Pharma GMP News of the Week: 17-October-2021
Period: October 10, 2021 to October 16, 2021
FDA uploaded draft guideline, Q13 Continuous manufacturing of drug substances and drug products on its site for comments. Comments needs to be submitted by 12/13/2021
Date of guideline upload on website: October 13, 2021
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has the mission of achieving greater regulatory harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed, registered, and maintained in the most resource-efficient manner. By harmonizing the regulatory expectations in regions around the world, ICH guidelines have substantially reduced duplicative clinical studies, prevented unnecessary animal studies, standardized safety reporting and marketing application submissions, and contributed to many other improvements in the quality of global drug development and manufacturing and the products available to patients.
Australia’s Therapeutic Goods Administration (TGA) releases guideline on risk classification for active medical devices
Guideline effective from: October 2021
This guidance is to assist manufacturers of active medical devices, including software-based medical devices, in correctly classifying their devices. Medical devices are classified according to the level of harm they may pose to users or patients.
There is a four-tier classification system for medical devices:
• Class I (lowest classification)
• Class IIa
• Class IIb
• Class III (highest classification)
The higher classification level, the higher the level of regulatory oversight. Classification is used to determine the minimum conformity assessment (CA) procedures (or comparable overseas regulator evidence requirements) to be determined by the manufacturer prior to an application being made for inclusion of the device in the Australian Register of Therapeutic Goods (ARTG).
An active medical device is defined as a medical device intended by its manufacturer:
• to depend on a source of electrical energy or other source of energy (other than a source of energy generated directly by a human being or gravity) for its operation; and
• to act by converting this energy; but
• is not a medical device intended by the manufacturer to transmit energy, a substance, or any other element, between an active medical device and a human being without any significant change in the energy, substance or other element being transmitted. Software-based medical devices are active medical devices. This includes software that is a medical device itself and medical devices that incorporate software.
The United States Pharmacopoeia (USP) has released a new chapter <1220> before its publication in the USP-NF regarding lifecycle approach to analytical method development.
The chapter will become official on: May 01, 2022
New general chapter <1220> The Analytical Procedure Lifecycle will be to more fully address the entire procedure lifecycle and define concepts that may be useful.
This general chapter holistically considers the validation activities that take place across the entire life cycle of an analytical procedure and provides a framework for the implementation of the life cycle approach.
The analytical procedure life cycle approach described in this chapter is consistent with the quality by design concepts described in International Council for Harmonisation (ICH) guidelines. The procedure life cycle approach emphasizes the importance of sound scientific approaches and quality risk management for the development, control, establishment, and use of analytical procedures.
CDER Pilot Program on Novel Excipient Review
FDA’s Center for Drug Evaluation and Research’s (CDER) Office of New Drugs (OND) recently launched a pilot program on Novel Excipient Review.
The pilot program offers a new pathway for drug manufacturers to obtain FDA review of certain novel excipients (inactive ingredients) before the excipients are used in drug formulations.
For detailed information refer: https://www.fda.gov/drugs/news-events-human-drugs/cder-conversation-novel-excipient-review-pilot-program
European Pharmacopoeia device version to be discontinued
Date of news: October 15, 2021
The European Directorate for the Quality of Medicines & HealthCare (EDQM) will discontinue the device version of the European Pharmacopoeia (Ph. Eur.) as of the 11th Edition, which is scheduled for publication in July 2022, and focus efforts on the online and paper versions.
The EDQM was the first pharmacopoeia to provide a device version, evolving from CD-ROM to DVD, to USB. In 2020, with the 10th Edition, a version was introduced for installation on USB sticks and/or computers, downloadable for all customers directly within the online interface.
Demand for these mobile versions has dwindled over time, however, and the vast majority of users prefer the online version. The EDQM has therefore decided to discontinue its device version as from the 11th Edition. This decision will also allow the EDQM to focus efforts on supporting and improving the version users prefer. Customers with the 10.6-10.8 subscription will still be able to use their device version until the end of 2022.
Users are invited to provide any feedback and suggestions for improvements to the Ph. Eur. online via the EDQM HelpDesk or via the customer survey to be conducted in the near future.