Guidelines for Inspection of Manufacturers of Medical Gases
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Guidelines for Inspection of Manufacturers of Medical Gases
- 3.1 These guidelines state generally applicable principles and practices that are acceptable to the Board GMP Inspectorate and that should facilitate compliance of firms involved in production, packaging/ or labelling, distribution, importation, of medical gases as well as home care providers and commercial operations involving sales of medical gases Cap 244 and related regulations and with principles of Good Manufacturing Practices (GMP).
- 3.2 The inspectorate does not consider packaging of gases (which includes the transfer of gases of a single grade in quality from one grade to another, including curb side or facility), performed within services such as fire departments, ambulance services, hospitals, or health care facilities, to be subject to Establishment Licensing and GMPs when the medical gases are for their own use or administration to a patient.
- 3.3 During establishment inspections carried out under the Pharmacy and Poisons Board Act (Cap 244) this document will be used as a guide in judging compliance with the GMP Regulations. However, the content of these guidelines should not be regarded as the only interpretation of the GMP Regulations and are not intended to cover every conceivable case. Alternative means of complying with the GMP Regulations will be considered with the appropriate scientific justification. Furthermore, as new technologies emerge, different approaches may be called for.
- 3.4 Establishments may use this guideline as a basis for the development of specific requirements appropriate to their individual needs. Similarly, Board departments involved in market authorization and quality assurance may find this regulatory guideline beneficial.
- 3.5 The Board inspects establishments to assess their compliance with the Pharmacy and Poisons Act (the Act) and associated guidelines and regulations. When we conduct an inspection, we will use this document as a guide in assessing your compliance with GMP requirements.
- 3.6 Due to their unique production and handling characteristics, the application of the GMP Regulations to medical gases may be different from their application to other pharmaceuticals. For example, the synthesis or manufacture of a medical gas constitutes a special situation in that the resulting gas may be used as a starting material or it may be sold as a bulk product or as a finished packaged product. These guidelines do not apply to aerosol preparations or to mixtures of solids that are used to generate gases.
Attached Files
| File | Action |
|---|---|
| 067_HPT_ISE_GMP_GUD_Guidelines_Inspection_Manufacturers_Medical_Gases.pdf | Download |
