GMP Flashcards
GMP protects customers from
Purchasing a product that is not effective or is even dangerous.
What is GMP
Quality assurance at ensures products are consistency manufactured and controlled to the quality standards appropriate for their intended use.
Warrants inplementation if set of privileges and procedures which when followed by manufacturers ensure product has required quality.
Eliminates insentces of contamination, mix ups, error.
cGMP
Current good manufacturing practice.
Requires companies to use technologies and systems that are up to date.
Flexibility allows use of modern technologies and innovative approaches.
Relevance of GMP
Manufacturing sites for MPs must have a manufacturing license.
Being GMP competent is a prerequisite.
GMP ensure the …. 3 …. Of MPs
Safey
Quality
Efficacy
QA
Organised arrangements ensuring products will be the quality required for their intended use
GMP
In relation to QA QC
Ensuring products are consistently manufactured to appropriate quality
QC is part of GMP which is part of QA
QC
Sampling, specification and testing of
Documentation and release procedures which ensure
Relevant tests are performed and the products is released only after ascertaining quality .
What is essential for any process that can affect quality?
Detailed written procedures.
The five ps
Premises Primary materials People Procedures Processes defined and recorded
QA is a … Tool
Management
Te total arrangements that ensure drug is continently of right quality …
Is QA
GMP GCP and GLP are part of
QA
GMP is part of QA that ensures …
Products are constantly produced and controlled ( diminishing risks that cannon be controlled by testing of the product - mixup, contamination)
GMP includes system of complaints and recalls?
Yes
Quality is measured as….
Fitness for purpose… GMP ensures this is built in
Does self assessment play a role
Not at the moment - mistrust is assumed. But it is part of the ideal quality by design idea
Roles of head of QC
Maintenance of his department, premises and equip
Approve starting materials, packaging, intermediates... Approve contract analysts Evaluate batch record Testing is carried out Validations a done
Qualified persons role
Ensure imported batch has undergone specified testing
Ensure UK batch has been produced in accordance with MA
Certify operations are carried out before any release
Must have qualification requirements laid down in article 23
Guidelines regarding key personnel
Posts must be occupied full time
No gaps/up overlaps in responsibilities
Organisational chart of people responsible for specific duties in job descriptions & authority to carry them out.
role of head of production
Maintenance of his department, premises and equip
Monitor storage and production according to documents
Approve prod instructions
Ensure followed
Evaluate and sign prod records before they are sent to QC
Validation
Shared responsibilities of heads
Monitoring GMP compliance environment/plant hygeine/suppliers/contract manufacters
Testing samples, investigation, inspection
Authorisation of written procedures
Process validation
Training
Ten principles of GMP
Document work Validate " Write step by stem written procedures Follow """" Design facilities and equip properly Monitor facilities and equipment Monitor components and processes Monitor contamination Design, develop, demo job competence Audit
