Pharma GMP News of the Week: 20-March-2022

Period: March 13, 2022 to March 19, 2022

European Pharmacopoeia (Ph. Eur.) invites experts to join the Ph. Eur. network.

Date of news: March 14, 2022

Ph. Eur. is inviting independent experts to join Ph. Eur. groups and working parties. This includes experts from authorities such as official medicines control laboratories, pharmacopoeial authorities, inspectorates, and licensing authorities, and from private sector of chemical and pharmaceutical industries, research organisations, academia, etc.

Details of application are provided here.

Source: https://www.edqm.eu/en/news/call-experts-join-ph-eur-network-0

The long awaited EU’s revision of Annex 1 applicable for sterile drug products may be published in 2022, mid-year.

Date of news: March 14, 2022

The news is based on the announcement by Chairperson of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), Paul Gustafson during ISPE Aseptic Conference on March 2014.

This regulation was drafted by EU, with the help of PIC/S and the WHO.

News from MHRA: Metformin in pregnancy shows no safety concerns

Date of news: March 15, 2022

As per the studies, it has been understood that there are no safety concerns relating to the use of metformin during pregnancy.

Now, the metformin can be considered for use during pregnancy as well is during periconceptional phase. This can be an addition or an alternative to insulin (when clinically needed).

Source: https://www.gov.uk/drug-safety-update/metformin-in-pregnancy-study-shows-no-safety-concerns

FDA released two draft guidelines –

(i) Human Gene Therapy Products Incorporating Human Genome Editing, and (ii) Human Gene Therapy Products Incorporating Human Genome Editing

Date of news: March 15, 2022

Source:

(i) https://www.fda.gov/media/156894/download

(ii) https://www.fda.gov/media/156896/download

European Pharmacopoeia to launch survey to have manufacturers’ opinion on use of total organic carbon (TOC) test in replacement of oxidisable substances test for WFI (Water for injections)

Date of news: March 17, 2022

Proposal for replacement of the test, (replacement of oxidisable substances test with TOC) was discussed with other Pharmacopoeias (Japanese Pharmacopoeia and United States Pharmacopeia,)

The purpose of this survey is to have official consultation from manufacturers on method and acceptance criteria for its appropriateness.

Survey: http://survey.edqm.eu/index.php?r=survey/index&sid=395252&lang=en

Source: https://www.edqm.eu/en/news/ph-eur-launch-survey-use-total-organic-carbon-toc-test-replacement-oxidisable-substances-test

PICS published following seven guidance documents in Feb 2022 and March 2022 (up to Mar 19, 2022)

(i) Assessment and joint reassessment programme audit report (template) – PS/W 12/2002 (Rev.3, Draft 4)

Date of guideline: February 16, 2022

Source: https://picscheme.org/docview/4633

(ii) Joint reassessment programme procedure – PS/W 10/2005 (Rev 1, Draft 4)
Date of guideline: February 16, 2022

Source: https://picscheme.org/docview/4630

(iii) Travel guidance for on-site assessment visits – PS/W 9/2014 (Rev. 1, Draft 2)
Date of guideline: March 1, 2022

Source: https://picscheme.org/docview/4639

(vi) Assessment & joint reassessment programme cv for auditors (template) – PS/W 9/2002 (Rev. 2, Draft 1)
Date of guideline: March 1, 2022

Source: https://picscheme.org/docview/4637

(v) Assessment and joint reassessment programme criteria for observing inspections (template) – PS/W 11/2002 (Rev. 3, Draft 2)

Date of guideline: March 1, 2022
Source: https://picscheme.org/docview/4636

Assessment and joint reassessment programme procedure for observing inspections – PS/W 10/2002 (Rev. 3, Draft 2)

Date of guideline: March 1, 2022

https://picscheme.org/docview/4635

(vi) Guidelines for accession to the pharmaceutical inspection co-operation scheme – PS/W 14/2011 (Rev. 3, Draft 3)

Date of guideline: March 1, 2022
Source: https://picscheme.org/docview/4626

(vii) Guidelines for the pre-accession procedure1 – PS/W 12/2019 (Rev. 1, Draft 1)

Date of guideline: March 1, 2022
Source: https://picscheme.org/docview/4625

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