The Challenge A global cosmetics manufacturer with a production site in Spain wanted to enter the OTC pharmaceutical market but had no prior GMP experience, no internal expertise to interpret FDA requirements, and no processes aligned with 21CFR 210-211.

The Result

Full compliance with 21CFR 210–211 achieved in 12 months, plant qualified for OTC production, and a self-sufficient internal team equipped with lasting GMP expertise.

Rephine helped transform our facility into a GMP-compliant site ready for FDA inspection. Their expertise not only ensured compliance but also gave our teams the knowledge and confidence to sustain high-quality standards as we expand into OTC product manufacturing.

About the Case Study

The Situation

A global cosmetics manufacturer with a production site in Spain wanted to enter the OTC pharmaceutical market, but had no prior experience with GMP regulations or FDA requirements. With no internal expertise to navigate 21CFR 210–211 compliance, they needed end-to-end support: from identifying gaps across all departments to preparing the site for FDA inspection and building a sustainable quality culture from the ground up.

Key challenges included:

1. No Internal GMP Expertise

The site had no prior experience with GMP regulations or FDA requirements. No internal processes, documentation systems, or personnel were equipped to meet 21CFR 210-211 standards.

2. Full Site Evaluation Required

Every department needed a comprehensive assessment, covering processes, equipment, documentation, and personnel readiness, before any remediation could begin.

3. Operational Continuity During Transition

The site needed to achieve FDA GMP compliance and qualify for OTC production without disrupting ongoing cosmetics manufacturing operations.

Our Approach to GMP Internal Audit Execution

A structured, four-phase methodology aligned with 21CFR 210-211:

Phase 1 – GMP Gap Assessment:Comprehensive review of all departments against US GMP (21CFR 210-211) requirements, identifying compliance gaps and prioritising remediation actions by risk level.
Phase 2 – Remediation & Implementation: Structured action planning and hands-on support to address deficiencies across processes, documentation, systems, and facilities, aligning all operations with FDA GMP standards.
Phase 3 – FDA Inspection Preparation: Step-by-step guidance to prepare the site for FDA inspection and obtain OTC production approval, including readiness reviews and mock inspections.
Phase 4 – Knowledge Transfer: Targeted training and mentoring to build internal GMP expertise across all departments and embed a sustainable compliance culture that reduces long-term regulatory risk.

Quantifiable Gains

FDA-ready site.

Full compliance with 21CFR 210-211 achieved and site successfully prepared for FDA inspection.

OTC production enabled.

Plant qualified to manufacture OTC products, opening new revenue streams and market opportunities.

Self-sufficient team.
Internal GMP expertise built through training and mentoring, reducing future compliance risks across all departments.

Why Outsource FDA GMP Compliance Support??

Cosmetics manufacturers entering the OTC pharmaceutical market face a structural challenge: FDA requirements under 21CFR 210-211 are complex, resource-intensive, and require deep regulatory expertise that most cosmetics sites simply don’t have in-house.

Outsourcing GMP compliance support to a specialised provider delivers: