
equipments in a facility that has been qualified to meet the designed specifications with respect to area and
environment. This is backed up by using validated support services and analytical methods.

The equipments are having pre-approved protocols subjected to DQ, IQ, OQ & PQ as per Operating , cleaning
& maintenance procedures are written down & approved. Maintenance Schedules are defined. Critical
Instruments attached to equipment are calibrated. Vendor of The equipment becomes a part of validation
team. Validation reports are reviewed and Concluded & finally signed off.

Equipment / Instrument Calibration Policy

List of laboratory equipments are calibrated as per the in- house calibration SOPS.
Some of the instruments like thermometer, standard weights & pressure gauges are calibrated by outside
agency or government testing house.
Method of calibration & frequency is defined for each laboratory equipment & critical instruments.
Out of calibration equipment/ instrument is reported immediately to QA Manager and concerned
department In-charge.
Destruction of replaced instrument is done immediately. Impact of out of calibration is assessed & actions
taken.
Calibrated equipments/ instruments are labeled. Date of calibration & next due is highlighted on the label.
Calibration records are maintained and kept with the manager quality assurance.
Validation
Validation process is differentiated in following categories:
1. Validation of Cleaning and Sanitation Procedure-
Validation of cleaning and sanitation procedure is conducted for to assure that the Procedure of cleaning
and sanitation for processing machine, equipment; in production areas including processing and packaging
area are consistently in line with the defined acceptance level for remainder active ingredient, detergent and
microbiology.
Cleaning validation of every cleaning procedure is performed after completion of every Batch.
2. Validation of Analytical Method-
Analytical method validation is validating by carrying out the analysis of 3 successive batches of the same

product. The testing parameters for analytical method validation are fixed as per the SOP of analytical
method validation.
Analytical method Validation is conducted for many products produced whose analytical method used has
not precisely complied with pharmacopoeia method.
3. Validation of Production Process-
Validation of production process is conducted at each steps of production process. Validation of production
process is also as to assure the consistency of the product manufacturing process.

11. Arrangement for the handling of starting materials, packaging materials,

bulk & finish products, including sampling, quarantine, release and storage:
Handling of Starting Materials, Packaging Materials, Bulk and Finished Product ,Raw Material Receiving
Step:
Upon receipt of the raw materials/packing materials, the material is unloaded on the receiving bay. The
material received is checked as per the specifications with the delivery note the details are logged in the
inward register Supplier s batch number and the quantities are cross verified. A Material receiving note is
prepared, immediately QUARANTINE LABEL enclosed on all containers and MRN forwarded to Quality control
department for sampling. Sampling is done by trained samplers as per the approved procedure.
Sampled containers are labeled with a Orange colored UNDER TEST LABEL along with the sampling
indication. The label indicates name of the material, batch number of the supplier, analytical report number,
date of manufacturing, date of expiry and the retest date. Analytical report number is assigned to each lot of
material received. The material is identified with this number. Samples are analyzed as per the approved
Specifications. If the sample complies with the approved specifications, An APPROVED LABEL in green
colored is pasted and if it does not meet the specifications, REJECTED red colored label is pasted on the
containers.
Sampling plan and quantity to be sampled are defined in the sampling procedure.
Approved materials are transferred from under test to the approved area and the rejected materials are
moved to secure rejected material area.
Weighing:
Materials are issued by stores on receipt of authorized raw material / packing material requisition sheet,
which is a Controlled document and approved by Manager Quality Assurance or his authorized chemist.
Dispensing is done in dispensing area through calibrated balance. For identification purpose, Weight ticket is
attached on every container of weighing result.
Q.A. supervisor confirms the correctness, quantity and criteria of weighed material of all weighing result.
Production Process :
Line clearance procedures are followed for all manufacturing and packing operations. Identity of materials at
processing stage is confirmed by reading dispensing labels. Weights are counter checked. The dispensed raw
materials are processed as per the instructions defined in the product specific batch manufacturing record.
Processing activity is implemented according to process stage flow of each type of product and BMR
documentation. BMR documentation contains the steps of process implementation that should be done.
In Process Inspection:
In-process control/ tests are carried out as per the frequency and procedure defined in product specific batch
records. In-process checks are conducted by Production and the Quality assurance, independently at defined
intervals.

QC department is responsible for testing and releasing implementation in production process according to
process flow of inspection plan. Testing and releasing implementation is guided by stipulated receiving
parameter.

