Commission Delegated Regulation (EU) No 1252/2014 of 28 May 2014 supplementing Di... (32014R1252)
INHALT
Commission Delegated Regulation (EU) No 1252/2014 of 28 May 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use Text with EEA relevance
- COMMISSION DELEGATED REGULATION (EU) No 1252/2014
- of 28 May 2014
- supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use
- (Text with EEA relevance)
- Article 1
- Scope
- Article 2
- Definitions
- Article 3
- Quality management
- Article 4
- Personnel
- Article 5
- Buildings and facilities
- Article 6
- Equipment
- Article 7
- Documentation and records
- Article 8
- Material management
- Article 9
- Production and in-process control
- Article 10
- Packaging and labelling
- Article 11
- Placing on the market
- Article 12
- Laboratory controls
- Article 13
- Validation
- Article 14
- Change control
- Article 15
- Rejection and returns
- Article 16
- Complaints and recalls
- Article 17
- Contract manufacturing
- Article 18
- Repackaging
- Article 19
- Entry into force
Feedback