Revised: 19 April 2021
Medicines
New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods
Part 1: Manufacture of Pharmaceutical Products (2018)
On 3 May 2021 the Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods Part 1: Manufacture of Pharmaceutical Products will be updated. This is following consultation with industry. The updated Code 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 009-14 PIC/S GMP Guide (Introduction
- PE 009-14 (Part I) PIC/S GMP Guide (Part I: Basic requirements for medicinal products)
- PE 009-14 (Part II) PIC/S GMP Guide (Part II: Basic requirements for active pharmaceutical ingredients)
- PE 009-14 (Annexes) Annexes 1, 2, 6 to 11, 13 to 15, 17, 19 and 20
