GMP News - Quality Assurance

13.07.22

GMP vs GACP: BfArM Makes some Clarifications

The German BfArM now clarified for medical Cannabis Manufacturers: A valid GMP certificate must be included with the drying step.

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06.07.22

EMA Annual Report published

The recently published EMA Annual Report 2021 gives a good overview of the Agency's activities in the first chapter, such as actions related to the management of the COVID 19 pandemic, work related to the scientific evaluation of medicinal products and their monitoring.

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06.07.22

Drug Shortages: EMA asks Companies to register a Single Point of Contact

Marketing authorisation holders should register a central contact point to inform the EMA about the availability of certain critical medicines.

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06.07.22

EDQM: List of Reference Standards Updated

Once again, the list of reference standards, which includes more than 3,000 substances, has been revised and the resulting changes and innovations have been listed in the Newsroom of the EDQM website.

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30.06.22

Benefit-Risk Assessment for Product Quality Evaluation

Before approving an application, the FDA must determine whether the drug product is both safe and effective for use. A new draft guidance describes the FDA principles when conducting product quality-related assessments of CMC information.

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29.06.22

MHRA (UK) now also a full ICH Member

The United Kingdom (UK) becomes a full member of three international associations, including the International Council for Harmonisation ICH.

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21.06.22

Draft on Labeling Requirements for IMPs Published

With the application of the EU Clinical Trials Regulation some labelling requirements for IMPs have changed, in particular regarding the expiry date. Now an initiative eliminates the obligation to include an expiry date on the immediate packaging of IMPs in specific circumstances.

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15.06.22

EFPIA Member Survey on Current Inspection Trends

The EFPIA has published its "Annual Regulatory GMP/GDP Inspection Survey 2021 Data". With some interesting results that perhaps not everyone would have expected.

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15.06.22

GMP Deficiencies in the Sterile Area

In a Warning Letter addressed to a US-American pharmaceutical manufacturer, the FDA points out various deficiencies in aseptic production. Among other things, deficiencies are described in the design of equipment and rooms, airflow and visual inspection.

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15.06.22

Interpretation of 21 CFR 211.67 Cleaning of Equipment

The US-American GMP regulations for medicinal products are laid down in 21 CFR 211. Section 21 CFR 211.67 requires the establishment of and adherence to written instructions regarding the cleaning and maintenance of equipment. What is exactly meant by this?

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08.06.22

MHRA introduces external consultants as Compliance Monitors in Companies

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched a pilot project for a new Compliance Monitor Process. External consultants are being used for this purpose.

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25.05.22

FDA plans Rating System for pharmaceutical Companies

The FDA is planning a programme to assess and classify manufacturing sites using surveillance data and company participation. A central point here is also the so-called Quality Culture.

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18.05.22

EMA tackles the Issue of Remote Batch Certification

EMA has today published a draft question and answer document on the remote certification of batches by the Qualified Person (QP).

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18.05.22

FDA Warning Letters for Products Containing CBD and Delta-8 THC

The FDA issued several Warning Letters to companies for illegally selling CBD products and products labeled as containing delta-8 THC. Violations include the marketing of unapproved new drugs, misbranding, and adding delta-8 THC to food products.

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11.05.22

Classification of Packaging Changes

Recently, the CMDh has added a recommendation for the classification of a proposed packaging change to the list of unforeseen variations ("Article 5 Recommendations"). What is the recommended category for a change of the “total thickness” for a blister foil?

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