《塑料药包材可控添加剂及使用指南（征求意见稿）》英文版.pdfVIP

ICS 11.120 C10 S o c i a l O r g a n i z a t i o n S t a n d a r d T/CNPPA XXXX-20XX Controllable Additives Used in Plastic Pharmaceutical Packaging Materials and Application Guidance （Exposure Draft） Issued on ××××-××-×× Effective on××××-××-× Issued by China National Pharmaceutical Packaging Association T/CNPPA XXXX -20XX Table of Contents FOREWORD 3 INTRODUCTION 4 1. SCOPE 6 2. NORMATIVE REFERENCES 6 3. TERMINOLOGY 6 4. CLASSIFICATION OF ADDITIVES USED IN PLASTIC PHARMACEUTICAL PACKAGING MATERIALS 7 5. LIST AND APPLICATION OF CONTROLLABLE ADDITIVES FOR PLASTIC PHARMACEUTICAL PACKAGING MATERIALS 8 5.1 GENERAL RULES FOR CONTROLLABLE ADDITIVES LIST OF PLASTIC PHARMACEUTICAL PACKAGING MATERIALS 8 5.2 BASIC PRINCIPLES FOR THE USE OF CONTROLLABLE ADDITIVES FOR PLASTIC PHARMACEUTICAL PACKAGING MATERIALS 8 5.3 REGULATIONS ON THE USE OF CONTROLLABLE ADDITIVES FOR PLASTIC PHARMACEUTICAL PACKAGING MATERIALS 9 6. FURTHER APPLICATION CONSIDERATION OF ADDITIVES FOR PLASTIC PHARMACEUTICAL PACKAGING MATERIALS 9 REFERENCE 43 2 T/CNPPA XXXX -20XX Foreword This standard is drafted in accordance with the rules listed in GB/T 1.1-2020 Directives for standardization- Part 1: Rules for the structure and drafting of standardizing documents. Please be aware that some contents in this standard may be patentable. China National Pharmaceutical Packaging Association shall not be held responsibility for identifying pa