Format is a basic identification field. It affects the questions a product record must answer, but format alone does not establish intended use, suitability or performance.
Pre-filled pen records
A clear record should identify the device presentation, confirmed stated quantity or concentration, storage information, batch reference and any device-specific source documentation.
Nasal spray records
A clear record should identify the spray presentation, confirmed stated quantity or concentration, container information only where verified, storage information and batch reference.
Compare like with like
Do not convert or compare quantities across formats without appropriate source information. Keep the record tied to the presentation supplied.
Browse the draft format indexes for pre-filled pens and nasal sprays.
Related reading
- How to Read a Product Specification
- Why Batch Information and Traceability Matter
- What Quality Documentation Should Look Like
Responsible information: This article is general educational material about product records and documentation. It is not medical advice and does not establish the specification, suitability, regulatory status or intended use of any individual product.