- Palabras clave > GMP inspection
- Palabras clave > Good Manufacturing Practices (GMP)
- Palabras clave > inspection - GMP
- Palabras clave > inspection and audit
- Palabras clave > inspection of manufacturing sites
- Palabras clave > manufacturing control
- Palabras clave > quality assurance
- Palabras clave > quality control
Guidelines on GMP Inspection of Foreign Pharmaceutical Manufacturing Plants Use in Uganda, February 2007 - National Drug Authority, Uganda
(2007; 5 pages)
(2007; 5 pages)
- All pharmaceutical-manufacturing sites at which human and veterinary drug products (finished pharmaceutical products, biologicals, vaccines, medical devices, herbal medicines, etc) used in Uganda are manufactured (Storage of raw and packaging materials, dispensing, formulation, processing, packaging, quality control and release) shall be subject to cGMP inspection by National Drug Authority before the drugs are registered and at least once every three years.
- The current Good Manufacturing Practices (cGMP) Guidelines as published by the World Health Organization (WHO) and NDA statutory requirements for manufacture of drugs shall be the basis against which National Drug Authority (NDA) shall inspect local and foreign manufacturing sites for GMP compliance.
- The Drug Inspectorate Department of National Drug Authority shall coordinate cGMP inspection of all local and foreign pharmaceutical sites at which human and animal drug products used in Uganda are manufactured.
- Each site of manufacture shall be inspected by at least two qualified cGMP inspectors for at least two days (depending on the number of manufacturing lines at each site) using the approved cGMP Inspection checklist.
- The inspection shall be announced and based on all plant processes, systems and production lines...