GMP News - Quality Assurance

08.12.21

HMPC starts Revision of GACP Guideline

The EMA committee adopted a concept paper for the revision of the Guideline on Good Agricultural and Collection Practice (GACP). Interested parties are invited to provide comments by 15 March 2022. 

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08.12.21

APIC: Update of the ICH Q7 "How to do" Document

The latest version (version 15) of the "How to do" document - Interpretation of ICH Q7 Guide and "Review form" for APIs was finalised and published on the APIC website in July 2021. It is also intended to facilitate the implementation of the ICH Q7 Guideline and provides recommendations on how to interpret it.

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08.12.21

Q&As from the EMA Webinar for Industry on Integration of EudraGMDP and OMS

At the beginning of October, we reported on important changes for entries in the EudraGMDP Database. To inform about the new developments, the EMA had organized a webinar for industry on the integration of EudraGMDP and OMS. The EMA has now published a 13-page Q&A document with 87 questions raised during that webinar.

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01.12.21

Increasing Number of FDA Warning Letters in the Area of Hand Disinfection

As a result of the increased demand for disinfectants, especially for hand hygiene, the number of inferior products with deficiencies in composition and/or approval is increasing rapidly. This is accompanied by an increase in Warning Letters from the FDA to disinfectant manufacturers.

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01.12.21

TGA: On-going use of Remote Inspections

As international travel restrictions remain in place, the TGA's GMP remote inspection programme will continue. This means remote inspections remain the only available option for certification applications during the pandemic.

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01.12.21

WHO publishes Guidance on Safe Production and Quality Control of Monoclonal Antibodies

In October, the WHO published a draft revision of the Guide for the Safe Production and Quality Control of Monoclonal Antibodies. It is a continuation of the guidance documents on this topic that have already existed since 1991.

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24.11.21

New FDA Commissioner - Online FDA Symposium available free of Charge

With Dr Robert Califf, President Biden has now nominated an expert in clinical trials who has previously served as an FDA Commissioner.

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24.11.21

HMPC adopts revised Quality Guidelines for Herbal Medicinal Products

EMA´s HMPC adopted the revised Guidelines on Quality and Specifications for herbal substances, herbal preparations and herbal medicinal products. Will a written GACP declaration for the herbal substance now become a requirement? 

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10.11.21

Fire in Production! What are appropriate CAPAs?

An interesting case of two fires occurred at an API manufacturer in the USA. This is described in a Warning Letter from the FDA that was recently published.

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10.11.21

FDA issues Warning Letter due to severe Violations of Data Integrity

Recently the FDA issued a Warning Letter due to lack of control over computer systems and violation of data integrity. During the inspection the use of multi user access to raw data files and falsification of records were observed.

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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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