SubscribeQualified Person Certification of Investigational Medicinal Products
Each batch of Investigational Medicinal Product (IMP) used in a clinical trial in the EU must be certified by a Qualified Person (QP) that it has been produced in accordance with EU Good Manufacturing Practice and the regulatory approval from the competent authority.
Investigational Medicinal Product Certification
The QP should be considering the following when providing certification for batches of Investigational Medicinal Products.
From the early development studies:-
- Toxicology data
- Dose ranges
- Dosage forms
- Manufacturing and testing methods
- Stability data
From the trial design:-
- Dosing protocols
- Placebo, comparator or dummy requirements
- Packaging and labelling
- Competent authority approvals
- Ethics Committee approvals
From previous trial results:-
- Pharmacokinetics
- Pharmacodynamics
- Dose escalation
- Dosage form suitability
- Manufacturing or analytical issues
From contractor selection:-
- GMP audit reports
- Technical Agreements
- Process and analytical method transfer
From the batch records:-
- Manufacturing data
- In-process testing results
- Finished product testing results
- Labelling
- Process deviations
- Quality assurance
Qualified Person Support
Clinical trial sponsors are expected to have established supplier approval procedures and to audit all of their contractors and suppliers – this includes CRO’s. regulatory, statistics, pharmacovigilance etc, as well as manufacturers and technical contractors. There is also a GMP input into activities such as returns & destruction, site to site transfers and relabelling at sites. The Qualified Person should review investigator site audit reports and technical agreements to ensure that GMP responsibilities are covered
All of this requires QP input throughout the development process, not just during a final batch record review.
Somerset House Consultants offers dedicated Qualified Person support to clinical trial sponsors worldwide, to ensure that all work is carried out in accordance with current GMP, regulatory and legislative requirements.