Pharma GMP News of the Week: 19-September-2021
Period: September 12, 2021 to September 18, 2021
MHRA launches public consultation on future of medical device regulation: People are being encouraged to contribute their views on changes to how medical devices will be regulated across the UK.
Date of announcement: September 16, 2021
Launched today by the Medicines and Healthcare products Regulatory Agency (MHRA), the 10-week consultation gives everyone the opportunity to draw on their own experiences and contribute to the improvement of the regulatory framework and therefore patient safety in the future.
ISPE published interesting article about Transportable Manufacturing on iSpeak Blog
Date on publishing: 13 September 2021
As per the article, “Transportable or Point of Care manufacturing is a capability that can be readily deployed temporarily in closer proximity to the patient base. This type of manufacturing can take various forms depending on the type of therapy and modality, and different solutions can be implemented depending on the scale and manufacturing requirements. Autonomous cleanroom PODs can be used for the larger footprint processes for clinical and commercial manufacturing. Customized trailers can be utilized for low volume manufacturing or labs as well as for some specific commercial applications. Portable, self-contained process skids can be placed either in a building or potentially on a truck, boat, or airplane. And the ultimate in future portability, suitcase manufacturing, can produce individual doses on demand in the field.”
ISPE published article about Reverse Logistics Planning Can Save Time, Money, and Effort on iSpeak Blog
Date on publishing: September 16, 2021
As per the article “Reverse logistics is the process of planning, implementing, and controlling the efficient and effective inbound flow and storage of secondary goods and related information for the purpose of recovering value or proper disposal. Within the Investigational Product’s Supply Chain, it is an essential element more commonly referred to as the Returns Reconciliation, and Destruction Process.”
ICH published Report of 2021 Implementation Survey on the ICH website on 17 September 2021
Monitoring the progress of international harmonisation and coordinating efforts in this regard is an important ICH focus. In support of this effort, an ICH-driven independent third party survey was conducted in 2021, building on the previous 2019 assessment. The main objective of this survey was to assist the ICH MC in determining whether the Regulatory Members would meet the eligibility criteria for the recent ICH MC elections and to allow participating Observers interested in future ICH Membership to reference the survey findings to confirm their eligibility.
The 2021 Implementation Survey Report and additional information can be found on the ICH Guideline Implementation webpage.
FDA update on Q2B Validation of Analytical Procedures
On September 2021, FDA incorporated Q2B Validation of Analytical Procedures: Methodology (May 1997)(Q2B) on methodology with the parent document Q2A Text on Validation of Analytical Procedures (March 1995)(Q2A) and retitled the combined document Q2(R1) Validation of Analytical Procedures: Text and Methodology (Q2(R1). This guidance consists of the previously published FDA guidances, Q2A and Q2B. It is the same, in substance, as those two guidances, and it is the same, in substance, as the November 2005 ICH Q2(R1) guideline.
FDA released New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3)
Draft New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3).”
Date of release: September 17, 2021
This guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilar products and proposed interchangeable products, as well as describe FDA’s interpretation of certain statutory requirements added by the BPCI Act.
This draft guidance document revises the draft guidance document entitled “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2),” issued December 12, 2018 to retain appropriate Q&As in draft.
Download Guideline: https://www.fda.gov/media/119278/download
FDA published final Questions and Answers on Biosimilar Development and the BPCI Act Guidance for Industry
Date of release: September 17, 2021
This guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and interchangeable biosimilars, as well as describe FDA’s interpretation of certain statutory requirements added by the BPCI Act.
Download Guideline: https://www.fda.gov/media/119258/download