Problem Statement
Client 1: One of the sites of a large Pharma company producing ophthalmic products (solutions and suspensions) was getting ready for Health Canada Pre-Approval Inspection (PAI) and hired a consulting company to prepare for PAI.
Client 2: One of the sites of a mid-size Biologics company producing monoclonal antibodies was getting ready for EMEA Pre-Approval Inspection (PAI) and hired a consulting company to prepare for PAi.
Client 3: One of the sites of a large Pharma company producing pharmaceutical products was getting ready for FDA pre-approval inspection (PAI) and hired a consulting company to prepare for PAI.
Expertise And Solutions
The consulting company hired a principal consultant from PJi Biotech to lead/prepare the site for Pre-approval inspection (PAI). We prepared a team of 4 experts to get the site ready for PAI. First, the team conducted a gap assessment of the site for readiness for manufacturing. The first few weeks were spent conducting facility and lab tours, observing testing practices, observing aseptic practices and techniques on the manufacturing floor, and reviewing process and facility EM data. Based on the first assessment, the gaps were shared with site management, and high-risk areas were identified. The next several weeks were spent on risk mitigation and staff training. The site staff worked with us to remediate the gaps and the site staff was trained in inspection preparedness and presentation skills during facility and lab tours. Site staff was also trained 1:1 basis on the presentation of documents, studies, and data during the readiness process. Simultaneously, we reviewed relevant data and reports for the completeness and adequacy of studies. The PAI readiness was completed within 3 months.
Results And Feedback
As a result, the client was able to get the product approval. The client firm was very happy with the support provided by the team to train staff and get the facility ready for inspection.