...educational materials, approved communication plans and evidence of communication of the materials in accordance with the approved communication plan. The contract should also include provision for audit of third-parties. GVP...
...and the subsequent black box testing was performed using scripts that were approved prior to the developer having made the changes. As a result the approved test scripts may not...
...principles and guidelines of good manufacturing practice, and (b)used in accordance with the approved protocol. [NOTE: This is a specific requirement of the legislation.] 2.12. Investigational products should be manufactured,...
...website Just this week the new website has been launched bringing together the online BP publication, the British Pharmacopoeia Chemical Reference Substances (BPCRS) catalogue and sales making it easier for...
...due to recent weather events (such as those in Puerto Rico, Southern USA, India and Bangladesh) take steps to identify any potential supply issues. We are also liaising with our...
...Immediate social media feedback was extremely positive - a very successful couple of days and well worth all of the hard work that the GCP team put into the event....
...which included updates on the various Pharmaceutical Inspection Co-operation Scheme (PIC/S) activities MHRA is leading and supporting, the International Coalition of Medicines Regulatory Agencies (ICMRA) and the EU/USA Mutual Reliance...
...a -20°C freezer instead of -70°C), sample processing (where a lack of documentation meant it was not possible to verify proper sample handling and processing), PK sample collection (unacceptable samples...
...new and updated Mutual Recognition Agreements (MRAs) with Canada, Japan and the USA, there was a lot for delegates to keep themselves appraised of. Martine also gave an update on...
...documents were not seen by the regulator or ethics committee approving the trial These issues have either resulted in the approved protocol stopping criteria being missed - with DE proceeding...
