GMP News - Quality Assurance

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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21.10.20

Warning Letter for US Repacker: Deficienceis in Cleaning and Stabilities

A repacker in the US has recently received a Warning Letter from the FDA. The described deficiencies are repackaging of products in non-equivalent primary packaging, the lack of cleaning validation and the establishment of a suitable quality unit.

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21.10.20

Q&As Cleaning Validation - Part 2

In last week's newsletter you could read about part I of Q&As on cleaning validation - asked during ECA's first Cleaning Validation Online Training Course in September. The ECA would like to share a selection of these Q&As on Cleaning Validation - now in part II.

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14.10.20

GMP Deficiencies in Packaging

A US-American pharmaceutical manufacturer has recently received a Warning Letter from the FDA due to deficiencies in packaging and quality assurance.

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14.10.20

Q&As Cleaning Validation - Part I

In September the ECA offered the first Cleaning Validation Online Training Course - with many questions for the speaker. The ECA would like to share a selection of these Q&As on Cleaning Validation with the community.

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07.10.20

How does an Authority react if no Process Validation is available?

A successfully completed process validation is one of the basic GMP requirements for a product to be marketed. So, how does an authority react if a product is already on the market but no process validation has been carried out? The FDA provides answers in a current Warning Letter.

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