GMP NEWS 2017

ICH announces new E19 Guideline on Optimization of Safety Data Collection

The ICH E19 Concept Paper and Business Plan have been released. Read more about the E19 Concept Paper on Optimization of Safety Data Collection.

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FDA & EMA´s collaborative Clinical Trials Approach for rare Diseases

The European Medicines Agency (EMA) recently published a collaborative clinical trials approach together with the FDA for rare paediatric diseases. Read more about the joint proposal "Paediatric Gaucher disease - A strategic collaborative approch from EMA and FDA".

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Revised Ph. Eur. Chapter Tablets

Recently, the revised Ph. Eur. Monograph Tablets (0478) has been published in Ph. Eur. Supplement 9.3. Read more about the revised monograph on the dosage form Tablets.

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Inspectorate clarifies Responsibilities and Duties of the IMP QP

In the manufacturing and release of IMPs, not all requirements of Annex 16 can be transferred one to one. MHRA is now trying to clarify the most important questions.

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New questions and answers about safety features - Version 7 of the EU Q&As published

The soon-to-be mandatory safety features for the implementation of the Falsified Medicines Directive have to be implemented by February 9th, 2019. The European Commission has published Version 7 of the questions and answers about safety features in June 2017. Find out more about the revised Q&A document of the EU about safety features.

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

During an inspection, the french authorities found major deficiencies at the site of a Brazilian manufacturer of sterile medicinal products. Learn more details about the EMA's non-compliance report.

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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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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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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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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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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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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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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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