Manufacturing Quality
Comprehensive consulting for FDA's Current Good Manufacturing Practice standards under 21 CFR Parts 210/211. From gap assessment through certification support and inspection readiness.
Discuss Your GMP NeedsUnderstanding the Standard
Current Good Manufacturing Practice (cGMP) regulations are enforced by the FDA to ensure that pharmaceutical products are consistently produced and controlled according to quality standards. The "c" in cGMP stands for "current," reflecting the expectation that manufacturers employ up-to-date technologies and systems.
Governed by 21 CFR Parts 210 and 211, cGMP covers all aspects of pharmaceutical manufacturing — from the design of facilities and equipment to the qualifications and training of personnel, the establishment of robust quality systems, and the meticulous documentation of every production step.
For international manufacturers seeking access to the US market, cGMP compliance is not optional. It is the baseline expectation that the FDA applies during facility inspections, and failure to meet these standards can result in warning letters, import alerts, consent decrees, and permanent loss of market access.
Quality Must Be Built In
Quality cannot be tested into a finished product — it must be designed into every stage of the manufacturing process
Process Controls
Manufacturing processes must be clearly defined, validated, and controlled to ensure consistent output and reproducibility
Documentation
Complete and accurate records must be maintained — if it wasn't documented, it didn't happen
Continuous Improvement
Systems must be regularly reviewed, and any deviations must be investigated with corrective actions implemented
Compliance Areas
cGMP compliance spans six critical domains. Our consultants bring deep expertise across every area to ensure your facility meets FDA expectations.
Quality unit organization, CAPA programs, change control, deviation management, annual product reviews, and management responsibility frameworks.
Facility design and layout, HVAC qualification, equipment validation, calibration programs, preventive maintenance, and environmental monitoring systems.
Analytical method validation, stability testing programs, out-of-specification investigations, reference standards, laboratory data integrity, and instrument qualification.
Batch record review, in-process controls, process validation, material management, yield calculations, and contamination prevention protocols.
Label control systems, packaging line clearance, tamper-evident features, serialization compliance, expiration dating, and storage condition requirements.
Standard operating procedures, batch production records, data integrity controls (ALCOA+ principles), record retention policies, and electronic records compliance.
Our Methodology
A structured, proven approach to achieving cGMP compliance and maintaining inspection readiness for international pharmaceutical manufacturers.
We conduct a thorough evaluation of your current manufacturing operations against FDA cGMP requirements, identifying gaps and prioritizing remediation activities by risk level.
We design a comprehensive quality management system tailored to your operations — covering quality unit structure, CAPA processes, change control, deviation management, and annual product review procedures.
We develop and refine your standard operating procedures to meet FDA expectations — ensuring clear instructions, appropriate detail, and alignment with your validated manufacturing processes.
We deliver targeted cGMP training programs for your production, quality, and laboratory personnel — ensuring every team member understands their role in maintaining compliance and product quality.
We conduct a rigorous mock FDA inspection of your facility, simulating the actual inspection experience to identify remaining vulnerabilities and prepare your team for real regulatory scrutiny.
We provide end-to-end support during the actual FDA inspection process — from pre-inspection preparation and document assembly to real-time guidance during the inspection and response to any observations.
Take the First Step
Contact our regulatory team for a confidential assessment of your manufacturing operations. We'll identify gaps, outline the remediation pathway, and prepare your facility for FDA inspection readiness.
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