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EMA/EC: Brexit Guidance Documents Updated

The Q&A document (Rev 4) features an overall of 37 questions – 14 of which are new. The new questions concern the topic of safety features, parallel distribution or the supervision of manufacturing sites previously supervised by UK authorities. Addressed is a situation where the UK becomes a third country on 30 March 2019 without […]

GMP Supplier Assessment Questionnaire – Personnel, Premises and Equipment

Personnel Premises and Equipment Source: The extent of supplier assessment depends on the significance of the supply. The more important the supply, the more information should be asked of the supplier to include it in the risk assessment. The GMP-Supplier Questionnaire for APIs and Excipients consists of: Part 1: Preliminary information on the supplier and […]

EMA: Brexit Preparedness Plan in Phase 4

GMP knowledge that convinces. On 7 June 2016 Maas & Peither GMP Publishing has received a SIPAward in the category “Best New Success Story” and was awarded with the 3rd place. The GMP MANUAL (now: GMP Compliance Adviser) impressed the jury with “Safe Drugs through Better GMP Understanding“.

US-EU Trade Agreement: News for the GMP sector

The existing MRA (Mutual Recognition Agreement) is to be extended to veterinary medicinal products. A detailed action plan should be available by July 2019. By 2022, the MRA shall also be extended to joint inspections of production facilities for human vaccines and plasma derivatives. The starting signal is to be given in 2019. The goal […]

When and how must OOS examinations be triggered?

The editorial staff of GMP Publishing regularly receives interesting questions on GMP regulations and their practical implementation.In today’s editorial, we answer questions on the triggering of OOS investigations with information from the GMP Compliance Adviser and further statements by a GMP inspector and a quality unit manager. As a LOGFILE subscriber, you too will be […]

GMP Compliance Adviser Update No. 1/2019

GMP Compliance Adviser Update No. 1/2019 GMP in Practice Chapter 3 Premises 3.C Airlock concepts For economic, technical or process-related reasons, high-cleanliness areas are enclosed or surrounded by areas of low cleanliness grades. This allows the areas with the highest cleanliness requirements to be reduced to a minimum, thus saving costs and minimising the risk […]

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