Both GLP and GMP are the critical pillars of regulatory compliance. GLP (Good Laboratory Practice) applies to research and development activities, ensuring quality and reliability in testing, while GMP (Good Manufacturing Practice) governs manufacturing processes to ensure product quality and safety. Each GLP and GMP plays a unique role in different phases of drug development-from […]
Both GLP and GMP are the critical pillars of regulatory compliance. GLP (Good Laboratory Practice) applies to research and development activities, ensuring quality and reliability in testing, while GMP (Good Manufacturing Practice) governs manufacturing processes to ensure product quality and safety.
Each GLP and GMP plays a unique role in different phases of drug development-from the laboratory bench to the production line. Adherence to these guidelines not only meets regulatory expectations but also protects patient safety, supports scientific integrity, and strengthens public trust in pharmaceutical products.
By implementing and maintaining robust GLP and GMP systems, pharmaceutical organisations can drive innovation responsibly while navigating complex regulatory landscapes with confidence.
In this article, I will discuss about comprehensive overview of GLP and GMP with key differences, requirements, examples, and FAQs.
| Aspect | GLP (Good Laboratory Practice) | GMP (Good Manufacturing Practice) |
|---|---|---|
| Definition | A quality system for non-clinical lab studies | A quality system for manufacturing and quality control of drugs |
| Purpose | Study plans, raw data, and final reports | Ensures consistent production and control of pharmaceuticals |
| Applies To | Preclinical safety testing (animals, toxicology, pharmacology) | Manufacturing, packaging, labelling, and storage of drugs and biologics |
| Regulated By | FDA, OECD, EPA | FDA, EMA, WHO |
| Focus | Study integrity, traceability, and data reproducibility | Product quality, safety, and compliance |
| Documentation | Study plans, raw data, final reports | Batch records, SOPs, validation records |
| Inspection Frequency | Less frequent, based on study types | Regular inspections, especially for marketed products |
| When Applied | Preclinical phase (before clinical trials) | During and after product development and commercial production |
A pharmaceutical company conducts a 28-day oral toxicity study in rats to assess the safety profile of a new compound before submitting an Investigational New Drug (IND) application. This study must follow GLP guidelines to ensure regulatory acceptance.
The same company begins producing the drug in a GMP-certified facility for Phase 2 clinical trials. Each batch produced is documented, tested, and released by quality control in accordance with GMP regulations.
| Phase of Drug Development | Key Standard Used |
|---|---|
| Preclinical (animal studies) | GLP |
| Clinical Trial Manufacturing | GMP |
| ost-approval Manufacturing | GMP |
Understanding the distinction between Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) is essential for ensuring the safety, efficacy, and quality of pharmaceutical products throughout their lifecycle. While GLP governs the standards for conducting reliable and reproducible non-clinical laboratory studies, GMP ensures that drugs are consistently manufactured and controlled according to quality standards during and after production
Related
No, GLP applies to non-clinical studies. Clinical trials must follow GCP (Good Clinical Practice).
Not typically. A GLP lab is not designed for manufacturing under GMP standards unless it also meets GMP requirements.
No. GLP ensures quality in laboratory studies; GMP ensures quality in manufacturing. Both serve different phases in the drug development lifecycle
Yes, for regulatory toxicology and safety studies submitted to FDA, EMA, etc
It may result in regulatory warning letters, rejection of study data (GLP), or product recalls and license revocation (GMP)
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