BioBricks
Get a shortlist

Gmp lentivirus production: Lab Standards Requirements

The Lab Standards Requirements carries 42 published figures read from 2 sources' own pages, from 3 to 90 day, read 24 October 2026.

3 to 90 day Range of the published figures 42 published figures, not one market: read the rows
42 Published figures from 2 source pages, read 27 Oct 2026
4 of 13 Sources read that publish one 31% publish a figure at all
  1. eCFR90 day
  2. eCFR60 day
  3. eCFR60 day
  4. eCFR60 day
  5. eCFR60 day
  6. eCFR60 day
  7. eCFR60 day
  8. eCFR60 day
  9. eCFR60 day
  10. eCFR45 day
  11. eCFR45 day
  12. eCFR40 day
Every published figure, highest first; the top 12 of 93.
Table view
RowValue
eCFR90 day
eCFR60 day
eCFR60 day
eCFR60 day
eCFR60 day
eCFR60 day
eCFR60 day
eCFR60 day
eCFR60 day
eCFR45 day
eCFR45 day
eCFR40 day
  1. 73 to 18
  2. 1518 to 32
  3. 1132 to 47
  4. 847 to 61
  5. 61 to 76
  6. 176 to 90
Where the 42 published figures fall, day, in six equal bands from the lowest to the highest.
Bands
BucketValue
3 to 187 figures
18 to 3215 figures
32 to 4711 figures
47 to 618 figures
61 to 760 figures
76 to 901 figure

4 of the 13 named sources read in full publish a figure; 9 publish none, read 24 October 2026.

By requirement

BreakdownMedianRangeSources
requirementCLIA certificate renewal window, 42 CFR 4939month9 to 9month1
requirementnotification of change, 42 CFR 493 CLIA30day30 to 30day1
requirementGLP reserve sample trigger, study duration, 21 CFR 584week4 to 4week1
requirementreserve sample retention, active ingredient, expiry dating 30 days or less, 21 CFR 2113month3 to 3month1
requirementreserve sample retention, active ingredient, expiry dating more than 30 days, 21 CFR 2116month6 to 6month1
requirementreserve sample retention, OTC active ingredient, 21 CFR 2113year3 to 3year1
requirementreserve sample retention, drug product, expiry dating 30 days or less, 21 CFR 2113month3 to 3month1
requirementreserve sample retention, drug product, expiry dating more than 30 days, 21 CFR 2116month6 to 6month1
requirementmaximum holding time, bromide, 40 CFR 13628day28 to 28day1
requirementdoctoral degree definition, minimum graduate study, 42 CFR 4933year3 to 3year1
requirementreferee laboratory, minimum satisfactory PT record, 42 CFR 4931year1 to 1year1
requirementvalidation review period, 42 CFR 4931year1 to 1year1
requirementcertificate of waiver validity, 42 CFR 4932year2 to 2year1
requirementregistration certificate validity, certificate of compliance applicants, 42 CFR 4932year2 to 2year1
requirementcertificate for PPM procedures validity, 42 CFR 4932year2 to 2year1
requirementcertificate of compliance validity, 42 CFR 4932year2 to 2year1
requirementhearing request window after sanction notice, 42 CFR 49360day60 to 60day1
requirementnotification of change, accreditation applicants, 42 CFR 493 CLIA30day30 to 30day1
requirementregistration certificate validity, accreditation applicants, 42 CFR 4932year2 to 2year1
requirementcertificate of accreditation validity, 42 CFR 4932year2 to 2year1
requirementnotification of change to HHS and accreditation program, 42 CFR 49330day30 to 30day1
requirementrelease of PT-failure action notice to CMS, 42 CFR 49330day30 to 30day1
requirementcertificate retention after accreditation withdrawal, 42 CFR 49345day45 to 45day1
requirementmaximum term of CMS approval, accreditation organization/State program, 42 CFR 4936year6 to 6year1
requirementaccreditation organization notice to CMS of laboratory actions, 42 CFR 49330day30 to 30day1
requirementnotice to CMS of immediate-jeopardy deficiency, 42 CFR 49310day10 to 10day1
requirementnotice to laboratories of withdrawn deeming authority, 42 CFR 49310day10 to 10day1
requirementnotice to CMS of condition-level deficiency, 42 CFR 49310day10 to 10day1
requirementelectronic PT adverse-action data to CMS, 42 CFR 49330day30 to 30day1
requirementadvance notice to CMS of requirement changes, 42 CFR 49330day30 to 30day1

Every figure, with its source

One row per published figure: the figure as the source's own page publishes it, the page, and the day it was read. A figure that is not on a page we read is not on this one.

