1. A SEMINAR ON
SELECTION AND
CERTIFICATION
OF VENDORS
PREPARED BY: GUIDED BY:
SWATHI M NAMBIAR Dr. JIGNESH SHAH
ROLL NO.2 ASSISTANT PROFESSOR
PMRA QA DEPARTMENT
L.J INSTITUTE OF PHARMACY
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3. VENDOR:
Vendor or Supplier is the seller of the API to
manufacturer of finished dosage form.
SELECTION OF VENDOR:
It is the process where by the vendor is approved by
the finished dosage form manufacturer for given API
that will be used in specific product.
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4. CERTIFICATION OF VENDOR:
It is the process by which the vendor is classified by
finished dosage form manufacturer relative to its
creditability and the degree of testing required to be
performed by finished dosage form manufacturer for the
receipt of each lot of the API.
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7. The two major aspects for this:
1) TO COMPLY WITH GMP REGULATIONS:
FDA Guidelines (1990,1993,1994,1998B)
ICH Guidelines (ICH 1998)
BPC Monograph (IQA 1992)
2) BUSINESS PROSPECTIVE:
For the final product validation it is necessary to
certify raw material.
Certificate is given by certified vendor.
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9. 1) Category A vendor:
-performs all tests listed in the dosage form
manufacturer’s material specification are performed by
the vendor’s laboratory.
2) Category B vendor:
-they are not performing all the test
-all tests are performed but there is not agreement
between manufacturer’s laboratory and CofAs.
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10. 3) Category C Vendor:
- Undergoing qualification process where the
manufacturer has to perform all the tests.
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12. BASED ON THE FOLLOWING
1) Consider that manufacturer is new to the company or
not.
2) Determine that API is new or second source.
3) Evaluate the vendor’s reputation:
Checking the FDA Inspection Profiles or
Establishment Inspection Report.
Relationship with other Company
Vendor’s Recall and failure History
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13. CONTINUED…
4) Define the vendor’s operation, as discussed
previously. In order to qualify a vendor properly, it
is imperative to know if the vendor is manufacturer&,
in this proposed program, we must “qualify each
manufacturing process.
5) CAPACITY OF VENDOR:
Supply the quantity in required amount and in
required time. It is wasteful to qualify a vendor if he
is not fulfilling requirement in given time.
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14. CONTINUED…
6)LOCATION OF VENDOR:
Providing supply in regular production schedule.
In sudden increase in demand local suppliers easily supply the
API.
Foreign manufacturer maintain inventories in local area .
7) SELLING PRICE API:
Necessary for profit evaluation.
8)TECHNICAL EVALUATION:
Three lots from API manufacturer are taken for testing
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15. CONTINUED….
9) Request for technical dossier from API manufacturer
validated test methods
impurities data
standards for testing
chromatogram
stability data on marketed container-
This data helps in final product specification
10) Test the production samples received in laboratory.
11) Vendor audit carried out by manufacturer
all operation of supplier 15
16. CONTINUED…
12) Produce a qualification lot of finished dosage form
product using API
The resultant data are taken for review and decision
making.
If API is second source it is it is taken for comparison
with regular lot.
13) Final Report : It is made on following data
• vendor’s background information
• audit report
• laboratory findings
• regulatory affairs 16
17. CONTINUED…
14) Emphasizing a change control:
• SOPs are prepared for the change in document given
by the supplier.
• revalidation
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19. 19
- SOPs are made for this purpose.
- Retesting program has been established.
- Out of specification result reported then
investigation is carried out and report has been
written.
- If it is confirmed then qualification of vendor is
cancelled
20. DECERTIFICATION:
Any failure by the supplier for meeting the customer’s
requirement may lead to the decertification.
OFFICIAL DECERTIFICATION:
OCJS : Ohio Office of Criminal Justice Services
1. If the error rate of materials is higher than 4% then
OCJS provides notice and get technical support. From
the date of E-mail received we get 12 months time and
within 2 months we have to correct the error and it
will not get decertified.
2. Within 4 months we have to submit data with error
less than 4%, if the material error rate is higher than
4% OCJS will again give the notice. 20
21. 3. Error of 4% cannot be submitted more than 3 times in a
year otherwise OCJS decertifies the vendors certificate.
4. For IBR :
Once the director signs the decertification certificate that
vendor will be decertified in Ohio for IBR. And vendor
gets decertification notice.
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23. There are many elements in an audit that is conducted by
a dosage form manufacturer or regulatory agency of the
facility that manufactures an API.
The person conducting the audit may want to use a
checklist developed for this purpose for two main
reasons:
1) The checklist will include all areas of the audit to be
covered so that nothing will be forgotten.
2) Boxes on the checklist can be marked, with brief
comments that can be added by the auditor, obviating the
need for much time spent writing,& allowing for more
time to be spent observing the facility & asking plant
personnel questions in a dialogue box.
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24. 24
cGMP
observation
NDN D N/A COMMENTS
DOCUMENT
ATION
SOP
MANUAL
QA/QC
PROGRAME
PERSONAL
TRAINING
MASTER
RECORDS
REWORK
FAILURE
INSPECTIO
N
Figure.1 vendors audit documentation
25. REFERENCES
GMP for Pharmaceuticals, A Plan for total quality
control, Sidney H. Willing, James R. Stoker, 4th edition ,
Marcel decker Inc. Page no. 89-93
http://cdsco.nic.in/html/GMP/SCHEDULEM(GMP).pdf
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