QUALITY ASSURANCE

 QUALITY ASSURANCE

Principle :

 A broad concept called "Quality Assurance" encompasses all elements that can have an individual or overall impact on a product's quality. The sum of all the measures made to guarantee that pharmaceutical products are of the quality needed for their intended purpose.

Quality  assurance consequently takes into account GMP as well as other elements, such as product development and design, that fall outside the purview of following guide.

The system of quality assurance appropriate to the manufacture of pharma[1]ceutical products should ensure that:

·       - Taking into consideration GMP's requirements as well as those of other related codes, such as good laboratory practice (GLP) and good clinical practice (GCP).

·       - Written specifications for production and control operations and the adoption of GMP standards.

·       - Job descriptions for managers clearly define managerial responsibilities.

·        -Correct starting and packaging materials are manufactured, supplied, and used.

·        -All necessary controls on raw materials, intermediate products, and bulk products, as well as other in-process controls, calibrations, and validations, are carried out.

·        -Finished product is correctly processed and checked, in accordance with the established procedures.

·        -Pharmaceutical Products are not supplied or sold before the authorized personnel have testified that each production batch has been manufactured and monitored in compliance  with the standards of the marketing authorization and any other regulation pertinent to the manufacturing, monitoring, and releasing of pharmaceutical drugs.

·        -there are adequate measures in place to make sure that the pharmaceutical products are produced, delivered, and then handled in a way that preserves their quality for the duration of their shelf-life.

·        -There is a process for self-inspection and/or quality audit that periodically evaluates the efficacy and applicability of the quality assurance system.

·        --Deviations are reported, examined, and recorded.

·        -There is a system for approving changes that could affect product quality.

·        -Routine assessments of the quality of pharmaceutical products should be carried out with the aim of confirming the consistency of the process and ensuring its continuous improvement.

 

•           The manufacturer is in charge of assuring that the pharmaceutical products meet the conditions of the marketing authorization, are suitable for their intended use, and do not endanger patients due to insufficient safety, efficacy, or quality. Senior management is in charge of achieving this goal, which calls for the involvement and dedication of employees from all levels and departments as well as the company's suppliers and distributors. A completely developed and correctly implemented system of quality assurance, comprising GMP and quality control, is required to dependably accomplish the quality objective. It should be properly documented, and its efficiency should be checked. Each component of the quality assurance system should have enough qualified workers, appropriate and sufficient facilities, tools, and resources, as well as facilities.