differences between Good Laboratory Practice (GLP) regulations and Good Manufacturing Practice (GMP) regulations as they relate to laboratory testing.
Scientists and quality control/quality assurance personnel play different roles in GLP than in GMP.
GLP and GMP testing regulations serve two different purposes. The GLPs are designed to protect scientific data integrity and to provide the EPA or FDA with a clear and auditable record of open-ended research studies. In contrast, the GMPs are intended to demonstrate to the FDA whether or not individual batches of a regulated product are manufactured according to pre-defined manufacturing criteria.
“Lot release” or “lot conformance” testing of regulated products produced for sale should be tested under GMPs. Safety and efficacy testing should be done under GLPs. It is a matter of debate whether validation studies should be done under GLP or GMP. It may depend on what is being validated; in some cases either GLP or GMP may be appropriate.
GLPs are defined at 40 CFR Part 160 (EPA) and 21 CFR Part 58 (FDA).
GMPs are defined at 21 CFR Part 111 (Dietary Supplements), Part 211 (Pharmaceuticals), and Part 820 (Medical Devices)
The table below summarizes key differences between the GLPs and GMPs with regard to lab testing.
|
Topic |
GLP |
GMP |
|
Study Director |
Single point of contact for the study, with overall responsibility and control of the study and its components. Appointed by Testing Facility Management. |
No Study Director assigned or appointed. No single point of contact is required. |
|
Quality Assurance Unit |
Quality Assurance Unit inspects critical phases of each study and periodically inspects the facility to inform Testing Facility Management of the integrity of the studies and compliance or non-compliance with the GLPs. Is entirely separate from the personnel engaged in the study. |
Quality Control Unit has responsibility and authority to approve or reject all procedures and aspects of testing/manufacturing. Quality Assurance periodically inspects facility and processes, and maintains quality system. |
|
Testing Facility Management |
Is responsible for designating a Study Director with appropriate education / training for each study. Ensures there is a Quality Assurance Unit separate from the personnel engaged in the study. Ensures facility, personnel, equipment, etc. is available and complies with the GLPs. |
Testing Facility Management is not a defined term in GMPs. However, company management in general is responsible for product quality and inspection findings will be addressed to owners/managers. |
|
Type of Testing Conducted |
Determination of product performance, often for submission to the EPA for registration or FDA for pre-market approval. |
Determination of whether or not the product/sample has met manufacturing specifications. |
|
Facility |
Design and construction must be suitable to the type of testing conducted, with separation of areas for minimizing mix-ups and contamination. Lighting, plumbing, sewage, washing facility regulations are not mentioned under GLPs. |
Facilities must be qualified for the intended use. Regulatory emphasis is placed on cleaning and contamination control processes. Specific requirements for lighting, plumbing, sewage, and washing. |
|
Equipment |
Data-generating equipment must be calibrated, verified and/or standardized as appropriate. Equipment maintenance must be documented. |
Equipment must be qualified for use in manufacturing processes. Data generating equipment for product testing purposes is calibrated, verified, and/or standardized. The accuracy, sensitivity, specificity, and reproducibility of test methods shall be established and documented. |
|
Standard Operating Procedure (SOP) / Written Procedure |
Drafted by any qualified personnel, approved by Testing Facility Management. |
Drafted by any qualified personnel, approved by Quality Control Unit. |
|
Standard Operating Procedure (SOP) / Written Procedure |
Each study requires a specific study protocol indicating study objectives and methods for conduct and is approved by both the Study Sponsor and Study Director prior to initiation. Protocol overrides SOPs. |
Study-specific protocols are not required. SOPs are written for methods and processes and are followed. |
|
Master Schedule |
An index of all studies is maintained by the Quality Assurance Unit. |
Master Schedule is not addressed. |
|
Records and Reports |
Signature or initials of personnel conducting all procedures, preparations, calibrations, etc. are required along with dates completed and must be on all records. Records are maintained in secure archives for at least 5 years following date of registration if used to support a marketing permit or 2 years following study completion/termination. Archivist is responsible for archives and ensures security of documentation. |
Signature of both the personnel conducting procedures and personnel verifying steps of procedures must be on all records. Records are maintained for at least 1 year, safe from damage, following product expiration date. A data archive is not defined in GMPs. |
|
CAPA System |
Not required. |
Required. |
Applicability of GLP or GMP by Product Type, in General:
- Disinfectant and Sanitizer Testing – GLP
- Medical Device Efficacy Testing – GLP
- Medical Device Sterility Testing – GMP
- OTC Drug Testing – GMP
- Dietary Supplement Testing – GMP
- Microbial Ingress Testing – GLP
- Cosmetic and Personal Care Testing – GMP/GLP
- Bioburden and Endotoxin Testing – GMP
Microchem Laboratory offers the full suite of testing, ranging from open-ended GLP antimicrobial efficacy studies to carefully controlled GMP studies for lot-release.