Basic Principles of GMP

Quality Management

Section 1 and 2
 Quality 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.

Quality Management
Quality relationships
Quality Management

Quality Assurance

GMP

Production and Quality Control

Section 1 and 2
 Quality Management
• Quality management,
– defining the overall policy of the organization towards quality, is over everything else.

• Next comes Quality assurance,

– which is the concept that ensures the policy is achieved.

• GMP is part of quality assurance.

– It deals with the risks that cannot be tested. It builds quality into the product.

• Quality control is a part of GMP.

– It is that part of GMP that is focused on testing of the environment and facilities, as
well as the testing of the materials, components and product in accordance with the
standard.
 Quality 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
 Quality Management
Philosophy and essential elements
The quality policy is a statement
by the top management of the company of
its overall intentions and direction relating to
quality, formally expressed as a corporate policy.
The top management of a company usually
includes the board of directors or general
manager of the company, the plant or factory
managers together with the senior managers.
 Quality 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”

 Quality 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
 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 1.1
 Quality Management
QA System should ensure (1):
• 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

1.1 a- d
 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
 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
 Quality Management
QA System should ensure (3):
• There is a self-inspection process: available and implemented, leading to a
programme of critical self-evaluation and continuous improvement.
– A very important part of the management of the manufacturing operation is the
means of auditing the operation for its compliance with all the GMP
requirements.
– The auditing is done at several levels within the company.
– There should be an internal audit function within departments (self-inspection).
– This is backed up by quality audit, an independent internal organization, charged
with looking at all departments and assessing the application of the quality
system within a company.
 Quality Management
QA System should ensure (3):
• There is a self-inspection process: available and implemented, leading to a
programme of critical self-evaluation and continuous improvement.
– The ultimate auditing organization is the external auditing organization. This is
normally the drug regulatory authority inspection or audit.
– Duties and responsibilities for the individual tasks need to be clearly defined
and assigned to departments and individuals.
This should be done in writing.
Again, this is all part of the SOP process.
Every department involved in quality assurance should have SOPs that describe
its activities and who is responsible for carrying out those activities.
 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

1.3
 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

1.3
 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)

2.1
 Quality Management
Good Manufacturing Practices (GMP)
These risks can best be controlled by having a properly managed system of working that
takes them into account. This means that:
There must be good design, sound operation, and planned maintenance of facilities.
It also means that the quality checking system must be designed with these risks in mind
and set out to find whether any errors have occurred.
Let us look at this problem in another way. If we do
not know what sort of cross contamination we have, then the work of the
analyst is very difficult. The analyst should ideally know what to test for before
commencing testing. In other
words, if we do not know what the likely cross-contaminant is then we cannot
analyse for it.
 Quality Management
Basic Requirements for GMP (1)
• 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, transport
 Laboratories and in-process control

2.1 a - c
 Quality Management
Basic Requirements for GMP (2)
• 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

2.1 d - j
 Quality Management

Group session – I

• How many GMP deficiencies can you find in the

photographs in the handout?
 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
 Quality Management

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

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