In pharmaceutical for
purchase of raw material mainly starting raw material you have to approve the
vendor.
In
following circumstance need to develop the vendor:
- When
new product is developed (For new raw material)
- As a
alternative of source of the existing
raw material
- Supply
of existing vendor is not satisfactory
- New
raw material from existing raw material.
Following
the procedure to qualification of new vendor:
Based
on the Vendor questionnaire
Based
on the R and D trial and QC analysis result
Based
on Vendor Audit
Based on the Vendor
questionnaire:
- Purchase
department shall identify the vendor
- After
identify the they send the vendor questionnaire
- Along
with vendor questionnaire, TSE / BSE declaration, GMO, declaration free from
volatile impurities, OVI declaration
shall be provided by the vendor
- QA
department evaluate the all the received documents.
- Based
on the evaluation of the documents they
procure the three samples.
Based on the R and D trial
and QC analysis result
- Purchase
department identify the vendor and send the required specification to the
vendor
- Procure
three samples from three different batches along with COA.
- QC
person shall analyze the samples as per the standard specification or the as
per the requirement for the new product.
- It
samples pass in the specification, sample shall be released with COA by QC
department.
- After
samples are released by QC, same shall be send to R & D for trial if required.
- Performance
trial of these samples shall be taken in R & D and samples analysis report
of trial batches results shall be recorded and submitted to QA.
- Based
on these data QA evaluate the sample
- After
successful evaluation & assessment vendor shall be qualified as approved
vendor.
Based on Vendor Audit
- Head-QA
decide for conducting the audit of the facility of the manufacturer if required
- Information
about vendor audit shall be given in advance to the concern person of
manufacturer/supplier in writing or through verbal communication along with
Audit agenda if required.
- Vendor audit shall be conducted by any
authorized person including Designee QA or Head Operations or Head QA along
with Designee purchase if required
- During the vendor audit, auditors shall review
the quality, manufacturing process, capabilities and commitment to prevent
quality problems of the vendor
- After conducting the audit report shall be
prepared and it shall be shared to the vendor
- Compliance report shall be provided by the
vendor if required
Based on the evaluation of the vendor
finally approved vendor list shall be prepared.
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