SourceFigureBreakdownRead
eCFR99%detection limit confidence level, 40 CFR 1362026-10-24
eCFR99%method detection limit confidence level, 40 CFR 1362026-10-24
eCFR90%gynecologic cytology PT pass score, 10-slide set, 42 CFR 4932026-10-24
eCFR90%gynecologic cytology PT pass score after second failure, 20-slide set, 42 CFR 4932026-10-24
eCFR90daymaximum holding time, total or dissolved trace level mercury, 40 CFR 1362026-10-24
eCFR60dayhearing request window after sanction notice, 42 CFR 4932026-10-24
eCFR60dayreconsideration request window after denial, 42 CFR 4932026-10-24
eCFR60dayCMS final determination after probation, 42 CFR 4932026-10-24
eCFR60daycertificate of accreditation continuation after deeming withdrawal, 42 CFR 4932026-10-24
eCFR60dayexempt status continuation after State program withdrawal, 42 CFR 4932026-10-24
eCFR60dayextension of continuation period, 42 CFR 4932026-10-24
eCFR60dayPT program reporting of lab scores, 42 CFR 4932026-10-24
eCFR60dayPT program approval continuation after withdrawal notice, 42 CFR 4932026-10-24
eCFR48hourmaximum holding time, orthophosphate analysis, 40 CFR 1362026-10-24
eCFR48hourtime to preservation, trace level mercury (EPA Method 1631), 40 CFR 1362026-10-24
eCFR45daycertificate retention after accreditation withdrawal, 42 CFR 4932026-10-24
eCFR45daycytology PT retest deadline after failure, 42 CFR 4932026-10-24
eCFR40daymaximum holding time after extraction, phenols, 40 CFR 1362026-10-24
eCFR40daymaximum holding time after extraction, phthalate esters, 40 CFR 1362026-10-24
eCFR40daymaximum holding time after extraction, nitrosamines, 40 CFR 1362026-10-24
eCFR40daymaximum holding time after extraction, nitroaromatics and isophorone, 40 CFR 1362026-10-24
eCFR40daymaximum holding time after extraction, polynuclear aromatic hydrocarbons, 40 CFR 1362026-10-24
eCFR40daymaximum holding time after extraction, haloethers, 40 CFR 1362026-10-24
eCFR40daymaximum holding time after extraction, chlorinated hydrocarbons, 40 CFR 1362026-10-24
eCFR40daymaximum holding time after extraction, alkylated phenols, 40 CFR 1362026-10-24
eCFR40daymaximum holding time after extraction, pesticides, 40 CFR 1362026-10-24
eCFR30daynotification of change, 42 CFR 493 CLIA2026-10-24
eCFR30daynotification of change, accreditation applicants, 42 CFR 493 CLIA2026-10-24
eCFR30daynotification of change to HHS and accreditation program, 42 CFR 4932026-10-24
eCFR30dayrelease of PT-failure action notice to CMS, 42 CFR 4932026-10-24

