Annual Product Quality Review
Annual Product Quality Review (APQR) is a regulatory requirement for pharma companies. As per FDA and cGMP APQR guidelines, companies must review their APQR at least once a year. Regular Product Quality Review (PQR) also helps drug manufacturers to revalidate their various processes. This review helps them assess changes required in the product specifications, manufacturing instructions, or control procedures.
Challenges with the Manual APQR process
APQR is a dossier that contains information about each batch of every product produced in a year. A lot of resources, time, and effort go into its preparation. Here are some major challenges associated with the manual APQR process.
- It involves collecting data in the form of Excel sheets from various departments and then manually entering it into formats.
- In the absence of a tool or engine, the process of generating an APQR becomes complex.
- It takes at least 3 to 6 months away from QA personnel and management’s schedules to prepare a Product Quality Review (PQR) manually.
- Due to the nature of this exercise, pharma companies limit this exercise of APQR preparation to only once a year.
Introducing 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. In doing this, it inevitably promotes a culture of continuous, ongoing Product Quality Review.
How to prepare for the Annual Product Quality Review with Caliber’s Anytime PQR
- Integration: 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, epiq By Caliber, CaliberBRM, CaliberDMS, and Nichelon5 CMS.
- Data Collection: Once CaliberAPQR interfaces with other applications, the relevant data gets automatically fetched from the respective source applications.
- Trend Analysis and Decision Making: 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.
Benefits of CaliberAPQR – Ensuring Quality Readiness
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-trailled for 21 CFR Part 11 compliance.
Key components of a Caliber APQR report
APQR is a detailed report, and it is termed 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
CaliberAPQR to 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 PQR anytime instead of once-a-year APQR. They can review and approve data from source applications or Excel sheets as per 21 CFR part 11. They can also review and approve the process of APQR as per 21 CFR part 11.
QA can create trend charts and data as annexures or part of the report, statistically analyze the data, where required, like CPK, PPK, Nelson rules, to name a few. They can perform Batch investigation (inter-batch or intra-batch) and simply schedule APQRs using the APQR software like CaliberAPQR.
Further, CaliberAPQR is validated as per GAMP5 guidelines. A company can generate APQR anytime with the click of a button. It is a win-win situation for everyone, from the QA department to the management.
To see CaliberAPQR in action, schedule a free demo.
