Making the transition to Good Manufacturing Practice (GMP) is a critical step for any company committed to delivering safe, high-quality products in a regulated market. The FDA enforces GMP through rigorous like 21 CFR Parts 210/211 for pharmaceuticals and Part 820 for medical devices, ensuring product integrity in the U.S. Similarly, the EU GMP guidelines, outlined in EudraLex Volume 4, set rigorous standards for manufacturing within Europe. Complementary ISO standards, such as ISO 13485 for medical devices and ISO 22716 for cosmetics, offer globally recognized frameworks to embed quality management into every process. Embracing these standards not only ensures compliance but also builds trust, opens market access, and mitigates risk — laying a solid foundation for sustainable growth in regulated industries.
Good Manufacturing Practice (GMP) — The Regulatory Backbone of Biotech Production
For biotech start-ups moving from Research Use Only (RUO) to clinical or commercial production, understanding GMP is essential. GMP is not just a set of best practices — it’s a binding regulatory requirement ensuring that products intended for human use are safe, effective, and consistently high in quality.
GMP in the EU: EudraLex Volume 4
The European Union defines GMP through EudraLex Volume 4, which applies to both human and veterinary medicinal products. Key principles include:
Product and Process Consistency: Manufacturing processes must be clearly defined, validated, and controlled.
Quality Built In: Quality cannot be tested into a product; it must be embedded throughout manufacturing.
Traceability & Documentation: Detailed records of every batch, deviation, and decision ensure full traceability.
Personnel & Hygiene: Staff must be qualified, trained, and follow strict hygiene protocols.
Controlled Environments: Facilities must prevent cross-contamination and ensure controlled storage and distribution.
Advanced therapies (ATMPs) and biologics face additional expectations under EU GMP Annexes, focusing on complex manufacturing and handling processes.
GMP in the US: FDA Guidelines
The FDA enforces GMP through:
21 CFR Part 210/211 – For drugs and biologics
21 CFR Part 820 – For medical devices (also known as Quality System Regulation, QSR)
Core FDA GMP expectations mirror EU principles but with a strong focus on:
Process Validation: Demonstrating that manufacturing processes perform reliably.
Risk-Based Approach: Emphasizing proactive risk management.
CAPA Systems: Mandatory Corrective and Preventive Action processes to address deviations and prevent recurrence.
Data Integrity: Ensuring ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate) for all records.
The FDA is also aligning its device regulations with ISO 13485 under the upcoming QMSR (Quality Management System Regulation).
Global Harmonization: ISO, ICH, and OECD
While FDA and EU guidelines are jurisdiction-specific, global biotech operations must also align with internationally harmonized standards (not a complete overview):
ICH Guidelines
The International Council for Harmonisation (ICH) provides critical guidance on GMP (ICH Q7 for APIs, Q8-Q10 for pharmaceutical quality systems, and Q9 for risk management). These promote consistency across regions.ISO Standards
Beyond ISO 13485, standards like ISO 14644 (cleanrooms) and ISO 14971 (risk management) support GMP compliance in controlled environments and product safety.OECD Principles of GLP
For pre-clinical studies, the OECD Good Laboratory Practice (GLP) ensures the quality and integrity of non-clinical safety data submitted to regulatory authorities.
Why This Matters for Your Transition
Moving from RUO to GMP means adapting to a regulated environment where:
Every process is defined, controlled, and documented
Risk management is proactive, not reactive
Compliance opens doors to clinical trials, market approvals, and global partnerships
These guidelines aren't obstacles — they're frameworks designed to protect patients, ensure product reliability, and foster trust with regulators and stakeholders.
Make it
From RUO to GMP Compliance
Moving from Research Use Only (RUO) production to a fully regulated environment is a defining milestone for biotech innovators. Good Manufacturing Practice (GMP) is not an option — it’s the legal and scientific foundation that ensures your therapies are safe, effective, and consistently high in quality.
In Europe, GMP is anchored in EudraLex Volume 4, requiring process validation, embedded quality, complete traceability, qualified personnel, and controlled facilities. In the US, the FDA’s 21 CFR Parts 210/211 and 820 define the framework, emphasizing validation, proactive risk management, CAPA systems, and strict data integrity.
Beyond local laws, global biotech operations must align with ICH Q7–Q10, ISO 13485, ISO 14644, ISO 14971, and the OECD GLP Principles, ensuring harmonized standards and inspection readiness worldwide.
Achieving GMP compliance means more than passing audits — it transforms your organisation into a trusted manufacturer capable of clinical trial supply, commercial distribution, and global partnerships. Compliance demonstrates that quality is built in, not tested in, and that your processes are reproducible, defensible, and designed to protect patients.