Official Tips for preparing an initial Drug GMP Inspection
Register now for ECA's GMP Newsletter
Health Canada provides a new pre-application package to assist organisations in preparing for an initial drug GMP inspection by the Inspectorate.
The package contains, for example, checklists of minimum requirements that should be in place before an inspection. Although this package is primarily intended to be used prior to the submission of a Drug Establishment Licence Application for the activities of wholesaling, importation and distribution products in the Canadian marketplace and health system, some parts can be used to prepare any regulatory inspection.
Wolfgang Schmitt
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)
Conference Recommendations
Related GMP News
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