Guidelines & Codes
New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods
Part 1: Manufacture of Pharmaceutical Products (2009)
On 1 September 2009 the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods Part 1: Manufacture of Pharmaceutical Products was updated and comprises of the following documents:
- Medsafe Introduction to the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods Part 1: Manufacture of Pharmaceutical Products
- PE 009-8 (Intro) PIC/S GMP Guide (Introduction)
- PE 009-8 (Part I) PIC/S GMP Guide (Part I: Basic requirements for medicinal products)
- PE 009-8 (Part II) PIC/S GMP Guide (Part II: Basic requirements for active pharmaceutical ingredients)
- PE 009-8 (Annexes) Annexes 1 to 3, 6 to 15, 17, 19 and 20