Thursday 28 June 2018

Pharmig News #71

The latest edition of Pharmig News has been issued (edition #71). In this issue:

  • Update on Pharmig events
  • Report from PHSS conference on Annex 1
  • Pharmig’s response to the draft Annex 1
  • Review of new electronic training module
  • Regulatory update
  • And more..
Copies have been sent to Pharmig members. If you are interested in reading a copy, contact:

There are two pieces by Tim Sandle in the newsletter:

The EU GMP Annex 1 draft was subject to a consultation period during which interested partiels submitted responses. Pharmig was one of the member organisations that submitted a response. Pharmig welcomed the draft and see it as a long overdue reclarification of the requirements of sterile products manufacturing. The stronger link to Quality Risk Management and references to new technologies were particularly welcomed.

Sandle, T. (2018) Pharmig’s response to EU GMP Annex 1 draft concept paper, Pharmig News, 71, pp4-7

Pharmig has established an interactive on-line training platform. The first module covers cleaning and disinfection, aimed at GMP cleanrooms. To understand how e-learning can be delivered effectively, Tim Sandle interviewed one of the co-developers, Laura Guardi.

Sandle, T. (2018) Insight into Pharmig’s new e-learning module, Pharmig News, 71, pp7-9

Posted by Dr. Tim Sandle

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