รายละเอียดเอกสาร

Annex 1 (Manufacture of sterile medicinal products)  1

Annex 2A (Manufacture of advanced therapy medicinal products for human use)  67

Annex 2B (Manufacture of biological medicinal substances and products for human use)  107

Annex 3 (Manufacture of radiopharmaceuticals)  127

Annex 4 (Manufacture of veterinary medicinal products other than immunologicals)  134

Annex 5 (Manufacture of immunological veterinary medical products)  136

Annex 6 (Manufacture of medicinal gases)  146

Annex 7 (Manufacture of herbal medicinal products) 157

Annex 8 (Sampling of starting and packaging materials) 162

Annex 10 (Manufacture of pressurised metered dose aerosol preparations for inhalation) 166

Annex 11 (Computerised systems) 168

Annex 12 (Use of ionising radiation in the manufacture of medicinal products) 173

Annex 13 (Manufacture of investigational medicinal products) 180

Annex 14 (Manufacture of medicinal products derived from human blood or plasma) 197

Annex 15 (Qualification and validation) 211

Annex 16 (Authorised person and batch release) 226

Annex 17 (Real Time Release Testing and Parametric Release) 239

Annex 18 [GMP Guide for active pharmaceutical ingredients]** 244

Annex 19 (Reference and retention samples) 245

Annex 20 (Quality risk management) 250