Getting FDA approval is however only the start of yet another equally tough journey. The drug formulation has to transit from the laboratory to the manufacturing floor, which has its own challenges. As obvious from the history of how cGMP came into being, many things can go wrong and it is vital to have sufficient control over all the factors that can influence the quality of the final drug product.
For several years, pharmaceutical companies relied a lot on
Quality Control (QC) for adequate testing of the quality of their products.
With time, however, as processing operations grew more complex, the realization
grew that testing often misses detecting problems because tests are run on
randomly selected samples. One cannot hope to “test quality into” products that
do not have the quality inherent in them.
This realization led to the development of the concept of
Quality Assurance (QA) which seeks to build quality into the products from the
very beginning of the process of drug manufacture. Through careful planning,
training, and monitoring QA is a means to control processes right from choosing
the right vendor for the starting and packing materials, to how the distribution of the finished product takes place. The aim is to cover all the
aspects that individually and collectively impact the quality of products.
The World Health Organization (WHO) defines QA as, “The
totality of arrangements made with the object of ensuring that pharmaceutical
products are of the quality required for their intended use.”
Objectives of Quality Assurance
The objectives of the QA system in the pharmaceutical
industry are to ensure that:
• Product design and development are in accordance
with the requirements of cGMP, Good Laboratory Practices (for non-clinical
developmental studies), and Good Clinical Practices (for clinical studies).
• All operations in production and control steps are
specified clearly in writing.
• Managerial responsibility is specified clearly in
each job description.
• Correct starting materials and packaging materials
are used to manufacture drug products.
• Appropriate controls – such as in-process checks,
calibrations, and validations – exist to ensure the quality of raw materials,
intermediate products, and finished products.
• Finished products are appropriately checked by
pre-determined procedures.
• Every production batch is certified by authorized
persons before it is released for sale and supply.
• There are satisfactory measures adopted to ensure the
quality of the product which is maintained throughout its shelf life.
• Procedures exist for regular self-inspection or
quality audits to assess the effectiveness of the QA system.
• Deviations of any nature are reported, and adequately
investigated and the results are recorded.
• Changes having an impact on product quality are
adopted through a system that calls for approval from management.
• Quality of products is regularly evaluated to
verify that the process is consistently providing quality products.