module 2 | slide 1 of 19 january 2006 quality management basic principles of gmp section 1 and 2
TRANSCRIPT
Module 2 | Slide 1 of 19 January 2006
Quality Management
Basic Principles of GMP
Section 1 and 2
Module 2 | Slide 2 of 19 January 2006
Quality ManagementQuality Management
Objectives
To understand key issues in quality assurance/good manufacturing practices/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 19 January 2006
Section 1 and 2
Quality Management Quality Management
Quality relationships
Quality Management
Quality Assurance
GMP
Production and Quality Control
Module 2 | Slide 4 of 19 January 2006
Quality ManagementQuality Management
Philosophy and essential elements
What is Quality Management?
The aspect of management function that determines and implements the “quality policy”
The overall intention and direction regarding quality, as formally expressed and authorized by top management
Module 2 | Slide 5 of 19 January 2006
Quality ManagementQuality Management
Quality Management
The basic elements are:
An appropriate infrastructure or “quality system” encompassing the organization structure, procedures, processes and resources
The systematic actions necessary to ensure adequate confidence that a product (or service) will satisfy given requirements for “Quality”
The totality of these actions is termed “Quality Assurance”
Module 2 | Slide 6 of 19 January 2006
Quality ManagementQuality Management
Quality Management
Quality assurance is a management tool
In contractual situations, it also serves to generate confidence in a supplier
QA, GMP and Quality Control are interrelated aspects of Quality Management
They are described on the following slides in order to emphasize their relationship and their fundamental importance to the production and control of pharmaceutical products
Module 2 | Slide 7 of 19 January 2006
1.1
Quality Management Quality Management
Principles of Quality Assurance (QA)
Wide-ranging concept covers all matters that individually or collectively influence the
quality of a product
Totality of the arrangements to ensure that the drug is of the right quality for the intended use
Quality Assurance incorporates GMP and also product design and development which is outside the
scope of this module
Module 2 | Slide 8 of 19 January 2006
1.1 a- d
Quality Management Quality Management
QA System should ensure:
Products are designed and developed correctly Complying with, e.g. GMP, GCP, GLP
Production and control operations are defined
Managerial responsibilities are defined In job descriptions
The manufacture, supply and use of correct starting and packaging materials
Module 2 | Slide 9 of 19 January 2006
Quality Management Quality Management
QA System should ensure (2):
Controls are performed, including intermediates, bulk, calibration and validation
Correct processing and checking of the finished product
Products are sold/supplied only after review by the authorized person Complying with marketing authorization, production and QC
requirements
Proper storage, distribution and handling
1.1 e - h
Module 2 | Slide 10 of 19 January 2006
Quality Management Quality Management
QA System should ensure (3):
Procedures for self-inspection and/or quality audits
Reporting, investigation and recording of deviations
System for change control/approval
Regular evaluation of product quality to verify consistency and continued improvement
1.1 i - l
Module 2 | Slide 11 of 19 January 2006
1.3
Quality Management Quality Management
Quality Assurance
Manufacturer is responsible for the quality of the product Fit for intended use Comply with marketing authorization Safety, efficacy and quality
Senior management and commitment of all staff
Module 2 | Slide 12 of 19 January 2006
1.3
Quality Management Quality Management
Quality Assurance
Requires a comprehensively designed and well implemented QA system
Fully documented, and effectiveness monitored
Competent personnel, sufficient premises, equipment and facilities
Module 2 | Slide 13 of 19 January 2006
2.1
Quality Management Quality Management
Good Manufacturing Practices (GMP)
That part of QA that ensures that products are consistently produced and controlled Quality standards Marketing authorization
Aim: Diminishing risks that cannot be controlled by testing of product Contamination and cross-contamination Mix-ups (confusion)
Module 2 | Slide 14 of 19 January 2006
2.1 a - c
Quality Management Quality Management
Basic Requirements for GMP – I
Clearly defined and systematically reviewed processes
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 15 of 19 January 2006
2.1 d - j
Quality Management 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 16 of 19 January 2006
Quality ManagementQuality Management
Group session – I
How many GMP deficiencies can you find in the photographs in the handout?
Module 2 | Slide 17 of 19 January 2006
Quality ManagementQuality 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 18 of 19 January 2006
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
Quality Management
Module 2 | Slide 19 of 19 January 2006
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
Quality Management