Workshop on Current Good Manufacturing Practices (cGMP)

Program overview:

CGMP refers to the Current Good Manufacturing Practice regulations enforced by the government regulatory agencies. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.

Current Good Manufacturing Practice (cGMP) Regulations is the process that ensures the quality of a product by establishing manufacturing procedures making certain that food is safe and has been prepared, packed, and stored under hygienic conditions.

The training will cover the core requirements, changes to former requirements and best practices on how to achieve compliance.  Participants will learn how to handle government agencies and third party Good Manufacturing Practice (GMP) inspections.

For whom:

This program is designed for Operations personnel, Quality Control Personnel, Quality Assurance/Control, Production personnel, and those charged with the responsibility for ensuring compliance with regulatory requirements.

Learning objectives:

At the end of the program, participants will be able to:

• list and explain the revised (cGMP’s) requirements;
• ensure proper design, monitoring, and control of manufacturing processes and facilities;
• develop guidelines on procedures and processes for establishing strong quality management systems;
• establish robust operating procedures, detecting and investigating product quality deviations;
• obtain appropriate quality raw materials and maintain reliable testing laboratories;
• develop methods to prevent instances of contamination, mix-ups, deviations, failures, and errors; and
• assure that products meet their quality standards as specified.

Course outline:

Day 1

Module 1: Principles of cGMP

Implications and Need to Comply

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

Module 2: Production/Processes

• Satisfy regulatory accreditation
• Standard operating procedures (SOP)

Module 3: Document control system.

• 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

Day 2

Module 1: 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.

Module 2: 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

Module 3: Change Control

• Procedures to record change or deviation
• Formal documented system for change control.
• Regulatory Expectations
• Relevant statutes
• Enforcement by competent authorities

Training Methodology

• Lectures, discussions, exercises, case studies, audio-visual aids will be used to reinforce these teachings/learning methods.