Good Manufacturing Practice (GMP)

Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made.

Guidance Docs
The goal of the ISPE Good Practice Guide: Critical Utilities GMP Compliance – How to Be Compliant and Ready to Prove It is to help pharmaceutical organizations achieve and maintain their critical utility systems in a state of control, and then be able to efficiently demonstrate their systems’ Good Manufacturing Practice (GMP) compliance to regulatory inspectors and auditors.
Training
This presentation describes the various problem areas relating to GMP in the Asia Pacific region, particularly the various GMP problem areas that currently exist in India and China. The presentation also highlights the...
Guidance Docs
1 Introduction Conducting a clinical trial is a complicated process because of the many factors to address and the numerous entities involved. One...
iSpeak Blog
FDA’s recent released Guidance for Industry on Data Integrity and Compliance with Drug CGMP Questions and Answers (CGMPs also known as current Good Manufacturing Practices), clarifies data integrity’s role for drugs and biologics as required in 21 CFR...
iSpeak Blog
There is a paradigm shift occurring in the biomanufacturing space around the advancement of personalized medicine that is creating new challenges for biomanufacturing facility design, both in terms of process technology and facility development...
Special Reports
China’s biological pipeline may take the lead China and India have demonstrated their capability in good manufacturing practice (GMP) manufacture of small-molecule drugs for decades. But...
Training
This highly-interactive, online course reviews the quality system and its importance within the USFDA Systems Inspection Approach, as well as the roles and responsibility of the quality control unit. Quality system...
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This course is designed to help participants understand the GMPs as they relate to the pharmaceutical industry. Participants will gather information....