GUIDANCE
Manufacturing and technology transfer
Quality oversight should address process transfer, scale-up, manufacturing readiness and documentation across sites and partners.
LH QUALITY CONSULTING RESOURCE
CMC Quality Consulting for Pharmaceutical & Biotech Sponsors
CMC quality sits at the intersection of development, manufacturing, analytical operations and regulatory expectations. Sponsors need quality oversight that remains practical as programs move toward commercialization.
GUIDANCE
Validation and qualification
Validation strategy, protocols, reports and lifecycle management should be appropriate to the process, product and stage of development.
GUIDANCE
Quality agreements
Clear responsibilities between sponsors, CDMOs and other partners help prevent gaps in investigation, change notification, release and regulatory support.
GUIDANCE
Batch disposition and release
Quality decisions should be supported by complete records, appropriate review and clearly defined responsibilities.
GUIDANCE
Supplier and contract-manufacturer oversight
Risk-based audits, performance monitoring and change management help sponsors maintain visibility over outsourced activities.
GUIDANCE
Commercial readiness
As programs mature, quality systems and manufacturing controls need to support commercial operations, regulatory commitments and inspection readiness.
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