GMP Batch Review as a
Service

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Structured GMP batch record review and release support to improve right-first-time, reduce cycle time, and strengthen inspection readiness.

TDP’s GMP Batch Review as a Service provides independent, compliant, and scalable batch record review and release support for regulated manufacturing operations. The service is designed to ensure consistent, timely batch disposition while relieving internal quality teams from resource constraints, workload peaks, and operational bottlenecks. 

Delivered by experienced GMP quality professionals, the service applies structured, risk-based review methodologies aligned with EU, UK, and global regulatory expectations. Each batch review is conducted with a strong focus on accuracy, data integrity, and regulatory defensibility, ensuring that batch release decisions meet both internal quality standards and external inspection requirements. Optionally we can also deploy proprietary Human in the loop batch review. Further to continued partnerships.

BEST FOR

Manufacturers needing extra capacity for batch record review

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Teams dealing with backlog, deviations, or recurring documentation issues

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Organisations preparing for inspection or expanding production

WHAT’S INCLUDED

GMP batch record review support (paper or electronic records)

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Identification of errors, trends, and recurring failure points

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Deviation support and documentation improvement recommendations

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Release-readiness checks and escalation of critical risks

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Practical actions to reduce repeat observations and rework

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Reporting: what was reviewed, what was found, what to fix

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Optional “right-first-time” improvement actions (templates/checklists)

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HOW IT WORKS

Confirm product/process context and review standards

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Agree review approach (sampling vs full review, timelines)

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Delivery of review + findings + actions

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Optional improvement support to prevent recurrence

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