The sentence each figure was read from (93)
  • eCFR, read 2026-10-24: (f) Detection limit means the minimum concentration of an analyte (substance) that can be measured and reported with a 99% confidence that the analyte concentration is distinguishable from the method blank results as determined by the procedure set forth at appendix B of this part.
  • eCFR, read 2026-10-24: 12.1 The method detection limit (MDL) is defined as the minimum concentration of a substance that can be measured and reported with 99% confidence that the value is above zero.1 The MDL concentrations listed in Table 1 were obtained using reagent water.9 Similar results were achieved using representative wastewaters.
  • eCFR, read 2026-10-24: (1) An individual is determined to have failed the annual testing event if he or she scores less than 90 percent on a 10-slide test set.
  • eCFR, read 2026-10-24: For an individual who fails a second testing event, the laboratory must provide him or her with documented, remedial training and education in the area of failure, and must assure that all gynecologic slides evaluated subsequent to the notice of failure are reexamined until the individual is again retested with a 20-slide test set and scores at least 90 percent.
  • eCFR, read 2026-10-24: A sample that has been collected for determination of total or dissolved trace level mercury must be analyzed within 90 days of sample collection.
  • eCFR, read 2026-10-24: If the laboratory requests a hearing within 60 days of the notice of sanction, it retains its certificate of compliance or reissued certificate of compliance until a decision is made by an administrative law jud
  • eCFR, read 2026-10-24: (1) If CMS denies a request for approval, an accreditation organization or State licensure program may request, within 60 days of the notification of denial, that CMS reconsider its original application or application for renewal, in accordance with part 488, subpart D.
  • eCFR, read 2026-10-24: CMS makes a final determination as to whether the organization or State continues to meet the criteria described in this subpart and issues a notice that includes the reasons for the determination to the organization or State within 60 days after the end of any probationary period.
  • eCFR, read 2026-10-24: After CMS withdraws approval of an accreditation organization's deeming authority, the certificate of accreditation of each affected laboratory continues in effect for 60 days after it receives notification of the withdrawal of approval.
  • eCFR, read 2026-10-24: After CMS withdraws approval of a State licensure program, the exempt status of each licensed or approved laboratory in the State continues in effect for 60 days after a laboratory receives notification from the State of the withdrawal of CMS's approval of the program.
  • eCFR, read 2026-10-24: After CMS withdraws approval of an accreditation organization or State licensure program, CMS may extend the period for an additional 60 days for a laboratory if it determines that the laboratory submitted an application for accreditation to an approved accreditation organization or an application for the appropriate certificate to CMS or a CMS agent before the initial 60-day period ends.
  • eCFR, read 2026-10-24: es for each laboratory's performance in a format as required by and approved by CMS for each CLIA-certified specialty, subspecialty, and analyte or test within 60 days after the date by which the laboratory must report proficiency testing results to the proficiency testing program;
  • eCFR, read 2026-10-24: Approval of the PT program remains in effect for 60 days from the date of notification.
  • eCFR, read 2026-10-24: Organic Carbon P, FP, G Cool to ≤6 °C 18, HCl, H2 SO4, or H3 PO4 to pH <2 28 days. Orthophosphate P, FP, G Cool, to ≤6 °C 18 24 Filter within 15 minutes; Analyze within 48 hours.
  • eCFR, read 2026-10-24: 17 Samples collected for the determination of trace level mercury (<100 ng/L) using EPA Method 1631 must be collected in tightly-capped fluoropolymer or glass bottles and preserved with BrCl or HCl solution within 48 hours of sample collection.
  • eCFR, read 2026-10-24: After an accreditation organization has withdrawn or revoked its accreditation of a laboratory, the laboratory retains its certificate of accreditation for 45 days after the laboratory receives notice of the withdrawal or revocation of the accreditation, or the effective date of any action taken by CMS, whichever is earlier.
  • eCFR, read 2026-10-24: For an individual who fails an annual proficiency testing event, the laboratory must schedule a retesting event which must take place not more than 45 days after receipt of the notification of failure.
