RMMs can help manufacturers understand problems and save money

Proposed changes to the EU Guide on variations to marketing authorisations for pharmaceuticals should simplify the variations procedure and at the same time assure patient safety and product quality, according to EMEA's Riccardo Luigetti.

Speaking at a Parenteral Drug Association (PDA) discussion forum to clarify regulatory expectations when implementing rapid microbiology methods (RMMs), Luigetti added: "Changes within the approved design space will be allowed without further regulatory review. Groups of variations to the same marketing authorisation (MA) as well variations (or a group of variations) that affect multiple MAs of the same MA holder will undergo a common assessment."

He said all this should help to implement technologies such as RMMs faster, thus reducing the risk of failure during sterile manufacturing, for example.

Gustavo Marco, pharmaceutical assessor at the UK's Medical and Healthcare products Regulatory Agency (MHRA), said 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," he said.

"I cannot emphasise enough the role of the expert summary report of the CTD written by the quality expert to clarify such inter-dependence and to justify the supporting data provided."

Marco recommended that when developing alternative RMMs, applicants should ask for a scientific advice meeting with the competent authorities to avoid misinterpretations.

"RMMs have reached a mature state as technology. They can be essential in building and maintaining appropriate sterility assurance levels in sterile manufacturing processes," added Paul Hargreaves, GMP Inspector at the MHRA.

"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 added that RMMs help pharmaceutical manufacturers understand better the root cause of problems and save money in avoiding reworking or recalls.

The PDA will provide further information on microbiology issues at its Pharmaceutical Microbiology conference being held next month in Berlin, Germany.