Good Laboratory Practices for Pharmaceutical Laboratories
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Good Laboratory Practices for Pharmaceutical Laboratories Course
Introduction:
A strong quality system that meets the standards set by pharmaceutical regulators is a vital component of any reputable pharmaceutical manufacturing operation. This course aims to familiarize participants with the key aspects of a quality management system that aligns with the requirements of US Good Manufacturing Practice (GMP) regulations, while also addressing recent developments in pharmaceutical regulation.
Course Objectives:
By the end of the course, participants will be able to:
- 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
Who Should Attend?
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 Outlines:
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