Good Manufacturing Practices (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
1 Introduction Conducting a clinical trial is a complicated process because of the many factors to address and the numerous entities involved. One...
Technical
This article presents the standards and guidelines typically used by manufacturers to design and build GMP washers and sterilizers. It describes the characteristics that differentiate GMP from regular laboratory equipment.
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...
Training
This classroom course uses the second edition of the ISPE Baseline® Guide: Sterile Product Manufacturing Facilities and the FDA's Guidance for....
Regulatory
The following is a quick list of things to do as an auditor . Using this list will help you to make sure that you are on track as you plan and conduct GMP audits. Maintain and Use a Written SOP for GMP Auditing...