Finished product:
Intermediate products are analyzed and approved by the Quality control prior to the packing operation. The
finished product is transferred to the finished product quarantine area. The goods are released for dispatch
after the completion of the finished product analysis and the review of the batch documents and the
analytical reports by Quality assurance. Products released by Quality Assurance are transferred to the
approved finished product storage area for dispatch.

12. Arrangement for reprocessing or rework:

The batches of drug products or intermediates or in process material that are rejected or that
does not conform to a standard or specification. Then QC department are reviewed to determine
whether they can be reprocessed/reworked to bring back for compliance with the specifications.

To make a decision, discussion will be held among the Head of QC, Head of Production and Head of QA
department.

If the decision is to reprocess or rework the material, the same will be communicated to the Incharge of
the block, after duly signed by the Head of Production and Head of QC department along with a copy of
analytical report.

The method of reprocessing or reworking will be given by the Head of QA.

The reprocessed or reworked material will be given the same batch No. with suffix R, R1......, for 1st &
2nd.... respectively and then sampled and tested by QC department. After approval from QC
 department, the reprocessed or reworked material will be treated as a fresh batch.
The reprocessing or reworking and testing have to be completed within a month after rejection.
The first batch of the reprocessed or reworked material shall be kept for accelerated or long-term
stability studies.

If there is any change in the method of reprocessing or reworking then also the first batch of the
changed method shall be kept for accelerated or long-term stability studies.

13. Arrangement of the handling of rejected materials and product:

Rejected product or material is identified clearly and place in separate location to prevent unwanted/
accidental usage. If the material/ product are to be destroyed, destroying program note is made and the data
is kept in material record or in BMR-for-product document.
Procedures for control of non-conforming products have been evolved, covering raw materials, packing
materials, intermediates and finished products.
If raw material is not conforming to the specifications, it is labeled rejected and is isolated. It is sent back to
the vendor.
If printed packing material is rejected, it is isolated and destroyed at the site in the presence authorized
persons. A record of the destroyed material is maintained.
If any intermediate or finished product is found to be non-conforming, it is isolated and marked with the
appropriate label. It is then referred to the Asst. Manager- Quality Assurance, who investigates the
problem.
The matter is referred to corporate technical team for action.
Corrective action could be either -
Help of Formulation and development department is sought to provide the reprocessing procedure. Batch is
reprocessed and kept under stability studies. Before reprocessing any product, necessary approval shall be
taken from the customer.
Details of any non-conforming products and any corrective action taken are recorded and a record is
maintained.

14. Brief description of general policy for process validation:

General Policy for Validation Process:

Validation activity for product is divided into 3 (three) stages/ steps, which are:
- Prospective,
- Concurrent and
- Retrospective validation.

Prospective Validation:
The Prospective Validation is conducted during implementation of first of 3 full scale of commercial batches
(based on validation BMR as the result of trial and developing formulation by PD department).
Prospective validation conducted for 3 continuous batches where the validation result comply all
requirements (In house, USP, BP and IP Standards) and satisfactory. The first 3 (three) validated batches
will then be used for the next BMR arrangement.
Concurrent Validation:
Concurrent validation conducted once in period of 1 year (latest) after prospective validation conducted, or if
the product has not been produced in one year, concurrent validation will be conducted on the next
production. Concurrent validation conducted complying with the prospective validated BMR.
Retrospective Validation:
Retrospective Validation conducted only for existed (well-established) product, carry out by collecting
historical data of the processing and packaging batch (BMR), the maintenance, the personnel/personnel
rotation, stability trend, including out of specification batch.
We have defined to collect 10(ten) data point for retrospective validation, which are collected from batch
#10 to Batch #20 (continuously).
Revalidation Policy:
One batch of each product every year.
Qualified equipment undergoes major modification, replacement of Critical spares that shall affect
equipment performance.
Location of equipment is changed.
Facility modification.
Modification/ Change in support services.
Change of cleaning agent/ method.
Process/ Formula Change.
Change of any critical equipment in the chain of equipments used for Product Manufacturing.
Change in analytical method etc.
Based on sufficient trend data, the process/ specification parameters are reviewed and tightened.

21.3. Quality Control & Assurance:

Responsible persons name, designation, Qualification and experience:

1. Number of specialized personnel in Quality Control & Assurance

(Pharmacist, Chemist, Others)