  • eCFR, read 2026-10-24: Phenols 11 G, FP-lined cap Cool, ≤6 °C 18, 0.008% Na2 S2 O3 7 days until extraction, 40 days after extraction.
  • eCFR, read 2026-10-24: Phthalate esters 11 G, FP-lined cap Cool, ≤6 °C 18 7 days until extraction, 40 days after extraction.
  • eCFR, read 2026-10-24: Nitrosamines 11 14 G, FP-lined cap Cool, ≤6 °C 18, store in dark, 0.008% Na2 S2 O3 5 7 days until extraction, 40 days after extraction.
  • eCFR, read 2026-10-24: Nitroaromatics and isophorone 11 G, FP-lined cap Cool, ≤6 °C 18, store in dark, 0.008% Na2 S2 O3 5 7 days until extraction, 40 days after extraction.
  • eCFR, read 2026-10-24: Polynuclear aromatic hydrocarbons 11 G, FP-lined cap Cool, ≤6 °C 18, store in dark, 0.008% Na2 S2 O3 5 7 days until extraction, 40 days after extraction.
  • eCFR, read 2026-10-24: Haloethers 11 G, FP-lined cap Cool, ≤6 °C 18, 0.008% Na2 S2 O3 5 7 days until extraction, 40 days after extraction.
  • eCFR, read 2026-10-24: Chlorinated hydrocarbons 11 G, FP-lined cap Cool, ≤6 °C 18 7 days until extraction, 40 days after extraction.
  • eCFR, read 2026-10-24: Alkylated phenols G Cool, <6 °C, H2 SO4 to pH <2 28 days until extraction, 40 days after extraction.
  • eCFR, read 2026-10-24: Pesticides 11 G, FP-lined cap Cool, ≤6 °C 18, pH 5-9 15 7 days until extraction, 40 days after extraction.
  • eCFR, read 2026-10-24: (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, read 2026-10-24: (2) Agrees to notify HHS within 30 days of any changes in ownership, name, location, director, or supervisor (laboratories performing high complexity testing only);
  • eCFR, read 2026-10-24: (a) Notify HHS and the approved accreditation program within 30 days of any changes in—
  • eCFR, read 2026-10-24: (6) Authorize its accreditation organization to release to CMS a notification of the actions taken by the organization as a result of the unsuccessful participation in a PT program within 30 days of the initiation of the action.
  • eCFR, read 2026-10-24: (1) Notify CMS within 30 days of the action taken, of any laboratory that has—
  • eCFR, read 2026-10-24: (8) A demonstration of its ability to provide CMS with electronic data, in compatible code, related to the adverse actions resulting from PT results constituting unsuccessful participation in PT programs as well as data related to the PT failures, within 30 days of the initiation of adverse action.
  • eCFR, read 2026-10-24: (13) An agreement to provide written notification to CMS at least 30 days in advance of the effective date of any proposed change in its requirements.
  • eCFR, read 2026-10-24: (i) Any laboratory that has had its licensure or approval revoked or withdrawn or has been in any way sanctioned by the State within 30 days of taking the action.
  • eCFR, read 2026-10-24: CMS may withdraw its approval of the accreditation organization or State licensure program, effective 30 days from the date of written notice to the organization or State of this proposed action, if improvements acceptable to CMS have not been made during the probationary period.
  • eCFR, read 2026-10-24: Laboratories will be notified of the time of each announced on-site testing event at least 30 days prior to each event.
  • eCFR, read 2026-10-24: The proficiency testing program must notify all of its participating laboratories of the withdrawal of approval within 30 days from the date of notification.
  • eCFR, read 2026-10-24: Chlorinated Phenolics G, FP-lined cap Cool, <6 °C, 0.008% Na2 S2 O3, H2 SO4 to pH <2 30 days until acetylation, 30 days after acetylation.
  • eCFR, read 2026-10-24: Bromide P, FP, G None required 28 days.
  • eCFR, read 2026-10-24: Chloride P, FP, G None required 28 days.
  • eCFR, read 2026-10-24: Fluoride P None required 28 days.
  • eCFR, read 2026-10-24: 13 Extracts may be stored up to 30 days at <0 °C. 14 For the analysis of diphenylnitrosamine, add 0.008% Na2 S2 O3 and adjust pH to 7-10 with NaOH within 24 hours of sampling.
  • eCFR, read 2026-10-24: The time to preservation may be extended to 28 days if a sample is oxidized in the sample bottle. A sample collected for dissolved trace level mercury should be filtered in the laboratory within 24 hours of the time of collection.
  • eCFR, read 2026-10-24: (4) A review of the accreditation organization or State licensure program whenever validation inspection results indicate a rate of disparity of 20 percent or more between the findings of the organization or State and those of CMS or a CMS agent for the following periods:
