Qc, qa
- 1. Dr. B.Poornima, Associate Professor, Department of Pharmaceutical Analysis, Krishna Teja Pharmacy College, Chalawada Nagar, Tirupati QC, QA & TQM
- 3. Quality Assurance It is the sum total of the organized arrangements with the objective of ensuring that products will be of the quality required for their intended use.
- 5. QA Facility Validation Equipment Validation Process Validation Cleaning Validation Batch Record Preparation Issue & Review Line Clearance Online GMP inspection IPQA
- 6. QA C GMP Training Self Auditing Annual Product Review Market Compliance Product Recall Plant & Regulatory Affairs DMF Submission ANDA Submission Annual Updates Documentation SOP/ Protocol preparation & Review Vender Qualification Document Review Process Control
- 8. GMP • Part of QA which ensures that products are consistently produced & controlled to the quality standards appropriate to their use. • GMP is an integral part of QA.
- 9. Ten Principles of GMP 1. Design & construct the facilities & equipments properly. 2. Follow written procedures & Instructions 3. Document work 4. Validate work 5. Monitor facilities , equipment & Perssonel 6. Write step by step operating procedures & work on instructions 7. Design, develop & demonstrate job competence 8. Protect against contamination 9. Control components & product related processes 10. Conduct planned & periodic audits
- 10. GMP includes Quality Management Perssonel Buildings & Facilities Process equipment Documentation & Maintenance of Records Materials & Management Production & In process control Storage & Distribution Laboratory control Validation Rejection & Reuse of materials
- 11. Quality Management Quality management ensures that an organization, product or service is consistent. It has four main components: o Quality planning o Quality control o Quality assurance & o Quality improvement
- 12. Perssonel
- 14. Buildings & Facilities Design & Construction Lighting Utilities Sewage & Refuse Water Containment Sanitation & Maintenance
- 16. Documentation system. Records of Raw materials, Intermediates, API labeling & Packaging Materials. Master Production & Control records. Batch Production & Control records. Laboratory Control records. Batch production record review.
- 17. List of important documents in GMP • Policies • SOP • Specifications • MFR (Master Formula Record) • BMR • Manuals • Master plans/ files • Validation protocols • Forms & Formats • Records
- 18. • All production, Control and distribution records should be retained for at least 1 year after expiry date of the batch. • For APIs with retest dates, records should be retained for at least 3 years after the batch is completely distributed.
- 19. Materials Management There should be written procedures describing receipt, identification, quarantine, storage, handling, sampling, testing, and approval or rejection of materials.
- 20. Storage & Distribution (Ware House activities ) Ware house Quarantine sampling QC Approved Storage area Finished/ Bulk products Packing material Dispensed REJECTED
- 21. Validation It is an documenting that a process or system meets its pre-determined specifications and quality attributes. It includes Process Validation Analytical method Validation Cleaning Validation Validation for dosage forms Validation for Bulk & Sterile products
- 22. Rejection & Re-use materials Records should be maintained for these materials. Documentation should include Name & Address of the Consignee Intermediate or API batch number, and quantity returned. Reason for return Use or disposal of the returned Intermediate or API.
- 23. Importance of GMP – A poor quality medicine may contain toxic substances that have been unintentionally added. – A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect.
- 25. Quality Control Quality control (QC) is a procedure or set of procedures intended to ensure that a manufactured product or performed service adheres to a defined set of quality criteria or meets the requirements of the client or customer.
- 26. Responsibilities of QC Validated test methods Release of a batch of product only after certification by Qualified person Maintenance of sufficient retention samples of starting materials and final product for future examination if necessary. Recording & investigation of out of specification results, changes, incidents/ deviations. Approved procedures, trained personnel, facilities for sampling, inspection & testing of raw materials, bulk & finished products. Maintenance of records to demonstrate all procedures have been carried out. certification of starting materials that specifies quality & purity their storage, Labeling before using.
- 28. Total Quality Management TQM is the integration of all functions and processes within an organization in order to achieve continuous improvement of the quality of goods and services. The goal is customer satisfaction.
- 31. Principles of TQM • The basic principles for the Total Quality Management (TQM) philosophy of doing business are …… • To satisfy the customer, • satisfy the supplier, and • continuously improve the business processes.
- 32. • Satisfy the customer • The first and major TQM principle is to satisfy the customer--the person who pays for the product or service. • Company philosophy • A company that seeks to satisfy the customer by providing them value for what they buy and the quality they expect will get more repeat business, referral business, and reduced complaints and service expenses.
- 33. • Satisfy the supplier • A second TQM principle is to satisfy the supplier, which is the person or organization from whom you are purchasing goods or services. • A company must look to satisfy their external suppliers by providing them with clear instructions and requirements and then paying them fairly and on time. • It is only in the company's best interest that its suppliers provide it with quality goods or services, if the company hopes to provide quality goods or services to its external customers.
- 34. • Continuous improvement • The third principle of TQM is continuous improvement by • Working smarter, not harder • Worker suggestions • Quality methods