CURRENT GOOD MANUFACTURING PRACTICES (CGMP)

SYNOPSIS: Current Good Manufacturing Practices (cGMP) are production and testing practices that help to ensure product quality. While applicable to almost any business, they are mandatory in certain industries.  The regulatory authorities can levy significant penalties for non-compliance.

This seminar will introduce participants to the fundamental requirements of cGMP, their responsibilities under the law, and the potential financial liabilities to which they are exposed.

COURSE CONTENT

Principles of cGMP

Implications and Need to Comply

• Product processing
• Manufacture
• Quality control
• Storage/warehousing
• Transportation
• Delivery

Production/Processes

• Satisfy regulatory accreditation
• Standard operating procedures (SOP)
• Document control system.

Documentation

• Procedures, instructions, specifications, records
• GMP focused
• An integral part of how everyone works
• Regular performance reviews

Personnel

• Competent and appropriately qualified personnel
• Sufficient numbers
• Timely, relevant and regularly updated training
• SOP “owned” and understood by the workforce

Premises and Equipment

• Validation & calibration of processes & equipment
• Accurate, efficient & verifiable components
• Operation designed to minimise the risks
• Designed to permit effective cleaning and maintenance
• Maintenance according to written instruction
• Adequate safety
• Adequate water and drainage.

Quality Assurance and Management

• Compliance with specifications
• Validated production steps
• Validated storage and transportation procedures
• Defined written procedures
• Validated methods
• Qualified, calibrated & maintained equipment
• Approved reagents and/or test kits
• Product consistency
• Quality incidence report
• Quality assurance

Change Control

• Procedures to record change or deviation
• Formal documented system for change control.

Regulatory Expectations

• Relevant statutes
• Enforcement by competent authorities

TARGET AUDIENCE: Quality Assurance/Control, Production personnel, and those charged with the responsibility for ensuring compliance with regulatory requirements.