Quality Management Systems Flashcards
What is the principle of quality management systems?
Manufacturers must make medicines that are fit for their intended use and no not put patients at risk due to inadequate safety, quality or efficacy.
What is a qualified person?
Primary legal responsibility of the qualified person is to certify batches of medicinal products.
What is ISO 9000?
A management system to direct and control an organisation with regard to quality
What is ICH Q10?
Uses ISO 9000 as a base and is a complementary system to GMP.
What are quality management systems?
A component of quality management encompassing the organisational structure, procedures, processes and resources and systematic actions necessary to ensure adequate confidence that a product (or service) will satisfy the given requirements for quality.
What does quality mean?
The totality of characteristics satisfying the stated and implied needs.
What does ICH Q10 do?
Described model pharmaceutical quality system and encourages the use of science and risk based approaches.
ICH Q8 =?
ICH Q9=?
ICH Q8 =Pharmaceutical development
ICH Q9=Quality Risk Management
What is ICH Q10 really about?
Understanding and implementing an appropriate quality system enables a pharmaceutical organisation to meet ethical and regulatory obligations including identity, purity, quality, safety and efficacy of medicines.
What are the 4 aspects of ICH Q10?
Development
Tech transfer
Manufacture
Discontinuation
What is GMP?
That part of the Pharmaceutical Quality System (QA) which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and the product specification.
What is quality control?
That part of GMP which is concerned with sampling, specifications and testing, and with the organisation, documentation and release procedures.
The principles of GMP are stated where?
EU Directive 2003/94
for the preparation of medicines who is ‘responsible’ for GMP?
The responsible/accountable pharmacist.
What is the quality manual?
The description of the PQS
