1. Quality Control department functions for assuring the quality of all the batches manufactured, at every stage of manufacturing/processing Drug Products.
2. This is achieved by performing the functions of QC systems for the following areas:
2.1. Sampling, inspection & testing as per specifications of Raw material for release or rejection & its documentation.
2.2. Sampling, inspection & testing as per specifications of packaging material for release or rejection & its documentation.
2.3. Sampling, inspection & testing as per specifications of in-process product for release or rejection for further processing or reprocessing & its documentation.
2.5. Release or rejection of every batch of Drug Products for distribution and sale.
2.6. Stability testing and evaluation of shelf-life of products.
2.7. Microbiological analysis of raw material, finished products, water and environmental bio-burden monitoring.
2.8. Analytical investigation for complaints and product recalls.
2.9. Analytical support for evaluating the Change Control proposals & Systems.
2.10. Out of specification investigations for laboratory results.
2.11. Investigation of deviations in the analysis.
2.12. Analysis of Returned products (salvage and disposal).
2.13. Internal Quality System Audits and Quality Review.
2.14. Analysis for Control of non-conforming products.
2.15. Reference standards, working standards, solution preparations.
3. To achieve the objectives of Quality Control, functions of the department can be classified as follows: -
3.1. To plan and manage all the activities of the Quality Control Dept. To assure the quality of all products manufactured by the Company.
3.2. To co-ordinate with manufacturing department in controlling their process and products at every stage of manufacturing to meet the established specifications through testing, auditing and reporting.
3.3. To co-ordinate for development of specifications, the analytical procedure in coordination with Quality Assurance Dept. and R&D.
3.4. To review the adequacy and relevance of specifications & analytical procedures in coordination with the Quality Assurance Dept. and R&D.
3.5. To co-ordinate technical audits of the Quality Control Laboratory to determine the analytical Quality Systems are yielding the highest quality information and to ensure that the analytical instrumentation is functioning properly and calibration and servicing is as per schedule.
3.6. To be responsible for the Quality Control functions and records, which shall include:
3.7. Maintenance of Quality Control records, Control samples of raw materials and drug products each batch manufactured.
3.8. Records of release, quarantine or rejection of components and finished products, containers, closures and labels based on Quality Control test results.
3.9. Routine “Good Laboratory Practices Auditing” of the control process, and related areas.
3.10. To suggest and organize training programs for the development of technical and administrative skills of all the employees to meet with cGLP regulations on the continuous basis, which shall be done by co-ordination with Plant and Quality Heads.
3.11. To establish guidelines and procedures on cGMP and Good Laboratory Practice – Standard Operating Procedures of overall Quality Control Activities. Protocols related to Method / Process/ Cleaning/ Analytical Method Validation etc.
3.12. To evaluate the Change Control suggestions for overall reviews of non-conformances, failure investigations, analyzing the Quality trends, investigations of market complaints, batch failure investigations, deviations, verifications of change control procedures, updating the specifications, test procedures, manufacturing processes etc.
3.14. To follow the reporting system to the Corporate Quality Head on the daily /weekly / monthly basis as per the standard procedure. (Reporting System)
2. This is achieved by performing the functions of QC systems for the following areas:
2.1. Sampling, inspection & testing as per specifications of Raw material for release or rejection & its documentation.
2.2. Sampling, inspection & testing as per specifications of packaging material for release or rejection & its documentation.
2.3. Sampling, inspection & testing as per specifications of in-process product for release or rejection for further processing or reprocessing & its documentation.
2.5. Release or rejection of every batch of Drug Products for distribution and sale.
2.6. Stability testing and evaluation of shelf-life of products.
2.7. Microbiological analysis of raw material, finished products, water and environmental bio-burden monitoring.
2.8. Analytical investigation for complaints and product recalls.
2.9. Analytical support for evaluating the Change Control proposals & Systems.
2.10. Out of specification investigations for laboratory results.
2.11. Investigation of deviations in the analysis.
2.12. Analysis of Returned products (salvage and disposal).
2.13. Internal Quality System Audits and Quality Review.
2.14. Analysis for Control of non-conforming products.
2.15. Reference standards, working standards, solution preparations.
3. To achieve the objectives of Quality Control, functions of the department can be classified as follows: -
3.1. To plan and manage all the activities of the Quality Control Dept. To assure the quality of all products manufactured by the Company.
3.2. To co-ordinate with manufacturing department in controlling their process and products at every stage of manufacturing to meet the established specifications through testing, auditing and reporting.
3.3. To co-ordinate for development of specifications, the analytical procedure in coordination with Quality Assurance Dept. and R&D.
3.4. To review the adequacy and relevance of specifications & analytical procedures in coordination with the Quality Assurance Dept. and R&D.
3.5. To co-ordinate technical audits of the Quality Control Laboratory to determine the analytical Quality Systems are yielding the highest quality information and to ensure that the analytical instrumentation is functioning properly and calibration and servicing is as per schedule.
3.6. To be responsible for the Quality Control functions and records, which shall include:
3.7. Maintenance of Quality Control records, Control samples of raw materials and drug products each batch manufactured.
3.8. Records of release, quarantine or rejection of components and finished products, containers, closures and labels based on Quality Control test results.
3.9. Routine “Good Laboratory Practices Auditing” of the control process, and related areas.
3.10. To suggest and organize training programs for the development of technical and administrative skills of all the employees to meet with cGLP regulations on the continuous basis, which shall be done by co-ordination with Plant and Quality Heads.
3.11. To establish guidelines and procedures on cGMP and Good Laboratory Practice – Standard Operating Procedures of overall Quality Control Activities. Protocols related to Method / Process/ Cleaning/ Analytical Method Validation etc.
3.12. To evaluate the Change Control suggestions for overall reviews of non-conformances, failure investigations, analyzing the Quality trends, investigations of market complaints, batch failure investigations, deviations, verifications of change control procedures, updating the specifications, test procedures, manufacturing processes etc.
3.14. To follow the reporting system to the Corporate Quality Head on the daily /weekly / monthly basis as per the standard procedure. (Reporting System)
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