Saturday, November 20, 2010

Annual Product Review of finished active pharmaceutical ingredient (APIs)

1.0         Purpose   :  To provide instruction for Annual Product Review of finished active pharmaceutical    ingredient (APIs)

2.0        Objective   :   To provide a documented procedure for Annual Product Review of finished active pharmaceutical ingredient (APIs)

3.0          Scope  :  This procedure is applicable to all Active Pharmaceutical Ingredients manufactured in QA department at -----Pharmaceuticals,

4.0         Responsibility  :
·        Manager QC / Manager Production / QA Manager.

5.0       Procedure  :
·        Total performance review of each finished active pharmaceutical ingredient (API) shall be carried out separately.
·        An annual product review shall be written on yearly basis.
·         An annual product review shall contain at least the following information:
Ø      Quality Attributes with respect to:
o               Assay trends
o               Related substance trends
o               Impurities profile
o               Residual solvents.
o               Summary of out of specification results
o               Other critical product specific quality attributes.
Ø      Production with respect to:
o               No. of batches produced
o               Product yield trends
o               Investigation on yield deviations
o             Deviation occurred during normal operations, investigation report of deviations                                    and corresponding corrective and preventive actions taken.
o               Reprocessed or reworked batches
Ø      Stability Data:        
Ø      Market Complaint and Returns:
Ø      Changes with respect to:
o               Standard testing procedures
o               Specifications
o               Standard operating procedures
o               Process
o               Equipment
Ø      Changes in product label or Packaging configuration:
Ø      Status on Process Validation:       
Ø      Product Distribution Data:
o       The designated persons shall provide the relevant details to quality assurance      for compilation.
o       The completed checklist as per attached annexure with necessary attachment shall be signed and dated by the person who prepared the report.
o       The product review documents shall be reviewed by manager quality assurance and approved by Head-Q.A.
o       The product review documents shall be preserved for 5 years with quality assurance.

6.0      Reference Document  :
v     Annual Product Review
v     Annual Product Review Report

7.0      Abbreviations  :
·        QA   = Quality Assurance department
·        SOP = Standard Operating Procedure
·        QC = Quality Control

8.0      Copies to Distribution Sites.  :
·        QA

                                       ANNUAL PRODUCT REVIEW CHECKLIST
Product name:                                                                                                  Date:
Review period:
Status Information

Number of batches produced

Batch list attached
: Yes / No

Number of batches rejected

Number of batches reworked

Number of deviations

Number of changes implemented

Number of customer complaints

Number of returned goods
Trend Information

Trend analysis of critical process monitoring information attached
: Yes / No

Trend analysis of critical quality attributes of finished product
: Yes / No
Evaluation Information

Summary report attached
: Yes / No

Prepared By                                                                                                            Head-Q.A

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