{ "name": "RunbookDesk Sop Regulatory Requirements", "title": "Sop Regulatory Requirements", "url": "https://runbookdesk.com/datasets/sop-regulatory-requirements/", "csv": "https://runbookdesk.com/datasets/sop-regulatory-requirements.csv", "markdown": "https://runbookdesk.com/datasets/sop-regulatory-requirements/index.md", "computed_at": "2026-10-05", "license": "https://runbookdesk.com/terms", "headline": "The Sop Regulatory Requirements carries 2 published figures read from 2 sources' own pages, from 2 to 2 year, read 26 September 2026.", "quotes": [ "The Sop Regulatory Requirements carries 2 published figures read from 2 sources' own pages, from 2 to 2 year, read 26 September 2026.", "2 of the 23 named sources read in full publish a figure; 21 publish none, read 26 September 2026." ], "citation": "\"RunbookDesk Sop Regulatory Requirements\", updated 2026-10-05, https://runbookdesk.com/datasets/sop-regulatory-requirements/.", "changed_since": null, "national": { "unit": "year", "n": 1, "median": 2, "min": 2, "max": 2, "p25": 2, "p75": 2, "mean": 2, "units": { "day": 1, "hour": 1, "month": 1, "year": 1 }, "published_sources": 2, "named_sources": 23, "read_sources": 23, "not_published": 21, "published_share": 0.087 }, "by_axis": {}, "rows": [ { "source": "eCFR 21 CFR Part 117 - Preventive Controls for Human Food", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-117", "figure": "2 years", "value": 2, "unit": "year", "vat": null, "axis": {}, "retrieved_at": "2026-09-26", "quote": "(C) By July 31 of the applicable calendar year, when the status of a facility changes from “not a qualified facility” to “qualified facility” based on the annual determination required by paragraph (c)(1) of this section; and (ii) Beginning in 2020, submitted to FDA every 2 years during the period beginning on October 1 and ending on December 31.", "source_class": "primary-government", "text_sha256": "ffe916377b6160d840a1b80c171e48e68e49185ac2c2eb0c57647894e4c426a8" }, { "source": "eCFR 21 CFR Part 117 - Preventive Controls for Human Food", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-117", "figure": "2 years", "value": 2, "unit": "year", "vat": null, "axis": {}, "retrieved_at": "2026-09-26", "quote": "(ii) On an annual basis thereafter, by December 31 of each calendar year, for the following calendar year; and (2) Obtains written assurance, at least every 2 years, that the supplier is producing the raw material or other ingredient in compliance with applicable FDA food safety regulations (or, when applicable, relevant laws and regulations of a country whose food safety system FDA has officially", "source_class": "primary-government", "text_sha256": "ffe916377b6160d840a1b80c171e48e68e49185ac2c2eb0c57647894e4c426a8" }, { "source": "Health Canada, Good manufacturing practices guide for drug products (GUI-0001)", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/gmp-guidelines-0001/document.html", "figure": "30 days", "value": 30, "unit": "day", "vat": null, "axis": {}, "retrieved_at": "2026-09-26", "quote": "A batch of raw material can be re-tested and used immediately (within 30 days) after the re-test, as long as it continues to comply with the current specifications.", "source_class": "primary-government", "text_sha256": "3c340af19926bd8cca955936765e85b700f13e18fdce1d8739a78402a6cce878" }, { "source": "Health Canada, Good manufacturing practices guide for drug products (GUI-0001)", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/gmp-guidelines-0001/document.html", "figure": "24 hours", "value": 24, "unit": "hour", "vat": null, "axis": {}, "retrieved_at": "2026-09-26", "quote": "It is expected that Establishment Licence holders provide Health Canada any relevant and important information brought to its attention from any foreign regulatory authority within 24 hours of receiving the information.", "source_class": "primary-government", "text_sha256": "3c340af19926bd8cca955936765e85b700f13e18fdce1d8739a78402a6cce878" }, { "source": "Health Canada, Good manufacturing practices guide for drug products (GUI-0001)", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/gmp-guidelines-0001/document.html", "figure": "30 days", "value": 30, "unit": "day", "vat": null, "axis": {}, "retrieved_at": "2026-09-26", "quote": "If the packager/labeller, distributor or importer receives a lot or batch of a drug on their premises in Canada the useful life of which is more than 30 days, the lot or batch shall be tested for identity and the packager/labeller shall confirm the identity after the lot or batch is packaged/labelled.", "source_class": "primary-government", "text_sha256": "3c340af19926bd8cca955936765e85b700f13e18fdce1d8739a78402a6cce878" }, { "source": "Health Canada, Good manufacturing practices guide for drug products (GUI-0001)", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/gmp-guidelines-0001/document.html", "figure": "24 months", "value": 24, "unit": "month", "vat": null, "axis": {}, "retrieved_at": "2026-09-26", "quote": "In the scenario presented above, any extrapolation of the expiry date beyond 24 months should be based on stability data, both at long-term and accelerated storage conditions. If the test results are satisfactory, the retest period can be extended to a period not exceeding 36 months.", "source_class": "primary-government", "text_sha256": "3c340af19926bd8cca955936765e85b700f13e18fdce1d8739a78402a6cce878" } ], "not_published": [ { "source": "eCFR 21 CFR 211.100 - Written procedures; deviations", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-F/section-211.100", "retrieved_at": "2026-09-26", "reason": "read in full and no accepted figure on the page" }, { "source": "eCFR 21 CFR Part 211 Subpart F - Production and Process Controls", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-F", "retrieved_at": "2026-09-26", "reason": "read in full and no accepted figure on the page" }, { "source": "eCFR 21 CFR 58.81 - Standard operating procedures (GLP)", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-58/subpart-E/section-58.81", "retrieved_at": "2026-09-26", "reason": "read in full and no accepted figure on the page" }, { "source": "eCFR 42 CFR 493.1251 - Standard: Procedure manual (CLIA)", "url": "https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493/subpart-K/subject-group-ECFRc96daead380f6ed/section-493.1251", "retrieved_at": "2026-09-26", "reason": "read in full and no accepted figure on the page" }, { "source": "eCFR 9 CFR Part 416 - Sanitation (SSOP)", "url": "https://www.ecfr.gov/current/title-9/chapter-III/subchapter-E/part-416", "retrieved_at": "2026-09-26", "reason": "read in full and no accepted figure on the page" }, { "source": "eCFR 21 CFR Part 820 - Quality Management System Regulation", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820", "retrieved_at": "2026-09-26", "reason": "read in full and no accepted figure on the page" }, { "source": "eCFR 21 CFR Part 11 - Electronic Records; Electronic Signatures", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11", "retrieved_at": "2026-09-26", "reason": "read in full and no accepted figure on the page" }, { "source": "eCFR 40 CFR 68.69 - Operating procedures (EPA Risk Management Program)", "url": "https://www.ecfr.gov/current/title-40/chapter-I/subchapter-C/part-68/subpart-D/section-68.69", "retrieved_at": "2026-09-26", "reason": "read in full and no accepted figure on the page" }, { "source": "OSHA 29 CFR 1910.119 - Process safety management", "url": "https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.119", "retrieved_at": "2026-09-18", "reason": "read in full and no accepted figure on the page" }, { "source": "OSHA 1910.119 Appendix C - compliance guidelines", "url": "https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.119AppC", "retrieved_at": "2026-09-12", "reason": "read in full and no accepted figure on the page" }, { "source": "eCFR 29 CFR 1910.119 (eCFR rendering)", "url": "https://www.ecfr.gov/current/title-29/subtitle-B/chapter-XVII/part-1910/subpart-H/section-1910.119", "retrieved_at": "2026-09-25", "reason": "every candidate on the page was refused" }, { "source": "eCFR 14 CFR 121.133 - Preparation of manual (air carrier)", "url": "https://www.ecfr.gov/current/title-14/chapter-I/subchapter-G/part-121/subpart-G/section-121.133", "retrieved_at": "2026-09-26", "reason": "read in full and no accepted figure on the page" }, { "source": "US EPA guidance for preparing SOPs", "url": "https://www.epa.gov/quality/guidance-preparing-standard-operating-procedures", "retrieved_at": "2026-09-12", "reason": "read in full and no accepted figure on the page" }, { "source": "GOV.UK - medicines: good manufacturing practice and good distribution practice (MHRA)", "url": "https://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practice", "retrieved_at": "2026-09-12", "reason": "read in full and no accepted figure on the page" }, { "source": "Management of Health and Safety at Work Regulations 1999, reg. 5 (legislation.gov.uk)", "url": "https://www.legislation.gov.uk/uksi/1999/3242/regulation/5/made", "retrieved_at": "2026-09-12", "reason": "read in full and no accepted figure on the page" }, { "source": "European Commission, EudraLex Volume 4 GMP guidelines", "url": "https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4-good-manufacturing-practice-gmp-guidelines_en", "retrieved_at": "2026-09-26", "reason": "read in full and no accepted figure on the page" }, { "source": "TGA - complying with the PIC/S Guide to GMP for medicinal products", "url": "https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medicine/good-manufacturing-practice-gmp/complying-pics-guide-good-manufacturing-practice-gmp-medicinal-products", "retrieved_at": "2026-09-12", "reason": "read in full and no accepted figure on the page" }, { "source": "ISO 9001:2015 catalogue record", "url": "https://www.iso.org/standard/62085.html", "retrieved_at": "2026-09-26", "reason": "read in full and no accepted figure on the page" }, { "source": "ISO 13485:2016 catalogue record", "url": "https://www.iso.org/standard/59752.html", "retrieved_at": "2026-09-26", "reason": "read in full and no accepted figure on the page" }, { "source": "FDA, Quality Systems Approach to Pharmaceutical CGMP Regulations", "url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quality-systems-approach-pharmaceutical-current-good-manufacturing-practice-regulations", "retrieved_at": "2026-09-19", "reason": "read in full and no accepted figure on the page" }, { "source": "the authority per regime", "url": "https://www.ecfr.gov/current/title-21", "retrieved_at": "2026-09-26", "reason": "read in full and no accepted figure on the page" } ], "sources": [ { "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-F/section-211.100", "label": "eCFR 21 CFR 211.100 - Written procedures; deviations", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-F", "label": "eCFR 