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