Quality Management Fundamentals

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

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

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 (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

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

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

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

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

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

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

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

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

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, 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

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