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 in 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.
APQR is a dossier which contains information about each batch of every product produced in a year. A lot of resources, time, and effort go into its preparation. 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. 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. Thanks to the nature of this exercise, pharma companies limit this exercise of APQR preparation to only once a year.
CaliberAPQR is not just an APQR software. It is an Anytime PQR system which resolves these issues efficiently and also gives the user much more than just a document.
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.
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, CaliberQAMS, CaliberBRM, CaliberDMS, and Nichelon5 CMS.
Once CaliberAPQR interfaces with other applications, the relevant data gets automatically fetched from the respective source applications. The complete set of statistical data analytics can then be reviewed by QA department or Management to take decisions based on the analysis reflected in the reports.
CaliberAPQR helps companies to
APQR is a detailed report, and it is termed as dossier for each product manufactured. CaliberAPQR covers the following for each product manufactured
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 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 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 on the click of a button. It is a win-win situation for everyone – from QA department to the management.
To see CaliberAPQR in action, please schedule a free demo.