PROBLEM STATEMENT
Client: A renowned large consulting company (client) needed a Principal consultant to get a virtual company ready for Pre-approval inspection (PAI). The virtual company was manufacturing ophthalmic API and Drug products and was getting ready for an FDA Pre-Approval inspection. The client needed to get the virtual company and their contracted facilities ready for Pre-Approval Inspection.
EXPERTISE AND SOLUTIONS
The client company hired one of the principal consultants from PJI Biotech to lead/support the project. The project started with developing the PAI readiness plan for about 15 manufacturing CDMOs (API and Drug Products), contract testing labs, and Storage facilities within the United States.
The first workstream was to conduct a risk assessment of all the contracted sites. Based on the risk assessment, high-risk sites were identified. All the high-risk contract sites went through detailed assessment and remediation over the period of about 2 months for PAI readiness. Gap assessment reports were developed for each site and remediation plans were developed for each site. All the remediations were completed by contracted facilities for the next few months to make the virtual company ready for Pre-Approval Inspection and verification.
Another workstream was started in parallel with a small team to conduct a gap assessment for the Virtual company that was the sponsor for the product for existing quality systems, data, records, and procedures. In addition, a gap assessment was conducted for conformance to filing and data integrity. A remediation plan was developed, and remediation was completed.
After the completion of the PAI readiness effort, a mock PAI audit was conducted to ensure that remediation was effective, and no additional gaps were identified.
RESULTS AND FEEDBACK
As a result, the client was able to get all the contracted facilities ready for inspection within 6-8 months. The client firm was very happy with the support provided, dedication, flexibility, and meeting of their objectives.