Introduction: What Is Batch Review and Why It Matters
Every batch tells a story — about quality, compliance, and patient safety. Batch Review is the critical process of examining production, quality control, and environmental records to confirm that every product is manufactured to the highest standards. It ensures deviations are investigated and resolved, while maintaining regulatory and data integrity compliance.
For commercial products, Batch Review is a legal requirement before Qualified Person (QP) certification in Europe. For investigational materials, it guarantees adherence to the Investigational Medicinal Product Dossier (IMPD). Beyond compliance, a robust Batch Review strengthens regulatory submissions, accelerates scale-up, reduces agency queries, and sets the foundation for commercially viable specifications.
What Arithmos’ Batch Review Service Covers
Our Batch Review goes beyond a box-ticking exercise, covering:
- Batch Production Records (BPR) Review – Verification of process documentation and adherence to SOPs.
- Laboratory Control Records (LCR) – Evaluation of test results for stability, purity, and potency.
- Deviation and Non-Conformance Review – Ensuring investigations are thorough and corrective actions are implemented.
- Equipment Calibration and Maintenance – Confirmation of equipment compliance and data integrity.
- Final Product Release Documentation – Validation reports, certificates, and COAs are verified and complete.
- Environmental Monitoring Checks – Verification that cleanroom and facility standards are consistently met.
Two Layers of Expertise
Arithmos Batch Reviewers bring extensive industry experience spanning early clinical phases to commercial products across multiple dosage forms. They combine technical and quality expertise to deliver a comprehensive review:
- Technical Review – Ensuring compliance with product licences or IMPDs, and validating specifications, analytical methods, and equipment suitability.
- Quality Review – Providing holistic product assurance, GMP compliance, CAPA tracking, and readiness for regulatory inspections.
Why Choose Arithmos? The Value of Experienced Reviewers
With Arithmos, you gain more than compliance — you gain a partner in quality and business continuity.
- From a Quality Perspective – Deep regulatory knowledge (GMP, ICH, etc.), proactive risk detection, and trend analysis.
- From a Business Perspective – Minimized recalls and delays, streamlined batch release, and greater regulatory peace of mind.
- Reputation Protection – Audit readiness, reduced risk of non-compliance, and strengthened stakeholder trust.
Continuous Improvement: More Than Just a Compliance Step
Batch Review isn’t just a regulatory hurdle — it’s a driver of operational excellence. By identifying inefficiencies, refining SOPs, and improving consistency, Arithmos helps clients achieve long-term quality, resilience, and competitive advantage.
Who Is This Service For?
Arithmos’ Batch Review Service is tailored for:
- Small to mid-size pharmaceutical and biotech companies
- CDMOs needing external review expertise
- QA teams facing resource or skill constraints
