It is a well-established maxim that “Good communication is the key to successful projects.” Clear, concise, specific communication is the goal, and this applies to business as well as day-to-day life. The trouble is following through on it.
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…