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: info@pharmig.org.uk
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.
Posted by Dr. Tim Sandle
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