As a Good Manufacturing Practice (GMP), the regulatory authorities require drug manufacturers to prepare the Annual Product Quality Review (APQR), also known as PQR (Product Quality Review) or APR (Annual Product Review). It requires that every product is evaluated based on the current specifications and records.  It helps manufacturers determine whether modifications to product specifications, manufacturing instructions, or control procedures are required. At the core, it evaluates the need for re-validation of the company’s existing processes. 

Overall, the Product Quality Review (PQR) is a powerful tool and much needed tool for drug manufacturers. The downside is that it takes weeks and even months to put together. This is where CaliberAPQR steps in. Caliber’s ‘Anytime’ Product Quality Review completes this entire process in just minutes. The Anytime PQR consolidates reports generated by various departments through different sources. As a result, this frees up the senior management’s time to let them focus on more pressing priorities that need their time.   

With the time factor out of the equation, the ‘Anytime’ PQR serves as more than a compliance tool. Apart from a GMP requirement, APQR can be leveraged by drug manufacturers to achieve continuous quality improvement. On one hand, the APQR serves as “ongoing validation“, and on the other, data and results obtained serve as crucial prerequisites for Continuous Improvement (CIP) or Continuous Process Verification (CPV).

Regulatory Authorities Emphasizing on PQR

Many regulatory authorities like US FDA, EU GMP, WHO GMP, ICH Q7, and others emphasize the preparation of the APQR on an annual basis. In essence, a periodic or rolling quality review of all licensed medicinal products is essential to keep things in check. Every drug manufacturer engages in APQR preparation at least once a year. 

Why Should PQR Become a Regular Habit?

The preparation of APQR is an exercise which focuses on achieving compliance. However, a regular Product Quality reviews can be a game-changer for drug manufacturers – 

  1. Timely check on process quality and out-of-specification leads to immediate improvement to procedures and processes.
  2. Check on quality of starting and packing materials helps in analyzing the final product quality.
  3. Eye on stability studies will find defects in product stability and straighten the path on time.
  4. The trend of the yield of every batch identifies issues with achieving appropriate quantity of final product.
  5. Trend of in-process and finished product checks determines the consistency of product quality.
  6. Batch failure and recall information determines the reasons for rejection and triggers essential process changes or improvements.

Caliber’s Anytime PQR (CaliberAPQR) generates the PQR within minutes, which usually takes months of senior management’s time. It is an effective tool for Continuous Process Verification (CPV) with 21 CFR Part 11 compliant function flow to generate APQR for multiple products and strengths. As a result, manufacturing companies can become robust in CPV activities. In turn, it helps the management to take critical and important decisions at a faster pace.

Get to know more on CaliberAPQR here. Ask us for a demo to see how you can make PQR a habit.