GMP: QA Flashcards
What decisions can consumers NOT make about drugs?
When to use, which to use, how to use, potential benefits and risks
Why is it important to regulate drugs?
To prevent therapeutic failure, exacerbation of disease, resistance to medicines, and death
(from ineffective, poor quality, harmful meds)
Who regulates drugs?
FDA,
EMEA,
Ministry of Health and Welfare,
MHRA, ICH
What is an active pharmaceutical ingredient (API)?
A drug in regulatory terms
What are the components of a medicine?
API, inactive ingredients (excipients), packaging components
What does the pharmaceutical industry do?
Develops medicines, makes a profit, provides therapies, conducts research, has social impact
What evidence do governments require for product approval?
Safety,
effectiveness,
suitable quality
How is the quality of medicine assured?
Through robust development processes
What exists to control the approval of new products?
A regulatory system
What is the role of the FDA?
To regulate and supervise the safety and efficacy of pharmaceuticals in the US
What is the role of the EMEA?
To evaluate and supervise the safety and efficacy of pharmaceuticals in the EU
What is the role of the MHRA?
To ensure that medicines and medical devices meet applicable standards of safety, quality, and efficacy in the UK
What is the role of the Ministry of Health and Welfare?
To regulate and supervise the safety and efficacy of pharmaceuticals in their respective countries
What is cGMP?
Current Good Manufacturing Practices
- minimum standards for pharmaceutical companies to comply with to ensure products are pure, safe, and effective.
Why do we need cGMP?
ensure high level of quality and consistency in manufacture of therapeutic products + protect end user.
What are the basic requirements of products in cGMP?
fit end purpose..
Free from contamination.
Contain the correct dose.
Have not deteriorated.
Provide the required therapeutic benefit.
Who’s responsibility is it to ensure all processes comply with cGMP?
companies
What is the difference between quality assurance and quality control?
QA is responsible for the overall quality of product
QC is responsible for sampling and testing raw materials.
What term encompasses GMP and QC?
quality assurance
What is the purpose of planned & periodic audits?
Ensure compliance with cGMP
What is the responsibility of QC?
Sampling and testing of raw materials, intermediate products, and final products
What are the requirements for a QC department?
Trained personnel, approved procedures and testing methods, maintenance of records, sufficient reference samples
What is the role of QC in GMP?
Ensure no materials or products are released until quality is evaluated and judged satisfactory
what ensures delivery of high quality products?
QA
What is ICH Q10?
Pharmaceutical Quality System - captures QA
What should Quality Assurance ensure about product design?
Based on sound scientific rationale and with GMP or GLP principles
Why are Good Laboratory Practices (GLP) important?
to ensure products are developed that are fit for purpose from the start.
What should Quality Assurance ensure about production and control operations?
Clearly specified and GMP is adopted
What is the objective of GLP?
Promote the quality & validity of data generated in the testing of pharmaceutical products, raw materials, manufacturing intermediates
What is the objective of GLP?
Promote the quality & validity of data generated in the testing of pharmaceutical products, raw materials, manufacturing intermediates
What is the importance of GLP?
Assure regulatory authorities that data submitted are a true reflection of the results obtained during the study & can therefore be relied upon
What are the three main goals of drug quality assurance?
Protection of human health & the environment, Time & resource efficiency, Avoidance of non-tariff barriers to trade
What is the purpose of Chemistry, Manufacturing and Controls (CMC)?
To build QUALITY into the product by assuring consistency and appropriate standards
What connection does CMC help maintain?
Quality between the drug used in clinical trials and the marketed drug.
What are some critical elements of CMC?
Raw material quality control, process control, sterilization validation, shelf life/expiry validation
What is the connection between CMC and drug quality in clinical studies and marketed drugs?
CMC helps maintain the connection in quality between the drug used in clinical studies and the marketed drug
What is the purpose of commercial batches and process validation batches?
To ensure consistency and quality of the product marketed to consumers
How is the connection between clinical and commercial batches made?
Through pilot batches and scale-up from engineering batches.
What should be consistent across batches at each stage?
Processes and raw materials.
What CMC factor is of particular concern for sterile injectable products?
sterility and endotoxin concentration.
What CMC factor is of particular concern for controlled-release products?
release profile of API over time
What CMC factor is of particular concerns for oral tablets?
dissolution profile
What CMC factors are of particular concern for soluble powders for drinking water?
moisture content of powder.
solubility in water.
What does CMC stand for?
Chemistry, Manufacturing, and Controls.
Why is testing alone of the finished drug product insufficient for control of product quality?
The manufacturer should know which steps and variables in the manufacturing process need to be controlled and why.
What is the foundation of a controlled manufacturing process?
Process understanding.
Why is process understanding vital to quality and consistency?
The manufacturer that understands the sources of variability in its process can preempt problems and quickly find the root cause and fix it.
What are the factors that should be constant (or improve) for product quality?
Raw material suppliers,
manufacturing sites,
manufacturing processes,
manufacturing equipment,
packaging,
specifications,
testing procedures.
Why are manufacturing changes inevitable over time?
Over time, change is inevitable.
What are the stages of the drug development process?
Drug discovery and screening, preclinical testing and IND application, human clinical trials: Phase I, II, III, new drug application, full-scale manufacturing.
What is the timeline for drug development?
3 to 6 years for preclinical, 6 to 7 years for clinical, 1 to 3 years for post-market.
What are the types of continuous testing?
GLP, GCP, GMP.
