SOP Gap Analyser

Built from primary regulatory sources. Gap analysis reflects current FDA inspection expectations, EU GMP requirements, USP chapters and ICH guidelines. All findings should be reviewed by a qualified regulatory professional before implementing changes.

Step 1 - Select the regulatory standard

Regulatory standard to analyse against *

SOP title or reference *

Site and product type (optional - improves analysis)

Step 2 - Provide your SOP content

Upload SOP file (PDF, Word or text) *

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Click to upload or drag and drop

PDF, Word (.docx) or plain text - up to 10MB

or paste SOP text directly

SOP text content

Analysis takes 15 to 30 seconds depending on SOP length.

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Analysing your SOP

Reading SOP content against regulatory requirements

SOP Gap Analysis

Analysis summary

This gap analysis is a starting framework based on current regulatory requirements and FDA inspection data. All recommended changes should be reviewed by a qualified regulatory professional before implementation. Always verify against the current published version of the cited regulation or guidance.

GMPify courses covering this regulation

Full catalog access from day one. Every course built from primary regulatory sources. Certificate on completion of every course.