VENDOR AUDIT CHECKLIST

1. Name of the material/code :

Manufactured by :
(Name and address)

Supplied by :
(Name and Address)

Manufacturing Site :
(Address)

Contact Persons:
Marketing department Name: Contact No.: Email:

Quality Assurance department Name: Contact No.: Email:

2. General Information :

Area of manufacturing site :

Products manufactured :

Major customers :

3. Organization and Personnel :

Managing Director : Name:

Plant Manager/In-charge : Name: Designation:

QA/QC Manager/In-charge : Name: Designation:

4. Employee details :

QA: QC: Production: Ware House: Total:

Page No. 1 of 9
 VENDOR AUDIT CHECKLIST

S.
Check Point To be checked Yes/No/NA Remarks
No.
A. GENERAL

1. Is organization chart available? Organization chart.

Is the manufacturing facility is certified ISO 9001 Certificate No. : Expiry date:
2.
ISO 9001 / 14001? ISO 14001 Certificate No.: Expiry date:
Is there any other products manufactured
3. List of products manufactured.
in the same plant?
Since how long you are manufacturing
4.
this product?
What is the lead time for delivery of the
5.
product from date of purchase order?
Is the material supplied by the company of
6. TSE/BSE certificate.
animal origin?
Are the materials being manufactured,
7. Physical verification.
along with cephalosporin/ penicillin?
Are route of synthesis, flowchart and brief
8. manufacturing process available for
product of concern?
Id the MSDS available for the product of
9.
concern?
B. WARE HOUSE
Are standard operating procedures
10. List of Ware house procedures.
available and followed?
Are adequate space provided for Demarcation of the areas. Rejected area
11.
quarantine/ approved/ rejected areas? under lock and key.
12. Are de-dusting of materials carried out? De-dusting area and record.

Page No. 2 of 9
 VENDOR AUDIT CHECKLIST

S.
Check Point To be checked Yes/No/NA Remarks
No.
Are materials properly segregated to avoid
13. Batch wise segregation of raw materials.
mix-ups and errors?
Under test, approved/rejected, sampled
14. Is material labeled for identification?
labels on the containers.
Is inventory record of each material Raw material inward register, Inventory /
15.
maintained? bin card.
Is sampling area / dispensing area cleaned Sampling area cleaning record.
16.
after activity? Dispensing area
17. Is FIFO system is followed? Inventory / bin card
Are finished product distribution records Finished product inward register, dispatch
18.
available? register.
Is handling of return goods SOP available Procedure on return goods.
19.
and followed. Return goods register.
Weighing balance calibration procedure.
Is calibration SOP and records available Calibration records (daily/monthly).
20.
for weighing scales and standard weights? External calibration certificate of weighing
balance and standard weights (from Govt.).
Are there pest and rodent control in ware Rodent traps in ware house.
21.
house (Records to be checked at HR department)
C. PRODUCTION

22. Are SOPs available and followed? Production standard operating procedures.

23. Is housekeeping schedule is followed. Housekeeping record.

Are preventive maintenance available Preventive maintenance calendar, Schedule
24.
If yes, followed as per schedule? and records.
Is the product manufactures in batch
25.
process of continues process?

Page No. 3 of 9
 VENDOR AUDIT CHECKLIST

S.
Check Point To be checked Yes/No/NA Remarks
No.
How the lot / batch numbering system
26. Lot / batch numbering system.
described?
Are equipment dedicated to produce this
27. Equipment logbook.
product?
If the equipment is non-dedicated, is
28. validation is done. Product changeover cleaning record.
Cleaning procedures are established.
Weighing balance calibration procedure.
Is calibration SOP and records available Calibration records (daily/monthly).
29.
for weighing scales? External calibration certificate of weighing
balance (from Govt.).
Is there an appropriate procedure for cross
30. Physical verification.
contamination and mix ups?
Are status boards available for all
31. Physical verification at equipment.
equipment?
32. Is equipment utilization log maintained Physical verification.
Are batch manufacturing records available
33. and followed? Master batch record.
If yes, approved by whom?
Are online documented the manufacturing
34. Online batch manufacturing records.
process (If yes, check the batch records)
Are raw materials and intermediates in
35. Physical verification.
plant labelled properly?
Is an in-process controlling system
36. Batch manufacturing record
available?
Is the batch size fixed for material?
37. Batch manufacturing record
What is the commercial batch quantity?
Is there a blending of batches?
38. Blending batch record.
What is the commercial batch quantity?

Page No. 4 of 9
 VENDOR AUDIT CHECKLIST

S.
Check Point To be checked Yes/No/NA Remarks
No.
Is there an appropriate place available for
39. Physical verification.
packing of finished product?
Is procedure for packaging and labelling
40. Dispatch docket/records.
of final product available?
Is the drums labelled with product label
containing product name, batch no.,
quantity, tare weight, gross weight, net
41. weight, manufacturing date, retest / expiry Product label.
date, manufacturing address, storage
condition, any precautions / instructions
for dangerous goods?
Do you paste additional label for
42. dangerous goods (if applicable) on each Packing instructions.
drum?
What is the packing, storage and retest
43.
condition of the product concerned?
Is there a procedure for non-confirming Product non-confirming procedure.
44.
products (rejections)? Logbook and records.
Is training given any process changes and
45. Training records of production persons.
records available?
Do you provide photographs of the
46. labelled containers prior to dispatch of the
product?
D. QUALITY CONTROL:
Are standard operating procedures
47. List of QC SOPs.
established and followed?
Are in-process test procedures available Specification and test procedure for in-
48.
and followed? process samples.
Is final product tested as per customer Specification and test procedure for
49.
MOA? finished product.
Page No. 5 of 9
 VENDOR AUDIT CHECKLIST

