GMP News

USP: Possibility to Comment on the "Residual Solvents" Chapter

As recently reported, the "ICH guideline Q3C (R8) on impurities: guideline for residual solvents)" has been updated and can be consulted on the ICH website under the section "Quality Guidelines". As a result, the USP chapter "<467> Residual Solvents" has now been revised and published for comment on the USP Pharmacopeial Forum website.

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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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FDA: Updated ANDA PFC Document Published for Comment

In December 2022, the US-American FDA published the draft of the so-called document entitled "ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions" for comment. This is the second revision of the guidance document, which has been in place since 2017. It is now open for comment until 07 March 2023.

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EMA: IRIS Guides Revised Again

The "IRIS guide to registration and RPIs" was updated again between the end of November and mid-December 2022. The "IRIS guide for applicants" has also been revised and is now valid as version 2.13. The latest versions of both documents are available on the EMA website.

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CMDh: Q&A Document on ASMF Updated

The CMDh, CMDv and EMA Q&A document "Q&A on Active Substance master file (ASMF)", last revised in March 2022, has been updated again and published on the HMA (Heads of Medicines Agencies) website in the CMDh section.

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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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USP-NF Stimuli Article on Quality by Design (QbD) Principles in Method Development

In the Pharmacopeial Forum, PF 49(1), a stimuli article entitled "A Novel Approach Using Quality by Design to Develop and Implement Flexible Methods in Non-Application Over-the-Counter Monographs" was published.

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Cloud Computing: Cloud Models in the GxP environment

Financial and organizational advantages also speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 2: What cloud models are there and where do they have applications in the GxP environment?

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ANVISA authorizes National Scientific Research with Cannabis

The agency now authorizes national scientific research with cannabis-derived products. The authorization granted will allow to conduct pre-clinical research to evaluate the efficacy and safety of cannabinoids in the management of signs and symptoms associated with neurological and psychiatric disorders.

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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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Further Revision of Ph. Eur. General Chapter 2.2.46 Concerning Signal-to-Noise Ratio

As already reported a few months ago, a revised general chapter 2.2.46. Chromatographic separation techniques has been published in Ph. Eur. 11.0. The implementation date is 01 January 2023. One of the changes is the sensitivity requirement. In this context, the EDQM has now published a press release, stating that this change might be technically challenging for a number of users. Therefore, there will be another revision.

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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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Pharmeuropa: Revised Chapter 2.9.3. Dissolution Test for Solid Dosage Forms published for comment

In the Pharmeuropa issue 35.1, a proposal for a revised chapter 2.9.3. Dissolution test for solid dosage forms was published. The deadline for submitting comments is 31 March 2023.

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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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Clinical Trials: EMA clarifies Dates for the Transition Period

In order to help sponsors using the CTIS, the EMA has published a sponsor handbook. Following the previous update on how to manage clinical trials transitioned to the CTR, the EMA now clarifies the timelines for the transition period.

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How to Manage Clinical Trials Transitioned to the CTR?

In order to help sponsors using the CTIS, the EMA has published a sponsor handbook. The EMA is continuously updating the CTIS Sponsor Handbook with further priority topics and a revised version 3 has now been published.

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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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Update on the EMA Guidance for Applicants/MAHs involved in GCP Inspections

The EMA published the revised Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by EMA. By this revision only the GCP section of the document has been amended. Amongst others it has been clarified that the reporting inspector should be contacted prior to submitting any documents.

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USP clarifies Requirements for Plastic Packaging Systems

The USP General Chapters—Packaging and Distribution Expert Committee is proposing a revision to the Scope section of chapter <661> Plastic Packaging Systems and Their Materials of Construction. The revision is published to clarify the testing expectations that are outlined in <661.1> and <661.2>.

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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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Expert Task Force issues new Version of CCS Guideline

With the publication of the final version of the revised Annex 1 in August, the ECA Foundation's CCS Task Force got together again to update the CCS Guide based on the final Annex 1 version. The new CCS Guide version 2.0 now comprises the revision of quoted passages, the modification and insertion of individual sections and tables as well as an improved clarity and the update of the attachments.

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FDA Draft Guidance for Industry on Statistical Approaches for Assessing Bioequivalence

The U.S. Food and Drug Administration (FDA) has published a draft guidance for industry entitled "Statistical Approaches to Establishing Bioequivalence". When finalized, the new document will replace the previous version, which was issued in February 2001.

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Cross Contamination in Steam Steriliser at US Sterile Manufacturer

In October, the US FDA issued a Warning Letter to a US sterile manufacturer due to numerous GMP violations. The inspection, which had already taken place from March to April 2022, had revealed numerous deficiencies. The main reasons for the Warning Letter were cross contamination and microbiological contamination of products.

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GDP Non-Compliance Report: Numerous Major GDP Violations at Irish Wholesale Distributor

The Irish Health Products Regulatory Authority has added a new GDP Non-Compliance Report to the EudraGMDP database. During an inspection of a wholesale distributor, a number of major deviations from Good Distribution Practice were found, leading to an immediate suspension of the authorisation.

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Change Control for Transport Processes

Any change from design or predefined processes requires risk assessment and potential impact evaluation for both the transport process and, consequently, the product. This article discusses the importance of having a structured, compliant Change Control (CC) process in place for medicinal product manufacturers as well as for their qualified logistics vendors.

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