PQS Flashcards
Quality management is a _________-range concept
Wide
The SUM TOTAL of the organized arrangements
Quality management
Quality management incorporates
GMP
It is necessary to assure that products are manufactured with DESIRED QUALITY and PERFORMANCE
PQS
Are subject to strict regulations
Operations of the pharmaceutical industry
It serves people DIRECTLY for HEALTH REASONS
Operations of the pharmaceutical industry
Needs to be RELIABLE on various parameters
Pharmaceutical field produce
Who emphasizes the adoption of QMS
Quality experts
It is the VAGUE CONCEPT of QA
PQS
Has the ultimate responsibility to ensure an effective PQS
Senior management
PQS should be
Defined and documented
Contains a DESCRIPTION of QMS and MANAGEMENT RESPONSIBILITIES
Quality manual
A part of quality management that ensures products are CONSISTENTLY PRODUCED
GMP
GMP is concerned with both
Production and quality control
The manufacturing company cannot produce drugs without it
Personnel
Concerned with SAMPLING, SPECIFICATIONS and TESTING
Quality control
Ensure that the necessary and relevant tests are CARRIED OUT
Quality control
Cause of deviations in QC
SAMPLING in every steps
Should be conducted with the objective of VERIFYING the CONSISTENCY of the process
Regular periodic quality reviews
A systematic process for the assessment, control, communication and review of RISKS to the quality
Quality risk management
The evaluation of the risk to quality is based on
Scientific knowledge
Experience with the process
Patient’s protection
Commensurate with the level of risks
Level of effort
Formality
Documentation of QRM process
No problem but there’s management
Proactive
With problem and management
Retrospective
