In 2018, the FDA released “Data Integrity and Compliance with Drug cGMP, Questions and Answers, Guidance for Industry.” Between 2015 and 2019, the number of 483 observations written globally increased by more than 10%. The increase indicates that either the industry is still catching up to compliance expectations or the FDA is inspecting with greater […]

In drug manufacturing, keeping track of data is crucial for the drug’s approval from the FDA. The “Continued Process Verification” (CPV) data needs to be maintained for ensuring that the product outputs are within predetermined quality limits. In spite of rising demand for the creation of digital data directly at the source itself, some companies […]

A big reshuffle has been made in one of the principal guidelines for Commissioning & Qualification (C&Q) within the pharmaceutical industry today. The changes seek to improve the application of Quality Risk Management (QRM), a growing element of regulatory expectation. This research investigates the impact and implications of the changes to a key area of […]

Since the publication of ICH Q9[1] in 2005, the pharmaceutical industry is encouraged to take a risk-based approach to the control and management of product quality. The expectation that Quality Risk Management (QRM) is integrated into the Pharmaceutical Quality System (PQS) is further developed in ICH Q10 [2]. ICH Q10 objectives are to achieve product […]