Scribd
Upload
103 views

Basic Principles of GMP - Quality Management (WHO Training)

The document discusses key principles of quality management in the pharmaceutical industry. It describes how quality management, quality assurance, good manufacturing practices, and quality control are interrelated aspects that ensure pharmaceutical products meet quality standards. It emphasizes that quality assurance relies on a comprehensive quality system implemented through standard operating procedures and involves competent personnel. A key part of quality assurance is managing quality risks through a systematic process of risk assessment, control, communication, and review over the lifecycle of a product.

Uploaded by

ssfranciswong
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
103 views

Basic Principles of GMP - Quality Management (WHO Training)

The document discusses key principles of quality management in the pharmaceutical industry. It describes how quality management, quality assurance, good manufacturing practices, and quality control are interrelated aspects that ensure pharmaceutical products meet quality standards. It emphasizes that quality assurance relies on a comprehensive quality system implemented through standard operating procedures and involves competent personnel. A key part of quality assurance is managing quality risks through a systematic process of risk assessment, control, communication, and review over the lifecycle of a product.

Uploaded by

ssfranciswong
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 27

Basic Principles of GMP

Quality Management

Section 1 and 2

Module 2 | Slide 1 of 27 2012


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.

Module 2 | Slide 2 of 27 2012


Quality Management
Quality relationships

Quality Management

Quality Assurance

GMP
Section 1 and 2

Production and Quality Control

Module 2 | Slide 3 of 27 2012


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

Module 2 | Slide 4 of 27 2012


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”
Module 2 | Slide 5 of 27 2012
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

Module 2 | Slide 6 of 27 2012


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
1.1

 Quality Assurance incorporates GMP


 also product design and development
Module 2 | Slide 7 of 27 2012
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
1.2

 Systems ensure that the correct starting and packaging


materials are used
Module 2 | Slide 8 of 27 2012
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 1.2

 Systems ensure that products are appropriately stored and


distributed

Module 2 | Slide 9 of 27 2012


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 1.2

Module 2 | Slide 10 of 27 2012


Quality Management
Quality Assurance
 Products must:
– safety, quality and efficacy requirements - fit for their intended use
– comply with the requirements of the marketing authorization

 Senior management is responsible - and all staff must be


committed to achieve this.

 Relies on a comprehensively designed, documented, correctly


implemented system of QA incorporating GMP and QC.

 Relies on competent personnel, suitable and sufficient premises,


equipment and facilities. 1.3

Module 2 | Slide 11 of 27 2012


Quality Management
Quality Assurance
 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
1.4 – 1.5

Module 2 | Slide 12 of 27 2012


Quality Risk Management

(ICH Q9)
Module 2 | Slide 13 of 27Advanced 2012
training workshop for GMP inspectors
Nairobi , 9-12 May, 2011
Quality Management
Quality Assurance
 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)

1.3

Module 2 | Slide 14 of 27 2012


Quality 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 15 of 27 2012
Quality Management
Quality Assurance
Product quality review (PQR)

 Regular, periodic or rolling quality reviews of all medicinal


products

 Normally annually

 Objective:
– Verifying the consistency of the existing process
– appropriateness of current specifications for both starting materials and
finished product
– highlight any trends 1.6

– identify product and process improvements.


Module 2 | Slide 16 of 27 2012
Quality Management
Quality Assurance
 PQR should include at least a review of:
– starting materials and packaging materials (especially from
new sources)
– 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 1.6

Module 2 | Slide 17 of 27 2012


Quality Management
Quality Assurance
 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
1.6

Module 2 | Slide 18 of 27 2012


Quality Management
Quality Assurance
 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 accuracy

1.6

Module 2 | Slide 19 of 27 2012


Quality Management
Quality Assurance
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 20 of 27 2012
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

Module 2 | Slide 21 of 27 2012


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, transport
 Laboratories and in-process control 2.1 a - c

Module 2 | Slide 22 of 27 2012


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 2.1 d - j

Module 2 | Slide 23 of 27 2012


Quality Management

Group session – I

 How many GMP deficiencies can you find in the


photographs in the handout?

Module 2 | Slide 24 of 27 2012


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 25 of 27 2012


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

Module 2 | Slide 26 of 27 2012


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

Module 2 | Slide 27 of 27 2012

You might also like