Both GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practice) are sets of regulations designed to ensure quality and safety, but they apply to different stages of a product’s life cycle。 Here’s an analogy to understand the difference:
GLP is like ensuring the accuracy of your research notes before writing a scientific paper.
GMP is like ensuring you follow a perfect recipe and quality control procedures when baking a cake for sale.
| Feature | GLP (Good Laboratory Practice) | GMP (Good Manufacturing Practice) |
| Focus | Ensuring the integrity and reliability of non-clinical safety and efficacy testing of products. | Ensuring the quality and consistency of manufactured products for human or veterinary use. |
| Applicability | Applies to studies done to support the safety and efficacy of drugs, medical devices, food additives, etc., before seeking regulatory approval. | Applies to the actual manufacturing process of those products once they are approved for sale. |
| Data Focus | Focuses on data integrity and ensuring data can be trusted and replicated by others. | Focuses on product quality and ensuring products meet specifications throughout the manufacturing process. |
| Documentation | Requires detailed documentation of study protocols, procedures, data, and quality control measures. | Requires detailed documentation of manufacturing procedures, quality control measures, and batch records. |
| Facility Requirements | Less stringent requirements for facilities compared to GMP. | Has strict requirements for facilities regarding cleanliness, environmental controls, and equipment maintenance. |
| Regulations | Varied by region, but often follows OECD (Organisation for Economic Co-operation and Development) principles. | Enforced by regulatory agencies like the FDA (US) and EMA (Europe). |
While GLP and GMP serve different purposes, they can sometimes overlap. For instance, validation studies (testing to ensure a process consistently delivers the desired outcome) might fall under either GLP or GMP depending on the context.