Pharmaceutical Quality Consulting

cGMP Systems for OTC, Rx, and API Operations

Whether you produce OTC products, prescription drugs, or active pharmaceutical ingredients, we bring the regulatory knowledge your team needs to stay in good standing: quality systems built to Parts 210 and 211, process validation that holds up, laboratory controls that survive scrutiny, and batch documentation that tells a complete, defensible story. For the regulation itself, see FDA's official cGMP regulations page.

• 21 CFR Parts 210 and 211 compliance
• Process validation and equipment qualification
• Laboratory controls and testing review
• Batch record review and documentation systems
• Deviation and OOS investigation practices
• FDA inspection readiness and response

Audit-Ready, Before and After FDA Visits

Our consultants help you maintain audit-ready operations and respond effectively to FDA findings. That runs from GMP gap analysis and testing compliance review through mock FDA audits before an inspection, to structured remediation when observations need real correction. Onsite across California, remote nationwide.

Pharmaceutical cGMP Questions

What is cGMP for pharmaceuticals?

Current Good Manufacturing Practice for drugs is defined in 21 CFR Parts 210 and 211. It covers the full manufacturing operation: quality units, facilities, equipment, components, production and process controls, laboratory controls, and records. We help drug manufacturers build and maintain systems that meet it.

Do OTC products need cGMP compliance?

Yes. Over-the-counter drug products are drugs under FDA law, and 21 CFR Parts 210 and 211 apply to them just as they do to prescription products. We work with OTC, prescription, and active pharmaceutical ingredient operations.

What do FDA investigators cite most at drug manufacturers?

Laboratory controls and data practices, incomplete investigations of deviations and out-of-specification results, and process validation gaps are among the most common 483 themes. Our reviews focus on the systems investigators actually probe.

Can you help us respond to a 483 or warning letter?

Yes. We help drug manufacturers respond credibly and run structured remediation programs that turn findings into verified fixes that hold up on re-inspection.