Jim is co-author of The ISPE (International Society for Pharmaceutical Engineering) Baseline Guide for the design of Sterile Manufacturing Facilities. It was produced in close CO-operation with FDA and therefore provides useful reference for ensuring the new facilities will comply with the requirements of Good Manufacturing Practice.
It came into being about four to five years ago after a meeting between the FDA and the ISPE Pharmaceutical Advisory Committee. There was a common interest in having consistency of regulations in the industry. One of the problems with inspections in the industry was that pharmaceutical companies didn't know exactly what the inspector was looking for and similarly inspectors sometimes were not certain as to what was being looked for. Furthermore there was the added problem of "The Ratcheting Effect", namely, when something new was seen in one area it became the object of search in the next area of inspection. The baseline guide wanted to avoid this problem.
The Guide is 250 pages long and consists of 12 chapters and 3 appendices. Chapters I and 2 cover the more fundamental aspects of sterile manufacture. The remaining chapters give practical help and advice on selection of equipment and facility design.
It is meant to be used by industry for the design, construction, commissioning and qualification of new aseptic/sterile manufacturing facilities. It is neither a standard nor a GMP nor meant to replace them. Instead it sets out to cross-reference existing, published documents such as CFRs [Code of Federal Regulations] and ISO Standards.
The purpose of the Guide is to focus on engineering issues and how to provide cost-effective facilities.
It should be used as:
Jim is Managing Director of Pharmaplan Ltd. He has extensive experience in pharmaceutical manufacturing projects and is a member of ISPE's European Pharmaceutical Advisory Committee.
Contact: Mr Jim Durkin at Pharmaplan Ltd (Tel. 01925 839 800) or email jim@pharmaplan.co.uk