What’s on the horizon for GMP Compliance
At the recent MHRA GDP & GMP Symposium Martine Powell, GMDP inspector examined the known future for GMP compliance.
Martine Powell GDMP Inspector discussed upcoming deadlines for the GMP industry. These included GMP for excipients – which is due to come into effect in March 2016, the documented update to Annex 16 – coming into effect in April 2016 and the possible effects from oncoming Clinical Trial Regulations on GMP requirements and the EU’s input.
The following 10 topics are discussed: GMP for Excipients, GMP GDP Annex 16, Annex 1, Future Annex 17 Parametric Release, Future Annex 21, Future Clinical Trial Regulations, Transitional QPs and CTs, New GMP for Advanced Therapy Medicinal Products, Data Integrity Guideline, and Safety features linked to the Falsified Medicines Directive delegated act.
Source: Cold Chain IQ