Quality Assurance Flashcards
What is Quality Assurance in general?
Each unit dose should contain the correct components, in the correct concentration and have the desired release properties.
Which 7 factors describe a product which is fit for purpose?
(1) Right drug
(2) Right amount
(3)
Released in the right place
(4) At the right time
(5) In a bioavailable form
(6) With no contaminents or degredation products
(7) Suitable for the person taking it
What are the rules and guidance for pharmaceutical manufacturers and distributors 2017?
Must follow:
(1) MHRA
(2) Guidance on good manufacturing practice
(3) Guidance on manufacture and importaion
(4) Legislation on manufacture and importation
(5) Guidance on good distribution and brokering and active substances
(6) Legislation on wholesale distribution and brokering medicines
(7) Appendices
Quality Assurance definition
The sum total of the organised arrangements made with the objective of ensuring that the medicinal products are of the quality required for their intended use
Good Manufacturing Practice definition
That part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketting authorisation or product specification
Quality Control definition
That mart of GMP which is concerned with sampling, specifications and testing, with organisation, documentation and release procedures which ensure that the necessary and relvant tests are actually carried out and that materials are not released for use, nor products released for sale or supply until their quality has been judgede to be satisfactory
GLP is
(1) ______ of any ____ carried out during the ___ and __ of medicines
(2) ______ of ___ of the medicines during and following ____ of the ____ ____
GLP is
(1) documentation of any work carried out during the development and evaluation of medicines
(2) documentation of analysis of the medicines during and following completion of the production process
GCP (Good clinical practice):
(1) Following ___ procedures during the ___ ___ of the medicines
(2) ___ of the ___ of the ___ and any ___ experienced by the ___ ___
GCP (Good clinical practice):
(1) Following documented procedures during the clinical evaluation of the medicines
(2) Documentation of the evaluation of the medicine and any effects experienced by the trial participants.
GMP
(1) Following ___ ___ and using the ___ ___ to produce medicine which meets the ___ approved in the ___ ___
(2) Ensuring all ___ taken during the production proccess are ___ and ___.
GMP
(1) Following documented procedures and using the correct materials to produce medicine which meets the specifications as approved in the product licence
(2) Ensuring all actions taken during the production proccess are documented and witnessed.
Why do we need to follow documented procedures?
(1)Reproduciblity
(2) The ability to be confident that it is what it states on the packet
Why do we need to be assure of the quality of a medicine?
(1) Prevent harm to patient and ensure medicine works
(2) Protect the professional integrity of the pharmacist
(3) Uphold the image and ensure continued survival of the companies manufacturing medicines.
Staff required to implement QA system
(1) Quality manager - ensure all systems, procedures etc. comply with the approprtiate GMP
(2) Qualified person - to assess compliance with QA and approve or reject products on the basis of their compliance or non-compliance
(3) Production manager - To oversee production facility and ensure QA procedures are being adhered to
(4) Quality control manager - To oversee the testing facilities to ensure QA procedures are adhered to and all testing complies with the procedures outlined
What is total quality management TQM
integrated effort to improve quality at every level of the organistaion
What is quality by design QbD
quality cannot be put into a product by testing, it has to be designed into the prodcut from the start.
