GMP News - Quality Assurance

26.01.23

FDA publishes Lists of planned Medical Device Guidances 2023

In October 2022, the Center for Devices and Radiological Health (CDRH) published a list of new guidances planned for fiscal year 2023 (1 October 2022 - 30 September 2023), as well as older guidances to be reviewed for topicality. What is planned?

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25.01.23

Risk Analyses do not always help - Example of Cross-Contamination

With ICH Q9 Quality Risk Management becoming effective, risk analyses have become the "magic word" in the GMP environment. But risk analyses do not always help. An example of this can be found in an FDA Warning Letter on the subject of cross-contamination.

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25.01.23

EMA/CMDh: Update of the Q&A Document on Nitrosamines

The Q&A document "Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products", which was jointly prepared by the EMA and the CMDh, has been updated and the latest version published on the EMA website.

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24.01.23

EMA revises Q&A Documents on the Topic of "Centralised Procedures"

In December 2022, the "Questions & Answers (Q&A)" documents relating to centralised marketing authorisation procedures were again revised and published on the website of the European Medicines Agency (EMA). The Q&A catalogues, which can be used by marketing authorisation holders and applicants of centralised procedures, provide answers to possible questions at the different stages of the centralised marketing authorisation application process.

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18.01.23

Update on the EMA Checklists for Changes & Variations

The European Medicines Agency has published pre-submission checklists for certain procedure types. In particular the Validation Checklist for Type II (non)clinical variations has now been updated.

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18.01.23

FDA signs MRA with Switzerland

The FDA has signed a Mutual Recognition Agreement on GMP inspections with Switzerland. It applies to both human and veterinary medicinal products.

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18.01.23

Clarification: UK maintains Acceptance of Batch Testing and EU-Certification

The UK government consulted stakeholders on an important decision regarding batch testing and certification. The result is that it should remain as it is.

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17.01.23

Sponsor Responsibilities with regard to Handling and Shipping of IMPs

Following the entry into application of the CTR at the beginning of last year, the final version of the "Guideline on the responsibilities of the sponsor with regard to handling and shipping of IMPs" has been published. IMPs may not be used in a clinical trial in a member state of the European Union until the completion of the two-step procedure referred to in this guideline.

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11.01.23

ICH Q3C: Corrected Version of the Guideline for Residual Solvents Published

Since the end of April 2022, the revision of the "ICH guideline Q3C (R8) on impurities: guideline for residual solvents" of the ICH can be consulted on the ICH website under the heading "Quality Guidelines". This version has now been corrected and published in the new form.

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14.12.22

FDA Warning Letter: Data Integrity and Good Documentation Practice Failures

In November 2022, the U.S. FDA issued a Warning Letter to the U.S. American company Kari Gran Inc. after having inspected its site in July 2022. The Warning Letter mentions the list of cGMP observations for finished products.

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14.12.22

USP issues Chapter "Elemental Impurities-Limits" for Comments

The second revision of the ICH "Guideline for Elemental Impurities Q3D(R2)" was finalised in April 2022 and is available on the ICH website under the heading "Quality Guidelines". As a result of this revision, the chapter "<232> Elemental Impurities-Limits" of the USP has now been revised and published for comments on the USP Pharmacopeial Forum website.

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14.12.22

Danish Authority updated Document on Requirements for a QP

The Danish Medicines Agency has revised its guidelines on the requirements and expectations of the QP. In places, these deviate from the requirements of Directive 2001/83/EC, especially with regard to education and experience.

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13.12.22

Amendment to the CTR on IMP Labelling

The European Commission (EC) amended the current requirements provided in the Clinical Trials Regulation (CTR) for the labelling of investigational medicinal products (IMPs) regarding expiry dates by means of a Delegated Regulation.

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07.12.22

FDA Warning Letter: Too low Ethanol Content in Hand Sanitizer Products

There has been a recent accumulation of Warning Letters from the U.S. Food and Drug Administration (FDA) to manufactures of hand sanitizer products. At the end of November, a further letter was published. In this case, FDA laboratory analyses showed that the ethanol content of several batches was too low. In addition, the FDA has also found numerous GMP violations. There was already a lack of the necessary basic SOPs.

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07.12.22

Cleaning in 6th Place in the FDA Warning Letter Statistics

The ECA regularly provides evaluations of the FDA Warning Letters per fiscal year. In 6th place in the fiscal year 2022 (Oct. 2021 - Sept. 2022) are deficiencies regarding the topic of cleaning/cleaning validation. What was found?

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