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