FDA submissions, management of clinical studies.

UNIT 4 08 Hours

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

UNIT 5 07 Hours

Indian regulatory requirements: Central Drug Standard Control Organization (CDSCO) and State

Licensing Authority: Organization, Responsibilities, Certificate of Pharmaceutical Product (COPP),

Regulatory requirements and approval procedures for new drugs.

Recommended Books: Latest Editions

1. Regulatory Affairs from Wikipedia, the free encyclopedia modified on 7th April available at http,

//en.wikipedia.org/wiki/Regulatory_ Affairs.

2. International Regulatory Affairs Updates, 2005. available at http://www.iraup.com/about.php

3. Douglas J Pisano and David S. Mantus. Text book of FDA Regulatory Affairs A Guide for Prescription

Drugs, Medical Devices, and Biologics, Second Edition.

4. Regulatory Affairs brought by learning plus, inc. available at http.//www.cgmp.com/ra.htm.

Contents

Preface vii

1. Introduction to Pilot-Plant and Scale-up 2

1.1 Plant 2

1.2 Pilot-Plant 2

1.2.1 Reasons for Conducting Pilot-Plant Studies 3

1.2.2 Objectives of Pilot-Plant 3

1.2.3 Pilot-Plant Operations 4

1.3 Scale-up 5

1.3.1 Need of Scale-up 5

1.3.2 Steps in Scale-up 5

1.3.3 Objectives of Scale-up 6

1.3.4 Relation between Pilot-Plant and Scale-up 6

Long Answer Type Questions 7

Short Answer Type Questions 7

Objective Type Questions 7

2. General Considerations and Pilot-Plant Considerations for

Different Dosage Forms 9

2.1 General Considerations 9

2.1.1 Reporting Responsibilities 9

2.1.2 Personnel Requirement 9

2.1.3 Space Requirements 10

2.1.4 Review of the Formula 11

2.1.5 Raw Materials 11

2.1.6 Equipment 11

2.1.7 Production Rate 11

2.1.8 Process Evaluation 11

2.1.9 Preparation of Master Manufacturing Procedures 12

2.1.10 Product Stability and Uniformity 13

2.1.11 Good Manufacturing Practices (GMP) Considerations 13

2.1.12 Transfer of Analytical Methods to Quality Assurance 13

2.2 Pilot-Plant Scale-up Considerations for Solids (Tablets) 13

2.3 Pilot-Plant Scale-up Considerations for Oral Liquids 18

2.4 Pilot-Plant Scale-up Considerations for Semisolids 20