Procedure for Annual Product Review

1.0	PURPOSE To lay down a procedure for Annual Product Reviews (APRs) for all pharmaceutical products.
2.0	SCOPE This procedure applies to all pharmaceutical products manufactured, packaged or tested during any annual time period.
3.0	RESPONSIBILITY Quality Assurance- collect and organize all quality control data associated with the APR, provide summaries of results, and generate conclusions and recommendations reflecting data. The Head Of Quality Assurance is the APR owner, that is, the individual ultimately responsible for assuring that all provisions of this SOP are fulfilled. QA Head coordinate the collection of all data and information required by this SOP, development of a summary report, solicitation of all APR approvals and coordination and tracking of all corrective actions identified by the APRs.
4.0	ACCOUNTABILITY Head QA
5.0 5.1 5.2 5.2.1 5.2.2 5.2.3 5.2.4 5.2.5 5.2.6 5.2.7 5.2.8 5.2.9 5.2.10 5.3 5.4 5.5 5.5.1 5.5.2 5.5.3 5.5.4 5.5.5 5.5.6 5.5.6.1 5.5.6.2 5.5.6.3 5.6 5.7   5.7.1 5.7.2 5.7.3 5.7.4 5.7.5 5.7.6   5.7.7	PROCEDURE An annual schedule for completing APRs will be published by the APR administrator. This schedule will establish the specific product to be reviewed and the ‘cut-off’ date for each APR will be communicated to all individuals and groups responsible for assembling data. The production personnel shall submit a requisition slip ‘Requisition For Sampling And Testing’ to the In process. The following data and/or information will be collected, summarized, and reviewed by the groups listed. Finished product analytical and physical data (Quality control). In-process analytical data and physical data (BPR). Process deviation and Investigations (Quality assurance). Rework batches (Quality Assurance). Stability Summaries (Stability Deptt.). Complaint trends and/or summaries (Quality Assurance). Quality related returned goods (Quality Assurance and/or distribution). Recall summaries (Quality Assurance). Analytical and physical out-of-specification results and/or trend summaries (Quality Control). Yields (Production) Product/process. Each set of data will be tabulated and /or graphed in such a fashion as to easily exhibit results deviations and trends. Each section listed above will be summarized to include any recommendations or action plans to address concerns or issues noted. An approval signature will be included with each summary. Summaries will be provided to the APR administrator no later than the date requested in the schedule. The APR administrator will generate an overall APR summary that will comprise the following:- Narrative summary of each section or reference to individual section summary. Listing of Quality issues or deviations identified by the section summaries. Listing of recommendations and action plans to address issues. Status of any action plans from previous APR  for this product. Individual responsible and target dates for completion of each action plan item. A statement indicating the conclusion of the individual APR as defined by one of the following:- Process in control- This conclusion indicates no abnormalities within sets of data and confirms that the process continues to function as validated. Actions recommended- This conclusion indicates that some recommended actions should be considered but the process is essentially functioning as designed and validated the process continues to operate in a state-of-control. Corrective action required- this conclusion indicates the need for immediate actions or corrections- the process is not operating in a state-of-control and an investigation is required that includes evaluating the impact on market product. The completed APR including each section summary and the overall APR summary with recommendations will be reviewed and approved by Head QA. Nu  Numbering of APR:          Th   QA officer / executive shall allocate a unique sequential number to each APR . The APR number shall consist of 11 alphanumerical characters e.g. “APR/YYY/001”. The first Three alphabetical characters “APR” shall indicate “Annual Product Review”. The fourth, character shall always be a slash.‘Year-‘012 for the year 2012. The next Three numerical characters shall indicate the year e.g. ‘Year-012 for the year 2012’. The Eighth character shall always be a slash. The last 3 numerical characters represent the unique sequential serial number for the APR, Starting from 001, 002, 003 …… 999.
6.0	REFERENCES      As per cGMP guideline

7.0

ANNEXURES

Annexure No.	Title of Annexure	Format No.
Nil

8.0	ABBREVIATIONS

Abbreviations						Full Forms
SOP						Standard Operating Procedure
QA						Quality Assurance
APR						Annual Product Review
BPR						Batch Processing Record
9.0	DISTRIBUTION
Master Copy							Head Quality Assurance Department
Controlled office Copy No. 1							Head Quality Assurance Department
10.0		REVISION HISTORY
S.No.			Revision No.	Effective Date	Reason for Revision			Details of Change	Authorized By (sign & Date)