LibGuides: SA Pharmacy Medicines Information Service: Manufacturing

SA Health

Specialised Resources and Pharmacopoeias

Regulatory and Compliance

Pharmaceutical Inspection Co-operation Scheme (PIC/S)

Legislation and Regulations

Title	Description
Controlled Substances Act 1984	Legislation governing controlled substances within South Australia.
Poisons Standard (the SUSMP)	The standard for the uniform scheduling of medicines and poisons.
Therapeutic Goods Act (1989)	Governing legislation for the regulation of therapeutic goods in Australia.
Therapeutic Goods Regulations	Detailed regulations complementing the Therapeutic Goods Act.
Goods (Microbial Standards for Medicines) (TGO 100) Order 2018	Specifies microbiological standards for medicines.

Standards and Guidelines

To access the Australian Standards, available via Techstreet, you will need to set up an account.

Category	Standard Number	Title	Description
Laboratory Safety and Containment	AS/NZS 2243.3:2010	Safety in Laboratories Part 3: Microbiological Safety and Containment	Focuses on safety measures for handling microbiological materials.
Cytotoxic Drug Safety	AS 2252.5:2017	Cytotoxic Drug Safety Cabinets - Design, Construction, Installation, Testing and Use	Requirements for cytotoxic drug safety cabinets.
Cleanroom Control	AS ISO 14644.3:2021	Cleanrooms and Associated Controlled Environments, Part 3: Test Methods	Test methods for cleanroom spaces.
	AS ISO 14644.1:2017	Classification of Air Cleanliness by Particle Concentration	Air cleanliness classification in cleanrooms.
	AS ISO 14644.2:2017	Monitoring to Provide Evidence of Cleanroom Performance	Monitoring cleanroom air cleanliness.
	AS/NZS ISO 14644.4:2002	Design, Construction, and Start-Up of Cleanrooms	Guidelines for cleanroom design and construction.
	AS/NZS ISO 14644.5:2006	Cleanrooms and Associated Controlled Environments Part 5: Operations	Operations in cleanrooms and controlled environments.

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