Pharmaceutical GMP Certification (WHO GMP & 21 CFR 210/211)

Our Pharmaceutical GMP Certification is an independent certification program for pharmaceutical and biotechnology manufacturers. It combines internationally recognized World Health Organization (WHO) Good Manufacturing Practices for Pharmaceutical Products: Main Principles with applicable requirements of US FDA 21 CFR Parts 210 and 211, covering areas such as quality systems, personnel, premises, equipment, documentation, production, quality control, validation, complaints, recalls and self-inspection.

21 CFR Part 210 sets general CGMP requirements for manufacturing, processing, packing or holding drugs, while 21 CFR Part 211 sets CGMP requirements for finished pharmaceuticals, including personnel, facilities, equipment, materials, production, packaging and labeling, laboratory controls, and records.

The certification provides an independent assessment of an organization's pharmaceutical quality systems and manufacturing practices against our defined certification criteria.

Both frameworks are designed to promote consistent pharmaceutical manufacturing and product quality, but they originate from different authorities and regulatory contexts. WHO GMP provides internationally recognized manufacturing principles, while 21 CFR Parts 210 and 211 establish US regulatory CGMP requirements for drug products. Our certification program brings these requirements together within one structured assessment, where applicable to the organization's certification scope.

The US Food and Drug Administration (FDA) does not issue or endorse any certification. Pharmaceutical GMP Certification (WHO GMP & 21 CFR 210/211) is an independent certification program that incorporates WHO GMP principles and applicable requirements of 21 CFR Parts 210 and 211.

Certification does not replace FDA registration, FDA inspection, product approval or any other applicable regulatory obligation. It demonstrates that we have independently assessed the organization against our defined program requirements, and can help organizations identify weaknesses, strengthen their GMP systems and improve overall inspection readiness.

The program may be relevant to organizations involved in pharmaceutical and biotechnology manufacturing, including:

• Drug product manufacturers
• Biotechnology and biological drug product manufacturers
• Contract manufacturing organizations (CMOs)
• Contract development and manufacturing organizations (CDMOs)
• Over-the-counter (OTC) product manufacturers
• Contract packaging organizations (CPOs)
• Organizations seeking to strengthen pharmaceutical supplier qualification
• Manufacturers seeking independent assessment of their GMP systems

We will work with you to confirm eligibility and the appropriate certification scope.

Yes. Manufacturers of OTC products subject to applicable pharmaceutical cGMP requirements may be suitable candidates for our certification program. We will review the organization's products, manufacturing activities, locations and proposed certification scope to determine applicability.

Yes, subject to program applicability. Pharmaceutical CMOs and CDMOs can use certification to demonstrate that their manufacturing and quality systems have been independently assessed against the applicable certification requirements. This can also support discussions with pharmaceutical customers as part of their supplier qualification and oversight processes.

Depending on the certification scope and manufacturing activities, the audit may cover areas such as:

• Pharmaceutical quality systems
• Personnel and training
• Buildings and facilities
• Equipment
• Materials and supplier controls
• Production and process controls
• Packaging and labeling
• Laboratory controls
• Validation and qualification
• Documentation and record management
• Data integrity
• Deviations and investigations
• Corrective and preventive action (CAPA)
• Change control
• Complaints and recalls
• Adverse events and field alerts
• Contract manufacturing and laboratory activities
• Internal audits and management oversight

The actual audit scope is determined according to the organization's activities and applicable certification requirements.

The process follows the standard certification model, including Stage 1 and Stage 2 audits followed by annual surveillance audits. Certification is renewable every three years. We will work with the organization to establish the appropriate certification scope and audit program.

The certification timeline varies according to factors such as organization size, the number and location of manufacturing sites, product types, manufacturing complexity, certification scope, existing quality systems, organization readiness, and audit findings and required corrective actions. We can provide a proposed audit program and timeline after reviewing the organization's application and certification scope.

Combined or integrated auditing opportunities are available depending on the organization's existing certifications, certification scope and applicable program requirements. We can evaluate opportunities to coordinate this certification with other relevant certification activities to help improve audit planning and reduce unnecessary duplication.

Certification may provide additional independent evidence of a supplier's pharmaceutical quality and manufacturing systems, supporting customer supplier-qualification processes. It does not, however, replace the customer's responsibility to establish appropriate supplier qualification, monitoring and oversight based on its own regulatory and quality requirements.

We combine pharmaceutical industry knowledge with established auditing and certification processes. Organizations benefit from:

• Experienced pharmaceutical auditors
• Auditor qualification and competency controls
• Independent technical review
• A structured three-year certification cycle
• Global capabilities supported by local expertise
• Consistent certification processes
• Access to broader testing, inspection, certification and training expertise

Contact us and provide information about your organization, including manufacturing locations, products, processes, number of employees, quality systems and proposed certification scope. We will review this information to determine program applicability, audit requirements, estimated audit duration and the appropriate certification proposal.