GMP/QA Flashcards
what is cGMP?
current Good Manufacturing Practices
–A series of minimum standards to which pharmaceutical companies must comply.
– These standards ensure that the products produced are PURE, SAFE and EFFECTIVE.
what are the basic rules of cGMP?
free from contamination
contain the correct dose - e.g. all batches
have not deteriorated - e.g. during storage/transport
provide the required therapeutic benefit
describe the process of cGMP
- Design & construct the facilities & equipment properly
- Follow written procedures & Instructions
- Document work
- Validate work
- Monitor facilities & equipment
- Write step by step operating procedures & work on instructions
- Design, develop & demonstrate job competence
- Protect against contamination
- Control components & product related processes
- Conduct planned & periodic audits
what is quality assurance/QA?
Has overall responsibility for the quality of the product encompassing all aspects of GMP (testing, personnel, training, validation, documentation, etc.), ensuring that quality is built into the process
what is quality control/QC?
Has the responsibility of sampling and testing raw materials (APIs, excipients, packaging), intermediate products (powder mixes, emulsions) and final products (before release of product and during stability)
what must you do for quality control?
- Adequate facilities
- Trained personnel
- Approved procedures and testing methods
- Maintenance of QC records&failure investigation records
- Ingredients comply with regulatory specification (grade, composition, strength)
- Review and evaluation of production documentation
- Assessment of process deviations
- Release of batches by authorized person(QP)
- Sufficient reference samples of starting materials and finished products
what is quality assurance?
That production and control operations are clearly specified and GMP is adopted
– Managerial responsibilities are clearly defined and specified
– All raw materials are suitable for use
– Ensure that finished products are correctly processed &
checked before release
– Provide satisfactory arrangement to ensure products
are stored, distributed & handled appropriatel
– Put in place a mechanism for regular self inspection / internal quality audit
what is GLP?
Good Laboratory Practice may be defined as:
– A set of principles that provides a framework within which lab studies are conducted
– These studies are undertaken to generate data & then assess the hazards & risks to users, consumers & 3rd parties
– Helps 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 objectives of GLP?
- Promote the quality & validity of data generated in the testing of pharmaceutical products, raw materials, manufacturing intermediates
- Facilitate the recognition of pharmaceutical products
- Protection of human health & the environment
- Time & resource efficiency
- Avoidance of non-tariff barriers to trade