In-Pharmatechnologist.com’s GMP regulatory development roundup
Health Canada has published a new guidance package designed to help would-be drugmakers, those which have applied for the right to manufacture pharmaceutical products, prepare for initial GMP inspections by auditors from its Establishment Licensing Unit.
In the document the agency explains that the aim of such visits, which occur within three months of the application, is to “assess compliance with Division 2 Part C of the Food and Drug Regulations” under the countries Food and Drugs Act.
Health Canada goes on to detail what a ‘typical’ inspection involves from the opening scheduling meeting and premises tour to the assessment phase, documentation review and closing and exit meetings.
Meanwhile on the other side of the Atlantic the European Medicines Agency (EMA) has added new requirements to its batch certification protocols in a bid to harmonise the rules on products shipped between countries where mutual recognition agreements (MRA) apply.
The revision, to part three of the EU guide, requires that each drug batch transferred between countries with reciprocal GMP rules must be accompanied by a certificate issued by the manufacturer in the exporting country.
“The respective certificate should be issued further to a full qualitative and quantitative analysis of all active and other relevant constituents to ensure that the quality of the products complies with the requirements of the marketing authorisation of the importing country.”
“It shall attest that the batch meets the specifications and has been manufactured in accordance with the marketing authorisation of the importing country. The batch certificate should be signed by the person responsible for certifying that the batch is suitable for release for sale or supply/export. For the EU, that's the Qualified Person (QP).”
The EMA goes on to explain that the revision applies to all countries covered by European MRAs and Israel under the Agreements on Conformity Assessment and Acceptance of Industrial Products (ACAA) and other appropriate arrangements on GMP with the European Union.
Also in Europe the European Directorate for the Quality of Medicines (EDQM) has published its findings on the use of membrane technologies for the production of water used for injections (WFI).
The organisation, which has been discussing the use of membrane systems for the production of WFI for more than a decade, said that it is prepared to discuss use of this approach in combination with other testing methods.
This is something of a step forward for the EDQM which has previously voiced concerns that making WFI using reverse osmosis-based processing is not sufficient enough to ensure it is free of microbiological contamination.
“In contrast to the workshop organized in 1999, the representatives from regulatory authorities considered that sufficient reasons had been provided for the European Pharmacopoeia Commission to recommend initiating discussions regarding potential use of membrane systems for the production of Water for Injections.
“However, such discussions would have to consider the points highlighted during the workshop regarding a revision of the current specifications and the introduction of additional methods and requirement to deal with the contaminants likely to be present in such systems and ensure an acceptable safety level of the material produced."
