Quality Management Fundamentals

Objectives of Quality Management

• 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

History of Quality Management

• 1937: Sulphanilamide tragedy in the USA, resulting in 107 child deaths
• 1965: Thalidomide tragedy in Europe, resulting in fetal abnormalities
• Despite increasing public demand for "no risk" products, errors continue to occur

Quality Management

• The health of humans depends on the availability of safe, effective, and affordable medicines
• Quality of pharmaceutical products and services should be monitored
• Quality Management (QM) refers to an appropriate infrastructure or "quality system" encompassing the organization structure, procedures, processes, and resources

Quality Assurance

• Quality Assurance (QA) is a management tool that covers all matters that individually or collectively influence the quality of a product
• QA ensures that products are fit for intended use, comply with marketing authorization, and meet safety, efficacy, and quality requirements
• QA involves senior management and the commitment of all staff

Purpose of Quality Assurance

• To provide confidence to the customer by consistently delivering products that work every time, any time, and all the time to specification

What Quality Assurance Should Assure?

• Products are designed and developed correctly, complying with GMP, GCP, and GLP
• Production and control operations are defined, and managerial responsibilities are defined
• Job descriptions are established, and the manufacture, supply, and use of correct starting and packaging materials are ensured
• Controls are performed, including intermediates, bulk, calibration, and validation
• Correct processing and checking of the finished product, and products are sold/supplied only after review by the authorized person
• Procedures for self-inspection and/or quality audits are established, and reporting, investigation, and recording of deviations are carried out
• System for change control/approval and regular evaluation of product quality to verify consistency and continued improvement are ensured

Requirements for Quality Assurance

• Requires a comprehensively designed and well-implemented QA system
• Fully documented, and effectiveness is monitored
• Competent personnel, sufficient premises, equipment, and facilities are ensured

Good Manufacturing Practice (GMP)

• GMP is part of Quality Assurance, a set of regulations aimed at ensuring that products are consistently manufactured to a quality appropriate to their intended use
• Current Good Manufacturing Practices (cGMP) are defined by the FDA as systems to assure proper design, monitoring, and control over manufacturing processes and facilities in pharma and other FDA-regulated industries

Why cGMP?

• The "c" stands for "current," reminding manufacturers that they must employ technologies and systems that are up-to-date to comply with the regulation
• Systems and equipment used to prevent contamination, mix-ups, and errors must be current and adequate

Role of cGMP in Pharmaceutical Production

• Adherence to cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring manufacturers to adequately control manufacturing operations
• This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories

Components of cGMP

• GMP is a part of QA
• GMP's main function is to produce quality products consistently
• GMP must meet legal requirements of the country
• GMP must meet both production and QC-related issues
• WHO comments that the main function of GMP is to avoid mix-ups and contamination risks

Principles of GMP

• People
• Products
• Premises
• Processes (and equipment)
• Procedures

Types of Manufacturing Areas

• Ancillary areas
• Storage areas
• Weighing areas
• Production areas
• Quality control areas

Personnel and Training

• Establishment and maintenance of a satisfactory system of QA, manufacture, and control of products actively rely on people
• Adequate number of personnel with necessary qualifications, practical experience, and training
• Key personnel include authorized person, head of production, head of quality control, and may delegate functions but not responsibility
• Heads of production and QC may share/jointly some responsibilities relating to quality

Key Personnel Requirements

• Appropriate qualifications and practical experience
• Education and experience enable personnel to take difficult decisions in an independent, professional, and scientific way
• Heads of production and QC may share/jointly some responsibilities relating to quality

Personnel and Training: Key Personnel Responsibilities

• Authorized person: compliance with technical and regulatory requirements, approval of the release of finished product for sale, establishment and implementation of quality system, and oversight of the QC department
• Head of production: product production and storage, approval and implementation of production instructions, in-process QC, and ensures that production records are evaluated and signed by designated persons
• Head of quality control: approval or rejection of materials, evaluation of batch records, ensures carrying out of necessary testing, and approval of QC procedures

Training

• Training, in accordance with a written, approved program
• All personnel whose duties take them into production areas, control laboratories, or whose activities could affect the quality of the product
• Special training for staff in special areas, including clean areas and areas where highly active, toxic, infectious, sensitizing materials are handled

Hygiene

• All personnel should undergo health examinations
• All personnel should be trained in personal hygiene practices
• Any person shown to have an apparent illness or open lesions that may adversely affect the quality of products should not be allowed to handle starting materials, packaging materials, in-process materials, or medicines products
• Direct contact should be avoided between the operator's hands and starting materials, primary packaging materials, and intermediate or bulk product
• Protective clothing should be worn, and personal hygiene procedures should apply to all persons entering production areas

Learn about the objectives and history of quality management, including key issues, assurance, and control. Understand the importance of quality management in preventing tragic events.