Finished Good Review SOP
1.0
PURPOSE:
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1.1. To provide the
guidelines for the final inspection and review of all necessary documentation
that has been generated during Production and Quality Control of the finished
product.
2.0 SCOPE:
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2.1. It is applicable
to all finished product ready for shipment at ________Pharmaceuticals.
3.0 RESPONSIBILITY:
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3.1. Quality Control Manager.
3.2. Quality Assurance Manager.
3.3. Quality Assurance Officer.
4.0 PROCEDURE:
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4.1. Production Manager and Quality Assurance
Manager / Incharge are responsible for ensuring that the batch records meet
these criteria.
4.2. Production Manager and Quality Assurance
Manager complete an individual review of the documents, and sign and date the
review section indicating that they are satisfied with all the information
included.
4.3. Quality Control Manager is responsible for
the completion and documentation of all the testing performed in the Quality
Control Laboratory, sign the documents and date the review section of all the
Batch Analysis Sheet.
4.4. Quality Assurance Manager after a careful
& complete review of all the documents designates Quality Officer to enter
information regarding the finished product in the Finished Product Review Log
Book. Then Quality Assurance Manager issues a certificate of review to the
Production Officer (Packaging).
4.5. The Quality Control Officer issues
Released card to the concerned Production Officer (Packaging) against the
batch.
4.6. The concerned Production Officer
(Packaging) transfers all the finished products to the Finished Goods Store
through Product Transfer Ticket.
4.7. Quality Assurance Manager also has the
authority and responsibility to inspect at random any In process Operation for
compliance, uniformity of material and any other aspect of the production to
test operations that may affect the identity, strength, purity or quality of
the finished product
5.0
QUALITY FORMS AND RECORD:
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N/A
EVIDENCES OF RECORDS & REFERENCES
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Log Book of Finished
Goods.
BMRs
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FORMAL KPIs (Key Performance Indicators)
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Retrieval and access is easy and possible as and when required.
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GENERAL
RISKS
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CONTROL MEASURES
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CUSTODIAN
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Risks
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Impact
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Finished Goods review not occurs properly and on time and by
authenticated person.
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Batch documents mix up may occurs.
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Maintain log Book and BMRS by authenticated person and reviewed
on time.
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QA Officer
QA Manager
Store Incharge
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