quality management and pharmaceutical quality system
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Basic Principles of GMP. Quality Management and Pharmaceutical Quality System. Section 1 and 2. Quality Management. Objectives To understand key issues in quality management, quality assurance, good manufacturing practices and quality control. - PowerPoint PPT PresentationTRANSCRIPT
Module 2 | Slide 1 of 31 2013
Quality Management
and
Pharmaceutical Quality System
Basic Principles of GMP
Section 1 and 2
Module 2 | Slide 2 of 31 2013
Quality ManagementQuality Management
Objectives
To understand key issues in quality management, quality assurance, good manufacturing practices and quality control.
To understand specific requirements on quality management and quality assurance including:
Organization Procedures, processes and resources.
To develop actions to resolve your current problems.
Module 2 | Slide 3 of 31 2013
Quality Management Quality Management
Quality relationships
Quality Management and PQS
Quality Assurance
GMP
Production and Quality Control
Module 2 | Slide 4 of 31 2013
PQS and Quality ManagementPQS and Quality Management
Comprehensive Pharmaceutical Quality System, GMP and Quality Risk management:
The manufacturer assumes responsibility. Ensures that products:
–fit for their intended use–comply with marketing authorization–do not place patients at risk due to inadequate safety, quality or efficacy
Senior management and participation and commitment of staff, suppliers and the distributors 1.1. – 1.2.
Module 2 | Slide 5 of 31 2013
PQS and Quality ManagementPQS and Quality Management
Pharmaceutical Quality System
Senior management - leadership and active participation in the PQS is essential. Ensure the support and commitment of all staff to the PQS.
Senior management has the ultimate responsibility to ensure:– effective PQS is in place– adequately resourced and that roles, responsibilities, and
authorities are defined, communicated and implemented throughout the organization 1.1. – 1.2.
Module 2 | Slide 6 of 31 2013
PQS and Quality ManagementPQS and Quality Management
PQS should be defined and documented
Quality manual or equivalent documentation describing the quality management system including management responsibilities.
Periodic management review of the PQS
Continual improvement of PQS, products and processes
1.6. – 1.7.
Module 2 | Slide 7 of 31 2013
PQS and Quality ManagementPQS and Quality Management
Pharmaceutical Quality System
Quality management is a wide-ranging concept
Totality of arrangements to ensure that products are of desired quality
It incorporates good manufacturing practices (GMP) and other factors such as product design and development
1.3.
Module 2 | Slide 8 of 31 2013
PQS and Quality ManagementPQS and Quality Management
GMP applies to the life-cycle stages – from the manufacture of investigational medicinal products,
technology transfer, commercial manufacturing through to product discontinuation
PQS: can extend to the pharmaceutical development life-cycle stage
Should facilitate innovation and continual improvement– link between pharmaceutical development and manufacturing
activities
Resourced and maintained (premises, personnel, equipment, facilities)
1.4.
Module 2 | Slide 9 of 31 2013
PQS and Quality ManagementPQS and Quality Management
The PQS should ensure that:
product realization is achieved– designing, qualifying, planning, implementing, maintaining and
continuously improving a system
product and process knowledge is managed
products are designed and developed (GMP, GLP,GCP)
SOPs for production and control operations
responsibilities are clearly specified in job descriptions1.5.
Module 2 | Slide 10 of 31 2013
PQS and Quality ManagementPQS and Quality Management
PQS should ensure that (2)
correct starting and packaging materials
controls on starting materials, intermediate products, and bulk products and other in-process controls, calibrations and validations are carried out
the finished product is correctly processed and checked
finished product release - certified that each production batch has been produced and controlled in accordance with the marketing authorization and regulations
1.5.
Module 2 | Slide 11 of 31 2013
PQS and Quality ManagementPQS and Quality Management
PQS should ensure that (3)
management of outsourced activities
storage, distribution and subsequently handling
self-inspection and/or quality audit
investigation of deviations and preventive action
changes and their approval
regular reviews of the products (PQR) - need for improvement1.5.
Module 2 | Slide 12 of 31 2013
PQS and Quality ManagementPQS and Quality Management
PQS should ensure that (4)
monitoring and control systems for process performance and product quality
continual improvement
quality risk management (QRM)
suspected product defects and other problems are reported, investigated and recorded
corrective actions and/or preventive actions (CAPAs) (effectiveness should be monitored)
1.5.
Module 2 | Slide 13 of 31 2013
PQS and Quality ManagementPQS and Quality Management
QA System should ensure that:
Products are designed and developed in accordance with GLP, GCP, and GMP
Production and control operations are clearly specified in SOPs
Managerial responsibilities are clearly specified in job descriptions
Systems ensure that the correct starting and packaging materials are used
1.5.
Module 2 | Slide 14 of 31 2013
PQS and Quality ManagementPQS and Quality Management
QA System should ensure:
Starting materials, intermediate products, bulk products are controlled
In-process controls, calibrations, and validations are carried out
Finished products are correctly processed and checked
Products are not sold or supplied before release by authorized persons
Systems ensure that products are appropriately stored and distributed 1.5.
Module 2 | Slide 15 of 31 2013
PQS and Quality ManagementPQS and Quality Management
QA System should ensure:
Self-inspection and/or quality audits are done regularly
Deviations are reported, investigated and recorded
Changes are controlled
Systems are followed to verify the consistency of processes and ensuring continuous improvement
Quality Risk Management is implemented 1.5.
