Monday, October 28, 2013

Quality Assurance In Pharmaceutical Industry

Quality Assurance In Pharmaceutical Industry




Pharmaceutical quality assurance is a dynamic process, a state of mind or an understanding of the regulations and guidance allying to the development and manufacture of pharmaceutical products.

Quality Assurance is a constituent of quality management riveted to ensure, 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 unique as the sum of all activities and responsibilities required to safeguard 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 authentic and packaging materials.
2. Any difference from the written production and process control procedures which are followed in the outcropping of various production and process control functions shall be reported investigated and recorded by the quality dept.
3. Deviations from the common time limits for the close of each conjuncture 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 needed 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 Forward.
8. Review of stability encounter and sill life of products.
9. Quality team frequently conduct regular GMP training to personnel at all levels of the organization.

Quality Assurance Goals

1 Make assured that each medicine path a patient is safe, effective and of probably quality.
2 Incurring medicaments that are safe and effective.
3 Assuring superiority of a product from decision to use.
4 Persistent products those are safe and effective through structured benchmark and procurement methods.
5 Exerting products through belonging storage, distribution, monitoring and use methods.

Conclusion

Quality Assurance does its best to maintain the reliability at every stage of manufacturing process pioneer from Research, Clinical studies, Quality Control, Production, Distribution and provides information on fit use, and analyzes safety and information of the products.

The Department will also assist in the politic direction and development of Quality Systems, standard operating procedures and document control programs, to confirm with the company policies and regulatory requirements.

It is a multi district activity, where in all the industries want professionally certified, competent, skilled managerial and entrepreneurial knack workforce to lead the industry.

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