Quality management systems (QMS) form the backbone of any commercial pharmaceutical or healthcare product. QMS comprises quality assurance (QA) and quality control (QC), working together to enable the testing, release, and sale of a commercial product. Regulatory agencies require a full GMP compliant system to be in place by the time phase III clinical trials are conducted.

Quality Systems are developed in phases throughout the pharmaceutical and clinical development process. During the early stages both the process and product are anticipated to rapidly change so benefit from less restrictive controls ahead of clinical studies.

Phases of clinical trials

Phase I clinical trials see fewer changes, however, the process and the product will not be completely defined, even at this stage and so only a small percentage of the overall quality system is required.

For phase II clinical trials expectations grow with the implantation of additional control measures, and for phase III a full GMP compliant quality system should be in place prior to licence submission and product approval.

The keys elements covered by a typical GMP QMS are depicted here:

Quality Assurance (QA)

The Quality Assurance (QA) department has oversight and responsibility for all control points during the manufacturing of a product throughout the preclinical/nonclinical, clinical, and commercial stages.

QA is responsible for overseeing the preparation of detailed procedures for all of the manufacturer’s operations, ensures compliance with regulations and internal written procedures, and is responsible for developing and tracking all documents within the quality system, including (but not limited to):

  • Standard Operating Procedures (SOPs)
  • Official forms, technical reports
  • Validation plans, protocols and reports
  • Batch Manufacturing Records (BMRs)
  • OOS, deviations and discrepancies

Qualified Person (QP)

The Qualified Person (QP) is responsible for managing and implementing a drug manufacturer’s core quality systems and ensuring compliance to cGMP and ICH standards. The QP has the “final word” on the release of raw materials, intermediates and final product.

The QP’ responsibilities consist of maintaining adherence with a range of processes and departments, including:

  • Change control
  • Deviations and OOS investigations
  • Training
  • Validation
  • Documentation
  • Auditing
  • Clinical trials
  • Technology transfer
  • Raw materials
  • Product release
  • Manufacturing
  • Customer complaints
  • Engineering
  • Marketing

Quality Control (QC)

Quality control is responsible for implementing many of the tests and measures to ensure product quality and safety throughout product development and commercialisations. This includes:

  • QC testing (raw materials, in-process controls, and release testing)
  • Stability testing (accelerated and real time)
  • Investigative testing (following, for example, OOS and failures)
  • QC activities must always be in compliance with cGMP and ICH standards