In recent months, the FDA has published a number of documents on gene therapy. With a draft guideline on "Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)", the next step in the update of the relevant guidelines has been taken.
The FDA published a new Draft Guidance on Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis. The recommendations contained in this guidance apply to the collection of blood and blood components, except source plasma.
With a new draft guidance on the risk of bacterial contamination of blood platelets for transfusion purposes, the FDA wants to give updated recommendations on risk minimization to affected donor institutions and transfusion centers.
The publication of EMA's "Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities" and the related Q&A documents have given the topic cross contamination a greater importance.
The Ph. Eur. Commission decided to restructure Ph. Eur. Section 3 on materials and containers. A new Subsection 3.3. has been added to cover items that are classified as medical devices according to EU legislation. Read more about 3.3. Containers for human blood and blood components, and materials used in their manufacture; transfusion sets and materials used in their manufacture; syringes.
In the course of the revision of the European Pharmacopoeia which allows the production of WFI with other methods than distillation, the revision of EMA's "Guideline on the quality of water for pharmaceutical use" has become necessary.
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?