21 CFR Part 211 Subpart F - Production and Process Controls", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-58/subpart-E/section-58.81", "label": "eCFR 21 CFR 58.81 - Standard operating procedures (GLP)", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493/subpart-K/subject-group-ECFRc96daead380f6ed/section-493.1251", "label": "eCFR 42 CFR 493.1251 - Standard: Procedure manual (CLIA)", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://www.ecfr.gov/current/title-9/chapter-III/subchapter-E/part-416", "label": "eCFR 9 CFR Part 416 - Sanitation (SSOP)", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820", "label": "eCFR 21 CFR Part 820 - Quality Management System Regulation", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11", "label": "eCFR 21 CFR Part 11 - Electronic Records; Electronic Signatures", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-117", "label": "eCFR 21 CFR Part 117 - Preventive Controls for Human Food", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://www.ecfr.gov/current/title-40/chapter-I/subchapter-C/part-68/subpart-D/section-68.69", "label": "eCFR 40 CFR 68.69 - Operating procedures (EPA Risk Management Program)", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.119", "label": "OSHA 29 CFR 1910.119 - Process safety management", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.119AppC", "label": "OSHA 1910.119 Appendix C - compliance guidelines", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://www.ecfr.gov/current/title-29/subtitle-B/chapter-XVII/part-1910/subpart-H/section-1910.119", "label": "eCFR 29 CFR 1910.119 (eCFR rendering)", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://www.ecfr.gov/current/title-14/chapter-I/subchapter-G/part-121/subpart-G/section-121.133", "label": "eCFR 14 CFR 121.133 - Preparation of manual (air carrier)", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://www.epa.gov/quality/guidance-preparing-standard-operating-procedures", "label": "US EPA guidance for preparing SOPs", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practice", "label": "GOV.UK - medicines: good manufacturing practice and good distribution practice (MHRA)", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://www.legislation.gov.uk/uksi/1999/3242/regulation/5/made", "label": "Management of Health and Safety at Work Regulations 1999, reg. 5 (legislation.gov.uk)", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4-good-manufacturing-practice-gmp-guidelines_en", "label": "European Commission, EudraLex Volume 4 GMP guidelines", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/gmp-guidelines-0001/document.html", "label": "Health Canada, Good manufacturing practices guide for drug products (GUI-0001)", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medicine/good-manufacturing-practice-gmp/complying-pics-guide-good-manufacturing-practice-gmp-medicinal-products", "label": "TGA - complying with the PIC/S Guide to GMP for medicinal products", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://www.iso.org/standard/62085.html", "label": "ISO 9001:2015 catalogue record", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://www.iso.org/standard/59752.html", "label": "ISO 13485:2016 catalogue record", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quality-systems-approach-pharmaceutical-current-good-manufacturing-practice-regulations", "label": "FDA, Quality Systems Approach to Pharmaceutical CGMP Regulations", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://www.ecfr.gov/current/title-21", "label": "the authority per regime", "license": "the publisher's own terms; quoted for reporting and comment" } ], "methodology": "Every row is a verbatim sentence read from the named source's own page through our fetch service on the date shown, hash-pinned to the stored read (the sha of the page's visible text; the raw page is mirrored to R2). 2 of the 23 named sources that could be read published a usable figure; 21 published none and are recorded as not published, never filled in; 0 could not be read (blocked, dead or unreachable) and count nowhere. The headline figures (median, minimum, maximum, quartiles) are over ONE figure per source in year (a source's median where its page yielded several accepted sentences), so N counts sources, never sentences; 15 candidate sentence(s) were refused by a reviewer with the reason recorded. The fuller derivation this dataset is chartered to grow into (not yet what the figures above are; they are each source's own published figure as read): one row per regime per obligation, quoted verbatim from the authority with its citation and effective date: who must have a written procedure, what the procedure must contain, who approves it, the review cadence the rule names (21 CFR 211.100 'reviewed and approved by the quality control unit'; 1910.119(f) 'certify annually that these operating procedures are current and accurate'), what must happen on a deviation, and the retention period. The derivation is the CROSS-REGIME comparison nobody publishes - which regimes name a review cadence at all, which require a historical file of superseded versions, which oblige a signature - plus changed-since on each read.", "embed": "

2 to 2 year

1 published figures, Sop Regulatory Requirements, across 2 sources, read 26 September 2026

Source: RunbookDesk Sop Regulatory Requirements
" }