The FDA proposes to allow greater flexibility for clinical investigators about informed consent in minimal risk situations. Read more about Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations.
On the MHRA Inspectorate blog a new post has just been published emphasizing that according to GCP dose escalation practices should be the same regardless of whether a clinical trial involves healthy volunteers or patients. Read more about "Dose Escalation - is it GCP compliant?"
A new ICH topic was endorsed by the ICH Management Committee in November 2018. Read more about the proposed new ICH Q14 guideline Analytical Procedure Development and the revision of Q2(R1) Analytical Validation.
The Pharmaceutical Inspection Co-operation Scheme as international association of pharmaceutical inspectors is currently elaborating a document on data integrity. This document was published for comment on 30 November 2018. Among others, the ECA Foundation has been given the opportunity by the PICS to comment on this third draft by 28 February 2019. Read more about the new draft 3 of PI 041-1 "Good Practices for Data Management and Data Integrity in regulated GMP/GDP Environments".
With the introduction of the Permitted Daily Exposure (PDE) values in conjunction with questions on cross contamination and on cleaning validation, the EMA began a new chapter a few years ago. This is a complex issue and it caused uncertainty within the industry. Insofar, the EMA brought a subsequent Q&A document. This is being interpreted by the British Regulatory Authority MHRA with regard to inspection results.
Again and again, the question arises as to whether a bracketing approach - i.e. selective skipping of individuals tests - may be used for the qualification of identical pieces of equipment. Can the answer to the question whether or not to skip individual tests be found in Part IV of the EU GMP Guide?
End of September the EMA together with the European Commission organised a meeting with industry stakeholders to discuss the UK's withdrawal from the European Union ("Brexit"). Now the report of the EMA-Industry stakeholder meeting was published.
The first inspection of an Indian pharmaceutical company ended with the worst imaginable result. Read more about the GMP violations found by the European inspectors with regard to documentation management, cleaning and process validation, as well as further violations of GMP basic requirements.
Data integrity plays an exceptional role in clinical studies. On 23-24 October, 2018, the US FDA and the British MHRA hosted a joint workshop on this topic. Learn more about the contents and results of the joint workshop "Good Clinical Practice: Data Integrity in Global Clinical Trials - Are we there yet?"
The USP Physical Stability Joint Subcommittee has published a Stimuli article regarding Guidelines For Assessing and Controlling the Physical Stability of Pharmaceutical Raw Materials, Intermediates, and Dosage Forms.
In the latest edition of the Pharmacopoeial Forum 44(6), the US pharmacopoeia USP has published a so-called Stimuli Article on pharmaceutical continuous manufacturing. Apart from important definitions, the document contains further information on material properties and characteristics as well as risk management approaches for continuous manufacturing.
Due to the ongoing scientific development of laboratory methods, the EMA published a draft revision of their "Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells" for public consultation.
In October 2018, the FDA published a new draft guidance with recommendations for a possible requalification of donors who had been deferred because of reactive test results for antibodies to Human T-Lymphotropic Virus Types I and II (anti-HTLV-I/II). Read more about the requalification method under 21 CFR 610.41.
Validating blend uniformity is a decisive factor for the validation of solid dosage forms. In Europe, there are no regulatory provisions for this. This is different in the USA: the 21 Code of Federal Regulation (CFR) 211.110 requires the regular assessment of the adequacy of mixing.
What are the supply chain and drug shortage problems often caused by GMP and quality related problems? To find out more about this issue and about the consequences of drug shortages on the key stakeholders - i.e. the patients, companies and the governments - the ECA conducted a survey. It also addressed potential strategies industry and authorities can employ to minimise the risk of drug shortage or its impact. Find out what the ECA survey on drug shortage problems brought to light.
The USP posted a new timeline for the implementation of the plastics packaging chapters 661.1 and 661.2. So far, the new chapters were to become applicable on May 1, 2020. The implementation of the new requirements will now be delayed until December 1, 2025.
Raw materials used in the manufacture of biopharmaceuticals may show highly different characteristics and risk potentials. Read here why and how risk assessments for raw materials must be performed and where practical advice therefore may be gained.
The API manufacture Zhuhai United Laboratories Co. Ltd. received a Warning Letter from the FDA in June 2018. The FDA criticized that the OOS results of assay determinations haven't been adequately investigated. According to the FDA, the sole use of outlier tests is not appropriate. Read more about FDA's Warning Letter to Zhuhai United Laboratories.
You can regularly read about an evaluation of the deficiencies in FDA warning letters concerning medical devices. Find out what the past fiscal year looked like in terms of FDA Warning Letters regarding medical devices and what changed compared to fiscal year 2017.