In the dynamic landscape of the life sciences industry, ensuring compliance with good manufacturing practices (GMP) is imperative to guarantee the safety, efficacy, and quality of pharmaceutical products.

One critical aspect of GMP is the analytical product quality review (APQR), an essential process for evaluating and monitoring the consistency of product quality throughout its life cycle. APQR is also known as annual product review (APR) in the U.S. Food and Drug Administration, and product quality review (PQR) in EU good manufacturing practice (GMP) guidelines. It is required to be conducted annually for every product to determine the need for changes in drug product specifications or manufacturing or control procedures.

However, challenges in the industry related to PQR have highlighted the need for innovative solutions. This article will leave you with a little more understanding about the challenges associated with PQR in the life sciences industry and how modern digital solutions can elevate the APQR while bridging existing gaps.

These are a few of the current challenges while conducting effective APQR.

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