5 good lab/clinical/marketing practices Flashcards
good laboratory practices ensure that all preclinical studies are:
-planned and performed under well-controlled conditions
-conducted and monitored by well-trained staff
-results are accurately and thoroughly documented and reported
who decides the good laboratory practices (GLP)?
-regulations were first proposed by US FDA in 1976, and adopted in 1987
-in canada, standard council of canada (SCC) act as the monitoring authority for GLP compliance of test facilities
what does are the GLPs for organization and quality of personnel?
-knowledge of the GLP principles
-record raw data
-responsible for the quality of the data
-exercise health precautions to minimize risk
-ensure the integrity of the study
What are the GLPs of testing facilities?
-suitable size, construction and location
-adequate degree of separation of the different activities
-storage room
what are the GLPs of equipment and materials?
-documented inspection, cleaning, maintenance and calibration of apparatus
-chemical, reagent and solutions should be labeled
what are the GLPs product characterization?
-identity, strength, purity, composition
-stability studies (including its container)
-each batch needs to be sent to analytical studies
what are the GLPs standard operating procedures (SOPs)?
-how to carry out protocol-specified activities
-routine inspection, cleaning, maintenance, calibration
what are the GLPs of animal selection and care?
-standard operating procedures for the housing, feeding, handling, and care of animals
-animals of different species are housed in separate rooms
-feed and water should be analyzed regularly to ensure that are no contaminants
what is another important aspect of GLPs?
documentation/records and reports
how expensive are GLPs?
-the cost of adhering to GLP regulations makes up about 30% of the total expenditure for an animal toxicology study
-GLP regulations are not limited to pharmaceuticals: medical devices, pesticides, cosmetics, food additives, veterinary drugs and animal feed additives, and industrial chemicals
what are the ICH guidelines? (GCP)
-internationally accepted approach to the design, conduct, recording and reporting of human trials based on highest ethical and scientific standards
-credible clinical trials that establish safety and efficacy of drugs
-in canada, regulatory operations and enforcement branch (ROEB) has the responsibility for the inspections and investigations of clinical trials
what are the principles of GCP?
-conducted according to the declaration of helsinki, with emphasis on safety and well-being of trial subjects
-based on adequate non-clinical studies
-using protocols approved by the research ethics board
-risk analysis before and during trials
-qualified medical practitioners
-informed consent required
-all data recorded, all studies reported
-confidentiality of records
-GMP materials and SOPs
-immediate reporting of serious adverse events
how are the people involved in clinical trials (GCP)
what are the good manufacturing practices (GMP)?
purpose: makes sure adhering to conditions
-plants and premises
-equipment
-personnel
-sanitation
-raw materials testing
-manufacturing control
-quality good
-packaging
-finished product testing
-records
-samples
-stability
