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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DEFINITIONS

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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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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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VENDOR

SELECTION AND

CERTIFICATION

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PURPOSE OF VENDOR QUALIFICATION

AND CERTIFICATION

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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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TYPES OF VENDOR

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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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3) Category C Vendor:

- Undergoing qualification process where the

manufacturer has to perform all the tests.

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SELECTION OF VENDORS

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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 History12

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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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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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 supplier15

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

CONTINUED…

14) Emphasizing a change control:

• SOPs are prepared for the change in document given

by the supplier.

• revalidation

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MONITORING OF VENDORS

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- 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

DECERTIFICATION:

Any failure by the supplier for meeting the customer’srequirement 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% thenOCJS provides notice and get technical support. Fromthe date of E-mail received we get 12 months time andwithin 2 months we have to correct the error and itwill not get decertified.

2. Within 4 months we have to submit data with errorless than 4%, if the material error rate is higher than4% OCJS will again give the notice.

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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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VENDORS AUDIT

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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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cGMP

observation

NDN D N/A COMMENTS

DOCUMENT

ATION

SOP

MANUAL

QA/QC

PROGRAME

PERSONAL

TRAINING

MASTER

RECORDS

REWORK

FAILURE

INSPECTIO

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Figure.1 vendors audit documentation

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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