INTRODUCTION TO PHARMACEUTICAL GOOD MANUFACTURING PRACTICES (GMP)

COURSE OBJECTIVES

• Interpret the GMP requirements for supply of medicinal products to meet regulatory and PIC/S requirements
• Apply these requirements into day to day operation to prevent contamination of pharmaceutical products supplied to end users
• Revise the current documented Quality Management System to meet the new requirements and apply this to perform internal audit of the new QMS to assess compliance

WHO SHOULD ATTEND

GMP Internal Auditors, QMR, Middle management (Supervisors, Executives & Engineers) & Top management (Senior Engineers, Head of Department, Managers)

TRAINING METHODOLOGY

• Lively interactive two-way training facilitation.
• Group Exercises/Workshop
• Case Studies and Application of theory
• Power point Presentation

Note: [Above program is 100% Fully HRDF levy claimable Trainer HRDF TTT Cert No 9391]

• Medium of Instruction:
  • English & BM

• Time Duration:
  • 2 days (Contact Hours: 7 hrs) Proposed Timing: 9am – 5pm

COURSE CONTENT

DAY ONE

• INTRODUCTION
• CHAPTER 1: Pharmaceutical Quality Management System

• • QA/QC Role in organization
  • GMP Requirements
  • Product Quality review
  • Quality Risk Management

• CHAPTER 2: Organization & Personnel

• • Qualification
  • Roles & responsibilities
  • Training & Development
  • Organization chart/Job Description
  • Personnel Hygiene Practices (Do’s and Don’t’s)

• CHAPTER 3: Building Premises and Equipment [REVISED]

• • Cleaning & Sanitation Method
  • Premise Cleanliness
  • Equipment Calibration & Verification
  • QUALITY RISK ASSESSMENT USED TO ASSESS AND CONTROL RISKS [NEW]

• CHAPTER 4: Documentation & Record:

• • SOP/Work Instruction
  • Good Record Keeping

DAY TWO

• CHAPTER 5: Production & Process Control [REVISED]

• • Handling of materials and packaging
  • Prevention of Contamination
  • Do’s and Don’t’s
  • Procedures for Handling & mix-up prevention
  • Storage & Contamination Prevention
  • Product Shortage Due to Manufacturing Constraints [NEW]

• CHAPTER 6: Quality Control:

• • Good Lab practices
  • Sampling & testing
  • Acceptance & rejection

• CHAPTER 7: Outsourced Activities

• • Contract Giver & Acceptor
  • Service Level Agreement Format

• CHAPTER 8: Complaints & Product Recall [REVISED]

• • Personnel and Organization [NEW]
  • Procedures for Handling and Investigating Complaints Including Possible Quality Defects [NEW]
  • Investigation and Decision-making [NEW]
  • Root Cause Analysis and Corrective and Preventative Actions [NEW]
  • Product Recalls and Other Potential Risk-Reducing Actions [NEW]

• CHAPTER 9: Self Inspection or Audit

• • Procedure
  • Audit checklist & records

• Pop Quiz (Verbal)

Group Exercise

• EXERCISE 1: Case Study- Identification of Bad GMP Practices
• EXERCISE 2: Application of Quality Risk Management-Building & Equipment [NEW]
• EXERCISE 3: Application of New Requirements To Handle Complaints & Recalls [NEW]

Summative Written Assessment/Exam-1 hour 40 MCQs