PharmaSchool: GMP for IMP manufacturing

Please contact Jo Burmester at jo.burmester@pharmaschool.co.uk to find out more about in-house courses and discuss your specific needs.

Course Code: GGL007

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Duration: 1 or 2 days

Description:

This course covers the basics of clinical research and the differences in GMP requirements between commercial medicinal product and Investigational Medicinal Product.

Who it is suitable for:

This course is most suitable for those directly involved in packaging, labelling and shipping IMP.

Content:

Overview of Drug Development Process and phases of clinical trials

Clinical Trial Process
Overview of clinical trial lifecycle and key milestones
Key people – roles and responsibilities
Dosage Forms & Comparators (Placebo/Active)
Clinical Trial Design – cross-over vs parallel group studies and implications for IMP
Randomisation and Blinding of IMP’s
Critical Implications and Risk Analysis

Current GMP for IMPs and GCP

Eudralex Vol 4, Annexe 13
Manufacturing licenses
Import Regulations
Special considerations for manufacturing/packaging of IMPs
Packaging Designs – Primary & Secondary
Labelling requirements and reconciliation
QC/QA checks and sample retention
Packaging instructions
Distribution Considerations – Cold Chain & Ambient.
Roles Responsibilities/QP
Recalls, returns and destruction
Relabeling
Documentation
Reconciliation
Accountability
IMP release requirements

Customised In-house Courses are designed for organisations wishing
to train a group of your employees at a location of your choice.
For information about Open Courses click here or for
online learning click here

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