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Quality management systems: (Unit:- 4):- Hand Written Notes


Quality management systems: Quality management & Certifications: Concept of Quality, Total Quality Management, Quality by Design (QbD), Six Sigma concept, Out of Specifications (OOS), Change control, Introduction to ISO 9000 Series of quality systems standards, ISO 14000, NABL, GLP, Quality Management Systems Quality Management System: Concept of Quality Introduction Quality Quality in Pharma Industry Quality Assurance (QA) Quality Control (QC) Scope of Pharmaceutical QMS ICH Guidelines Sources of Quality Variation Control of Quality Variation Total Quality Management Introduction Definition Focus of TQM Statistical Quality Control Advantages Quality by Design (QbD) Introduction Definition Objectives of QbD Elements of QbD Quality Target Product Profile (QTPP) Critical Quality Attributes (CQA) Risk Assessment: CMAs (Critical Material Attributes) and CPPs (Critical Process Parameters) Control Strategy Six-Sigma Concepts Introduction Aim of Six-Sigma Concept Six-Sigma Process Out of Specifications (OOS) Introduction Identification of OOS: Reports of Laboratory Investigation Identification of OOS: Reports of Full-Scale Investigation Analysis of Investigated Results Change Control Introduction Definition Function Area of Change Written Procedures and Documentation ISO Quality Standards Quality Management System (QMS) ISO Quality Standards ISO 9000 ISO 9000 Series Requirements of ISO 9000 Series Advantages of ISO Certification ISO 14000 Introduction Principle of ISO 14000 Features of ISO 14000 Advantages of ISO 14000 ISO 14000 Series Process of ISO 14001 Certification Environmental Management System (EMS) Features of EMS NABL (National Accreditation Board for Testing
and Calibration Laboratories) Introduction NABL and ISO Principles Need of NABL Recognition of NABL in International Level Scope of NABL Advantages of NABL GLP (Good Laboratory Practice) Introduction Definition Fundamentals of GLP GLP Principles Aim of GLP

Quality concepts in pharmaceutical industry ICH guidelines and Total quality management Quality by design and six sigma concepts
ISO standards and series
Good laboratory practice
4.1.1 Introduction
Quality Management System (QMS) is an important aspect for the pharmaceutical
industry for maintaining the quality and safety for their products and services. QMS relies on the regulations and guidelines to maintain the effective quality in pharmaceutical industries. According to US FDA, the international harmonized guidance is intended to assist pharmaceutical manufacturers by describing a model for an effective quality management system for the pharmaceutical industry. This guidance is referred as ICH (International Council for Harmonization) guideline.
4.1.2 Quality
Quality can be defined according to US FDA as; “A measure of a product’s or service’s ability to satisfy the customer’s stated or implied needs.”
4.1.3 Quality in Pharma Industry
Due to the effect of globalization, market competition, cost constrains, supply and
demand, complexity of supply chain system and development of international guidelines and regulations, the environment of pharmaceutical industry is changing day by day. The quality, safety and efficacy cannot be ignored or compromised as pharma-industry is directly concerned with the patients to provide them zero defect products.
Long-Answer Questions:
1. Write a note on ICH guidelines.
2. Explain the principles of TQM and QBD.
3. Write about the six sigma concepts.
4. Define OOS. How will you find out the possible OOS in the results? Explain.
5. Write the basic principles of ISO 9000. Explain ISO 9000 series in detail. Write a note on requirements of ISO 9000 Series.
6. What is EMS? Write the basic working principle of ISO 14000 series. What are the advantages of it?
7. Write a short note on GLP and NABL