GMP News - Quality Assurance

10.11.21

Testing into Compliance - FDA Warning Letter due to non-compliant GMP Invalidation of OOS results and Falsification of Data

A few but fundamental GMP requirements for pharmaceutical quality control laboratories are a frequent focus of regulatory inspections. During a visit to a U.S. contract laboratory, FDA inspectors found serious deficiencies in these requirements, resulting in a Warning Letter due to inadequate handling of OOS results, lack of electronic system security and data manipulation.

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03.11.21

EU: Important Document for Inspections revised

The EU Commission has published a revision of the "Compilation of Union Procedures on Inspections and Exchange of Information". This is the eighteenth revision. It mainly involves editorial changes, a few adjustments and two new documents.

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03.11.21

Contract Manufacturing as a Topic in a new Warning Letter

Supplier qualification, contracts and quality oversight are also important to the FDA. This is reflected in a recent Warning Letter from the authority.

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27.10.21

GMP Inspections: Do you know IRIS?

In the course of an expansion, the IRIS platform will also be used by marketing authorisation holders and applicants to communicate with the EMA about GMP inspections.

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27.10.21

Inspection Deficiencies in Process Equipment increase

The US FDA reports deficiencies during inspections in the so-called Form 483s. These reports are partly public, and the FDA subjects them to trending by key points. The evaluation of the last year 2020 shows a significant increase in inspection deficiencies with regard to equipment.

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27.10.21

Particles lead to Warning Letter for Japanese Sterile Manufacturer

The frequent occurrence of particles in sterile injection solutions and the inadequate investigation of the cause led to a Warning Letter to a sterile manufacturer in Japan. In addition, data integrity breaks and falsifications had occurred in the environmental monitoring.

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21.10.21

New Limits for Heavy Metals in Food Supplements

The European Commission sets new limits for Cadmium and Lead in certain Foodstuffs and Food supplements. Products placed on the market before the entry into force of the new regulations and not complying with the new maximum levels should only be allowed to remain on the market for a limited period of time.

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20.10.21

Northern Ireland: EU accommodates Great Britain

The European Commission has proposed further arrangements to respond to possible difficulties in the movement of goods between Northern Ireland and Great Britain

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19.10.21

Update on UDI Requirements

The FDA has published a draft Guidance for Industry with the title "Selected Update for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices". What will come?

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13.10.21

FDA criticizes Manual Visual Inspection

In a recent Form 483 issued as part of an FDA inspection conducted at an Indian sterile manufacturer, the FDA criticized the manual visual inspection, among other things.

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13.10.21

Aide-Memoire from the PIC/S regarding the Inspection of Quality Risk Management

The PIC/S has developed a stand-alone Aide-Memoire (PI 038-2) on Quality Risk Management (QRM) for GMP inspectors. The aim of the document is to provide guidance to GMP inspectors on the inspection of QRM systems in the pursuit of harmonisation.

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06.10.21

New FDA Draft Guidance - Microbiological Quality Control of Non-Sterile Medicinal Products

Based on the experience of the past years, the FDA has published a new draft guidance that deals with the microbiological control of non-sterile medicinal products and clarifies it by means of case studies.

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06.10.21

EU: further Extension of GMP and GDP Certificates

The EU will extend GMP and GDP certificates until the end of 2022 due to ongoing pandemic restrictions. The relevant document has been updated for this purpose.

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06.10.21

Important Change for Entries in EudraGMDP Database

The new regulatory framework for veterinary medicinal products requires several changes to the EudraGMDP database. One important change is the integration of EudraGMDP into the EMA's Organization Management Service (OMS).

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06.10.21

USP Chapter on Impurities in Food Supplements

USP´s Expert Committees for Non-Botanical & Botanical Dietary Supplements and Herbal Medicines propose the elaboration of a new USP general chapter <2760> on impurities in food supplements.

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