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:
01.
Status Information


Number of batches produced

02.
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
:
03.
Trend Information


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

Trend analysis of critical quality attributes of finished product
: Yes / No
04.
Evaluation Information


Summary report attached
: Yes / No
Remarks:

Prepared By                                                                                                            Head-Q.A

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