A quality management system (QMS) is essential at all drug development and commercialization stages. At different stages, i.e., non-clinical, earlier clinical, and later clinical, the regulatory bodies have specific needs, which companies must control through a robust QMS. Regulatory authorities evaluate all the generated data and observations to ensure data authenticity, integrity, and compliance with regulatory requirements. The quality assurance, the management representatives, and the respective area owners share the responsibility of designing a QMS. During setting up the QMS, the premier points that the companies should make are:
Selection of applicable regulations
The selection of relevant regulations is the first step before designing the QMS. Each country has its central drug(s) controlling agencies, and based on the company requirements, the applicable regulations must be followed from beginning to end while designing the QMS. The selection of the applicable regulation is sorely based on the company’s business plans.
GAP Assessment
After selecting the applicable regulation(s), QA and the management should perform a detailed GAP assessment. In the GAP assessment, all the functional segments/clauses of the relevant regulation must be evaluated, and QA must prepare a robust action plan against each segment/clause.
Designing of the proposed organizational chart and assignment of responsibilities
Designing a proposed organization chart and assigning the responsibilities to smoother preparation, review, and approval of the QMS-related documentation are key points to consider before designing the QMS. QMS designing is everyone’s responsibility, and pre-assigned responsibilities help in timely and efficient document preparation as part of the QMS setup.
QMS Structure
Designing a QMS structure is an important step that helps design the critical modules of the QMS and assign the QMS-controlled nomenclature to each QMS-controlled document. Each module of the QMS is essential, and the document author must write all the required documents under each category along with the assigned nomenclature. This pre-recorded document list helps better track the project.
Selection of controlled templates
All QMS-controlled documents must be prepared using dedicated QMS templates. Hence, pre-approved templates are required before designing QMS-controlled documents. Using similar controlled documents is a great reflection of a robust QMS.
It helps streamline all the documents with identical formatting practices, components, and segments.
Regulatory reference
Every document prepared under QMS must have a rationale, and the author must provide a reference to the applicable regulatory segment/clause(s) in those documents. Various regulatory bodies have many bridging components and requirements, and in those cases, the document author must provide the references of all those applicable regulations.
Risk/Impact assessment
Each document prepared under QMS must include a risk/impact assessment-based approach. While designing a QMS-controlled document, the author and management must evaluate its feasibility from operational and regulatory aspects.
At GxP Cellators Consultants Ltd., we are experts in setting the QMS for any stage (GCP, GLP, GMP) of your project. We have successfully designed 25+ projects, designing complete QMS projects for our clients based on their needs. Our project completion timelines are significantly quick, and we use a quality and compliance-first approach.
