# Gmp lentivirus production: Lab Standards Requirements

> The Lab Standards Requirements carries 2 published figures read from 4 sources' own pages, from 28 to 30 day, read 15 September 2026.

BioBricks · https://biobricks.org/datasets/lab-standards-requirements/ · computed 2026-09-15

**Median of the published figures:** 29 day (range 28 to 30 day; 2 sources with a figure; 4 of 15 sources read publish one).

4 of the 15 named sources read in full publish a figure; 11 publish none, read 15 September 2026.

## By requirement

| Breakdown | Median | Range | Sources |
|---|---|---|---|
| requirement CLIA certificate renewal window, 42 CFR 493 | 9 month | 9 to 9 month | 1 |
| requirement notification of change, 42 CFR 493 CLIA | 30 day | 30 to 30 day | 1 |
| requirement GLP reserve sample trigger, study duration, 21 CFR 58 | 4 week | 4 to 4 week | 1 |
| requirement reserve sample retention, OTC active ingredient, 21 CFR 211 | 3 year | 3 to 3 year | 1 |
| requirement maximum holding time, bromide, 40 CFR 136 | 28 day | 28 to 28 day | 1 |

## Every figure, with its source

One row per source: the figure the source's own page publishes, the page, and the day it was read.

| Source | Figure | Breakdown | Read |
|---|---|---|---|
| [eCFR](https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493) | 30 day | notification of change, 42 CFR 493 CLIA | 2026-09-12 |
| [eCFR](https://www.ecfr.gov/current/title-40/chapter-I/subchapter-D/part-136) | 28 day | maximum holding time, bromide, 40 CFR 136 | 2026-09-12 |
| [eCFR](https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493) | 9 month | CLIA certificate renewal window, 42 CFR 493 | 2026-09-12 |
| [eCFR](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-58) | 4 week | GLP reserve sample trigger, study duration, 21 CFR 58 | 2026-09-12 |
| [eCFR](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-I) | 3 year | reserve sample retention, OTC active ingredient, 21 CFR 211 | 2026-09-12 |

## The sentence each figure was read from (5)

- [eCFR](https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493), read 2026-09-12: "(2) Agrees to notify HHS or its designee within 30 days of any changes in ownership, name, location, director or technical supervisor (laboratories performing high complexity testing only);"
- [eCFR](https://www.ecfr.gov/current/title-40/chapter-I/subchapter-D/part-136), read 2026-09-12: "Bromide P, FP, G None required 28 days."
- [eCFR](https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493), read 2026-09-12: "(1) Complete the renewal application prescribed by HHS and return it to HHS not less than 9 months nor more than 1 year before the expiration of the certificate; and"
- [eCFR](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-58), read 2026-09-12: "(d) For studies of more than 4 weeks' duration, reserve samples from each batch of test and control articles shall be retained for the period of time provided by § 58.195."
- [eCFR](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-I), read 2026-09-12: "(ii) Six months after the expiration date of the last lot of the drug product containing the active ingredient if the expiration dating period of the drug product is more than 30 days. (3) For an active ingredient in an OTC drug product that is exempt from bearing an expiration date under § 211.137, the reserve sample shall be retained for 3 years after distribution of the last lot of the drug pro"

## Read in full, publishes no figure

- [CMS](https://www.cms.gov/regulations-and-guidance/legislation/clia), read 2026-09-12: read in full and no accepted figure on the page
- [eCFR](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11), read 2026-09-11: read in full and no accepted figure on the page
- [EMA](https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/compliance-research-and-development/good-manufacturing-practice), read 2026-09-12: read in full and no accepted figure on the page
- [European Commission (EudraLex)](https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en), read 2026-09-12: read in full and no accepted figure on the page
- [GOV.UK (MHRA)](https://www.gov.uk/government/publications/guidance-on-gxp-data-integrity), read 2026-09-12: read in full and no accepted figure on the page
- [ISO](https://www.iso.org/standard/66912.html), read 2026-09-12: every candidate on the page was refused
- [ISO](https://www.iso.org/standard/82931.html), read 2026-09-12: read in full and no accepted figure on the page
- [ISO](https://www.iso.org/standard/68347.html), read 2026-09-12: read in full and no accepted figure on the page
- [NIST](https://www.nist.gov/nvlap/nvlap-handbooks), read 2026-09-12: read in full and no accepted figure on the page
- [the regulator per regime](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11), read 2026-09-11: read in full and no accepted figure on the page
- [ecfr.gov](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11), read 2026-09-11: read in full and no accepted figure on the page

