Links - Documents

Links - GMP-Regulations

Links - Pharmaceutical Associations

The association of Pharmaceutical Research and Manufacturers of America (PhRMA) also has a section on its homepage commenting on current regulatory developments, e.g. new FDA Guidelines.

IPEC, the International Pharmaceutical Excipients Council is the world wide Trade Association of Manufacturers and users of Pharmaceutical Excipients.

The International Federation of Pharmaceutical Manufacturers Associations (IFPMA) represents the worldwide research-based pharmaceutical industry and manufacturers of prescription medicines generally.

The European Chemical Industry Council is both the forum and the voice of the European chemical industry. It represents, directly or indirectly, about 40,000 large, medium andsmall chemical companies in Europe, which employ about two million people and account for more than 30% of world chemicals production.

Links - Regulatory Authorities

Here you will find the homepage of the European regulatory authority EMA.

The European Commission Public Health provides the legal framework for the pharmaceutical legislation in Europe.

Here you will find the homepage of the US Food and Drug Administration.

Links - Others

The API Compliance Institute has been founded to organise Third Party GMP Audits according to APIC Auditing Programme.

The Pharmaceutical Consulting Alliance is a leading Consulting Company in the field of GMP and Regulatory Compliance.

International Pharmaceutical Quality (IPQ) is one of the most important publications in the GMP environment. Each story provides an in-depth analysis of a key problem area or developing regulatory initiative. IPQ seeks to improve understanding of the issues and aid the development of harmonized global CMC and GMP policies and corporate quality systems.