The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.
EC-Canada MRA, SECTORAL ANNEX ON GOOD MANUFACTURING PRACTICES (GMP)
Origin/Publisher:
EG Kommission
Content:
This Mutual Recognition Agreement (MRA) Sectoral Annex on Good Manufacturing Practices
(GMP) Compliance Certification pertaining to medicinal products/drugs has been developed by
the European Community (EC) and Canada to:
(a) enhance bilateral regulatory cooperation;
(b) establish mutual recognition for GMP compliance certification and acceptance of
Manufacturing Authorizations/Licences directly issued by the authorities designated
equivalent after the successful completion of a confidence building exercise;
(c) develop an infrastructure for on-going communications/consultations between Canada,
the European Commission, and the Regulatory Authorities of the EC Member States to
enable regulators to determine and maintain the equivalency of their GMP compliance
programmes.
GMP Conferences by Topics
- General Quality Assurance and GMP Compliance Topics
- Hygiene
- General Microbiology Topics
- Regulatory Affairs
- Development
- General Analytics Topics
- Good Distribution Practice
- Sterile Manufacturing
- Computer Validation
- General Qualification/Validation Topics
- General Engineering Topics
- APIs/Excipients
- GMP Basic Training Courses
- Medical Devices and Combination Products
- Packaging and Packaging Material
- Data Integrity
- Qualified Person (QP)
- GMP Auditing
- Documentation
- Cleaning Validation
- General IT Compliance Topics
- Impurities
- OOS / OOE / OOT
- Material Testing
- Validation of Analytical Methods
- Analytical Instrument Qualification
- Stability Testing
- Microbiological Testing
- Technology
- General Manufacturing Topics
- Solid Dosage Forms/Semi-Solid Dosage Forms
- Biotechnology/Blood/ATMP
- Herbal Drug Products/Cannabis/Radiopharmaceuticals
- Others