Quality Assurance In Pharmaceutical Industry
Pharmaceutical quality assurance is a dynamic process
, a state of mind or an understanding of the regulations and guidance relating to the development and manufacture of pharmaceutical products.
Quality Assurance is a constituent of quality management riveted to assure, generate precise and reliable results on all lab activities that are undertaken. Drugs that are marketed must be safe and therapeutically active. Performance should be consistent and predictable. Or it can be defined as the sum of all activities and responsibilities required to ensure that the medicine that reaches the patient is safe and effective.
The System of Quality Assurance
This department can be divided into four major areas: Quality control, production, distribution, and inspections.
1.QA ensures the arrangements made for the manufacture, supply and use of the correct starting and packaging materials.
2. Any deviation from the written production and process control procedures which are followed in the execution of various production and process control functions shall be reported investigated and recorded by the quality dept.
3. Deviations from the established time limits for the completion of each phase of production shall be justified and documented by the assurance dept.
4. All the activities involved in the manufacturing process, in-process control and bulk testing shall be approved by the QA dept.
5. All necessary control on intermediate products and any other in-process controls and validations are carried out by the dept.
6. Quality improvement plans.
7. Validation and Technology Transfer.
8. Review of stability date and shelf life of products.
9. Quality team frequently conduct periodic GMP training to personnel at all levels of the organization.
Quality Assurance Goals
1 Make sure that each medicine reaching a patient is safe, effective and of standard quality.
2 Incurring medicaments that are safe and effective.
3 Assuring superiority of a product from selection to use.
4 Persistent products those are safe and effective through structured selection and procurement methods.
5 Exerting products through appropriate storage, distribution, monitoring and use methods.
Conclusion
Quality Assurance does its best to maintain the reliability at every stage of manufacturing process starting from Research, Clinical studies, Quality Control, Production, Distribution and provides information on appropriate use, and analyzes safety and information of the products.
The Department will also assist in the strategic direction and development of Quality Systems, standard operating procedures and document control programs, to ensure with the company policies and regulatory requirements.
It is a multi fold activity, where in all the industries want professionally qualified, competent, skilled managerial and entrepreneurial talent workforce to lead the industry.
by: Likithasriram
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