GMP News - Quality Assurance

02.12.20

EMA Publishes New Q&A Guide on Brexit

There are only a few days left until the UK will leave the EU. On 01. January 2021 the UK will be considered a "Third Country" with massive consequences for the GMP environment for medicinal products and APIs. Now the EMA published a new Question and Answer Document which clarifies a number of questions which have been raised during the Brexit negotiations. Please read more about EMAs Q&A Document

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25.11.20

Covid-19: Swissmedic adapts Inspections

Swissmedic inspections may be carried either out on-site, (partly) by means of remote assessments or at a later point in time.

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18.11.20

Brexit: Phased Process for implementing Medicines Regulation in Northern Ireland

An agreed approach had been reached on a phased process for implementing medicines regulation in Northern Ireland up to 31 December 2021.

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18.11.20

Does GMP apply to Development?

In view of the recent need for the fast development of medicinal products for COVID-19, the World Health Organization (WHO) published a new guideline on Good Manufacturing Practice (GMP) for development batches. According to the WHO, there are currently no regulatory guidelines available which address this matter.

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11.11.20

WHO Draft Document on GMP for IMPs

In view of recent experiences from inspections carried out for COVID-19 therapeutics, the World Health Organization (WHO) published a new working document entitled "GOOD MANUFACTURING PRACTICES FOR INVESTIGATIONAL PRODUCTS".

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11.11.20

What do Authorities expect from Cleaning in the GMP Area?

Cleaning is an important process step in the field of pharmaceutical production. So what are the requirements for GMP-compliant cleaning from the perspective of the authorities? A current FDA Warning Letter provides information on this.

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11.11.20

French Cannabis Specifications and Quality Requirements

The French Ministry of Health has published the specifications and quality requirements for medical cannabis in the pilot phase. The document covers flowers, extracts and finished products for oral, sublingual and inhalation use (including devices).

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04.11.20

OOS, Complaints also need CAPA Plans

Some companies still might think that only deviations lead to corrective and preventative actions (CAPA). But that is not true, as a recent FDA Warning Letter points out.

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04.11.20

Labelling and Packaging Flexibilities for Covid-19 Vaccines

To facilitate the rapid deployment of the vaccine the European Commission (EC) recently published a document regarding labelling and packaging flexibilities for COVID-19 vaccines.

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04.11.20

Can Cannabis be Imported into the EU without GMP Certification?

The answer to this question is: It depends. Recently, medical cannabis grown in a non-EU-GMP-certified facility in Uruguay became available on the German market.

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04.11.20

Regulatory Requirements for Ongoing/Continued Process Verification

With the coming into force of the FDA Process Validation Guideline 2011 and the revision of Annex 15 (2015), the process life cycle has become state of the art in the field of validation. What does this mean in practice?

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28.10.20

Brexit: MHRA updates Guidance

MHRA has issued/ updated a set of guidance documents for UK companies, which will also have impact on EU companies supplying medicines into UK.

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28.10.20

FDA and Design Qualification

The term Design Qualification is not used in the current FDA Guidance on Process Validation. However, it is addressed that the design of a facility plays a role within the scope of a qualification. Moreover, in a current Warning Letter the FDA criticizes design deficiencies in a water system.

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28.10.20

Track and Trace: What to do with Recalls?

When complying with the requirements of the Anti-Counterfeiting Directive, the status message "recall" for recalled batches is of great relevance for the entire supply chain. What has to be considered here?

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21.10.20

MHRA joins Consortium of Regulators - without EU

The British MHRA has joined an Australia-Canada-Singapore-Switzerlan Consortium to explore opportunities for information and work-sharing.

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