The Parenteral Drug Association (PDA) has held a debate on implementing rapid microbiology methods with representatives from European health authorities, such as the European Medicines Agency (EMEA).
During the discussion forum, health-authority representatives revealed continuing discussions within EMEA working groups on procedures to better enable improvements.
As a result of legislation passed by the European Parliament and in cooperation with the European Commission, changes have been made to the EU Guide on Variations to marketing authorisations (MAs).
One option under evaluation by the EMEA was the introduction of preauthorised, post-approval change management plans and protocols.
Dr Riccardo Luigetti of the EMEA said: 'The purpose of the changes, which 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.
'Changes within the approved Design Space will be allowed without further regulatory review 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 such as rapid microbiology methods faster, thus reducing the risk of failure during sterile manufacturing, for example,' he added.
According to Dr Gustavo Marco, pharmaceutical assessor at MHRA, data from suppliers, such as equipment manufacturers, are needed to assess the appropriateness of claims made in MA applications.
He said: '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 emphasise 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.
'In case of doubt or before embarking into a resource-consuming endeavour such as developing alternative rapid microbiology methods, I recommend applicants to ask for a scientific advice meeting with the competent authorities to avoid misinterpretations,' added Marco.
Paul Hargreaves, GMP inspector at MHRA, said: '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.
'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.
'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,' he added.
More details and information on microbiology issues in pharmaceutical manufacturing will be given at the PDA Conference on Pharmaceutical Microbiology, which will be held in Berlin, Germany, on 23-24 February 2010.
