Inspection Readiness
BioTechLogic has experience managing global Inspection Readiness efforts. Our experience allows us to perform risk evaluations based on the current regulatory environment, and focus your resources more effectively. BioTechLogic can develop readiness plans for the sites, as well as provide assistance in completing the remediation activities.
Based on the level of product support and inspection history, BioTechLogic can prepare risk reduction plans for both FDA and EMEA inspections. During the remediation phase, we will communicate overall inspection readiness progress, as well as constraints identified at individual sites.
BioTechLogic has managed inspection readiness at numerous supply chain locations, including drug substance facilities, drug product facilities, and analytical labs. Our team has prepared the following documentation for inspection readiness:
- Inspection Readiness Strategies
- Team Role Responsibility and Organization
- PAI Readiness Process Map
- Site Approval Master Plans
- Risk Ranking Tools
- US and EMEA Inspection Program Overview
The team at BioTechLogic has presented to global inspection authorities for multiple technologies and processes. Our familiarity with the regulatory environment and systematic approach to readiness resulted in successful PAI audits for a PEGylated protein and oligonucleotide manufacturing process, as well as an MAA inspection for a PEGylated protein process. BioTechLogic has given presentations and shared case studies on Inspection Readiness at industry conferences.