Vendor Qualification SOP

Vendor Qualification SOP         

To provide a procedure for identification, selection, evaluation and qualification of Raw Material (Active and Inactive) and Primary / Printed  Packaging material vendors.

Responsibility of Vendor Qualification SOP     :    

Head-SCM  for identification and selection of Vendor.

Head – Quality Control for testing of samples.

Head – R&D for taking trial of product batches.

Head – Quality Assurance/Head-Compliance for evaluation and qualification of Vendor.


Identification of Vendor :         

Identify vendor(s) for each raw material and primary/printed packaging material.

Selection of Vendor :    

Selection of Vendor shall be made after evaluating the following factors.

The Vendor’s capability to supply the required quality of material.

The Vendor’s capability to supply the required quantity.

Reputation and reliability of the Vendor.

Whether  Vendor is a DMF holder/inspected by Regulatory agencies/ISO.

The Vendor’s capability to expand to the increased need, if any.

Whether the vendor is the manufacturer or distributor.

Evaluation and Qualification :

Vendor of each material shall meet the following relevant qualification criteria before commercialisation of drug product using the material.

Raw materials :             

Three separate lots from the vendor satisfactorily tested and approved as per specifications.

Certification of the vendor based on any of the following.

Satisfactory on-site inspection (For specimen checklist refer Annexure-1).

Certification by officially accredited body.

Self assesment by the vendor.

Primary / Printed Packaging Materials : 

One lot  from the vendor satisfactorily tested and approved as per specifications.

Certification of the vendor based on any of the following.

Satisfactory on-site inspection (For specimen checklist refer Annexure-2).

Certification by officially accredited body.

Self assesment by the vendor.

Note :   With one lot testing, vendor of raw materials and primary / printed packaging materials may be ‘provisionally qualified’ for use in non commercial  batches.

Requalification of Vendor :     

Vendor shall be requalified periodically in the following manner.

Complete testing of one lot of material at frequency specified in SOP ‘Reduced testing procedure’.

Recertifiation through the procedure outlined as per following schedule.

Active Raw material : Once in two years

Inactive Raw material : Once in four years

Primary / printed packaging material: Once in four years

Qualification of Alternate vendor :    

Qualification of alternate vendor shall be initiated through change request notice.

CRN shall be circulated to R&D, QC, IRA, QA, SCM and other concerned departments.

Forms and Records (Annexures)

Raw Material Vendor Audit Checklist – Annexure 1.

Packaging Material Vendor Audit Checklist – Annexure 2.


Master copy –  Quality Assurance

Controlled copies- Quality Assurance, Production, Quality Control


Date Revision Number Reason for Revision


00 New SOP




1. Adequate space with specially defined

areas available.

2. Adequate lighting and ventilation .
3. Disposal of waste in safe and sanitary manner.
4. Sanitation procedures and schedules  available.
5. Procedures for use of Rodenticides and Insecticides.
6. Records indicating material name, Lot No., quantity, manufa

cturer name, suppliers    name, material code and date received.

7. Visual examination of materials for damage at the time of

receipt and  is documented.

8. Containers of raw materials cleaned externally, upon receipt

according to a     written procedure.

9. Containers, bags and boxes are off floor    and suitably spaced

for cleaning  &    inspection. Different  materials and / or different batches of same material stored  on different pallets

to prevent mix-ups

10. Released materials properly segregated from undertest


11. Rejected materials identified and      controlled.
12.Rejected materials handling procedures.
13. Receipt, storage and issue of labels.
14. Handling of rejected printed labels.
15. Materials properly identified and adequately segregated to avoid mix ups.
16. First in first out followed, deviation if any, justified and authorised.
17. Materials inspected and retested at      regular intervals, as per a written      procedure.
18. Inventory record of each material maintained.
19. Controlled storage conditions maintained wherever required.
20. Calibration procedures and records for weighing scales.
21. Cleaning & maintenance of dispensing       equipments, dispensing area.
22. Dispensing operation ensures identification, quantity, batch application      and avoid cross contamination.
23. Separate finished products storage.
24. Finished products distribution records.
25. Handling of Returned products in warehouse.
1. Personnel wear adequate protective    apparel.
2. Gowning & degowning procedures.
3. Cleaning & sanitation of uniforms.
4. Adequate space with specially defined areas.
5. Adequate lighting, ventilation and air    filtration  systems.
6. Adequate clean toilet facilities.
7. Sanitation procedure and schedules.
8. Disposal of waste in safe and sanitary manner.
9. Drains are of adequate size and have adequate mechanical device to prevent back siphonage.
10. Ceilings,walls,windows,pipes etc. are free from dust.
11. Equipments are validated (IQ, OQ & PQ).
12. Equipments are suitably located for easy      cleaning operation and maintenance.
13. All equipments identified with numbers.
14. All the equipments are status labeled all       the time.
15. Log books for major equipments      providing details of cleaning maintenance and use available. Such  records show date time, products and lot number of each batch processed. In cases where dedicated equipment is employed such  records shall be part of batch records.
16. Equipment cleaning procedures and      schedules available and validated.
17. Procedures, schedules and records available for calibration of gauges, thermometers, level indicators, flowmeters etc.
18. Preventive maintenance procedures and schedules available. Records maintained.
19. Non fibre releasing filters used otherwise      suitable additional filters provided
20. Written procedures for cleaning/replacing of filters available.
21. Solvent pipelines labeled to show the contents and flow direction.
22. Manufacturing processes are validated.
23. Master Production Records available.      They are reviewed and approved by appropriate units.
24. All the operations related to manufacturing process are recorded.
25. Detailed process flow diagram, depicting all operations.
26. Deviations from the normal practice recorded and investigated.
27. All the raw materials and intermediates      in the plant identified with proper labels.
28. Weighing, measuring and subdividing operations of materials adequately supervised and examined by

