Conformity with good manufacturing practice
- Follow GMP and hold authorisation for investigational medicinal products
Retained EU Law
2017
United Kingdom
Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections (Text with EEA relevance)
At a glance
What's here
12 compliance obligations
What this Act requires
Sections that create concrete duties on businesses or carry penalties. Procedural and definitional sections are folded into the “Browse other sections” expander at the bottom of each group. Click any section title to read the source text on legislation.gov.uk.
Compliance with clinical trial authorisation
- Ensure manufacturing complies with clinical trial authorisation and keep methods up to date
Pharmaceutical quality system
- Set up a pharmaceutical quality system for investigational medicines
Personnel
- Ensure competent staff, defined roles, training and hygiene for IMP manufacturing
Premises and equipment
- Design, maintain and validate premises and equipment for investigational medicinal products
Documentation
- Set up and maintain a full documentation system for manufacturing
Production
- Control production, validate processes and prevent contamination
Quality control
- Set up and maintain a quality control system for investigational medicinal products
Retention of samples used for quality control
- Retain samples of investigational medicinal products and starting materials for at least two years
Complaints, product recall and emergency unblinding
- Set up systems for complaints, recalls and emergency unblinding
Self-inspection by the manufacturer
- Carry out regular self-inspections and take corrective action
Access to premises
- Allow inspectors access to premises and documentation at all times
Browse 15 other sections — procedural / definitional / commencement
Subject matter
Definitions
Responsibilities of the qualified person
Outsourced operations
Advanced therapy investigational medicinal products
Supervision by inspection
Cooperation and coordination of inspections
Recognition of inspection conclusions
Empowerments of the inspectors
Competence and obligations of the inspectors
Quality system
Impartiality of inspectors
Suspension or revocation of manufacturing authorisation
Transitional provision
Entry into force
Explore more
Browse legislation
Find other UK business legislation with related guidance.