GMP News 2017

Distribution to the US: quicker Import Decisions

FDA's new automated system to assist in making import decisions for FDA-regulated products seems to shorten up processing time, according the agency. Learn more about the FDA Automated Commercial Environment/International Trade Data System.

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Loophole in GDP Legislation puts Medicinal Products at Risk

The European Institute for Pharma Logistics (EIPL) conducted a field study on drug deliveries by online pharmacies - with some alarmingly results. Find out more about the EIPL field study.

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Do Manufacturers need Pharmacovigilance (PV) Agreements with Wholesalers?

Marketing Authorisation Holder (MAH) might require Pharmacovigilance Agreements with Wholesale Distributors according to the U.K. Medicines and Healthcare products Regulatory Agency (MHRA).

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Non-Compliance Report for manufacturing of three Products at Biocon, India

The European Medicines Agency (EMA) and the French Agence nationale de sécurité du médicament et des produits des santé (ANSM) published a Non-Compliance Report after a Pre-Approval Inspection for three biosimilar products of Biocon Limited in Bangalore, India.

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How to prepare for a Data Integrity Inspection

Data governance and integrity have been getting more and more in the focus of regulatory inspections. But companies can prepare for these inspections. Find out how planned and periodic internal audits can help companies to prepare for regulatory inspections.

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Brexit: EMA prioritises Activities

The European Medicines Agency (EMA) expects some uncertainty and higher workload because of the Brexit. Now, the EMA has defined three categories to prioritise activities in a business continuity plan.

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FDA Warning Letters and EU Non-Compliance Reports after Inspections of API Plants - a Comparison

Just like the FDA's Warning Letters which have been publicly available for many years, the EU non-compliance reports are also accessible now for some time past. Therefore, it's interesting to take a look at those deficiency reports which have been addressed to the same manufacturer. Read here which GMP violations by manufactureres of APIs were found by FDA as well as EU GMP inspectors.

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EMA updates Guidance for Post-Authorization Activities

The EMA announced on July 14, 2017, that it has revised three post-authorization activity guidance documents, including type II variations, post-authorization safety studies and changes related to quality aspects. Read more EMA´s updated post-authorizaiton guidelines.

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Missing OOS Trending leads to FDA Warning Letter

The India-based pharmaceutical manufacturer Mylan Laboratories received a Warning Letter by the FDA in April 2017. The FDA inspector found that over 70% of initial OOS results were invalidated without sufficient investigation to determine the root cause of those OOS results and that there was no appropriate trending. Get more information about the Mylan Laboratories FDA Warning Letter.

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USP monograph <1790> "Visual Inspection of Injections" comes into force

The long-awaited new monograph <1790> of the US Pharmacopoeia about the visual inspection of injections, which is supposed to be an explanation for the already valid chapter <790>, will finally come into force on August, 1st. Read more about the new Visual Inspections Monograph.

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Comment Period Extended for USP Packaging General Chapters Appearing in PF 43(3)

The comment period  for USP Packaging (and Materials) General Chapters appearing in PF 43(3) has been extended to September 30, 2017. Read more about new and revised USP Packaging Chapters.

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EMA non-compliance report on Indian manufacturer of sterile medicinal products

During a pre-approval inspection, the French supervisory agency found major deviations by an Indian manufacturer of sterile medicinal products. Find out more details about the EMA's non-compliance report here.

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API starting materials: EMA publishes updated reflection paper

In the recently published updated EMA reflection paper about starting materials, the passage about description of the manufacturing process of an API in an authorisation dossier has been revised. Read more on how to deal with intermediates along the synthesis route which are already monographed in the Ph. Eur. or part of an already authorised product.

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The API warning letters of the last 21 months - facts and trends

The warning letters issued to API manufacturers, viewed over a period of one and three quarter years, repeatedly point to fundamental deficiencies. Read here which GMP violations concerning quality assurance, quality control and data integrity were criticised by the FDA inspectors.

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The MRA between Japan and EU will be extended

The Mutual Recognition Agreement on GMP products (MRA) between the EU and Japan will soon be amended to include APIs, biologics, and vaccines.

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Heparin in the FDA's Focus once more: Warning Letter for Chinese Contract Lab

Despite many regulatory initiatives resulting from the heparin scandal, inspections still discover companies linked to contaminated heparin. Read more about the GMP violations concerning the analysis of heparin and the handling of raw data in a Chinese contract laboratory.

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EMA's updated Implementation Plan for the Introduction of Safety Features

The soon-to-be required safety features for the execution of the Falsified Medicines Directive have to be implemented by February 9th, 2019. The EMA has published an updated plan for the implementation of safety features on the packaging of centrally authorized products for human use. Read more about the EMA's implementation plan for safety features.

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FDA Warning Letter for inadequate Batch Record Review

The US Food and Drug Administration (FDA recently posted a Warning Letter for a Chinese API manufacturer criticising the quality unit for not exercising its responsibility adequately.

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What is GMP compliant Equipment Design?

It's a frequent question what GMP compliant equipment design is or how a system has to be made up in order to be GMP compliant and suitable for the manufacturing of medicinal products/APIs. There is a short and a long answer to these questions around GMP compliant equipment design.

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ECA Visual Inspection Group Chairman appointed to EDQM Expert Group

Dr Tobias Posset, Head of Production Support at Roche Diagnostics in Mannheim, Germany and chairman of the ECA Visual Inspection Group, was recently appointed into expert group 12 of the EDQM (European Directorate for the Quality of Medicines & Health Care). Amongst other things, this expert group develops recommendations for the revision of monographs concerning visual inspection. Learn more about Dr Posset's appointment to the EDQM Expert Group.

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How to use Freezers and Refrigerators

In a recent post MHRA describes some of the main issues with freezers used by pharmaceutical wholesalers.

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GDP: Questions & Answers about the Scope of the EU-GDP Guidelines

Do the EU-GDP Guidelines apply for Veterinary products and IMPs? These questions are answered in a new set of Q&As of the European GDP Association.

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Comprehensive Overview on WHO Storage and Transportation Guidelines

The European GDP Association has now put together WHO's GDP documents to provide a better overview and easier access.

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Glass Particles due to Delamination

The formation or flakes of glass particles on the inside of glass containers is referred to as delamination. These glass fragments, created by the interaction of the solution with the container walls, can pose a risk, especially when it comes to parenterals.

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WHO's Position on the Import Alert for a Chinese API Manufacturer's Products

When an inspection unearths severe GMP violations, the FDA sometimes issues a ban on imports for the concerned products of a company. Read here what conflicts can arise when such an import alert concerns APIs of a Chinese manufacturer which were classified as prequalified in an inspection by the WHO beforehand.

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