second   person

29. Addition of materials to the batch verified      by second person.
30. Actual yields and percentages of theoretical yield are determined at the conclusion of each stage and verified      by a second person.
31. In process controls for each stage      described in writing.
32. Rejected in-process materials identified      and controlled.
33. Time limitations for completion of each phase of production are available and       followed.
34. Clean area facilities maintained for isolation and packing of finished product.
35. Clean room design.

a) HVAC systems are validated (IQ, OQ & PQ)

b) Quality of air is class 10,000 at the  point of entry.

c) Pressure gradients maintained and    monitored.

d) Filters cleaning/replacement schedule.

e) Dust extraction system to avoid cross contamination.

f) Entry and gowning procedures.

36. Written procedures exist for reprocessing of  rejected intermediates and finished  products.
37. Lot numbers reflects one homogeneous product run
38. Mother liquors/solvent reused are tested      against specifications before use .
39. Method of packing and storage of finished  products
40. Finished products labeling indicate product name, name of the production site, batch or lot No., manufacturing date, expiry  date, quantity, storage conditions and safety instructions if any
41. Safety

a)Safety training

b)Location of safety equipment

i)fire fighting system

ii)handling of solvents, acids and alkalies.

1. Personnel wear protective apparel.
2. Procedures for cleaning of glass apparatus
3. Procedure for calibration of volumetric    glassware.
4. Acceptance of RM & PM

-Approved vendor list

-Vendor audit programme.

-Sampling procedures

-Control sample procedures.

-Specifications & test procedures.

-Validation of in-house test procedures

-Analytical reports.

5. In-process testing.

-Sampling procedures

-Specifications & test procedures.

-Validation of in-house test procedures.

-Analytical reports.

6. Finished product testing.

-Sampling procedures.

-Specification & test procedures.

-Validation of test procedures.

-Analytical reports.

7. Laboratory testing records contain :

– Date sampled.

– Date received in lab.

– Sample quantity received.

– Location sampled.

– Sample description.

– Statement of method used. Is it current ?

– Weight of sample used for each test.

– Identification of reference standard.

– Is there RAW DATA to confirm reported values.

– Are instrument’s used in the analysis identified?

Are calibration due dates identified ?

– Are volumetric solutions identified ?

– Are documents in order ?

– Is release performed by a second


8. Control samples of finished products.






9. All specifications and test methods    reviewed and approved.
10. Purified water/process water/potable water.

-Specifications and test procedures.

-Tested for total bacterial count, E.coli, Salmonella, Pseudomonas aeruginosa and Staphylococcus aureus.

-Stains of above organisms available

11. Bulk drug substance tests for bioburden      and the limit for total count available. Organisms identified.
12. All analytical reports signed by chemist      with date and checked by  second person.
13. Standard volumetric solutions.



14. Reference standards.



15. Working standards

– standardization

– storage

– records.

16. Laboratory equipment/Instruments

– Validated (IQ, OQ and  PQ if any)

-Operation procedures.

-Calibration procedures.

-Calibration records.

-Maintenance records.

17. Animal house


-Identification of animals.

-History records of use.

18. In-house microbiology laboratory.
18a. Sample receipt, storage and documentation.
18b. Test Procedures and media preparation         records.
18c. Stock cultures, handling of reference         cultures.
18d. Periodic monitoring of environment in clean rooms
19. Investigation of out of specification results.
20. Retesting schedules for RM and PM available and records maintained.
21. Stability study programme.

-Sample size.

-Stability indicating tests.

