Pharmaceutical Good Manufacturing Practice هذه الدورة تدرس باللغة الإنجليزية

تفاصيل الدورة

Why Attend

A robust quality system that meets the requirements of pharmaceutical regulators is an essential element of every good pharmaceutical manufacturing operation. This course will introduce participants to the essential features of a US Good Manufacturing Practice (GMP)-compliant quality management system as well as covering recent developments in pharmaceutical regulation. The duties of personnel in the production, quality control and quality assurance departments will be explained, together with requirements for GMP-compliant documentation and records. The expectations of regulators regarding the qualifications, experience and on-going training/development of personnel will also be covered.

Special emphasis will be given to the relatively recent topic of pharmaceutical data integrity, including controls required over quality-critical electronic data systems. Participants will also be introduced to the concept and application of quality risk management in a GMP environment.

Course Methodology

The material used in the training course will be based on exercises as well as regional and international case studies. Participants will frequently work in pairs with one another as well as in larger teams.

Course Objectives

• Explain the importance of Good Manufacturing Practices (GMP) in ensuring patient safety and drug efficacy
• Apply US-compliant pharmaceutical standards to enhance the current pharmaceutical quality management system within their own organization
• Find and continuously implement the current GMP requirements and updates frequently released by US authorities
• Implement pharmaceutical data integrity regulations
• Produce GMP-compliant documents, records and written procedures
• Prepare for regulatory inspections as well as internal and supplier audits

Target Audience

This course is designed for production and quality control professionals in the pharmaceutical manufacturing industry. It will be particularly beneficial for individuals responsible for compliance or quality assurance such as quality auditors, regulatory affairs professionals, production auditors, regulators, training and production managers, as well as anyone interested in effective GMP compliance tools and techniques. Professionals working with finished pharmaceuticals, combination products or devices will also gain insight on how to better structure their respective quality systems.

Target Competencies

• Good Manufacturing Practice
• Understanding Pharmaceutical Quality Systems
• Performing Pharmaceutical Audits
• Data Integrity
• Producing GMP documents

Course Outline

• Essential elements of Good Manufacturing Practices (GMP)
  • Historical background
  • General GMP requirements (21 CFR 211)
  • Organizational units
  • Key roles
  • Building management
  • Facilities management
  • Where to find current information and guidance
  • International harmonization
  • United States Pharmacopeia
  • Quality risk management
• Equipment, processes and materials
  • Validation master plan
  • Validating processes: US Federal Drug Authority guidance
  • Qualifying equipment: A risk-based approach
  • Laboratory equipment
  • Computerized data systems
  • Good Automated Manufacturing Practices (GAMP) classification
  • Control of materials 
    • Specifications
    • Approval
    • Rejection
    • Quarantine
• Documentation and the pharmaceutical quality system
  • Pharmaceutical quality system (ICH Q10)
  • Quality manual
  • Standard operating procedures
  • Analytical procedures
  • Production records
  • Equipment records
  • Document control
  • Personnel records
  • Out-Of-Specification (OOS) investigations
  • Out-Of-Trend (OOT) investigations
  • Deviation reports
• Audits
  • The audit process: Planning, documentation and corrective actions
  • Internal audits: Audit schedule
  • Supplier audits
  • Regulatory inspections: FDA audit observations
• Pharmaceutical data integrity
  • Data integrity definitions and expectations
  • Data integrity risks in the analytical process
  • Data integrity risks in computerized systems
  • Examples of data system controls
  • Extracts from FDA data integrity warning letters