Annexure – I for Anual product quality Review

 Pharmaceutical Guidanace  April 2, 2016  Other Topic, Uncategorized  921 Views

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                              Annual Product Quality Review Report

1. Product Description

1. Product Name:

2. Generic Name:

3. Label Claim:
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 4. Strength:

5. Packaging Types Available:

6. M.F. Nos.

7. Batch sizes available:

8. Markets

9. Shelf Life

10. Indications

2. Time Period Covered for APR

1. ___________________ to ______________________

2. Batches Manufactured: Batch Number _____________ to _____________

3. Manufacturing and testing procedures followed

1. Technical direction (Manufacturing)

2. Technical Direction (Packaging)

3. Specifications / STP (In-process)

4. Specifications / STP (Finished Product)

5. Specifications / STP (Packaging component)

4. Finished Product Results

5. In-Process Results

6. Environmental conditions during manufacturing operation

7. Critical Equipment performance

8. Process Deviations / Change controls

9. Out of Specification and Out of trend

10. Non Conformance Report

11. Product complaints

12. Returned goods or recalled products

13. Yield reconciliation

14. Adverse drug reactions

15. Active Pharmaceutical Ingredient data

16. Raw material (API) Manufacturer / Supplier Performance review

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All types of Glass Test

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Supplier
Manufacturer
Consignment /
Name (Name Consignments Consignments Cause of
(Name and Batches 
of API and Approved Rejected Rejection
Address) Received
Address)

Conclusions and recommendations:

Prepared By Checked By Approved By

Sign / Date Sign / Date Sign / Date Sign / Date

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 Pharmaceutical Guidanace
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of
rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco
remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA,
EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a
regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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