  • eCFR, read 2026-10-24: Some older methods do not include any criterion for the calibration curve—for these methods, if RSE is used the value should be ≤20%.
  • eCFR, read 2026-10-24: Chloride P, FP, G None required 28 days. Chlorine, total residual P, G None required Analyze within 15 minutes.
  • eCFR, read 2026-10-24: Sulfide P, FP, G Cool, ≤6 °C 18, add zinc acetate plus sodium hydroxide to pH >9 7 days. Sulfite P, FP, G None required Analyze within 15 minutes.
  • eCFR, read 2026-10-24: 2 Except where noted in this Table II and the method for the parameter, preserve each grab sample within 15 minutes of collection.
  • eCFR, read 2026-10-24: Cyanide, total or available (or CATC) and free P, FP, G Cool, ≤6 °C 18, NaOH to pH >10 5 6, reducing agent if oxidizer present 14 days.
  • eCFR, read 2026-10-24: (2) Notify CMS within 10 days of any deficiency identified in an accredited or CLIA-exempt laboratory if the deficiency poses an immediate jeopardy to the laboratory's patients or a hazard to the general public.
  • eCFR, read 2026-10-24: (4) Notify each accredited or licensed laboratory within 10 days of CMS's withdrawal of the organization's deeming authority or State's exemption.
  • eCFR, read 2026-10-24: (6) Notify CMS within 10 days of any conditional level deficiency under §§ 493.41 or 493.1100(a).
  • eCFR, read 2026-10-24: (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, read 2026-10-24: n is between 0.6-1.0 mg/L; control charts are performed on at least 25 GGA checks with three standard deviations from the derived mean; the RSD must not exceed 7.5%; and any single GGA value cannot be less than 150 mg/L or higher than 250 mg/L.
  • eCFR, read 2026-10-24: (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.
  • eCFR, read 2026-10-24: (ii) Six months after the expiration date of the drug product if the expiration dating period of the drug product is more than 30 days.
  • eCFR, read 2026-10-24: CMS approval may not exceed 6 years.
  • eCFR, read 2026-10-24: (1) Every 6 years, or sooner, as determined by CMS, an approved accreditation organization must reapply for continued approval of deeming authority and a State licensure program must reapply for continued approval of a CLIA exemption.
  • eCFR, read 2026-10-24: Adsorbable Organic Halides (AOX) G Cool, <6 °C, 0.008% Na2 S2 O3, HNO3 to pH <2 Hold at least 3 days, but not more than 6 months.
  • eCFR, read 2026-10-24: These costs are 5 percent of the same costs as those that are incurred when inspecting nonaccredited laboratories of the same schedule (or range) and are paid biennially by each accredited laboratory whether the accredited laboratory has a validation inspection or not.
  • eCFR, read 2026-10-24: (d) Maintain records of laboratories' performance for a period of five years or such time as may be necessary for any legal proceedings; and
  • eCFR, read 2026-10-24: (2) A period of at least 5 years following the date on which the results of the nonclinical laboratory study are submitted to the Food and Drug Administration in support of an application for a research or marketing permit.
  • eCFR, read 2026-10-24: (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, read 2026-10-24: (i) Three 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 30 days or less; or
  • eCFR, read 2026-10-24: (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
  • eCFR, read 2026-10-24: (i) Three months after the expiration date of the drug product if the expiration dating period of the drug product is 30 days or less; or
  • eCFR, read 2026-10-24: Doctoral degree means an earned post-baccalaureate degree with at least 3 years of graduate level study that includes research related to clinical laboratory testing or advanced study in clinical laboratory science, medical laboratory science, or medical technology.
  • eCFR, read 2026-10-24: (6) A mechanism for notifying participants of the PT shipping schedule and for participants to notify the proficiency testing program within three days of the expected date of receipt of the shipment that samples have not arrived or are unacceptable for testing.
  • eCFR, read 2026-10-24: (3) For an OTC drug product that is exempt for bearing an expiration date under § 211.137, the reserve sample must be retained for 3 years after the lot or batch of drug product is distributed.
  • eCFR, read 2026-10-24: Samples for acrolein receiving no pH adjustment must be analyzed within 3 days of sampling.
  • eCFR, read 2026-10-24: Samples for acrolein analysis receiving no pH adjustment must be analyzed within 3 days of sampling.
  • eCFR, read 2026-10-24: (1) A certificate of waiver issued under this subpart is valid for no more than 2 years.