Module 2 | Slide 16 of 31 2013
PQS and Quality ManagementPQS and Quality Management
Quality Risk Management
Manufacturers should manage quality risks. Quality Risk Management (QRM) is a systematic process for:
– assessment, control, communication and review of risks to the quality of the medicinal product.
QRM: – can be applied both proactively and retrospectively– Should be based on scientific knowledge and experience with
the process– Should be linked to the protection of the patient 1.8. – 1.9.
Module 2 | Slide 17 of 31 2013
Quality Risk ManagementQuality Risk Management
(ICH Q9)Advanced training workshop for GMP inspectors
Nairobi , 9-12 May, 2011
Module 2 | Slide 18 of 31 2013
Quality Risk Management Quality Risk Management
Quality Risk Management
Quality Risk Management follows a cycle of assessment, control, communication and review.
An appropriate tool should be used in risk assessment, such as:– Fault Tree Analysis (FTA)– Hazard and Operational Studies (HAZOP)– Failure Mode and Effect Analysis (FMEA)– Hazard Analysis and Criticality Analysis (HACCP)– Failure Mode, Effect, and Criticality Analysis (FMECA)
Module 2 | Slide 19 of 31 2013
Quality Risk Management Quality Risk Management
Failure Mode Effect Analysis
•Breakdown in manageable steps
•Process and product understanding needed
•Evaluate failure mode and effect on outcome
•Eliminate, contain, reduce, control
•(Identify mode, cause, effect)
Module 2 | Slide 20 of 31 2013
Product Quality ReviewProduct Quality Review
Product quality review (PQR)
Regular, periodic or rolling quality reviews of all medicinal products
Normally annually – can also be more frequently
Objective:– Verifying the consistency of the existing process– appropriateness of current specifications for both starting materials and
finished product– highlight any trends– identify product and process improvements. 1.10.
Module 2 | Slide 21 of 31 2013
Product Quality ReviewProduct Quality Review
PQR should include at least a review of:– starting materials and packaging materials (especially from
new sources and review of supply chain)– critical in-process controls and finished product results– all batch failures and their investigation– deviations or non-conformances (and investigations and
CAPAs)– all changes made to the processes or analytical methods– dossier variations submitted, granted or refused– results of the stability monitoring programme and any adverse
trends 1.10.
Module 2 | Slide 22 of 31 2013
Product Quality ReviewProduct Quality Review
PQR should include (cont).: – quality-related returns, complaints and recalls and the
investigations– adequacy of previous corrective actions on product process or
equipment– Post marketing commitments– qualification status of relevant equipment and utilities– technical agreements
1.10.
Module 2 | Slide 23 of 31 2013
Product Quality ReviewProduct Quality Review
Product quality review (PQR)
Results should be reviewed- assessment should be made whether CAPA or revalidation should be undertaken
CAPA completed in a timely and effective manner – verified
Product types can be grouped
Agreements in case of contracted parties
PQR in a timely manner and verified for accuracy1.10.
Module 2 | Slide 24 of 31 2013
Product Quality ReviewProduct Quality Review
When inspecting PQR, also verify:
Correctness of data transferred
Trending of results
Calculations such as process capability index (CpK) - where appropriate
Accuracy in terms of APIs reflected, approved suppliers used, number of batches, variations, changes, complaints etc.
CAPAs and conclusion
Module 2 | Slide 25 of 31 2013
2.1
PQS and Quality ManagementPQS and Quality Management
Good Manufacturing Practices (GMP)
That part of QA that ensures that products are consistently produced and controlled Quality standards Marketing authorization, clinical trial authorization and/or
product specification
Aim: Diminishing risks that cannot be controlled by testing of product Contamination and cross-contamination Mix-ups (confusion)
Module 2 | Slide 26 of 31 2013
2.1 a - c
PQS and Quality ManagementPQS and Quality Management
Basic Requirements for GMP – I
Manufacturing processes are clearly defined and systematically reviewed for risks – scientific knowledge and experience
Qualification and validation is performed
Appropriate resources are provided: Qualified and trained personnel Premises, space, equipment and services Materials, containers, labels Procedures, storage, transportLaboratories and in-process control
Module 2 | Slide 27 of 31 2013
2.1 d - j
PQS and Quality ManagementPQS and Quality Management
Basic Requirements for GMP – I
Clear, written instructions and procedures
Trained operators
Records of actions, deviations and investigations
Records for manufacture and distribution
Proper storage and distribution
Systems for complaints and recalls
Module 2 | Slide 28 of 31 2013
PQS and Quality ManagementPQS and Quality Management
Group session – I
How many GMP deficiencies can you find in the photographs in the handout?
Module 2 | Slide 29 of 31 2013
PQS and Quality ManagementPQS and Quality Management
Group session II
Imagine you are inspecting a pharmaceutical company for compliance with GMP
Consider the situations in the next slides which may have impact on a company’s quality management programme
Describe the action to be taken in each case
Module 2 | Slide 30 of 31 2013
Issues – I
Quality Management manual not established in writing
Limited human resources
Lack of qualified people
Processes not properly validated
Poor SOPs or standard batch documentation
More consideration to cost than quality
Family members in key positions of authority
PQS and Quality ManagementPQS and Quality Management
Module 2 | Slide 31 of 31 2013
Issues – II
Substandard materials deliberately purchased
Technical staff not involved in purchasing
Inability to re-export substandard materials
Owner insists on selling rejects
Corruption
No commitment to training
PQS and Quality ManagementPQS and Quality Management