Quality Management System (QMS) is an essential requirement at all drug development and commercialization stages. At different stages, i.e., non-clinical, earlier clinical, to 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 and integrity and compliance with the 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 regulation must be followed from beginning to end while designing the QMS. The selection of the applicable regulation is sorely based on the company business plans.

GAP Assessment

After selecting the applicable regulation(s), QA, along with 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 is one of the key points to consider before designing the QMS. QMS designing is everyone responsibility, and pre-assigned responsibilities help in timely and efficient document preparation as part of the QMS set up.

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 in better tracking the project.

Selection of controlled templates

All the QMS-controlled documents must be prepared using the QMS-controlled dedicated templates. Hence, the pre-approved templates are the requirement before designing the 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 document author must provide a reference to the applicable regulatory segment/clause(s) in those documents. Various regulatory bodies have many bridging components and requirements 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 document author and management must evaluate the document 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 the complete QMS projects for our clients based on their needs. Our project completion timelines are significantly quick, and we work at the Quality and compliance first approach.