The leading authority on CMC and regulatory consulting for biologics, cell, and gene therapies.
To ensure a successful regulatory inspection, a risk evaluation and inspection readiness plan should be prepared well in advance of the inspection window.
The evaluation is designed to determine the high-risk locations in the supply chain. The readiness plan is then developed to drive resource allocation, rank critical action items according to risk, and to define the remediation plans. The team at BioTechLogic has the expertise to help clients achieve these tasks.
The risk evaluation is performed on each of the supply chain entities. For example: sponsor, API manufacturer, DP manufacturer, analytical lab, raw material suppliers, and packaging locations. Risk is calculated by the following combined factors:
- Probability of being inspected
- Number of outstanding critical action items (severity based on process impact)
- Ability to manage a favorable inspection
This exercise will consider the site’s regulatory history, product support history (development, manufacturing, stability, and analytical method development), performance history (nature of deviations/investigations), and outstanding audit items.
The readiness plan is then created based on the target inspection readiness date, the outcome of the site risk evaluation, and the resources allocated to complete the readiness effort. Site teams manage the remediation activities on the readiness plan, as well as communicate progress and constraints. The overall readiness for an inspection is then tracked based on the readiness date and site progress.
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 also develop readiness plans for the sites, as well as provide assistance in completing the remediation activities.
Examples of our Inspection Readiness Services:
- Multiproduct Facility Inspection Audits
- Pre and Post Viral Inactivation Controls Audits
- Commercialization and Submission Readiness
- Global Pre-Approval Inspection (PAI) Readiness Program
- Mock PAI-Inspections
- Site Approval Master Plans
- Audit Observation and Corrective Action Risk Ranking Strategies
- Corrective Action, Prioritization and Remediation Strategies
- Project Plans and Schedules