## Methodology

Every row is a verbatim sentence read from the named source's own page through the estate's 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). 4 of the 15 named sources that could be read published a usable figure; 11 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 day (a source's median where its page yielded several accepted sentences), so N counts sources, never sentences; 31 candidate sentence(s) were refused by a reviewer with the reason recorded. Derivation as chartered: one row per requirement per regime, quoted verbatim from the authority with its effective date and edition: what an electronic record must carry (21 CFR Part 11), what the QC laboratory must retain and for how long (21 CFR 211 subpart I), what a CLIA laboratory must demonstrate (42 CFR 493), the ISO 17025 and ISO 8655 clause numbers and their current editions, and the EPA method a given analyte must be run by (40 CFR 136); the cross-regime comparison - what the FDA, the MHRA and the EU each demand of the same audit trail - is the figure

## Sources

- [CMS](https://www.cms.gov/regulations-and-guidance/legislation/clia) (the publisher's own terms; quoted for reporting and comment)
- [eCFR](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-I) (the publisher's own terms; quoted for reporting and comment)
- [eCFR](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11) (the publisher's own terms; quoted for reporting and comment)
- [eCFR](https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493) (the publisher's own terms; quoted for reporting and comment)
- [eCFR](https://www.ecfr.gov/current/title-40/chapter-I/subchapter-D/part-136) (the publisher's own terms; quoted for reporting and comment)
- [eCFR](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-58) (the publisher's own terms; quoted for reporting and comment)
- [EMA](https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/compliance-research-and-development/good-manufacturing-practice) (the publisher's own terms; quoted for reporting and comment)
- [European Commission (EudraLex)](https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en) (the publisher's own terms; quoted for reporting and comment)
- [GOV.UK (MHRA)](https://www.gov.uk/government/publications/guidance-on-gxp-data-integrity) (the publisher's own terms; quoted for reporting and comment)
- [ISO](https://www.iso.org/standard/66912.html) (the publisher's own terms; quoted for reporting and comment)
- [ISO](https://www.iso.org/standard/82931.html) (the publisher's own terms; quoted for reporting and comment)
- [ISO](https://www.iso.org/standard/68347.html) (the publisher's own terms; quoted for reporting and comment)
- [NIST](https://www.nist.gov/nvlap/nvlap-handbooks) (the publisher's own terms; quoted for reporting and comment)
- [the regulator per regime](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11) (the publisher's own terms; quoted for reporting and comment)
- [ecfr.gov](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11) (the publisher's own terms; quoted for reporting and comment)

## Cite or embed

- The Lab Standards Requirements carries 2 published figures read from 4 sources' own pages, from 28 to 30 day, read 15 September 2026.
- 4 of the 15 named sources read in full publish a figure; 11 publish none, read 15 September 2026.
- Lab Standards Requirements, requirement CLIA certificate renewal window, 42 CFR 493: median 9 month across 1 source, read 15 September 2026.
- Lab Standards Requirements, requirement notification of change, 42 CFR 493 CLIA: median 30 day across 1 source, read 15 September 2026.
- Lab Standards Requirements, requirement GLP reserve sample trigger, study duration, 21 CFR 58: median 4 week across 1 source, read 15 September 2026.
- Lab Standards Requirements, requirement reserve sample retention, OTC active ingredient, 21 CFR 211: median 3 year across 1 source, read 15 September 2026.
- Lab Standards Requirements, requirement maximum holding time, bromide, 40 CFR 136: median 28 day across 1 source, read 15 September 2026.

Cite as: "BioBricks Lab Standards Requirements", updated 2026-09-15, https://biobricks.org/datasets/lab-standards-requirements/.

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