GMP NEWS 2018

USP chapter on packaging and storage revised

New suggestions by the USP on chapter <659> have been published in the Pharmacopeial Forum (PF) 44 (4). It addresses plastic packaging as well as the regulations and requirements for child-resistant packaging. Read more about chapter <659> - Packaging and Storage Requirements in this article.

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Revised FDA Guidance on the validation of analytical methods

After five years and thorough revision, the FDA Guidance "Bioanalytical Method Validation" has been finalised. Read here what requirements the FDA lays down for a completely validated bioanalytical procedure.

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Post-Approval Change Management - Does ICH Q12 offer a solution?

ICH Q12, currently in draft form for public consultation, provides an opportunity to save time and money associated with regulatory submissions. Read more about "new" lifecycle tools and enablers for global post-approval change management provided in the proposed guideline on "Life Cycle Management".

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21st Edition of the GMP Matrix Published

Published in its 21st edition by now, the GMP Matrix has been a recognised standard for GMP auditors or QA units since 2005, and not only in multinational companies. The Matrix juxtaposes the US cGMP requirements as per CFR 210/211 with the EU GMP Guidelines. What has changed in recent years in particular?

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Being inspected by ANVISA?

Quite a few supervising authorities in the health care sector come for GMP inspections also to foreign countries. Read what the Brazilian ANVISA and the Mexican COFEPRIS will expect.

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Two FDA warning letters to manufacturers of creams

The US Food and Drug Administration (FDA) recently issued  two warning letters to a contract manufacturers based in Australia and a Korea-based drugmaker.

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FDA Drafts on Shared System REMS

The FDA published two new draft guidelines on Risk Evaluation and Mitigation Strategy (REMS) for sponsors of clinical trials. Read more about the draft documents on developing a shared system REMS, and waivers associated with the single, shared system REMS requirement.

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Highly Purified Water (HPW) Monograph to be suppressed

The EDQM has announced the suppression of the Highly Purified Water (HPW) Monograph (1927) in 2019. This was justified with the revision of the European Pharmacopoeia which now allows non-distillation methods for the production of water for injection (WFI). As a consequence, the monograph became redundant.

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No more EU Audits in the US?

EU inspectorates already accept inspections of the FDA at US sites. But there will still be auditors coming from the EU to the US.

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IMPs: EMA updates timeline for portal and database

The EMA has announced a new timeline for the application of the Clinical Trials Regulation due to EMA`s move to Amsterdam because of the Brexit.

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Ireland’s HPRA Guide for Sponsors of Clinical Trials

Ireland’s Health Products Regulatory Authority (HPRA) recently shared an advice for Academic Sponsors and has updated its guide to clinical trial applications.

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GCP: FDA Draft on Data Integrity in Clinical Studies

The FDA published a draft guidance on Data Integrity in clinical studies of veterinary medicinal products to support new animal drug applications. Read more about the documentation of  Electronic Data Files and Statistical Analysis Programs.

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Revised Annex 17: RTRT and Parametric Release

The revised Annex 17 of the EU GMP Guide has been publised and will come into operation on 26 December 2018. Read more about the guideline on Real Time Release Testing and Parametric Release.

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New: ICH Q13 supports continuous manufacturing

On 22 June, it became official: the International Council for Harmonisation (ICH) announced in a press release that with the new Guideline ICH Q13, they would support the introduction of continuous manufacturing processes into the pharmaceutical industry.

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Lack of OOS investigation leads to FDA Warning Letter

Chinese manufacturer of active pharmaceutical ingredients Jilin Shulan Synthetic Pharmaceutical received an FDA warning letter in May 2018. It was criticised in particular that the Company did not record, investigate and solve laboratory OOS results. It was also criticised that the Audit Trails of the electronic laboratory instruments (HPLC, GC, IR) were not enabled. Find out more about the Jilin Shulan Synthetic Pharmaceutical Warning Letter.

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The Return of FDA's Quality Metrics Programme

The US FDA announced two updated programmes: the Quality Metrics Feedback Program and the Quality Metrics Site Visit Program.

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FDA publishes ICH Q12 for comment

The US Food and Drug Administration (FDA) recently made available the ICH Q12 draft guidance on "Product Life Cycle Management" together with its Annex.

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Batch Release without a QP - Is this possible?

Batch certification by a QP is one of the essential requirements in the EU GMPs. However one company in Spain has released products to the market without the QP - with reasonable consequences.

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Brexit: Two new Documents published by EMA

The European Medicines Agency (EMA) has published two updated documents on U.K.´s withdrawal from the EU - giving a lot of new Questions and Answers on Brexit.

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New ICH Guidelines: ICH Q13 on Conti Manufacturing and ICH Q14 on AQbD

In a press release from 22 June 2018 the International Council for Harmonisation (ICH) has announced that they will prepare new topics for the future that are of great importance for the pharmaceutical industry. The Council intends to begin developing the ICH Guidelines Analytical Procedure Development and Revision of Q2(R1) Analytical Validation (Q2(R2)/Q14)" and "Continuous Manufacturing (Q13)". Find out more about this important ICH Press Release.

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