Compliance with Current Good Manufacturing Practices (cGMP) is mandatory for all pharmaceutical manufacturers, repackers, relabelers, and distributors who want to market drug products in the United States. Governed under 21 CFR Parts 210 and 211, cGMP regulations establish the minimum requirements for methods, facilities, and controls used in the manufacturing, processing, and packaging of drug products.

Failure to comply with FDA cGMP standards can result in warning letters, product recalls, import alerts, or facility shutdowns. Therefore, maintaining a strong quality management system and robust documentation processes is critical for regulatory approval and long-term business success.

Key areas of cGMP compliance include:

• Facility design & equipment qualification to ensure a clean and controlled environment.
• Comprehensive documentation review, including SOPs, master batch records, and QC logs.
• Quality control & assurance systems for testing raw materials, intermediates, and finished products.
• Batch record setup and maintenance, ensuring traceability from raw material to finished product.
• Personnel training and hygiene practices to reduce contamination risks.
• Internal audits and mock FDA inspections to identify and correct deficiencies before regulatory review.

At XPRO America, we support pharmaceutical companies by conducting cGMP compliance audits and preparing facilities for FDA inspections. Our services include:

• Gap analysis audits to identify non-compliance issues.
• Documentation preparation and review for 21 CFR 210/211 alignment.
• Quality system setup including CAPA, deviations, and change control processes.
• Batch record development and verification to ensure traceability and accountability.
• Audit readiness training for staff to handle FDA inspections effectively.

With our guidance, drug manufacturers can establish strong compliance frameworks, reduce regulatory risks, and ensure that their products meet FDA quality standards. XPRO America helps you stay inspection-ready and compliant with 21 CFR Parts 210 & 211, ensuring safe and effective drug products for U.S. markets.

XPRO America provides FDA cGMP compliance audits, documentation review, and quality system support under 21 CFR Parts 210 & 211 for drug manufacturers.