Pharmaceutical packaging can pose a serious problem for manufacturers. As legislation on the display of ingredients, side effects and safety warnings increases, the demands on the labelling and packaging become extreme. This can lead to pages of instructions and disclaimers included in the pack to meet regulations and cover pharmaceutical companies from prosecution, so having the right regulatory information at your fingertips is key to your business.
Find out about:
- How international standards for pharmaceuticals packaging could affect your organisation
- The latest regulations on child resistant, tamper evident and eco-friendly packaging
- Regulatory frameworks in each country
Chapter I: Introduction and methodology
Chapter II: Global overview
- A comparative analysis of different country's labelling regulations
- Product - pack security and integrity
- Tamper evidence
- Child resistant packaging
- Elder-friendly packaging
- Eco-friendly packaging
Chapter III: WHO's guidelines on pharmaceutical packaging
- Overview
- Aspects of packaging
- Packaging materials and closures
- Quality assurance aspects of packaging
- Protection of the environment
- Quality specifications
Chapter IV: International standards for pharmaceuticals packaging
- Introduction to ISO
- PS 9000:2001 - pharmaceutical packaging materials
- Overview
- PS 9004 - a guide to PS 9000
- ISO 15378:2006 I - new international GMP standard for pharmaceutical packaging materials
Chapter V: North America Including Canada, Mexico and United States
- Regulatory framework
- The Federal Food, Drug, and Cosmetic Act
- The code of federal regulations
- U.S. pharmacopeia/national formulary
- Compliance policy guides that concern packaging
- Food and Drugs Act and regulations
- Ley General de Salud (the general health law)
Chapter VI: Europe Including Russia and United Kingdom
- Regulatory framework
- The Council Directive 2001/83/E
- Statutory instruments
- MHRA guidance
- Marking and labelling requirement
- Environmental certification and labelling
Chapter VII: Asia Pacific Including Australia, China, Japan and India
- Regulatory framework
- The State Food and Drug Administration (SFDA)
- Drug Administration Law of the People's Republic of China
- Pharmaceutical Affairs Law
- The Drugs and Cosmetic Act, 1940
- The Drugs and Cosmetics Rules, 1945
- Therapeutic Goods Act 1989
Appendix
- Storage areas
- Labels
- The basic requirements for quality control
- Self-inspection and quality audits
- International standards on packaging
- Clauses and GMP requirements
- List of excipients included in the guidelines published pursuant to Article 65
- References