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.
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.
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.
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.
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.
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.
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.
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.
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?
Broader Acceptance of GMP Inspection Reports from PIC/S Countries
Some authorities within the PIC/S want to mutually recognise GMP inspection reports in order to avoid duplication of work. There is now a corresponding statement on this.
FDA Warning Letters of the Fiscal Year 2022: the "Top Ten" GMP Deficiencies
The analysis of the Warning Letters sent out in fiscal year 2022 offers a revealing overview of what FDA inspectors find when they visit the production facilities of medicinal product manufacturers. Read more about the "Top Ten" GMP violations.
APIC: New Update of the ICH Q7 "How to do" Document
The latest version (version 16) of the "How to do" document - Interpretation of ICH Q7 Guide and "Review form" for active pharmaceutical ingredients was finalised in July 2022 and published on the new APIC (Active Pharmaceutical Ingredients Committee) website at the end of October. The document further on aims to facilitate the implementation of the ICH Q7 Guideline and provides recommendations on how to interpret it.
FDA criticises Root Cause Analysis and CAPA in a Warning Letter
In a Warning Letter to a US manufacturer, the FDA criticises investigations after deviations in the media fill. Also, derived CAPA measures did not go far enough for the FDA.
Vulnerabilities in global Supply Chains: Reasons and possible Solutions
The EU Commission has published a document on a "Structured Dialogue on the security of medicines supply". This document presents the most important results of the analysis of the security of supply and possible measures.
The FDA released the final guidance on Comparability Protocols for postapproval CMC changes. The revised guidance follows the draft version issued in April 2016.