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.
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.
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.
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>.
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.
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.
The U.S. Food and Drug Administration (FDA) has published a draft guidance for industry entitled "Statistical Approaches to Establishing Bioequivalence".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.
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.
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.
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.
According to the EU GDP Guidelines, wholesale distributors must obtain their supplies of medicinal products only from persons who themselves hold a wholesale distribution authorisation or a manufacturing authorisation which covers the product in question. Thus, all suppliers must be qualified in an adequate way. But what is the rationale for this point and how to implement the requirements?
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.
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.
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 U.S. Food and Drug Administration (FDA) has issued a Warning Letter to Glenmark Pharmaceuticals Limited. During an inspection at the site in Goa, India, several GMP violations were found. The company failed to thoroughly investigate OOS results. In addition, the FDA considers the chromatographic data integration procedure as inadequate.
The European Commission published an updated Version of the Questions & Answers relating to the EU Clinical Trials Regulation. What are patient facing documents and how are these documents expected to be submitted ?
Following the delayed 2019 Annual Report of the Good Clinical Practice Inspectors’ Working Group (GCP IWG) published earlier this year, the EMA released the 2020 and 2021 annual GCP reports. An increase in findings related to computer systems is noted compared to the last reports.
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.
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.
Observations made by the inspector during an FDA inspection are listed on the FDA Form 483. The FDA has now published the data for the fiscal year 2022. Deficiencies in the stability programme in the area of "drugs" were mentioned in numerous FDA 483 forms.
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?
In the Pharmacopeial Forum, PF 48(6), a proposal for a revised Chapter <711> Dissolution was published. The purpose of the revision is to replace USP Prednisone Tablets RS with a new Reference Standard, USP Dissolution Performance Verification Standard-Prednisone RS, to qualify the Dissolution Apparatus 1 and Apparatus 2.
The U.S. FDA warns five companies for illegally selling food and beverage products containing cannabidiol (CBD). According to the agency, the use of CBD raises safety concerns, especially with long-term use.