Processing a registration can involve preparation of different documents from different sources. To start with, generally site documents are easier to complete. Internally, we refer to Site Documents as documents that are related to the overall registration, and can be related to a specific Vendor but not product. Based on the type of documents, there are a few examples:
Administrative documents
• Application form for a site registration
• Documents that establish the relationship between Customer/AdvaCare/Vendor
• Authorization Letters
• Letter of invitation for inspections
Quality Certifications
• GMP of a pharmaceutical production line
• CE/ISO of a range of medical devices
Technical Documents
• Site Master File of a pharmaceutical manufacturing site
These documents do not normally take a long process to gather as they should be either:
• Can be prepared in-house by BD Salesperson/RA Specialist
• Certificates Vendors already have
• Certificates Vendors will obtain within a known period of time
For each registration that is handled by an RA Specialist, Site Documents are tracked under each Registration Agreement (RA) page of a Registration SO in the system. This SOP will list the steps of how to gather these documents as well as how to update the registration status for other departments reference.