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.

Figure 1: Frequency of mention of specific contaminants/impurities in case studies reported in the past 15 years (2007–2021).
Technical
Contamination Trends & Proposed Solutions

Contamination is one of the top reasons for medicinal product1

  • 1UK Medicines and Healthcare Products Regulatory Agency. “A Guide to What Is a Medicinal Product.” March 2020.
Video

503B Compounding Pharmacies: Principles, GMPs and Case Studies

Join us on 6 May 2021 for the FREE live webinar "503B Compounding Pharmacies: Principles, GMPs, and Case Studies" to take an in-depth look at how this field has developed since section 503B was created as part of the...
Good Practice Guide: Critical Utilities GMP Compliance
Guidance Docs

Good Practice Guide: Critical Utilities GMP Compliance

Good Practice Guides
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.
Concept Paper
Guidance Docs

Investigator Initiated Trials (IIT) – Considerations and Guidance from the Perspective of Clinical Trial Supplies and GMP

1 Introduction Conducting a clinical trial is a complicated process because of the many factors to address and the numerous entities involved. One...
Training
Training

GMP Fundamentals for the Pharmaceutical Industry

This course is designed to help participants understand the GMPs as they relate to the pharmaceutical industry. Participants will gather information about both European regulators and the FDA, how the various agencies enforce GMP requirements, and what to expect during a routine GMP inspection. They....