Annual Product Quality Review (APQR) is a regulatory requirement for pharma companies to validate the consistency of the existing manufacturing process and quality standard of a finished drug product. As per FDA and cGMP APQR guidelines, companies must conduct and document a product quality review (PQR) at least once a year. The US GMPs have been mandating Annual Product Reviews since 1978. Annual Product Review (APR) is essential for communication between manufacturing, quality, and regulatory affairs. Regular Product Quality Review (PQR) helps drug manufacturers to revalidate their various processes. This review helps them assess changes required in the product specifications, manufacturing instructions, or control procedures.
APQR is a dossier that contains detailed information about each batch of every product manufactured in a year. An APQR typically includes the following information, but is not limited to:
- Product details including batch no, batch size, pack size, details of customers, etc.
- General product information
- Product specifications
- Critical process parameters
- Review of the water system and starting/packing material
- Staging periods of the batches returned batches/product recalls
- Batch re-processing/reworking details
- Regulatory changes
- Incidences, deviation, market complaints, change control
- Analytical data for finished products, yield data for in-process stages/finished products
- Vendor details
- Details of instruments, equipment, utility support
It is an extensive list that consumes a significant amount of time, resources, and effort for preparation. Moreover, the level of accuracy and the number of minute details to be recorded is a cumbersome, resource-intensive process. It involves collecting data in the form of excel sheets from various departments and then manually entering it into prescribed formats. In the absence of a software platform or automated tool, the process of generating an APQR becomes complex. Moreover, it takes at least 3 to 6 months away from QA personnel and management’s schedules to prepare a Product Quality Review (PQR) manually. The APQR preparation process is annual, so companies can view the report once a year after months of effort.
Transitioning from Annual to Anytime
With everything quickly accessible these days, the lengthy APQR procedure becomes a setback to operational efficiencies. PQR that can be generated at any instance would make analysts more agile. It would further secure data integrity and improve business decisions. CaliberAPQR is a product developed to simplify the PQRs. Driven by technological expertise and innovation, the software is an Anytime PQR system that gives the user much more than just a document.
What is CaliberAPQR?
Caliber Anytime Product Quality Review (CaliberAPQR) is a Pharma process analytics engine. It turns the complex Annual Product Quality Review process into a hassle-free affair. CaliberAPQR extracts, cleans, and organizes large complex data from various departments like Quality Control, Quality Assurance, Manufacturing, ERP, etc. to provide crucial decision-making analytics.
CaliberAPQR goes beyond the basic regulatory requirements and provides users with ready-on-demand analytics for crucial functions while inevitably promoting a culture of continuous, ongoing Product Quality Review.
Generating an APQR with CaliberAPQR
To generate the APQR, CaliberAPQR interfaces with source applications like LIMS, Quality Systems, Batch Records Management system, or data captured in excel sheets by Quality Control (QC), Quality Assurance (QA), ERP (SAP), and manufacturing departments. The source may be from the Caliber Product Suite too – CaliberLIMS, CaliberBRM, or epiq (enterprise platform for integrated quality).
CaliberAPQR automatically fetches relevant data from the respective source applications. The software helps in preparing reports and trends using the statistical data analysis feature. The complete set of statistical data analytics can then be reviewed by the QA department or management to make decisions based on the analysis reflected in the reports.
Be Quality-Ready with CaliberAPQR
CaliberAPQR helps companies to
- Have crucial analytics readily available within minutes as and when needed
- Save massive amounts of time, resources, and effort
- Ensure data integrity as source data cannot be edited or deleted in the system
- Meet compliance standards set by regulatory authorities as all the data ingested is audit trailed for 21 CFR Part 11 compliance
What does the CaliberAPQR Report Furnish?
APQR is a detailed report and it is termed as a dossier for each product manufactured. CaliberAPQR covers the following for each product manufactured
- A review of starting and primary packing materials, especially those from new sources
- Record and evaluation of all analytical results obtained from the certificate of analysis (COA)
- A tabulated review and statistical analysis of quality control and in-process control & finished product results
- Yield control
- Qualification status of critical equipment, facilities & utilities
- Change to starting material & product specifications
- A review of all critical deviations or non-conformance and related investigations
- A review of all changes carried out to the processes or analytical methods
- Details of stability testing & process validations, etc.
- A review of the results of the stability-monitoring program
- A review of all quality-related returns, complaints, and recalls
Get More Than Just a Report
The exhaustive list of information provided by CaliberAPQR software helps the QA department in generating APQR for any date range, making it Anytime PQR instead of once-a-year PQR. It facilitates the review and approval of data from source applications or excel sheets as per 21 CFR part 11. It also helps in the review and approval of the process of APQR as per 21 CFR part 11. QA can create trend charts and data as annexures or part of the report, and statistically analyze the data, where required like CPK, PPK, and Nelson rules to name a few. They can perform batch investigation (inter batch or intra batch) and simply schedule an APQR using the innovative CaliberAPQR software.
Further, CaliberAPQR is validated as per GAMP5 guidelines. It empowers the users to generate an APQR anytime with the click of a button – convenience with excellence for simplified, value-based data analytics and reporting. CaliberAPQR is a win-win situation for everyone – from the QA department to the management and regulatory authorities.
