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Establishing a Robust Quality Management System (QMS)
What is a Quality Management System (QMS)? A quality management system (QMS) is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.
The basic awareness that a quality management system (QMS) might influence a product’s quality was initially presented in the 1970s by Ford Motor Company and the United Kingdom Ministry of Defense. In 1971 the first standard published in UK was by the BSI (British Standards Institution), the BS 9000. This standard was specially planned for the electronics industry. Moreover, BSI published the BS 5179 and 5750 as well. Both standards were established very closely around the standards of the Ministry of Defense. For the first time, the responsibility of quality assurance was transferred to the supplier from the customer, instigating the practice of third party assessors. In the 1980s, the UK’s standards were implemented by the International Organization for Standardization into their international parameters and certification qualifications. In 1987, the initial ISO 9000 was published as ISO 9001:1987.
ISO Standard 9001:2015, is the current international standard specifying requirements for quality management systems and is recognized as the most prominent approach to quality management systems. While some use the term “QMS” to describe the ISO 9001 standard or the group of documents detailing the QMS, it refers to the entirety of the system. The documents only serve to describe the system.
As previously presented, the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use published ICH Q10 Pharmaceutical Quality System guidance document, which is intended to assist pharmaceutical manufacturers by describing a model for an effective quality management system for the pharmaceutical industry, referred to as the pharmaceutical quality system.
ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Organization for Standardization (ISO) quality concepts, includes applicable good manufacturing practice (GMP) regulations, and complements ICH Q8 Pharmaceutical Development and ICH Q9 Quality Risk Management.
Quality Management applies to the systems supporting the development and manufacture of pharmaceutical drug substances (i.e., active pharmaceutical ingredients (APIs)) and drug products, including biotechnology and biological products, throughout the product lifecycle.
A robust Quality Management System (QMS) is essential for ensuring consistent product quality and regulatory compliance. A well-designed QMS encompasses policies, procedures, and processes that govern every aspect of pharmaceutical operations, from research and development to manufacturing and distribution. The QMS must reflect the specific needs of the pharmaceutical company and applicable regulatory requirements.
According to ICH Q10 the pharmaceutical quality system “…assures that the desired product quality is routinely met, suitable process performance is achieved, the set of controls are appropriate, improvement opportunities are identified and evaluated, and the body of knowledge is continually expanded.”
QMS Lifecycle starts at the drug development stage including Drug Substance development; Drug Product formulation development, commercial manufacturing process development and scale-up, and analytical method development, with the goal being to design a product and process that consistently delivers intended performance and meets the needs of the patient.
Second stage of the QMS Lifecycle continues with Technology Transfer, e.g.., the transfer of knowledge of a new product during development into commercial manufacturing. Knowledge transfers within or between manufacturing and testing sites for new or marketed product with the object to have successful transfer of product and process knowledge to achieve successful product manufacturing.
Third stage of the QMS Lifecycle is the launch of commercial manufacturing process, including acquisition and control of materials, qualified and validated facilities, utilities, and equipment, and fully validated production processes including packaging and labeling. Quality control testing and Quality Assurance policies and procedures including release testing specifications, storage specifications and distribution processes, are implemented for establishing, achieving, and maintaining a state of control for product manufacturing and packaging, and facilitating continual improvement during the drug product life cycle.
Fourth stage of the QMS Lifecycle is with the discontinuation of the product, which happens while maintaining continued product assessment and reporting through product expiry, and document archiving and sample retention until all product is assured to be off the market.
The Quality Management System elements necessary for a successful QMS includes quality focused processes, include:
- Document management policies and procedures;
- Change control procedures with Subject Matter Expert input and management approval;
- Training management for all employees on QMS purpose and for policies and procedures;
- Audit management to ensure compliance with QMS policies and procedures;
- Deviation management to capture and investigate deviations that can have an adverse effect on product quality and, possibly patient safety;
- Corrective Action /Preventative Action [CAPA] management process to understand why Deviations occur and taking corrective and preventative actions to prevent reoccurrence;
- Management review of process performance and product quality to occur annually or semi-annually so that management is aware of potential problems in manufacturing and produce quality before more serious problems arise.
