Annual Product Quality Review (APQR) Software
Every commercial product manufactured in the Pharmaceutical, Biotech, and Bio-sciences Industries undergo a Product Quality Review (PQR). This requirement is published as the final current good manufacturing practices (CGMP) regulations for drug products (21 CFR 211.180(e), 21 CFR 211.180(e)). The PQR has largely been termed ‘Product Annual Review’ or the ‘Annual Product Review’ (APQR) by FDA and within the pharmaceutical industry. The products follow the established protocols of the US FDA with GMP standards, and they are distributed within the United States markets.
The Annual Product Quality Review (APQR) was introduced as part of the GMP practices to provide manufacturers of pharmaceutical products with a set of reliable procedures. These procedures must be followed in reviewing the quality standards of every drug product. The content and management of Quality Product Reviews are to be established according to the regulatory requirements.
The Annual Product Quality Review within pharmaceutical companies is therefore necessary for the verification of the consistency of the manufacturing procedures, examination of trends, identification of changes required in the specifications or the methods or production technique.
The guideline established in ICH Q7 2.5 Product Quality Review 2.50 states that regular quality reviews of APIs should be conducted to verify the consistency of the process. This is referred to by EU guidelines for Good Manufacturing Practice as PQR (Product Quality Review), and the processes adopted for Product Quality Review (PQR) are based on EU GMP standards.
Developed on LOW CODE PLATFORM, AmpleLogic APQR Software captures information manually and collects information from other sources. It extracts this information by combining it with software systems that the company may utilize. LMS, QMS, BMS, and MES/eBMR are examples of these software systems. The program may also collect data from a range of different software systems and legacy products in your organization’s IT infrastructure.