Procedure for preparing the annual product review of all marketed products.

1.0.            OBJECTIVE:  

1.1.            To lay down the procedure for Annual Product Review (APR) of all drugs products (here after referred as product) which are in commercial distribution.

1.2.            Following are the purpose of conducting Annual Product Review:

To assess changes required in specification of drug substance and drug product.

                        To assess changes required in manufacturing or control procedures.

                        To determine if validation or re-validation is required.

                        To identify area of product and process improvement or cost reduction opportunities.

                        To confirm change control systems.

                        To communicate product and process status to management for assuring products are safe,

                        pure and effective.

2.0.            SCOPE:

This SOP is applicable to all products manufactured, packaged and/or tested at company- location during a calendar year.

3.0.            RESPONSIBILITY:

3.1.            Officer / Executive QA shall be responsible for;

Collection and preparation of all data and information required as per this SOP.

Preparation of summary report.

Co-ordination and tracking of all corrective actions identified in to the APR.

3.2.            Executive QA shall be responsible for;

Review of prepare data and reports.

Identification and verification of corrective actions.

3.3.            Head QA shall be responsible for;

Approval of APRs and summary reports.

Ensuring the conduction of APR.

4.0.            PROCEDURE:

4.1.            The review period the APR shall be one calendar year for the products of which at least 3 batches manufactured in previous year.

4.2.            APR shell be prepared for each strength of product .

4.3.            The following data and/or information shall be collected summarized and reviewed on Annex-I.

4.3.1.      Batch details :

4.3.2.      Finished product trend analysis review : 

4.3.3.      All quantitative parameters of finished product analysis shall be considered for trend analysis.

4.3.4.      Statistical parameters viz. Average, standard deviation (SD) as well as relative standard deviation (RSD) shall be calculated for each quantitative analysis. Tabulated data shall be transformed in to graphical presentation for better understanding of trend. Graphical presentation shall be prepared as per below example.

4.3.5.      Post-production Stability study review :      

4.3.5.1.Data of ongoing stability study of all post-production batches shall be reviewed.

4.3.6.      Process validation review :

4.3.6.1.Data shall be collected from approved deviation reports and/or from revision of batch production and control records.

4.3.7.      Non-conformance / out of specification review.

4.3.8.      Regulatory changes or Pharmacopoeia / Drug act review.

Major changes review viz. Change in facility, equipment/batch size/ process/vendor/composition.

4.3.9.      Market complaint review

4.3.10.  Product return / recall review.

4.3.11.  Status of any action plan recommendation in previous APR.

4.3.12.  Recommendation / Action plan for this review.

4.3.13.  APR summary and conclusion.

4.4.            Each set of data shell be tabulated and/ or graphed in such fashion as to easily exhibit Result, deviations and tends. (Only parameters to be verified for which quantitative Trend can be performed).

4.5.            Each section listed above shall summarized as inference to include any recommendations or action plans to address concern or issues noted.

4.6.            A statement including the conclusion of the individual APR as defined by one of the following :

4.6.1.      Process in control :

4.6.1.1.This conclusion indicates no abnormalities within set of data and confirms that the process confirms to function as validated.

4.6.2.Action recommended :

4.6.2.1.This conclusion indicate that some recommended actions should be considered, but the process is essentially functioning as designed and validated– the process continues to operate in state- of -control.

4.6.3.      Corrective action required :

4.6.3.1.This conclusion indicate the need for immediate action or corrections – the process is not operating in a state-of-control and an investigation is required that includes evaluating the impact on marketed product.

4.7.            The completed APR including each section summary and the overall APR summary with recommendations, shall be reviewed by QA and the final APR report shall be approved by Head QA.

4.8.            QA executive shall prepare the summary report of all approved APRs as per Annex-II.

4.9.            QA- Head shall review this summary report and approve accordingly along with comments/recommendations.

4.10.        The record will be preserved in Quality Assurance.

5.0.            ANNEXURE:

Annex- I          : Annual Product Review

Annex- II        : Annual Product Review Summary Report

6.0.            REFERENCES: Nil

7.0.            ABBREVIATION     :

Abbreviation used	Full form of abbreviation used
SOP	Standard Operating Procedure
QA	Quality Assurance
APR	Annual Product Review
mg	Milligram

8.0.            DISTRIBUTED TO:

Quality Assurance Department

9.0.            REVISION HISTORY:

Revision No.	Change Control No.	Reason for the Modifications

Annx-1 Annual Product Review

(PRODUCT NAME)

(GENERIC NAME)

PRODUCT CODE
MFR DETAILS	NUMBER
	REV. NO.
	EFFECTIVE DATE
FINISHED PRODUCT	NUMBER
SPECIFICATION DETAIL	REV. NO.
	EFFECTIVE DATE
NUMBER OF BATCHES
MANUFACTURED
REVIEW PERIOD

* Shall be written as: name-dosage form – Pharmacopoeial status- strength

Product Name													:
Review Period													:
1.0  Batch Details :
Sr. No.	Batch No.				Mfg Date					Exp Date					Batch size (in ________)						Release/ Rejected						Pack Size
2.0 Finished Product Trend Analysis Review :
2.1 Trend Analysis Data :
		Parameter
Test à
Limit à
Batch No.
Average:
%SD
%RSD
2.2 Graphical Presentation of Trend Analysis Data :
Attachment No.														Parameter														Attached By
Inference of finished product trend analysis :
3.0 Post-production stability study review ( all batches under ongoing study ) :
Batch NO.				Mfg Date					Exp Date									Study condition		Total study duration					Reason for study					Number of months completed till review date				Study result
Inference :
4.0 Process Deviation Review :
Inference :
5.0 Non-conformance / Out of Specification Review :
Nature of non-conformance , out-of-specification observed (Mention Batch No.)																				Conclusion During approval
Inference :
6.0 Regulatory Changes / Drug Act Review :
Reference name & No.														Nature of Deviation observed (Mention Batch No. )														Conclusion During approval
Inference :
7.0 Major Change Review ( viz. Change in facility, equipment, Batch size, vendor, process- composition) :
Change Control No.												Nature of Approved Change
Inference :
8.0 Market Complaint Review :
Complaint No. (Batch No. )							Nature of Complaint															Status
Inference :
9.0 Product Return / Recall Review :
Batch No.							Reason of return / recall															Status
Inference :
10.0 Product Return / Recall Review :
Review period							Ongoing / Pending action plan															Status
Inference :
11.0 Product Return / Recall Review :
Sr. No.			Recommendations / action plan																												Responsibility
Inference :
12.0 APR summary and conclusion ( tick mark whichever is applicable ) :
Process in Control   /   Action Recommended   /   Corrective Actions Required.
								Prepared By																Approved By
Signature
Name
Designation
Date

Annx -2 Annual Product Review Summary Report

Review Period				:
Sr. No.	Product Name		No. of Batches Manufactured			No. of Batches Reviewed		APR Summary	Remarks
Summary report Approval :
		Prepared By					Approved By
Signature
Name
Designation
Date
Comments / Recommendations by management :
General manager         :
Date                            :