Quality assurance
Good Manufacturing Practice
Defined processes
Validated processes
Suitable facilities
Clear instructions/procedures
Trained operators
Full and accurate records
Batch traceability
Quality maintained during distribution
Complaints procedure
Recall procedure
Quality Control
Electronic records and electronic signatures
Good Manufacturing Practice guidelines and enforcement around the world
The Us
Western Europe
The Pacific Rim
Latin America
Central and eastern Europe and the Former Soviet Union
Poland
Ukraine
Russia
Central Asian republics
Middle East and Africa
Asia
The role of the World Health Organization
WHO codes and guidelines
GMP and the multinationals
Harmonisation of standards
PIC/s
Mutual recognition between Europe and North America
Mutual recognition between Europe and other countries
ICH
Other harmonisation programmes
Conclusion
TABLE OF CONTENTS
