Current Good Manufacturing Practices are, in some countries, enforced regulations for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.
Even where it’s not strongly enforced, reputable manufacturers, especially of food and pharmaceuticals, should adopt the practices for their products quality, purity and strength by adequately controlling their manufacturing operations. This includes establishing strong quality management systems, use of quality raw materials only, establishing reliable standard operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.
Introducing the Principles of cGMP – the 5 Ps
- Procedures (or paperwork)
Implications and Need to Comply
- Product processing
- Quality control
- Satisfy regulatory accreditation
- Standard operating procedures (SOP)
- Document control system.
- Procedures, instructions, specifications, records
- GMP focused
- An integral part of how everyone works
- Regular performance reviews
- 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 ehavior 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
- Procedures to record change or deviation
- Formal documented system for change control.
- Relevant statutes
- Enforcement by competent authorities
Putting 5-S System to Work for Shopfloor Excellence.