  • eCFR, read 2026-10-24: (1) Valid for a period of no more than two years or until such time as an inspection to determine program compliance can be conducted, whichever is shorter; and
  • eCFR, read 2026-10-24: (e) A certificate for PPM procedures is valid for a period of no more than 2 years.
  • eCFR, read 2026-10-24: (d) A certificate of compliance issued under this subpart is valid for no more than 2 years.
  • eCFR, read 2026-10-24: (d) A registration certificate is valid for a period of no more than 2 years.
  • eCFR, read 2026-10-24: (d) A certificate of accreditation issued under this subpart is valid for no more than 2 years.
  • eCFR, read 2026-10-24: (14) If approved, reapply to CMS every 2 years to renew its exempt status and to renew its agreement to pay the cost of the CMS-administered validation program in that State.
  • eCFR, read 2026-10-24: (1) CMS calculates the inflation rate using the compounded CPI-U over 2 years and, provided that the calculated rate is greater than zero, applies an increase to all fee amounts equal to the calculated rate.
  • eCFR, read 2026-10-24: (2) If the total fee amounts, including any increase applied under paragraph (a)(1) of this section, do not match or exceed actual program obligations based on a review of the previous 2 years' obligations, CMS applies an additional across the board increase to each laboratory's fees by calculating the difference between the total fee amounts and actual program obligations.
  • eCFR, read 2026-10-24: by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event.
  • eCFR, read 2026-10-24: (2) Remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event.
  • eCFR, read 2026-10-24: (1) A period of at least 2 years following the date on which an application for a research or marketing permit, in support of which the results of the nonclinical laboratory study were submitted, is approved by the Food and Drug Administration.
  • eCFR, read 2026-10-24: (3) In other situations (e.g., where the nonclinical laboratory study does not result in the submission of the study in support of an application for a research or marketing permit), a period of at least 2 years following the date on which the study is completed, terminated, or discontinued.
  • eCFR, read 2026-10-24: ntly in compliance with applicable CLIA requirements, that has had a record of satisfactory proficiency testing performance for all testing events for at least one year for a specific test, analyte, subspecialty, or specialty and has been designated by an HHS approved proficiency testing program as a referee laboratory for ana
  • eCFR, read 2026-10-24: Validation review period means the one year time period during which CMS conducts validation inspections and evaluates the results of the most recent surveys performed by an accreditation organization or State laboratory program.
  • eCFR, read 2026-10-24: equal to, or more stringent than, CLIA requirements, CMS may give a conditional approval for a probationary period of its deeming authority to an organization 30 days following the date of CMS's determination, or exempt status to a State within 30 days of CMS's determination, both not to exceed 1 year, to afford the organiza
  • eCFR, read 2026-10-24: (2) If CMS determines that there are widespread or systematic problems in the organization's or State's inspection process, CMS may give conditional approval during a probationary period, not to exceed 1 year, effective 30 days following the date of the determination.
  • eCFR, read 2026-10-24: (3) For each specialty, subspecialty and analyte or test, participate in one approved proficiency testing program or programs, for one year before designating a different program and must notify CMS before any change in designation; and
  • eCFR, read 2026-10-24: Any laboratory that CMS determines intentionally referred a proficiency testing sample to another laboratory for analysis may have its certification revoked for at least 1 year.
  • eCFR, read 2026-10-24: (1) For an active ingredient in a drug product other than those described in paragraphs (a) (2) and (3) of this section, the reserve sample shall be retained for 1 year after the expiration date of the last lot of the drug product containing the active ingredient.
  • eCFR, read 2026-10-24: (1) For a drug product other than those described in paragraphs (b) (2) and (3) of this section, the reserve sample shall be retained for 1 year after the expiration date of the drug product.
  • eCFR, read 2026-10-24: PCBs 11 G, FP-lined cap Cool, ≤6 °C 18 1 year until extraction, 1 year after extraction.

