Pharma GMP News of the Week: 27-March-2022

Period: March 20, 2022 to March 26, 2022

News from EDQM, “Metals and alloys used in food contact materials and articles: updated technical guide released for consultation”

Date of news: March 21, 2022

EDQM open the text for 2nd edition, for consultation by all concerned parties viz. business operators, national authorities, control laboratories and manufacturers from March 21, 2022 – April 29, 2022.

This edition includes:

  • Alignment of text with Council of Europe Resolution;
  • Updating of (SRLs) specific release limits, and (TDIs) tolerable daily intakes;
  • use recommendations and quality requirements;
  • Section about zirconium (New);
  • Enhancement related to release testing;
  • improvements in terms of uncertainty measurements.

Source: https://www.edqm.eu/en/news/metals-and-alloys-used-food-contact-materials-and-articles-updated-technical-guide-released

FDA released final guidance on “Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4 Guidance for Industry”

Date of news: March 22, 2022

The objective of this FDA guidance is to provide guidance to manufacturers with respect to compliance requirements as per 21 CFR part 4 applicable for ophthalmic drugs packaged with eye droppers, eye cups, or other dispensers.

This guidance applies to approved products, pending applications, and products marketed under the section 505G of the FDA without an approved application under section 505 as per OTC monograph drugs).

FDA did not seek public comments prior to implementing this guidance because the FDA has determined that it is feasible or appropriate.

Source:

https://www.fda.gov/media/157067/download

https://freepub.edqm.eu/publications

IPEC (The International Pharmaceutical Excipients Council) releases guideline on “How to document to the ECHA’s Proposal for an EU-wide Restriction on Intentionally Added Microplastics Implications for pharmaceutical excipients, medicinal products and food additives”

Month of news: March 2022

IPEC has published how to guideline to help the pharmaceuticals to comply with latest labeling and reporting rules for microplastics which are intentionally included in pharmaceuticals.

Source: https://ipecamericas.org/sites/default/files/20220322_IE-IA-HowTo-Microplastics.pdf

DoP organization (India) is seeking comments on Uniform Code for Medical Devices Marketing Practices (UCMDMP).

This draft has been made in response to a request from the medical device industry. As per current requiring, the guidance is must to comply however, industry seeking own voluntary regulatory requirements.

Feedback will be accepted by DoP is until April 15, 2022.

Date of notice: March 16, 2022

Source: Indian Department of Pharmaceuticals (DoP) https://pharmaceuticals.gov.in/sites/default/files/DoP_Public%20Notice_Dated%2016032022.pdf

MHRA has granted a list of herbal medicines currently holding a traditional herbal registration.

Date of news:  March 25, 2022

Source: https://www.gov.uk/government/publications/herbal-medicines-granted-a-traditional-herbal-registration-thr

MHRA updated “Medicines: get scientific advice from MHRA”

Date of news:  March 25, 2022

Source: https://www.gov.uk/guidance/medicines-get-scientific-advice-from-mhra

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