BP 606T Lecture 1
- 1. Unit 1: Lecture 1: Quality Assurance and Quality Management concepts: Definition and concept of Quality control, Quality assurance By D2 Sir
- 2. Disclaimer: All the content material provided here is only for teaching purpose.
- 3. QUALITY MANAGEMENT IN THE DRUG INDUSTRY (WHO): In the drug industry at large, quality management is usually de鍖ned as the aspect of management function that determines and implements the quality policy, i.e. the overall intention and direction of an organization regarding quality, as formally expressed and authorized by top management. The basic elements of quality management are: an appropriate infrastructure or quality system, encompassing the organizational structure, procedures, processes and resources; systematic actions necessary to ensure adequate con鍖dence that a product (or service) will satisfy given requirements for quality
- 4. QUALITY CONTROL: A system of maintaining standards in manufactured products by testing a sample of the output against the specification. ISO 9000 defines quality control as "A part of quality management focused on fulfilling quality requirements". It is that part of GMP concerned with sampling, specification and testing, documentation and release procedures which ensure that the necessary and relevant tests are performed and the product is released for use only after ascertaining its quality.
- 5. RESPONSIBILITIES OF QC: 1. QC is responsible for day to day control of quality within the company. 2. QC is responsible for analytical testing of incoming raw materials and inspection of packaging components, including labeling, they conduct in-process testing when required, perform environmental monitoring, and inspect operations for compliance. 3. They also conduct the required tests on finished dosage form. 4. QC plays a major role in the selection of qualified vendors from whom raw materials are purchased. 5. The environmental areas for manufacturing of various dosage forms are tested and inspected by QC department.
- 6. QUALITY ASSURANCE: DEFINITIONS: As per WHO) - Quality assurance is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. With regard to pharmaceuticals, quality assurance can be divided into major areas: development, quality control, production, distribution, and inspections. The totality of these actions is termed quality assurance.
- 7. Within an organization, quality assurance serves as a management tool. In contractual situations, quality assurance also serves to generate con鍖dence in the supplier. The concepts of quality assurance, GMP and quality control are interrelated aspects of quality management. They are described here in order to emphasize their relationship and their fundamental importance to the production and control of pharmaceutical products.
- 8. ISO 9000 define QA as a Part of quality management focused on providing confidence that quality requirements will be fulfilled. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use. Quality assurance therefore incorporates GMP and other factors, including those outside the scope of this guide such as product design and development.
- 9. RESPONSIBILITIES OF QA 1. Pharmaceutical products are designed and developed in a way that takes account of the requirements of GMP and other associated codes such as those of good laboratory practice (GLP) and good clinical practice (GCP). 2. Production and control operations are clearly speci鍖ed in a written form and GMP requirements are adopted. 3.Managerial responsibilities are clearly speci鍖ed in job descriptions. 4.Arrangements are made for the manufacture, supply and use of the correct starting and packaging materials.
- 10. 5. All necessary controls on starting materials, intermediate products, and bulk products and other in-process controls, calibrations, and validations are carried out. 6. The 鍖nished product is correctly processed and checked, according to the de鍖ned procedures. 7. Pharmaceutical products are not sold or supplied before the authorized persons) have certi鍖ed that each production batch has been produced and controlled in accordance with the requirements of the marketing authorization and any other regulations relevant to the production, control and release of pharmaceutical products. 8. Satisfactory arrangements exist to ensure, as far as possible, that the pharmaceutical products are stored by the manufacturer, distributed, and subsequently handled so that quality is maintained throughout their shelf-life.
- 11. 9. There is a procedure for self-inspection and/or quality audit that regularly appraises the effectiveness and applicability of the quality assurance system. 10. Deviations are reported, investigated and recorded. 11. There is a system for approving changes that may have an impact on product quality. 12. Regular evaluations of the quality of pharmaceutical products should be conducted with the objective of verifying the consistency of the process and ensuring its continuous improvement.
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