Results from the PDA survey on Technology Transfer have now been published documenting key highlights and findings from the participant response! This publication which was co-authored by one of CAI’s principal consultants, Beth Haas, can be found in the PDA Bookstore. Learn more about Beth below.
Over the years, the roles and responsibilities of Engineering and Quality/Validation have evolved for Commissioning and Qualification (C&Q) activities. Now more than ever, risk-based approaches rely heavily on Engineering Subject Matter Experts (SMEs) and the application of Good Engineering Practices (GEPs) as an Engineering Quality Process to underpin C&Q.
Background In 1998, the EU and the US signed a broad Mutual Recognition Agreement (MRA), which included a Pharmaceutical Annex providing for anticipated and limited reliance on each other’s Good Manufacturing Practice (GMP) inspections. However, this Agreement was never fully implemented.
Everyone in the pharmaceutical manufacturing industry understands or has at least heard of current Good Manufacturing Practices (cGMP). The requirements of the cGMPs are prescribed in Title 21 of the Code of Federal Regulations parts 210 and 211 (better known as 21 CFR part 210 and 211). But there is…
Intro ISPE has just released the second edition of Baseline Guide 5 for Commissioning and Qualification (C&Q) The objective of the 2019 C&Q Baseline Guide revision is to define and explain a simplified risk-based C&Q process in a single guide that meets present-day standards and provide focus to ensure a…
A considerable amount of effort goes into developing an asset maintenance plan that combines all the technical and administrative measures throughout the life cycle of a piece of equipment aiming to preserve as well as restore its readiness so it can perform its required function. Often, the premise of these…
Imagine the following scenario: The capital project is large, multinational, and complex. It is in the early stages of the project lifecycle, and the schedule is not fully developed nor the team fully formed. Uncertainty abounds, and frustrations are building due to the perceived lack of progress. The pressure is…
Design Review (DR) and Quality Risk Management (QRM) are considered current industry practice and are essential as enabling processes for verification of facilities, systems, and equipment. But what is Design Review? Why is Design Review underutilized in CQV projects? What are the risks of not performing Design Review? And more…
“The ultimate goal of providing a robust, safe method to transfer solutions in the Manufacturing Facility was achieved and CAI played a major role with this safety initiative.”
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