GMP NEWS 2021

Revision of USP <831> Refractive Index

A new draft of USP Chapter <831> Refractive Index has been published for comments in the current Pharmacopeial Forum, PF 47(3).

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GMP: Are there "planned" Deviations?

One discussion we have again and again in seminars is the question of planned variations. But such terminology can lead to problems.

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What are the requirements for an eCRF?

What is an eCRF? The MHRA GCP Inspectorate recently informed about the requirements for eCRFs (electronic case report forms). In addition they listed several findings from current GCP inspections.

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MHRA establishes own GMDP Database

The UK MHRA has established a new GMDP database with information issued by the MHRA and from EudraGMDP relating to manufacturing, wholesale authorisations and certificates and non-compliance statements.

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FDA Report on Impact of Pandemic on Inspections

From March 2020 to March 2021, the FDA carried out 821 mission-critical inspections, but only 49 of these were in the area of "Human Drugs". A recent report provides details and an outlook.

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New Version of WHO Guidelines on Process Transfer Published as a Draft

The WHO has recently published a new version of its guidelines on the transfer of technology as a draft. Many new chapters have been added to the previous document.

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ATMP - Critical Deficiencies during an Inspection in the Netherlands

An inspection by the Dutch authority in February revealed a number of deficiencies at a manufacturer of advanced therapy medicinal products (ATMPs). The Non Compliance Report that was published shows which of these were critical.

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GMP for Advanced Therapies (ATMP) - Many Questions and some Answers

With the development of more and more guidance documents in the field of ATMP, new questions arise. The EMA has therefore published a Q&As paper on the GMP requirements for ATMPs.

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Revision of the PIC/S Guidelines for ATMPs and Biological Medicinal Products

In order to take account of the rapid development in the field of biological medicinal products and ATMPs, the PIC/S has revised Annex 2 of its GMP Guideline and made it available for comment.

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FDA Warning Letter for Colombian API manufacturer

In April 2021, the U.S. FDA issued a Warning Letter to a Colombian API manufacturer due to significant violations of cGMP regulations for Active Pharmaceutical Ingredients (APIs).

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Ph. Eur. Essential Oils: Revised Monograph and New General Chapter

The European Pharmacopoeia (Ph. Eur.) Commission, adopted the revised general monograph on Essential oils and a new chapter on Monographs on essential oils.

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EMA confirms full functionality of CTIS - on track to go live January 2022

Last week, the EMA confirmed that the clinical trial EU Portal and Database (Clinical Trial Information System (CTIS)) is now fully functional and on track to go live by 31 January 2022.

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Covid-19 Vaccine Mix-Up in the US - what's behind it?

It has been recently reported in the press that there was a mix-up in the manufacturing of the J&J Covid-19 vaccine at a contract manufacturer. Already one year before, considerable quality deficiencies were found at the site. Now the site had to stop producing for now.

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APIC: Update of the "Cleaning Validation" Guide for APIs

The new version of APIC's document "GUIDANCE ON ASPECTS OF CLEANING VALIDATION IN ACTIVE PHARMACEUTICAL INGREDIENT PLANTS" was finalised in February 2021 and is now available.

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Questions & Answers on Good Distribution Practices (GDP) - Part 3

In October 2020, the ECA Academy offered the Live Online Training "The GDP Compliance Manager". During the Q&A sessions, many interesting questions were posed to the speakers' team. The ECA would like to share a selection of these Q&As sorted by topic. Part 3 deals with questions related to the Quality Management System (QMS).

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GDP-Non-Compliance-Report for German Wholesale Distributor

The Competent Authority of Germany (Bezirksregierung Düsseldorf) has entered a new GPD Non-Compliance Report dated into the EudraGMDP database due to serious GDP violations at a German wholesaler. The case involves trading of falsified medicinal products and storage of expired medicinal products in regular stock. Furthermore, there are doubts on the reliability of the Reponsible Person and the CEO due to an ongoing criminal procedure.

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GDP Non-Compliance Report for Romanian Wholesale Distributor

The competent authority of Romania (National Agency for Medicines and Medical Devices of Romania) has entered a new GPD Non-Compliance Report dated 15 April 2021 into the EudraGMDP database.

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FDA publishes Guidance for Remote Interactive Evaluations - but not to replace Inspections

Teleconferencing, livestreaming sessions and screen-sharing technologies will be used by the FDA in future remote evaluations- but these remote evaluations will not be considered inspections.

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No Distribution of CBD Products Allowed?

According to recent decisions of two Administrative Courts in Germany, Berlin and Hamburg, food supplements containing cannabidiol may not be marketed without further action.

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Track & Trace: Amendment of the Delegated Regulation on Safety Features

On 17 March 2021, the Delegated Regulation (EU) 2021/457 was published in the Official Journal of the European Union. It amends the Delegated Regulation 2016/161 regarding an exemption from the obligation for wholesalers to decommission the unique identifier (UI) of medicinal products exported to the UK.

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