PQS Flashcards
What is the objective of a PQS
The Pharmaceutical Quality System is the sum of all the management arrangements made with the objective of managing the quality system and ensuring that the finished product, as delivered, will be fit for its intended use.
It is the effectiveness of the design and operation of the Quality System that should give a QP the confidence to certify product.
ICH Q10 defines a pharmaceutical quality system as
“A management system to direct and control a pharmaceutical company with regard to quality”
The key components of the Quality System include:
Quality Vision and Mission
* Policies and Procedures
* People management; including Organisational Structure, Education and Training
* Document Management
* Validation and Qualification
* Change and Deviation Management; including CAPA
* Monitoring and Feedback Mechanisms
* Batch Release
What is the QPs role in the PQS
- Development
- Implementation
- Maintenance
- and Review
…of the quality system.
The QP should have an intimate understanding of the effectiveness of the Quality System.
How is the effectiveness of the PQS monitored
Assessment of Quality Systems
Assessment, or audit, is a prime mechanism by which a QP can judge the effectiveness of the quality management system.
Auditing and self-inspection should form part of management’s strategy to continually improve and prevent mistakes.
One key way for management and the QP to monitor the effectiveness of a quality system is to identify and trend ‘Key Performance Indicators’ (KPIs).
Quality management review
Typical KPIs for a pharmaceutical quality system include:
- Recalls
- Complaints
- Product returns due to company errors
- Out of Specification results
- Rejected lots
- BMR non-conformances
- Deviations and investigations
- Internal and external audits
- Adherence to programme and findings
- CAPA closeout
- Batches reworked
- APRs done on time
QPs must review trends in quality KPIs and ensure that
management are driving continual improvement in product, processes and systems.
When issues and problems arise QPs must ensure that management are made aware of the issue and that they then take appropriate action in a timely manner.
The main components of a quality system should be defined and applied to all parts of the business, such as:
- Management Support Systems
➢ Quality vision and mission
➢ Policies and procedures
➢ Definition of Processes
➢ Quality review and improvement - People management: including organisational structure, education and training
- Document management
- Validation and qualification
- Control of contractors and suppliers
- Change and deviation management; including CAPA
- System for managing customer feedback, e.g. complaints and recalls
- Other monitoring and feedback mechanisms, e.g. in-process checks
- Self-inspection
- Batch release system or final approval system
- The design and development of the product and process
- The manufacturing system and production controls
- Packaging system and controls
- Maintenance and monitoring of the facilities, utilities and equipment
- Laboratory and analytical testing system
- Control of materials and suppliers
- Distribution controls
The ‘lifecycle’ of a product includes:
Market research
* Development chemistry and pharmaceutics
* Toxicology studies
* Synthesis and purification
* Clinical trials
* Manufacture and dosage form (plus packaging and labelling)
* Validation and process control
* Ongoing stability testing and shelf life
* Storage and distribution
* Monitoring of the safety profile after marketing (PV)
* Product discontinuation
ICH Q10 (Pharmaceutical Quality System) defines 4 major lifecycle phases:
Pharmaceutical development
* Technology transfer
* Commercial manufacturing
* Product discontinuation
Change management stage gates
1.Propose Change
2.Risk Assessment
3.Approve/Reject Change
4.Plan and Implement
5.Review and Close-Out
6.Post Implementation Actions
Effectiveness verification methods
Audit, sampling, real-time review, trend analysis, post event review, periodic review, process confirmation
A large part of the materials management system is defined in Chapters 3 and 5 of EudraLex Volume 4 and in the Good Distribution Guidelines (2013/C 343/01)
What controls are available for People
- Access control
- Job descriptions/structure
- Staffing resources (turnover, use of temps)
- Cleaning team
- Training
A large part of the materials management system is defined in Chapters 3 and 5 of EudraLex Volume 4 and in the Good Distribution Guidelines (2013/C 343/01)
What controls are available for Premises
- BMS, limits, specs, monitored, controlled (heat, cool, humidity)
- Outside storage areas for large tank farms etc.
- Secure
- Structure and fabric
- Covered unloading
- Housekeeping including high level
- Pest control
- Capacity
- Alarms
- Where is sampling performed?
- Sampling environment and area classification
A large part of the materials management system is defined in Chapters 3 and 5 of EudraLex Volume 4 and in the Good Distribution Guidelines (2013/C 343/01)
What controls are available for Product
- Adequate identification
- Segregated
- Control in place
- Cold chain/controlled storage
- Controlled drugs stored correctly
- Printed components securely stored and transported
