Standards hub
The standards behind a P&ID.
A P&ID answers to more than one rulebook. Two standards govern the drawing itself: ISA-5.1 for the instrument symbols and tags, and ISO 10628 for how a PFD or P&ID is classified and how its equipment is drawn. Two more come up only when the software used to draw it is evaluated: where a P&ID drawing tool sits under GAMP, and whether a P&ID is a 21 CFR Part 11 record. This hub is a working reference to all four, taken a page at a time, and the symbols on the reference pages are drawn in PharmaDiagrams.
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- ISA-5.1Identification letters, tag formats and loop numbering for the P&IDs your QA will review, per ANSI/ISA-5.1-2024.Read the page →
- ISO 10628Diagram classification and equipment symbols for PFDs and P&IDs, and how the standard combines with ISA-5.1 in European practice.Read the page →
- GAMP Category 1How much you have to validate a P&ID drawing tool, and why the honest answer is: very little.Read the page →
- 21 CFR Part 11Are P&IDs Part 11 records? The authoring-tool versus system-of-record split, and how to document it for your QMS.Read the page →
Each page shows the date its regulatory facts were last verified.