Pharmaceutical quality systems (PQS) Flashcards
What are the principles of a quality management system?
Manufacturers must make medicines that are fit for their intended use and do put patients at risk due to inadequate safety, quality or efficacy
Quality assurance
GMP
Quality control
What is the ISO 9000 definition of a QMS?
A management system to direct and control an organisation with regard to quaility
What is the ICH Q10 definition of QMS?
No definition - ‘its a complementary system to GMP’
What is the WHO QMS definition?
A component of quality management encompassing the organisational structure, procedures, processes and resources and systematic actions necessary to ensure adequate confidence that a product will satisfy the given requirements for quality.
According to the ICH Q10 what is the product life cycle?
Development - inception, design, develop
Tech transfer -
Manufacturer - transport, sell, use
Discontinuation - disposal
What is quality?
Degree of excellence….the degree of fitness for purpose.
What is GMP?
That part of the PQS which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use.
It concerns both production and QC
What is quality control?
The part of GMP which is concerned with sampling, specifications and testing
and with the organisation, documentation and release procedures
- which ensures that the necessary and relevant tests are actually carried out
- materials are not released for use, nor products released for sale or supply until their quality been judged to be satisfactory
Principles of GMP are stated in what directive?
EU Directive 2003/94
What do the GMP regulations stated in the EU Directive 2003/94 state?
The mandatory and minimum requirements.
Who is responsible for GMP, in the preparation of medicines?
Responsible/accountable pharmacist is responsible for GMP
ISO 9001 states the requirements of an organisation in achieving QMS. What are these requirements ?
Policies, equipment, SOPs - identify the processes needed for the quality management system and their application throughout the organisation
Validation - determine the sequence and interaction of these processes
SOPs and monitoring - determine the criteria and methods needed to ensure that both the operation and control of these processes are effective
Materials suppliers and SLAs - ensure the availability of resources and information to necessary support the operation and monitoring of these processes.
Audit and PQR - monitor, measure and analysed these processes
Change control - introduce actions necessary to achieve planned results and continual improvement of these processes.
What are the limitations of PQS?
Cost of quality Documentation - don't want to overcomplicate Processes Detail Knowledge management
