EU GMP Guide, Part II
Active substances for clinical trials must be made in suitable facilities using appropriate production and control procedures; retest dates must be based on stability data.
Case studies · Mid-sized company in pharmaceutical research
Stored active substance tested and taken forward to an investigational medicinal product
A highly potent cancer active substance manufactured some time ago is to be used for an investigational medicinal product. We assessed its GMP compliance and tested the substance. The project is ongoing.
5
services from one provider
2
experts on the project
At a glance
How does a stored active substance become a released investigational product?
- Client
- Mid-sized company in pharmaceutical research
- Task
- An active substance manufactured some time ago is to be used to manufacture an investigational medicinal product.
- Outcome
- Analytical testing, project management for manufacture of the investigational medicinal product, trial-specific packaging and labelling, and batch release come from a single provider.
How it went
Starting point, approach, outcome.
Told plainly, in the order it actually happened.
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01
Starting point
What the client came to us with. An active substance manufactured some time ago is to be used to manufacture an investigational medicinal product. The active substance is a highly potent cancer therapeutic, and its GMP compliance must be assessed first. The client needs a partner to help establish GMP compliance and to confirm that the active substance can be used in a clinical trial. The GMP-compliant manufacture of the investigational medicinal product is also to be overseen. Finally, the product must be packaged and labelled for the specific trial in compliance with GMP and released for use.
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02
Approach
What we actually did. We assessed whether the active substance had been manufactured in compliance with GMP and carried out GMP-compliant analytical testing of the substance.
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03
Outcome
The outcome. Analytical testing, project management for manufacture of the investigational medicinal product, trial-specific packaging and labelling, and batch release come from a single provider. The project is currently being implemented.
Terms used in this case
Anonymised. Confidentiality is part of our business; we only name clients with their consent.
The legal framework
What the rules required in this case.
Regulation (EU) No 536/2014, Art. 63
Investigational medicinal products must be manufactured in line with good manufacturing practice to protect trial participants and ensure the reliability of trial data.
Regulation (EU) No 536/2014, Art. 66 and Annex VI
The outer and immediate packaging of unauthorised investigational medicinal products must carry the Annex VI particulars on contacts, the trial, the product and its use.
Regulation (EU) No 536/2014, Art. 62
The Qualified Person ensures that each batch of the investigational medicinal product meets the requirements of Article 63 and certifies this.
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