GMP NEWS 2020

The Herbal Medicinal Products Committee (HMPC) of the EMA has published the draft of the updated public statement of the HMPC on pyrrolizidine alkaloids (PAs). The document contains, among other things, the limits for the maximum daily intake of PAs.

The ECA regularly provides you with analyses of the deficiencies in FDA Warning Letters regarding medical devices. In the comparable period of the years 2017, 2018 and 2019 (1 October - 30 September), we mentioned the noticeably low number of Warning Letters. This trend is also evident for the first half of the fiscal year 2020 (1 October 2019 - 31 March 2020). Learn more about the top 3.

The UK Medicines and Healthcare Products Regulatory Agency MHRA has published a guide the marketing of medical devices after the transitional period in the UK.

Governments have been implementing different emergency measures in the fight against the current pandemic. Now an overview of the various measures in the EMEA region has been published.

Deficiencies in aseptic production have led to a Warning Letter for the Japanese company Takeda Pharmaceutical Company Limited. Part 1 of the News deals with inadequate cleanroom performance and inadequate controls of materials used in aseptic production.  What were the reasons for this Warning Letter?

In the current Pharmacopeial Forum revised drafts of the two previously published USP Chapters <665> and <1665> on plastic materials used in pharmaceutical manufacturing have been published for comment.

The unpopular deficiency letters of the FDA contain numerous standard formulations and follow a fixed scheme in their structure. Read more here about the structure of the Warning Letters and why their reading can be very useful in preparing for an FDA inspection. 

Swissmedic has announced that inspections will again be carried out on site, provided that appropriate protective measures are observed.

In June you could already read about a WHO draft guideline on the topic of limit values in cleaning validation. This draft has now been significantly revised and re-issued with a new title "Point to consider when including Health-Based Exposure Limits (HBELs) in cleaning validation". What changes have been made?