S.
Check Point To be checked Yes/No/NA Remarks
No.
Is there an Out-of-Specification procedure OOS procedure.
50.
available and implemented? OOS logbook and records.
Are control samples available for all Control sample register.
51.
dispatched products? Physical verification.
Specification and test procedure for in-
Are all specifications and test methods
52. process, intermediates and finished
reviewed and approved?
products.
Analytical reports.
53. Is laboratory testing records available?
Calculation protocols.
Are analytical test reports signed by Analytical reports.
54.
analyst and checked by the supervisor? Calculation protocols.
Is working standard available for final Working standard COA.
55.
product? Working standard evaluation.
IQ/OQ for all QC instruments.
Are qualification reports and calibration
56. Calibration schedule and records for all QC
schedules available for instruments?
Instruments.
Is training given to chemists? Training plan.
57.
(If yes, check there any training record) Training record to QC chemists.
Are stability / holding time study program Protocol for stability / holding time study.
58.
conducted for final product? Reports and raw data for the studies.
Is there expiry / retest period established
Protocol for stability / holding time study.
59. for the product of concern?
Reports and raw data for the studies.
Mention the retest / expiry period.
Weighing balance calibration procedure.
Are calibration with standard weights SOP
Calibration records (daily/monthly).
60. and records available for weighing
External calibration certificate of weighing
balances
balance and standard weights (from Govt.).
Are instruments logs available and
61. Instrument logbooks.
followed?
Are quality trend charts for final product
62.
available?
Page No. 6 of 9
 VENDOR AUDIT CHECKLIST

S.
Check Point To be checked Yes/No/NA Remarks
No.
E. QUALITY ASSURANCE
Are there procedures for document
Document control procedure.
63. preparation, control, review, approval and
Distribution record.
distribution?
Are there procedures for change control, Change control procedure.
64. do they cover changes to site, process, Change control logbook.
method, specification changes? Change control records.
Is there a provision for informing
65. customer in case of a major change Change control procedure.
occurs?
Deviation control procedure.
Are there procedures for deviation
66. Deviation control logbook.
handling
Deviation control records.
Are there procedures for complaint Complaint handling procedure.
67.
handling Complaint logbook and records.
Are there procedures for internal audit? Internal audit procedure.
68. Are there records to show the compliance Frequency of Internal audit.
to the procedures? Schedule and records.
Are the deviations, audit findings,
complaints investigated? Corrective and preventive action logbook.
69.
Are the corrective and preventive actions Corrective and preventive action reports.
taken?
How the vendors are approved? Is there Vendor approval procedure.
70.
any procedure for approval of vendors? Records.
Training procedure.
71. Is training SOP and records available.
Training schedule and records.
Is there an Annual Product Review
72. Annual product review report.
available?
CHEMICAL SUBSTANCE
F.
MANAGEMENT (RoHS):
Page No. 7 of 9
 VENDOR AUDIT CHECKLIST

S.
Check Point To be checked Yes/No/NA Remarks
No.
Do you ever handle the 6 substances
prohibited by RoHS in its manufacturing
[NOTE 1] RoHS stands for Restriction Of
site? (Here, manufacturing site means not
the use of certain Hazardous Substance in
only production line but also all value
electrical and electronic equipment
added sites, eg finished goods store,
[NOTE 2] Prohibited 6 substances by
packaging, and the like)
RoHS
If Yes, has the supplier already abolished
[NOTE 3] Upper limit value (threshould
the use of the prohibited 6 substances
value) for (c) in NOTE2 is 100ppm and the
completely? (Such abolishment shall
rest of others are 1,000ppm. The limit value
include the case in which prohibited
73. is determined by weight of the prohibited
substances content is within the limit
substance in homogeneous part of material
value specified by Murata)
in question. Note that these limit values are
(a) Lead (Pb) and its compound
only for unintentionally added impurity. If
(b) Mercury Hg) and its compound
intentionally added in order to enhance
(c) Cadmium (Cd) and its compound
performance of finished product, the upper
(d) Hexavalent chromium (Cr[VI]) and its
limit value shall not be applied, i.e., no 6
compound
substances shall be contained in its finished
(e) Poly-brominated biphenyl's (PBB)
product.
(f) Poly-brominated biphenyl ethers
(PBDE)
Do you perform acceptance tests on
74. Chemical Substance Management
(RoHS)?
Do your supplier / manufacturer has
75.
chemical substance management program?
If your supplier / manufacturer give
76. training their employees on Chemical
Substance Management (RoHS)?

Page No. 8 of 9
 VENDOR AUDIT CHECKLIST

1. COMENTS :

2. RECOMMENDATIONS:

3. CONCLUSION:

4. MEMBERS PRESENT:
S. No. Department Name Designation Sign & Date

5. AUDITED BY:
S. No. Department Name Designation Sign & Date

Page No. 9 of 9