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Overview on development, quality control & method validation
- 1. Overview On Development, Quality Control & Validation Al Fahad Ul Islam ID: 171-29-981 Batch: 17th A Department Of Pharmacy Daffodil International University Date: 03-02-2020
- 2. Pharmaceutical product development Steps for drug discovery, design and development
- 3. QC & QA QC = Testing + Assessment QA = Product Design + GMP+ QC+ Quality Goal Activities The distinction between the Quality Control (QC) and Quality Assurance (QA) approaches can be explained further with the following examples. In course of quality evaluation of Pharmaceuticals one would come across two groups of sub-standard manufacture. Firstly, products that fail to conform to quality when manufactured. Secondly, products that initially conform to quality, but later deteriorate on the shelf before expiry date.
- 4. Continue… QC Objectives: • Quick sale of quality goods • Production of standard quality goods • Improvement in quality • Efficient use of men and machines • Reduction in cost per unit • Decreased inspection cost Steps: There are 12 steps of quality control The 4 Main responsibilities of quality control in pharmaceutical industry include: • Efficacy • Safety • Quality • Compliance QA Objectives: • Technology transfer • Validation • Documentation • Assuring quality of products • Quality improvement plans • cGMP • GLP • Developing HACCP plan Steps: There are 8 steps of quality assurance
- 5. Continue… Quality variation Cost of quality
- 6. TQM Advantage of TQM • Less product defects • Satisfied customers • Lower costs • Well-defined cultural values
- 7. Validation Definition: The action of checking or proving the validity or accuracy of something Necessity of validation: • To obtain consistent, reliable and accurate data. • For identification of source of potential errors. • Reduce the rate of failure • Reduced the cost • Process optimization • To improve customer satisfaction Types of Validation
- 9. Conclusion Quality is an important factor when it comes to any product or service. With the high market competition, quality has become the market differentiator for almost all products and services. Quality control is essential to building a successful business that delivers products that meet or exceed customers’ expectations.