The QP must confirm that each Lot of material to be used in a Clinical Trial has been manufactured in accordance with the Product Specification File, Clinical Trial Application and Good Manufacturing Practice. The aim of this module is to outline how Almac will review each of the manufactured lots against the IMPD, emphasising the evidence that will be required in order to support the compliance of the lot. Included within this module will be information detailing how working together collaboratively, the QP will gain the detailed knowledge of your product to assist in the certification process.
Focus will also be given to some of the common challenges that our Clients have encountered during this part of the certification process.
Please fill in your details below to gain access to the Lot Confirmation module.
Should you have any questions, don’t hesitate to contact us.
This presentation contains information that is confidential and proprietary and is not for distribution beyond Almac and/or the client organisation.