Laboratory medicine (ICS 11.100)

CDC 16(5438) P3 Hospital based intravenous fluids - Good manufacturing practice (GMP) - Requirement for regulatory purposes (7 page(s), in English)

This Tanzania Standard shall be used to justify good manufacturing practices (GMP) status for Intravenous fluids produced in hospital Infusion Units.

Note 1: The standard is applicable to all small-scale operations for the production of infusion in their finished dosage forms, including small-scale processes in hospitals.

Note 2: The good practices outlined below are to be considered general guides, and they may be adapted to meet individual needs on risk bases. The equivalence of alternative approaches to quality assurance should be validated. Non-proprietary names for pharmaceutical substances designated by WHO should be used when available, together with other designated names.