Industry
Contract Development & Manufacturing Organisations
Independent GMP audit, quality system assessment and regulatory consulting for CDMOs navigating multi-client quality management, technology transfer and inspection readiness across global regulatory frameworks.
The CDMO Compliance Challenge
CDMOs occupy a complex position in the pharmaceutical supply chain. They are simultaneously suppliers to their pharmaceutical clients, and therefore subject to client qualification and periodic audit, and regulated manufacturers in their own right, subject to inspection by regulatory authorities in all markets where their clients hold marketing authorisations.
The compliance demands on CDMOs are correspondingly complex. They must satisfy the GMP requirements of multiple regulatory authorities, the quality expectations of multiple pharmaceutical clients and the technical demands of multiple products manufactured in the same facility. Quality systems that serve these demands effectively require expertise, resources and consistent management that goes beyond what many CDMO quality teams alone can deliver.
Sthira Assure provides CDMOs with independent assessment of their GMP quality systems, both as a proactive quality management tool and as preparation for the regulatory inspections and client audits that are an inevitable feature of the CDMO business model. We work with CDMOs at all stages of maturity, from early-stage facilities building GMP infrastructure to established contract manufacturers managing complex multi-product portfolios.
Key Frameworks
- EU GMP Chapter 7
- ICH Q10
- FDA 21 CFR 210/211
- ICH Q7 (API)
- GDP Guidelines
- WHO GMP
Discuss Your Requirements
Get in TouchTypical Risk Areas
Multi-Client Quality Management
CDMOs serve multiple pharmaceutical clients simultaneously, each with its own product requirements, quality agreements and regulatory commitments. Managing this complexity without cross-contamination of processes, data or documentation requires robust quality systems that are actively managed, not just documented. Inspectors look for evidence that client-specific requirements are consistently implemented in operational practice.
Technology Transfer Quality
Technology transfer from sponsor to CDMO is a high-risk activity that frequently generates quality problems. Inadequate transfer documentation, incomplete process characterisation from the sponsor and insufficient validation of the transferred process at the CDMO site create product quality risks that manifest during commercial manufacturing operations.
Client Audit Management
CDMOs are subject to audit by multiple pharmaceutical clients, each conducting supplier qualification and periodic reassessment audits. Managing these client audits, ensuring consistent, documented responses and that CAPA commitments are tracked across multiple clients, requires dedicated resources and structured processes that many CDMOs underestimate.
Regulatory Inspection Under Multiple Frameworks
CDMOs that manufacture for clients in multiple markets may be subject to inspection by EMA, MHRA, FDA and other regulatory authorities, potentially in the same year. Maintaining compliance with multiple regulatory frameworks simultaneously requires regulatory expertise that not all CDMO quality teams possess.
Speak with a CDMO Audit Specialist
Contact our team to discuss your CDMO quality system requirements and audit programme.