Pharmaceutical Quality Systems (PQS)/Quality Management Systems (QMS) Flashcards
What is a Quality Management System?
The concepts of QA, GMP and QC, which are interrelated, from the basis of such a system for the manufacture of pharmaceutical products
What are the main points of understanding that an applicant must be expected to demonstrate for a QMS?
- The design criteria for an effective QMS
- Deviations and change control
- The interpersonal skills (leadership, communication, delegation etc) necessary to implement an effective QMS
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
- It’s a complementary system to GMP with key objectives and enablers
- It describes model PQS/QMS
- > Science and risk based approaches
- > Implemented throughout all stages of a product lifecycle
What are the key objectives and enablers of ICH Q10?
- Product realisation
- State of control
- Continual improvement
- Enablers
- > Knowledge Management
- > Quality Risk Management
What is the WHO definition of Quality Management Systems?
A component of quality management encompassing: - The organisational structure - Procedures and processes - Resources - Actions Necessary to ensure quality.
What is Quality?
The totality of characteristics satisfying the stated & implied needs
Quality is not just complying with specification it is about also meeting the needs and expectations of customers and patients
Understanding and implementing an appropriate quality system enables a pharmaceutical organisation to…
meet ethical and regulatory obligations including:
- Identity, purity, quality, safety and efficacy
Describe the normal life-cycle of a product
Inception Design Develop Manufacture Transport Sell Use Dispose
A PQS appropriate for the manufacture of medicinal products should ensure that: (may not need to learn all?)
- Product is achieved by design, planning, maintaining and continuous improvement
- Managed through whole of product lifecyle
- GMP is met
- Specified production and control
- Management roles clear
- Approved material and supply chain
- Assured processes
- Monitored
- Root Cause Analysis
What is GMP?
That part of QA that ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and the product specification
It concerns both:
- Production
- Quality Control
What is QC?
That part of GMP which is concerned with:
- sampling, specifications and testing
- organisation, documentation and release procedures
Ensures that the necessary and relevant tests are actually carried out and that materials are not released for use until their quality has been judged to be satisfactory
What legislation are the Principles of GMP stated?
EU Directive 2003/94
The GMP regulations establish what kind of requirements?
Mandatory and minimum
- Compliance is not an option
- It is the lowest acceptable quality standard
Describe the interrelationship between PQS/QMS, QA, GMP and QC
PQS/QMS (outer level)
QA
GMP
QC centre (inner most level)
