What does GMP mean for extraction equipment?

GMP (Good Manufacturing Practice) for extraction equipment means the equipment meets documented standards for its intended use. There is no such thing as GMP-certified equipment — GMP applies to the process and the documentation around it, not the equipment itself.

What is a User Requirement Specification (URS)?

A User Requirement Specification defines what a piece of extraction equipment must do to meet your operational and regulatory requirements. It is the foundation of GMP qualification and the first document in the IQ/OQ/PQ process.

What is the BOEXCO Legacy Equipment GMP Certification?

The BOEXCO Legacy Equipment GMP Certification creates proper GMP documentation for existing extraction equipment that is operationally capable but lacks formal qualification records. It includes URS development, equipment assessment, and IQ/OQ/PQ documentation.

Does BOEXCO support EU GMP and CGMP compliance?

Yes. BOEXCO provides GMP consulting for both EU GMP and CGMP (US Current Good Manufacturing Practice) standards, including cleaning validation, change control, and batch record development.

GMP Extraction Consulting | GMP Facility Design Equipment Validation

What We Do

GMP Services

Most operators arrive at the GMP conversation after they have already bought equipment. We help you get it right from the beginning - or fix what was built without a proper specification process.

URS Development

We develop your User Requirements Specification before equipment procurement begins. Your URS defines production targets, material contact standards, cleanability requirements, instrumentation, data logging, qualification support, and the specific regulatory frameworks your equipment must meet. This document is the foundation of every qualified GMP project.

Design Qualification

Before a dollar is committed to fabrication, we verify that the proposed equipment design actually meets your URS requirements. DQ includes a formal risk assessment of the design, identification of failure modes that could affect product quality, and documented evidence that the design is capable of being qualified and validated after installation.

IQ / OQ / PQ Support

We support the full qualification lifecycle from Installation Qualification through Operational Qualification to Performance Qualification. We develop protocols, execute testing, document results, resolve deviations, and produce the qualification package your regulatory environment requires. We also support requalification schedules and change-control-triggered requalification activities.

EU GMP Compliance

For operations serving European pharmaceutical and medicinal product markets, we provide consulting to EudraLex Volume 4 standards including Annex 11 for computerized systems and data integrity, and Annex 15 for qualification and validation. EU GMP requirements are more conservative than US standards in several areas and require specific expertise to navigate correctly.

CGMP Compliance

Current Good Manufacturing Practices under 21 CFR Parts 110, 111, and 211 govern food, dietary supplement, and pharmaceutical production in the United States. We provide consulting for operations building to CGMP standards, including equipment specification to ASME BPE, 21 CFR Part 11 compliance for electronic records, and process documentation to FDA inspection standards.

Cleaning Validation

A cleaning procedure is not the same as a validated cleaning procedure. We develop cleaning validation protocols that define acceptance limits based on the toxicological profile of your compounds, verify that your cleaning process removes product residues and cleaning agents to below those limits, and produce the documented evidence regulators will look for during inspections.

Legacy Equipment GMP Certification

Already have extraction equipment that works? You may not need to buy new equipment to achieve GMP compliance. BOEXCO has developed a structured process to evaluate, certify, and validate your existing extraction equipment against GMP standards. Through a nine-phase program - Equipment Assessment, Gap Analysis, Retrospective URS Development, Remediation Support, IQ Documentation, OQ Execution and Documentation, Cleaning Validation, PQ Execution and Documentation, and Full Qualification Package delivery - we produce the same documentation a regulator, pharmaceutical customer, or investor will look for, at a fraction of the cost of new equipment. New GMP-spec extraction equipment commonly runs $70,000–$375,000 or more. Certifying your existing equipment costs a fraction of that. Download the white paper for full details on this process.

Regulatory Expertise

Frameworks We Work In

Your URS must reflect the specific regulatory requirements of the markets you are selling into. We work across all major frameworks and understand where they diverge.

United States

CGMP - 21 CFR 110, 111, 211

Part 110/111 for food and dietary supplements. Part 211 for pharmaceuticals. Part 11 for electronic records and data integrity where applicable.

European Union

EU GMP - EudraLex Volume 4

Annex 11 for computerized systems. Annex 15 for qualification and validation. More conservative than US requirements in several areas and requires market-specific expertise.

International Botanical

ISO 22000 / FSSC 22000

Food safety management standards applied in international botanical markets. Requirements vary significantly by country and product category.

Equipment Standard

ASME BPE 2024

The internationally recognized standard for bioprocessing equipment design, materials, surface finish, fabrication, and hygienic requirements. Supports GMP compliance across multiple regulatory frameworks.

"The equipment does not define the compliance. The requirements you define before you buy the equipment do."