Read in full, publishes no figure

9 named sources were read in full on the dates shown and print no usable figure. They are counted, never filled in.

  • CMS, read 2026-10-10: read in full and no accepted figure on the page
  • eCFR, read 2026-10-24: read in full and no accepted figure on the page
  • EMA, read 2026-09-12: read in full and no accepted figure on the page
  • European Commission (EudraLex), read 2026-09-26: read in full and no accepted figure on the page
  • GOV.UK (MHRA), read 2026-09-19: read in full and no accepted figure on the page
  • ISO, read 2026-10-24: every candidate on the page was refused
  • ISO, read 2026-10-24: read in full and no accepted figure on the page
  • ISO, read 2026-10-24: read in full and no accepted figure on the page
  • NIST, read 2026-10-24: 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 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).

4 of the 13 named sources that could be read published a usable figure; 9 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 for each breakdown it prices, in day (a source's median where its page yielded several accepted sentences for one breakdown), so a page that gives figures for several breakdowns gives one for each and N counts 42 figures, never sentences; 171 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 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

171 candidate sentences on these pages were refused by a reviewer; each refusal and its reason is recorded in the review ledger.

Sources (13)
  • CMS(the publisher's own terms; quoted for reporting and comment)
  • eCFR(the publisher's own terms; quoted for reporting and comment)
  • eCFR(the publisher's own terms; quoted for reporting and comment)
  • eCFR(the publisher's own terms; quoted for reporting and comment)
  • eCFR(the publisher's own terms; quoted for reporting and comment)
  • eCFR(the publisher's own terms; quoted for reporting and comment)
  • EMA(the publisher's own terms; quoted for reporting and comment)
  • European Commission (EudraLex)(the publisher's own terms; quoted for reporting and comment)
  • GOV.UK (MHRA)(the publisher's own terms; quoted for reporting and comment)
  • ISO(the publisher's own terms; quoted for reporting and comment)
  • ISO(the publisher's own terms; quoted for reporting and comment)
  • ISO(the publisher's own terms; quoted for reporting and comment)
  • NIST(the publisher's own terms; quoted for reporting and comment)
Cite or embed this figure

Cite or embed this figure

The Lab Standards Requirements carries 42 published figures read from 2 sources' own pages, from 3 to 90 day, read 24 October 2026.

4 of the 13 named sources read in full publish a figure; 9 publish none, read 24 October 2026.

