GMP Regulations in Pharmaceutical Industry

GMP and Regulations

• The pharmaceutical industry is highly regulated by the application of Good Manufacturing Practice (GMP) principles.
• Regulation is enforced by governmental and international agencies.

GMP in Microbiology

• Top-level microbial oversight "governance" should be driven by senior-level site management and involve multifunctional representatives from:
• Manufacturing (technical and operations)
• Engineering
• QA management
• Quality control (QC)
• This ensures microbiological control.

Global GMP Bodies

• The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) = European Union (EU) are two main global bodies that oversee GMP.
• The World Health Organization (WHO) has a GMP system, drawing upon EU GMP to an extent.
• National GMP systems operate in most countries (e.g., AIFA).

GMP Rules and Licences

• GMP rules govern the manufacture of safe and efficacious pharmaceutical products.
• Regulatory agencies control production through various licenses, including:
• Manufacturer's license
• Manufacturer's specials license (e.g., produce or import unlicensed medicines)
• Marketing authorization license
• Wholesale dealer license
• Investigational medicinal products (IMPs) license

GMP Regulatory Agencies and Inspections

• Compliance with licenses is assessed through GMP inspections, normally conducted every 2 years (with "risk-based" inspections, this frequency can alter).

GxP and GMP Subsets

• GMP is connected to:
• Good Distribution Practice (GDP) = distribution of medicines
• Good Clinical Practice (GCP) = clinical trials
• Good Laboratory Practice (GLP) = animal experimentation
• Good Control Laboratory Practice (GCLP) = QC (a subset of GMP)
• Collectively, these best practices are abbreviated to GxP.

Key Aspects of GMP Compliance

• GMP has five main attributes:
• Safety
• Identity
• Strength
• Purity
• Quality
• Critical aspects include:
• Proper documentation and records
• Control of materials
• Thorough housekeeping and cleaning
• Responsible personnel behavior
• Process control at all steps
• Maintenance of equipment

GMP Training

• Initial and on-going training must be provided for all personnel involved in production areas or controlled laboratories, and for personnel whose activities could affect product quality.

The Ten Rules of GMP

• For staff training or as a reminder:
• Confirm training and correct written instructions before starting a job
• Follow instructions exactly
• Report errors and bad practices immediately
• Ensure correct materials before starting a job
• Use correct equipment and confirm its status and cleanliness
• Maintain good segregation and protect against contamination
• Work accurately, precisely, and methodically
• Maintain good standards of cleanliness and tidiness
• Ensure changes are pre-approved through the change control system
• Do not make assumptions—check it out.

Importance of GMPs

• GMPs play a long-established role in regulating medicines.
• They set standards for active and inactive materials used in preparing and manufacturing medicines.
• They provide minimum or "default" requirements for medicine registration and control.