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EMA - Submission comments on 'Concept paper on the revision of annex 1 of the guidelines on GMP'

30 July 2015   (0 Comments)
Posted by: Tamsin Marshall
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EMA  - Submission comments on 'Concept paper on the revision of annex 1 of the guidelines on GMP'

 

The industry and healthcare (pharmacies) involved in manufacture of both Sterile and non-sterile products that need to conform to GMP, are more challenged than ever in an environment with changing regulatory requirements based on science and risk.

With the anticipated revision to Annex 1, manufacture of sterile medicinal products, is expected to be significant in impact on the industry so it is really important to follow and keep up to date with any changes.

Conversely regulations need to keep in-line with new product types, unique manufacturing challenges often requiring a balance between GMP and containment for contamination and cross contamination control, new technologies and complementary good manufacturing practice.

 

 

Please click here for full Annex EMA Submission of comments on ' Concept paper on the revision of annex 1 of the guidelines on good manufacturing practice – manufacture of sterile medicinal products’ EMA/INS/GMP/735037/2014

 

If you are interested in learning more, please click here for more details on the PHSS Annual Conference in association with UCL on 11th September in London

 

If you are interested to submit comments within the PHSS Working group, then we would be pleased to hear from you. contact PHSS Office info@phss.co.uk

 


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