WHO-GMP (World Health Organization - Good Manufacturing Practice) is a set of
guidelines and standards for the manufacture of pharmaceutical products, ensuring
their quality, safety, and efficacy.
Key Philosophy WHO-GMP
Quality Management: Establish a quality management system to ensure products meet
quality standards.
Personnel Qualifications and Training: Ensure personnel are qualified and trained to
perform their tasks.
Premises and Equipment: Maintain premises and equipment in a clean and sanitary
condition.
Materials Management: Control the purchase, storage, and use of materials.
Production and Process Controls: Establish controls for production and processes to
ensure consistency and quality.
Packaging and Labeling: Control packaging and labeling to ensure accuracy and
compliance.
Testing and Inspection: Conduct regular testing and inspection to ensure products
meet quality standards.
Advantages of WHO-GMP Certification
Enhance Product Quality: WHO-GMP certification ensures products are consistently
produced and controlled according to quality standards.
Regulatory Compliance: WHO-GMP certification demonstrates compliance with regulatory
requirements.
Elevate Customer Confidence: WHO-GMP certification provides assurance to customers
that products are safe and of high quality.
Competitive edge: WHO-GMP certification can be a competitive edge in the market.
Reduced Risk: WHO-GMP certification reduces the risk of product recalls and
regulatory action.
WHO-GMP Certification Process
Application: Submit an application for WHO-GMP certification.
Audit: Conduct an on-site audit to assess compliance with WHO-GMP standards.
Report: Receive a report detailing findings and recommendations.
Certification: Receive WHO-GMP certification upon successful completion of the audit
and implementation of recommended improvements.
Documents Required for WHO-GMP Certification
Quality Manual: A document outlining the quality management system.
Standard Operating Procedures (SOPs): Documents outlining procedures for various
tasks.
Batch Records: Documents recording batch production and control.
Testing and Inspection Records: Documents recording testing and inspection results.
WHO-GMP Certification Bodies
National Regulatory Authorities: Certification by national regulatory authorities,
such as the FDA in the US.
WHO Collaborating Centers: Certification by WHO collaborating centers.
Other International Certifying Bodies: Certification by other international
certifying bodies, such as the International Organization for Standardization (ISO).
Other National and International Certifications: Various countries and organizations
offer GMP certification programs.
