[This post is the second part in a series that will focus on achieving operational excellence with an effective quality management system.]
Quality documents and guidance from various regulatory bodies state that a Quality Management System (QMS) addresses quality planning, quality adherence, quality control/quality assurance and quality improvements, and comprises of organizational structure, responsibilities, resource management, procedures, processes, compliance management and record management.
Organizational structure, responsibilities and resource management pertains to the availability of a sufficient number of competent and appropriately qualified and trained personnel with clear roles and responsibilities (job descriptions), and also pertains to the availability of computational and other infrastructure.
Quality planning is about being prepared for and anticipating issues and problems, along with the need to stay up-to-date on new regulations, technology and processes.
Compliance management refers to the need to have execution mechanisms and controls in place to manage compliance to requirements outlined by the Competent Authorities (CAs) with respect to quality, completeness of safety data, assessment and timeline compliance, independence of pharmacovigilance (PV) activities and effective communication. A key element of compliance management is to have valid, traceable processes with audit trails and to have the right technology.
Record management is about documentation of a quality system; everything should be documented in a systematic and orderly manner in the form of written policies and procedures, quality manuals and quality records. Data security and privacy are critical requirements. Quality system documentation by the marketing authorization holder (MAH) in the PV system master file (PSMF) is also a part of record management.
EMA’s GPV Module I enumerates the following quality objectives of a PV system:
- Complying with legal requirements for PV tasks and responsibilities
- Preventing harm from adverse reactions in humans arising from the use of authorized medicinal products within or outside the terms of marketing authorization or from occupational exposure
- Promoting the safe and effective use of medicinal products, in particular through providing timely information about the safety of medicinal products to patients, healthcare professionals and the public contributing to the protection of patients’ and public health
To read the full white paper click here