Annual Product Review

Annual Product Review (APR) is an important part of the overall regulatory compliance process. Annual Product Review (APR), a solution by Sarjen - comes as a module in KnowledgeNET, helps client compile and review data and documentation related to the manufacture of a drug product or active pharmaceutical ingredients (API) annually, where they can assess the need for changes in product specifications or manufacturing or control procedures.

It is an important part of the overall regulatory compliance process.

Requirements for APRs are found in 21 CFR 211.180(e) and includes:

• Written procedure
• Review of every batch (or representative) to determine the need for changes in specifications or manufacturing or control procedures
• Review of complaints
• Review of recalls
• Review of returned or salvaged products
• Review of investigations

APR data can essentially be presented in tabular form or in graphical form (i.e., charts or graphs). With graphs, any trends or deviant results can be spotted quickly.

KnowledgeNET provides an augmentation of managing all the documents of APR. KnowledgeNET manages a repository of all the documents regarding consistency of the manufacturing process, assess trends, determine the needs for changes in specifications, production, manufacturing and/or control procedures.

KnowledgeNET also provides a facility of User management i.e. different users will be assigned by APR Coordinator for creation and review of different documents. According to the rights assigned, creators and reviewers will be able to manage the status of each APR document, thus maintaining the life cycle of APR documents. Although final approval of all the documents will be done by the APR Coordinator.

One can now see that an effective APR can do both: provide compliance to GMP regulations, and provide an effective means for evaluating and implementing improvements to your products.

Salient Features:

• Data collected and assembled in the APR
• Reminder Alert on schedules and delays- APR Approval Date, Review Period Start Date and Review Period End Date
• Snapshot view of all APRs' tracking
• Data/document access as per assigned user rights
• Facility of publishing the APR documents
• Evaluating data for trends that might indicate a shift in the process before approval