Quality assurance and quality management concepts

The presentation is intended for B.Pharm Third Year students of PCI Syllabus for subject Quality Assurance of Sixth Semester.

1. Quality Assurance and Quality Management concepts By : Dr.K.B.Gabhane Vidyabharti College of Pharmacy, Amravati

2. SYLLABUS CONTENTS: 2 Dr. K.B.Gabhane

3. Objectives: Upon completion of this section, the student should be able to : Define the terms Quality Assurance and Quality Control and their objectives. Describe the major events that led to the development of quality concepts in the pharmaceutical industry. Differentiate between Quality Assurance and Quality Control. Define the term Good Manufacturing Practices (GMPs) Explain the areas covered under current Good Manufacturing Practices (cGMPs). Quality Assurance and Quality Management concepts 3 Dr. K.B.Gabhane

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7. What is Quality? Quality is simply stated: "Fit for use or purpose." It is all about meeting the needs and expectations of customers with respect to functionality, design, reliability, durability, & price of the product . What is Assurance? Assurance is nothing but a positive declaration on a product or service, which gives confidence . It is certainty of a product or a service, which it will work well. It provides a guarantee that the product will work without any problems as per the expectations or requirements. 7 Dr. K.B.Gabhane

8. DEFINITION: Quality assurance is a procedure or set of procedures intended to ensure that a product or service under development meets specified requirements. 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: 8 Dr. K.B.Gabhane

9. Inside an organization, quality assurance provides a management tool. The quality assurance provides confidence for the customer (whether that is a pharmacist, doctor or patient) in the quality of the drug being supplied. An important part of the systematic actions is the availability of a complete system of standard operating procedures (SOPs). They describe all the actions that need to be taken in a standardized way. This means that everyone involved in pharmaceutical manufacturing has a book of procedures, which guides them in the way that they should do their job. It thus provides a standardized way of working. In the European Union guidelines, QA is defined as ‘a wide-ranging concept that covers all matters which individually or collectively influence the quality of a product’. 9 Dr. K.B.Gabhane

10. Components of Quality Assurance : Design and development of pharmaceutical product Production and control operation . Managerial responsibilities . Arrangements for manufacturing supply . All necessary control . Checking and verification of finished product. Requirement of marketing authorization and regulation Assurance of product throughput product shelf life. Quality Audit 10 Dr. K.B.Gabhane

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17. Objectives of Quality Assurance : The objectives of QA system in a pharmaceutical industry are to ensure that : Product design and development is in accordance with requirements of cGMP, GLP, and GCP. All operations in production and control steps are specified cleared in writing . Managerial responsibility is specified clearly in each job description. Correct starting materials and packaging materials are used to manufacture drug products. Finished products are appropriately checked in accordance with pre-determined procedures. Every production batch is certified by authorized persons before it is released for sale and supply. There is satisfactory measure adopted to ensure quality of he product which is maintained through out its shelf life 17 Dr. K.B.Gabhane

18. Procedures exist for regular self-inspection or quality audits to assess the effectiveness of the QA system. Deviation of any nature are reported, adequately invesitgated and the results are recorded. Changes having an impact on product quality are adopted through a system that calls for approval Quality of products is regularly evaluated in order to verify that the process is consistently providing quality products. Objectives of Quality Assurance : 18 Dr. K.B.Gabhane

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