-Test intervals.

-Storage conditions.


22. Laboratory log books and records control.
23. Training and Qualification of chemists.
24. Validation of In-house analytical method
25.  Deviations investigation.
1. Building, facilities and facility layout.
2. Operation procedures for all equipments.
3. Calibration procedures and records for all instruments.
4. Preventive maintenance schedules for all equipments.
5. Usage and maintenance logs for all utilities available.


-Purified water plant

-Soft water plant.


-Air conditioning systems.

6. Validation of potable water distribution system.
6a. Treatment of raw water to make it potable
6b. Testing of potable water for chemical and microbial attributes.
7. Validation of purified water plant and distribution systems.
7a.IQ,OQ, and PQ of DM plant and its      accessories like UV purifiers, heat  exchangers etc..
7b. As built drawing for the DM water circulation system.
7c. Feed water for DM water plant
7d. Regeneration of the DM water plant
7e. Sanitization of  DM water circulation
loop, storage tanks etc.
7f. Microbiolgical and chemical monitoring of Purified water.
8. Validation of softwater plant and
distribution system.
9. Validation of steam generation and distribution system
10. Validation of compressed air generation and distribution system.
11. Validation of HVAC system.
11a. IQ, OQ and PQ protocols of AHUs, VAM and other elements of HVAC
11b. Up-to-date P&ID drawings covering all elements of HVAC system.
11c. Pressure differentials, air flow patterns indicated in drawings.
11d.  Monitoring of temperature and  RH.
11e. Checking of filters in the system.
11f. Calibration of pressure gauges.
11g.  Filter replacement schedules
11h. Deviations justified, and authorized.
1. Organogram of various departments.
2. Qualification, experience and responsibilities of personnel.
3. Training procedures & records.
4. Periodic health checkup of personnel.
5. House keeping and sanitation.
6. Waste disposal system.
7. Pest control system.
7a. Detailed map showing the locations of  pest control performed throughout the facility      .
1. SOPs preparation, approval and control system.
2. Guidelines on validation of equipments.
3. Guidelines on process validation.
4.  Guidelines on cleaning  validation.
5. Guidelines on raw material vendor qualification.
6. Guidelines on packaging material vendor qualification.
7. Specifications & test methods preparation, approval and control systems.
8. Change control.
8a. Review of changes made during last year
8b. Relevant tests (stability etc.,) performed after the change is made.
8c. Relevant documents like validation protocols updated.
9. Area and equipment clearance during batch change over.
10. Area and equipment clearance during product change over.
11. Assignment finished product batch no. and expiration date.
12. Review of Batch Production Record.
13. Investigating deviations.
14. Approval and release of finished product
15. Guidelines on post market surveillance.
16. Annual review of drug substance quality
17. Product failure investigation.
18. Internal quality audits.
19. Customer complaints.
20. Handling of return drugs substances.
21. Product recall.
22. Disposition of rejected batches.

Annexure 2.   

Packaging Material Vendor Audit Checklist 

A. Adhesive :
1. Grade of raw materials used whether original or recovered material.
2. Supplier certificate of RM available.
3. RM used is food grade and certified.
4. Testing of RM as per any Official/ Pharmacopoeial specifications.
5. Receipt and Storage procedures of RM,    Issue of RM.
6. Storage facility is clean, pest and rodent free
7. Possibility of microbial contamination.
8. P.O for the R.M, Invoice, Shipping details, D.C. etc.
B. Paper & Backing paper
 1. Grade of paper used whether original or recycled material
2. Supplier certificate (if any)
3. Testing of paper as per any official methods
4. Receipt & Storage procedures of paper, issue of RM
5. Storage facility is clean, pest and rodent free
6. Possibility of microbial contamination
1. Testing facilities for RM and Finished    products available.
 2. Acceptance and release of RM and    Finished product.
3. Any raw data to confirm the tests performed
 and checked ?
4. Release performed by a second individual.
5. Deviations are recorded and authorised.
 1. Area well defined, closed with proper air circulation and ventilation.
2. In-Process checks monitored during production such as grammage of adhesive,    tackiness etc.
 3. In-process checks monitored during production such as thickness/guage,    pinholes.
4. Packaging of finished products into shippers,    paper bags or other methods
5. Traceability of Lot No. of RM used for the    manufacturing of a particular batch of product.
6. Packaging of finished products into Polybags/ shippers/paper bags or any other methods
7. Finished products suitably identified.
8. Finished product storage conditions,    segregated and controlled.
9. Proper handling of finished products to avoid microbial or other contamination.
10. Release of finished product after confirming the conformance to approved specifications.
11. Certificate of analysis enclosed with every batch of finished product despatched.

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