Quality Assurance (Week 1) Flashcards
What is meant by quality?
Complies with specification
Or fit for purpose
What does QC in manufacturing involve?
Sampling and testing of products and intermediates in pharmaceutical manufacture
Intermediated and products not released until they pass QC check
What does QC involve in analytical labs?
Preparing calibration graphs
QC standards included with samples to be tested
QC standards are check to ensure they give expected answers
Problems with relying on QC alone?
Only samples can be tested - not all pharmaceutical products
QC department may not detect issues - contaminated
If batches fail QC test, may have to be re worked/ discarded - costs time and money
If QC samples don’t give expected results - have to identify source of error
Relying on QC can waste time and money
So QA also used
What is QA?
Covers all matters which influence the quality of a product or service
Sum total of organised arrangements for ensuring that products and services are fit for purpose
Whole process follows a set of written procedures
Ensures you make correct product, and get correct values
How does QA eliminate time and materials wasted?
Ensures customers requirements are understood and agreed
Ensures all products and services are fit for purpose by controlling the whole process
What does QA in pharmaceutical manufacture include?
Ensuring all staff are trained to carry out duties
Ensuring SOPs are written and adhered
Ensuring raw materials have been checked before used
Ensuring equipment such as stirrers, heaters, pumps are working correctly and calibrated
Documentation to prove all above
What does QA in analytical labs include?
All staff are trained Used properly validated methods Having SOPs and adhering to them Ensuring instruments are calibrated Ensuring glassware, benches are clean Ensuring data is recorded accurately Documentation to prove all above
How can QA be ensured?
By having an appropriate and effective quality management system - QMS
Reviewed at regular intervals to ensure its working correctly - internal/external audits
Overview of QA standards
ISO 9001:2015 - QMS requirements - general manufacturing and service sectors
ISO 17025:2017 - General requirements for the competence of testing and calibrating labs
ISO 15189:2012 - Medical labs - hospital labs - quality and competence
GLP - Safety testing of chemicals
GMP - Pharmaceutical manufacture
What is GMP?
Ensures proper management procedures
Requirement for pharmaceutical manufactures in UK and Eu
Ensures effective data audit trails for the manufacture of each batch of pharmaceutical
What is GLP
Ensures that data from safety trials can be authenticated
Required for pharmaceutical and other products - perfumes, paints, cleaning
What is ISO 9001:2015?
General quality standard, applicable applicable to a wide range of manufacturing and service industries
Ensures that the process or service is carried out consistently and reliably by having appropriate procedures, and adhering to them
Concerned with meeting the needs of the customer
What is ISO 17025:2017
Standard for assessing the competence of testing and calibration labs
Ensures calibration and lab analysis is carried out correctly, consistently and reliably
What is ISO 15189:2012
Standard for medical labs
Examination of materials derived from body, provides information for diagnosis, prevention and treatment of disease
