Pharma GMP News of the Week: 9-January-2022

Period: January 02, 2022 to January 08, 2022

New European Pharmacopoeia texts and that have undergone technical revisions are published for comments.

Date of news: January 05, 2022

Total 48 drafts monographs published for comments on Pharmeuropa 34.1 and deadline for the comments is 31 March 2022.

 Sr. No.Drafts published
12.7.28. Colony-forming cell assay for human haematopoietic progenitor cells
22.7.29. Nucleated cell count and viability
33.1.17. Cyclo-olefin copolymers
4Agnus castus fruit
5Bismuth subcarbonate
6Bismuth subgallate
7Bismuth subnitrate, heavy
8Bismuth subsalicylate
9Black horehound
10Bogbean leaf
11Burdock root
12Caspofungin acetate
13Centaury
14Donepezil hydrochloride
15Eclipta herb with root
16Edotreotide acetate for radiopharmaceutical preparations
17Fenbendazole for veterinary use
18Gallium (68Ga) DOTANOC injection
19Gallium (68Ga) oxodotreotide injection
20Gozetotide for radiopharmaceutical preparations
21Halofantrine hydrochloride
22Horse-chestnut bark
23Immortelle flower
24Ispaghula husk
25Mepyramine maleate
26Mercaptopurine monohydrate
27Milk thistle fruit
28Norgestrel
29Oak bark
30Oxodotreotide acetate for radiopharmaceutical preparations
31Pelargonium root
32Pimozide
33Potassium acetate
34Psyllium seed
35Rabeprazole sodium
36Salbutamol
37Salbutamol sulfate
38Sotalol hydrochloride
39Sulfobutylbetadex sodium
40Tormentil
41Valerian dry aqueous extract
42Valerian dry hydroalcoholic extract
43Valerian root
44Valerian root, cut
45Valerian tincture
46Xanthan gum
47Xylose
48Zinc acetate dihydrate

Source: https://www.edqm.eu/en/news/pharmeuropa-341-just-released

ICH published brief overview ICH’s mission, structure and current work

Date of publication: January 05, 2022

ICH released a Leaflet on ICH’s mission, structure and current work.

Source: https://admin.ich.org/sites/default/files/inline-files/ICH_leaflet_2021_1221.pdf

MHRA updated guidance for regulating medical devices in the UK

Date of publication: January 01, 2022

The purpose of the guidance updated was to reflect changes to medical device regulatory requirements that will take effect from January 1, 2022. It covers what one should do to deploy a medical device in the Great Britain, European Union (EU) markets, and Northern Ireland.

Source: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk

MHRA published official Statistics regarding expected time taken to process and grant a marketing authorisation or a variation to a marketing authorisation.

Date of publication: January 04, 2022

 Source: https://www.gov.uk/government/statistics/medicines-licensing-time-based-performance-measures

MHRA updated various documents and guidance from January 1, 2022 to January 7, 2022

Date of updates: January 1, 2022 to January 7, 2022

Source: https://www.gov.uk

The eur-lex.europa.eu on January 04, 2021 officially acknowledged harmonized standards for medical devices that device manufacturers can use in order to comply requirements under the Medical Devices Regulation (MDR).

Date of publication: January 04, 2021

This includes:

Sterilization

Biological evaluation of medical devices

Aseptic processing

Use of symbols in product information

Quality management systems

According to the European Commission, “devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, are to be presumed to be in conformity with the requirements of that Regulation covered by those standards or parts thereof.”

Commission Implementing Decision (EU) 2021/1182 dated 16 July 2021

Sr. No.EN ISO StandardDescription of standard
1.EN ISO 25424:2019Sterilization of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)
2.EN ISO 11137-1:2015Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
3.EN ISO 11135:2014Sterilization of health care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
4.EN ISO 11737-2:2020Sterilization of health care products – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
5.EN ISO 10993-23:2021Biological evaluation of medical devices – Part 23: Tests for irritation (ISO 10993-23:2021)

Commission Implementing Decision (EU) 2022/6 dated 4 January 2022

Sr. No.EN ISO StandardDescription of standard
6.EN ISO 10993-12:2021Biological evaluation of medical devices – Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
7.EN ISO 10993-9:2021Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
8.EN ISO 13408-6:2021Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2021)
9.EN ISO 11737-1:2018Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)
10.EN ISO 14160:2021Sterilization of health care products – Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives – Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2020)
11.EN ISO 13485:2016Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)
12.EN ISO 17664-1:2021Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)
13.EN ISO 15223-1:2021Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements (ISO 15223-1:2021)
14.EN IEC 60601-2-83:2020Medical electrical equipment – Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment

Source:

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32021D1182&from=EN

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022D0006&from=EN

FDA mission-critical work certain – inspectional activities has temporarily postponed

Date of press-announcements: January 4, 2022

According to press-announcements, “On Dec. 29, the FDA implemented temporary changes to its inspectional activities to ensure the safety of its employees and those of the firms it regulates as the agency further adapts to the evolving COVID-19 pandemic and the spread of the omicron variant. Through Jan.19, the agency intends to continue mission-critical work but has temporarily postponed certain inspectional activities with the hopes of restarting these activities as soon as possible”.   

Source: https://www.fda.gov/news-events/press-announcements/fda-roundup-january-4-2022

Delay in Indian rules for use of unique device identifiers

Source: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODAxMQ

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