GMP News - Quality Assurance

17.02.22

How to handle Expiry Dates under the CTR

The reflection paper on the use of interactive response technologies (IRT) has been updated in view of the entry into application of the EU Clinical Trials Regulation (CTR) on 31 January 2022. It clarifies that the removal of expiry dates from the labels is not allowed for clinical trials conducted under the CTR.

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17.02.22

PIC/S revises GMP guide to reflect EU Clinical Trials Regulation

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) revised its GMP guide to reflect the EU Clinical Trials Regulation, which became applicable on 31 January 2022. In addition, a new PIC/S Annex 16 on the certification by the authorized person and batch release has been included.

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16.02.22

US Gov. Office asks FDA to improve Foreign Inspection Program

The US Government Accountability Office (GAO) has released a report to Congress entitled "FDA Should Take Additional Steps to Improve Its Foreign Inspection Program".

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16.02.22

EMA updates Questions and Answers Document

Do active substances for veterinary medicinal products have to fulfil the same GMP requirements for active substances for human medicinal products? This is just one of the new questions in the EMA Q&A document.

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16.02.22

Herbal Drugs: Ph. Eur. Cannabis Monographs and other relevant Topics

EMA´s Herbal Medicinal Products Committee (HMPC) released the minutes for the HMPC meeting held in November 2021. Amongst others, the HMPC noted three new Ph. Eur. Cannabis Monographs for flowers and extracts in the pipeline. Other relevant topics were nitrosamines, GACP revision and elemental impurities in herbal medicinal products.

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09.02.22

ECA publishes Contamination Control Strategy Guideline

In order to support its members, but also to support the industry in general in implementing the requirement of the upcoming revised Annex 1 for a Contamination Control Strategy, the ECA has published a CCS Guideline. This document provides guidance and a template for the development of a contamination control strategy.

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09.02.22

EU: Strengthening the EMA

A regulation strengthening the role of the EMA in crisis preparedness and management has been published in the Official Journal of the EU. The document also assigns several new tasks to the EMA.

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09.02.22

Nitrosamine Drug Substance-related Impurities: FDA Recommendations for Minimising Risks through Formulation Design Changes

To prevent the formation of nitrosamines and establish an effective control strategy, it is necessary to consider all possible risks as comprehensively as possible. A communication from the FDA provides information on the risks that can arise from the formulation of the medicinal product and what needs to be considered when formulating a product. 

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09.02.22

Will the EU Concept of the QP spread the World?

The PIC/S has adopted the EU GMP Annex 16 and asks Member State authorities to implement it.

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02.02.22

Cleaning Validation from the FDA's Point of View

The requirements for cleaning validation are not very clearly defined in the US GMP regulations 21 CFR 210/211. Even a Guide to Inspection on this topic dating back to the 1990s does not represent the FDA's current interpretation. Current Warning Letters on the subject of cleaning validation are helpful here.

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02.02.22

GMP Requirements for Supplier Qualification

Supplier Qualification is more than auditing. Supplier qualification can be seen as a risk assessment tool. But what are the exact requirements?

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27.01.22

EU restructures Website on Medicinal Devices

A very helpful source of information on the regulation of medical devices is the website of the EU Commission. This has now been restructured. How does the new structure look like? 

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27.01.22

EMA publishes Guidance on Companion Diagnostics

As May 2022 approaches, the need for guidance on the In Vitro Diagnostics Regulation (IVDR) is growing. Regarding the topic of companion diagnostics, the EMA published a draft document at the end of last year about the consultation procedure between the EMA and a Notified Body.

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27.01.22

FDA Audit Policy for Medical Devices: a Comprehensive Document

In the field of medical devices, the Medical Device Single Audit Program (MDSA) is accepted and even mandatory in some countries. Now, the FDA has published a very comprehensive policy on this audit approach consisting of 215 pages. 

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26.01.22

FDA: Delays in Resumption of Inspections

The FDA announced that the agency is adjusting its planned inspection activities to the spread of the Omicron variant and has therefore temporarily postponed certain inspection activities.

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