Parenteral Drug Association Europe Announces Findings from Rapid Microbiology Methods Forum

Published: Jan 22, 2010

FRANKFURT, Germany, (January 22, 2010)- The Parenteral Drug Association (PDA) recently held a Discussion Forum on ‘Implementing Rapid Microbiology Methods’ with representatives from European Health Authorities including the European Medicines Agency (EMEA). During the debate, health authority representatives revealed ongoing discussions within EMEA Working Groups on procedures to better enable continuous improvements.

As a result of legislation passed by the European Parliament and in co-operation with the European Commission, changes have been made to the EU Guide on Variations to marketing authorizations (MAs). One option under evaluation by EMEA was the introduction of pre-authorized, post-approval change management plans and protocols.

"The purpose of the changes, that will be introduced with the implementation of the revised Variation Regulation, is to simplify the Variations procedure and at the same time assure patient safety and product quality”, said Riccardo Luigetti, Ph.D., EMEA.

“Changes within the approved Design Space will be allowed without further regulatory review”, he continued, “and groups of variations to the same MA as well Variations (or group of variations) that affects multiple MAs of the same MA Holder will undergo a common assessment. All this should help to implement technologies like Rapid Microbiology Methods faster thus reducing the risk of failure during sterile manufacturing, for example."

Gustavo Marco, PharmD., Pharmaceutical Assessor at MHRA, UK, said that data from suppliers, such as equipment manufacturers, is needed to assess the appropriateness of claims made in MA Applications. "When data from suppliers is required, we may need the applicant to put us in direct contact with suppliers so we have access to such crucial data. I cannot emphasize enough the role of the Expert Summary Report of the CTD written by the Quality Expert to clarify such interdependence and to justify the supporting data provided”, said Dr Marco.

“In case of doubt or before embarking into a resource-consuming endeavor like developing alternative Rapid Microbiology Methods, I recommend applicants to ask for a Scientific Advice Meeting with the Competent Authorities to avoid misinterpretations," he concluded.

"Rapid Microbiology Methods have reached a mature state as technology. They can be essential in building and maintaining appropriate Sterility Assurance Levels in sterile manufacturing processes", said Paul Hargreaves, GMP Inspector at MHRA, UK.

“It is disappointing to see, how few sites in Europe have actually implemented such technologies, although they are relatively easy to establish in a GMP environment”, he continued. “Having inspected many sterile manufacturing premises, it is safe to say that several critical observations could have been avoided if such methods had been in place. They actually help to understand better the root cause of problems and save money in avoiding reworking or even worse recalls."

More details and essential information on microbiology issues in pharmaceutical manufacturing will be given at the PDA Conference on Pharmaceutical Microbiology, held in Berlin, Germany, 23 to 24 February 2010. To book your place at the conference please visit

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