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50 - LONG - Long-Term Programs


LONG 517 - Good Manufacturing Practice (GMP) (4 Weeks)

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Course Description

Good Manufacturing Practices (GMP) are a set of measures that aim to provide guidance for manufacturing, testing, and quality assurance in order to ensure that the products are safe for human consumption.

Course Objectives

  • Know about GMP regulations and their application to laboratory activities, manufacturing processes and support functions,
  • Gain a fundamental knowledge of the basis of GMP regulations,
  • Demonstrate the need for thorough and comprehensive GMP training and documentation.
  • Understand the common terminology and the role GMPs play in their day-to-day responsibilities.
  • Managing the implementation of GMP efforts and proactively sustaining a culture of compliance in all scientific and manufacturing efforts.

Who Should Attend?

  • Managers
  • Professionals 
  • Purchasers
  • Anyone who is involved in Good Manufacturing Practice

Course Details/Schedule

Week 1

Introduction

  • What is Good Manufacturing Practice? 
  • Why is GMP important? 
  • Official GMP Directives. 
  • The basic requirements of Good Manufacturing Practice.

Pharmaceutical Quality System (PQS)

  • Principle and overview of the Pharmaceutical Quality System. 
  • Major updates. 
  • Development, contents and implementation of PQS
 

Week 2

Personnel

  • Key personnel. 
  • Background and duties of the Qualified person. 
  • Duties of the Head of production department. 
  • Duties of the Head of quality control. 
  • Person releasing the batch and consultants. 
  • Personnel training and hygiene.

Premises & Equipment

  • Premises. 
  • Production area. 
  • Storage area. 
  • Quality control areas. 
  • Ancillary areas. 
  • Equipment.

Week 3

Documentation

  • Premises. 
  • Generation & control of documentation. 
  • Types of documents & specifications. 
  • Manufacturing formula & processing instructions. 
  • Packaging instructions. 
  • Procedures & records.

Production

  • General principles. 
  • Prevention of cross-contamination in production. 
  • Guidelines for starting materials. 
  • Processing operations. 
  • Packaging materials and operations. 
  • Guidelines for finished products.

Week 4

Quality Control

  • General principles. 
  • Main tasks of the Quality control department. 
  • Technical transfer of testing methods. 
  • Transfer protocol.
Complaints & Recalls
  • GMP Guidelines related to complaints. 
  • Classification of defects. 
  • Product Recalls.