Quality Flashcards
What is quality?
Ensuring that a product meets specific specifications and is fit for purpose. The right drug, concentration, release and no contaminants or degradation products
What is quality assurance?
A wide ranging concept that covers all matters which individually and collectively influence the quality of a product
What is quality control?
Part of GMP that is concerned with sampling, specifications, testing and the the organisation, release and documentation procedures that ensure the necessary tests are actually carried out
What is ICH?
International committee on the Harmonisation of technical requirements for the registration of pharmaceuticals for Human use
What is the role of a QP?
Ensures that each batch is manufactured in compliance with manufacturing authorisation and specific marketing authorisation
Each batch approved must be entered in an appropriate register ASAP after manufacture
Ensure QC is satisfactory
What is a marketing authorisation?
A document that allows the marketing of a medicinal product
How is a marketing authorisation presented?
In a Common Technical Dosier
Examples of other types of licenses
Manufacturing licenses for IMPs
Manufacturing specials license
What is good manufacturing practice?
Part of QA that ensures that products are consistently produced and controlled to quality standards appropriate to their intended use and required by the marketing authorisation
What is good laboratory practice?
Documentation of any work carried out during development and evaluation of medicines
What is good clinical practice?
Following documented procedures during the clinical evaluation of the medicines
Documentation of the evaluation of the medicine and any effects experienced by the trial participants
How is quality assurance implemented?
Written systems in place to control all aspects of medicine development, production, evaluation and distribution
Ensure all audits are documented
Ensure adequate staff training and kept up to date
What is the role of a quality control manager?
Oversee the testing facility to ensure QA procedures are adhered to and all testing complies with the outlined procedures
What is quality improvement?
A system for evaluation of processes to ensure that 99.9999% of all products meet the specification, by reducing waste and improving yield
