The Annual Product Quality Review (APQR) stands as an imperative regulatory obligation for pharmaceutical companies, mandated by both the FDA and cGMP guidelines. According to these regulatory directives, companies are obligated to conduct a thorough review of their Manufacturing at least once annually to revalidate their diverse processes. The preparation of such a report demands considerable allocation of resources, time, and effort.
The comprehensive suite of functionalities offered by APQR significantly facilitates the Quality Assurance (QA) department in the seamless generation of Annual Product Quality Reviews (APQR) for any desired date range, thereby transforming it into an Anytime PQR system rather than a once-a-year endeavour.
Furthermore, APQR enables QA professionals to create trend charts and incorporate data as annexures or integral parts of the report. It equips them with advanced statistical analysis tools, allowing for the calculation of parameters such as CPK, PPK.
One of the key advantages of APQR lies in its streamlined scheduling capabilities, simplifying the process of APQR generation and ensuring adherence to regulatory timelines.
Offering Includes:
Conducting
Stability-Monitoring
Program
Review
Reviewing
Quality-Related
Returns, Complaints,
and Recalls
Investigating Critical Deviations or Non-Conformance and related investigations
Performing Statistical Analysis of Quality Control and In-Process Control
