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TRICK QUESTION
100
Required for the conduct or management of human clinical trials.
What is GCP?
100
Required for the validation of a residual solvent test method for the characterization of an active pharmaceutical ingredient.
What is GMP? Test Methods which are used to test drugs have to be validated under GMP.
100
Required for procurement of human tissues and cells.
What is GCP? Any time you obtain human tissue or cells, you need to have informed consent and subject privacy provisions of the GCPs.
100
Required for repeat dose toxicity studies in experimental animals that are to be used to support an Investigational New Drug application.
What is GLP? Repeat dose toxicity studies are considered pivotal in the IND application, and needs to be done under GLP.
100
Required for the manufacture of inactivated vaccines for animals.
What is GMP? Although animal health usually falls under USDA regulations, manufacturing of vaccines for animals resides with the FDA.
200
Required for the manufacture of engineered/processed tissues or cells procured from human subjects to be reintroduced into a human patient.
What is GMP? Good Tissue Practices have to follow good manufacturing practices, including detection of potential infectious agents.
200
Required for storage stability testing (aka accelerated storage testing) of three lots of an active pharmaceutical ingredient (API).
What is GMP? Stability of drugs needs to be done under GMP (ICH Q1A (R2)).
200
Required for the manufacture of a medical device.
What is GMP? Medical Devices have to be manufactured under GMPs.
200
Required for long-term toxicology safety studies, e.g., 1-2 year carcinogenicity studies in animals.
What is GLP? Although most long-term studies such as carcinogenicity or reproductive toxicology is done after clinical trials have begun, they need to be done under GLP.
200
Required for validation of LC-MS/MS bioanalytical methods to support regulated studies in nonhuman primates.
What is Non-GxP? 1981 FDA Good Laboratory Practice: Questions and Answers. Question: Do the GLPs apply to validation trials conducted to confirm the analytical methods used to determine the concentration of test article in animal tissues and drug dosage forms? Answer: No.
300
The Quality Control Group is responsible for the approval of the manufactured batch or lot.
What is GMP? Quality Control is the main responsible group in the U.S. FDA GMP regulations.
300
Required for testing dose formulations in regulated nonclinical studies to confirm dose levels.
What is GLP? Samples from the dose formulations from a GLP study have to be tested under GLP (Subsection 113).
300
Requires de-identification of subject specimens that are sent out for testing (subject privacy).
What is GCP? Subject privacy, covered under HIPAA in the U.S., is a component of GCPs.
300
Required for early phase proof-of-concept efficacy studies of a new pharmaceutical.
What is Non-GxP? Early phase studies, including initial toxicity, metabolism, and efficacy should not be conducted under GLP, although data from these studies can be included in an IND application.
300
Required for testing of investigational new drugs (Certificate of Analysis) to be used in nonclinical toxicology studies (Tox Lot).
What is GLP? Analysis of API being tested in GLP studies needs to be done under GLP, although the FDA has accepted GMP testing in the past.
400
Requires a corrective and preventive action plan (CAPA).
What is GMP? CAPAs are specified in the GMP regulations for medical devices. FDA is proposing implementation in GLP and GCP.
400
Required for EPA "six-pack" of acute studies (acute oral, acute dermal and acute inhalation toxicity studies), for testing the safety of toxic substances
What is GLP? Although most six-pack studies are single dose, they have to be done under EPA GLP.
400
Required for high throughput screening (usually in vitro) for lead discovery efforts.
What is Non-GxP? Lead optimization is usually exploratory and not required to be done GxP.
400
Requires that study protocols be approved by the federal agency and Institutional Review Boards/Ethics Committees in the US.
What is GCP? In the US, the FDA and local IRBs must approve of the clinical trial protocol.
400
Required for the manufacture of a raw material used in the manufacture of a marketed pharmaceutical product.
What is Non-GxP? Oddly enough, raw materials do not need to be manufactured under GMP. They are put under quarantine until they are tested to make sure they meet the specifications. Also suppliers must be qualified.
500
Primary Point of Study Control is the Study Director.
What is GLP? The main responsible person for a GLP study is the Study Director.
500
Required for in vivo safety testing of a new implanted medical device.
What is GLP? Testing of GMP manufactured medical devices in animals is within the scope of the GLPs.
500
Requires security of private subject/patient information, including electronic media (servers & web)
What is GCP? Servers and web storage of human subject data need to be tested/validated to ensure compliance with subject privacy (HIPAA in the US) requirements of the GCPs.
500
Required for safety and clinical studies of veterinary drugs.
What is GLP? The Center for Veterinary Medicines requires safety testing and clinical testing of veterinary drugs to be done under GLP.
500
Required to manufacture an investigational new drug to be used exclusively in nonhuman toxicology IND-enabling studies (Tox-Lot).
What is Non-GxP? Interestingly, the GLPs do not include manufacture of lots or batches of API to be used in GLP studies.