GMP NEWS 2011

Official Tips for preparing an initial Drug GMP Inspection

Health Canada provides a new pre-application package to assist organisations in preparing for an initial drug GMP inspection. Read more.

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New WHO guidance for Storage and Transportation

WHO has published a model guidance for the storage and transport of time and temperature-sensitive pharmaceutical products. Read more.

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Final Report on the International API Inspection Programme published

In a press release the EMA announced the publication of a final report on the International API Inspection Programme. The report presents the results of a 2-year international collaboration between competent authorities from Europe, Australia, FDA and EDQM. Read more here.

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EMA Guideline on bioanalytical Method Validation adopted

On June 21, the CHMP adopted the Guideline on bioanalytical method validation. This guideline defines key elements necessary for the validation of bioanalytical methods. Read more here.

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EMA Position Statement on Creutzfeldt-Jakob Disease and advanced Therapy medicinal Products

In June 2011, the CHMP/CAT position statement on Creutzfeldt-Jakob disease and advanced therapy medicinal products was agreed to by the Biologics Working Party and adopted by the CHMP/CAT. Read more here.

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EMA: New Guideline on Development of Medicines for Paediatric Use

The European Medicines Agency has recently published a draft guideline on pharmaceutical development of medicines for paediatric use. Read more.

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ECA Foundation Board Annual Meeting Report

Every year the ECA Foundation Advisory Board conducts its annnual meeting to review past and determine future activities. Read more about the developments and planned activities.

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Urgent Revision of EP 5.2.8. Minimising the Risk of Transmission of animal Spongiform Encephalopathy

With date of application on 1st july, the chapter 5.2.8 of the EP about Minimising the Risk of transmission of Animal Spongiform Encephalopathy agents via human or veterinary medicinal products was revised. More details can be found here.

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Revised EU Guideline on Good Distribution Practice with major Changes

The European Commission's Directorate General for Health and Consumer Policy (DG SANCO) published the draft of the revised 'Guideline on Good Distribution Practice of Medicinal Products for Human Use' for public consultation. The guideline has been completely revised. Read more.

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ECA Analytical Quality Control Working Group - OOS SOP Development

The generation of a harmonised SOP on managing analytical deviations within the laboratory including OOS, OOE, and OOT results is the first project of a new ECA Analytical QC Working Group. In a first step the OOS Flow Chart had to be established, the second step comprised the development of an OOS SOP. Please read here for more details.

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EU Product Quality Review now also part of WHO GMP main Principles

The WHO has incorparated a new section on "Product Quality Review" in its GMP Main Principles for Pharmaceutical Products. Read more.

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New WHO Document on Transfer of Processes with detailed Guidelines for Analytical Method Transfer

The new WHO document on technology transfer also provides interesting and detailed indication for analytical method transfer. Click here to read the full news and to access the WHO document.

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ECDC - Technical Report on the Prevention of Creutzfeldt–Jakob (vCJD) published

In June the ECDC (European Centre for Disease Prevention and Control) published a technical report on the prevention of Creutzfeldt-Jakob (vCJD) disease transmission in medical settings in EU Member States and Norway. Read more.

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New PIC/S Q&A Document regarding Distribution Activities for APIs

In March, the PIC/S published a Questions & Answers document which should provide support to inspectors in two areas: APIs Distribution/Supply Chain and Repackaging/Relabelling. Read more here.

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FDA publishes SOP for "Notice to Industry" Letters for the Medical Devices Industry

The FDA Center for Devices and Radiological Health (CDRH) has published a SOP to describe how it will inform Medical Devices manufacturers about new or modified requirements/expectations by use of "Notices to Industry" Letters in the future. Read more.

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WHO in charge of Qualifying QC Laboratories for the UN

Private and governmental quality control laboratories may undergo a standardised quality assessment by the WHO to prove their compliance with the WHO requirements and therefore to be in a position to take over contracts for the UN. Read more here.

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WHO Technical Report incuding Annex 2 "Good Practices for pharmaceutical microbiological Laboratories"

The WHO Expert Committee published  their Technical Report on specifications for pharmaceutical preparations. In its Annex 2 his report includes the "WHO good practices for pharmaceutical microbiology laboratories". More details can be found here.

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FDA proposes Changes in Sterility Testing of Biological Products

In the latest edition of the Federal Register, FDA announced proposed changes in the requirements on sterility testing of biological products. Get the details here.

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New EMA Draft Guideline on Stability Data regarding Applications for Variations to a Marketing Authorisation

Because of the extensive reorganisation of applications for variations contained in the Variations Regulation from 2010, a revision of the "Guideline on stability testing for applications for variations to a marketing authorisation" became necessary. Read here, which stability testing data are required by regulatory authorities in case of applications for variations.

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EMA publishes Compilation of Community Procedures on Inspections and Exchange of Information

The European Medicines Agency (EMA) has published the new Compilation of Community Procedures on Inspections and Exchange of Information. Although primarily addressed to inspectorates, it is also an interesting document for those being inspected. Read more.

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