Lab Standards Requirements, requirement CLIA certificate renewal window, 42 CFR 493: median 9 month across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement notification of change, 42 CFR 493 CLIA: median 30 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement GLP reserve sample trigger, study duration, 21 CFR 58: median 4 week across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement reserve sample retention, active ingredient, expiry dating 30 days or less, 21 CFR 211: median 3 month across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement reserve sample retention, active ingredient, expiry dating more than 30 days, 21 CFR 211: median 6 month across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement reserve sample retention, OTC active ingredient, 21 CFR 211: median 3 year across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement reserve sample retention, drug product, expiry dating 30 days or less, 21 CFR 211: median 3 month across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement reserve sample retention, drug product, expiry dating more than 30 days, 21 CFR 211: median 6 month across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement maximum holding time, bromide, 40 CFR 136: median 28 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement doctoral degree definition, minimum graduate study, 42 CFR 493: median 3 year across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement referee laboratory, minimum satisfactory PT record, 42 CFR 493: median 1 year across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement validation review period, 42 CFR 493: median 1 year across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement certificate of waiver validity, 42 CFR 493: median 2 year across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement registration certificate validity, certificate of compliance applicants, 42 CFR 493: median 2 year across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement certificate for PPM procedures validity, 42 CFR 493: median 2 year across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement certificate of compliance validity, 42 CFR 493: median 2 year across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement hearing request window after sanction notice, 42 CFR 493: median 60 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement notification of change, accreditation applicants, 42 CFR 493 CLIA: median 30 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement registration certificate validity, accreditation applicants, 42 CFR 493: median 2 year across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement certificate of accreditation validity, 42 CFR 493: median 2 year across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement notification of change to HHS and accreditation program, 42 CFR 493: median 30 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement release of PT-failure action notice to CMS, 42 CFR 493: median 30 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement certificate retention after accreditation withdrawal, 42 CFR 493: median 45 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement maximum term of CMS approval, accreditation organization/State program, 42 CFR 493: median 6 year across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement accreditation organization notice to CMS of laboratory actions, 42 CFR 493: median 30 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement notice to CMS of immediate-jeopardy deficiency, 42 CFR 493: median 10 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement notice to laboratories of withdrawn deeming authority, 42 CFR 493: median 10 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement notice to CMS of condition-level deficiency, 42 CFR 493: median 10 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement electronic PT adverse-action data to CMS, 42 CFR 493: median 30 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement advance notice to CMS of requirement changes, 42 CFR 493: median 30 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement State program notice to CMS of sanctioned laboratories, 42 CFR 493: median 30 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement State exempt status reapplication interval, 42 CFR 493: median 2 year across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement reconsideration request window after denial, 42 CFR 493: median 60 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement reapplication interval for deeming authority/CLIA exemption, 42 CFR 493: median 6 year across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement validation disparity rate triggering review, 42 CFR 493: median 20 percent across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement maximum conditional approval probationary period, initial approval, 42 CFR 493: median 1 year across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement maximum probationary period for inspection-process problems, 42 CFR 493: median 1 year across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement CMS final determination after probation, 42 CFR 493: median 60 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement effective date of approval withdrawal after notice, 42 CFR 493: median 30 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement certificate of accreditation continuation after deeming withdrawal, 42 CFR 493: median 60 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement exempt status continuation after State program withdrawal, 42 CFR 493: median 60 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement extension of continuation period, 42 CFR 493: median 60 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement validation inspection cost share, accredited laboratories, 42 CFR 493: median 5 percent across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement fee inflation adjustment period (CPI-U), 42 CFR 493: median 2 year across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement fee obligations lookback period, 42 CFR 493: median 2 year across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement minimum PT program participation before changing program, 42 CFR 493: median 1 year across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement CLIA certificate revocation for intentional PT referral, minimum period, 42 CFR 493: median 1 year across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement PT attestation retention, 42 CFR 493: median 2 year across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement PT remedial action documentation retention, 42 CFR 493: median 2 year across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement advance notice of announced on-site cytology PT event, 42 CFR 493: median 30 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement gynecologic cytology PT pass score, 10-slide set, 42 CFR 493: median 90 percent across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement cytology PT retest deadline after failure, 42 CFR 493: median 45 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement gynecologic cytology PT pass score after second failure, 20-slide set, 42 CFR 493: median 90 percent across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement participant notice of missing or unacceptable PT samples, 42 CFR 493: median 3 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement PT program reporting of lab scores, 42 CFR 493: median 60 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement PT program retention of lab performance records, 42 CFR 493: median 5 year across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement PT program approval continuation after withdrawal notice, 42 CFR 493: median 60 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement PT program notice to labs of approval withdrawal, 42 CFR 493: median 30 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement GLP record retention after application approval, 21 CFR 58: median 2 year across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement GLP record retention after study submission, 21 CFR 58: median 5 year across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement GLP record retention, study not submitted, 21 CFR 58: median 2 year across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement reserve sample retention, active ingredient, 21 CFR 211: median 1 year across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement reserve sample retention, drug product, 21 CFR 211: median 1 year across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement reserve sample retention, OTC drug product without expiry date, 21 CFR 211: median 3 year across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement detection limit confidence level, 40 CFR 136: median 99 percent across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement BOD GGA check RSD limit, 40 CFR 136: median 7.50 percent across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement maximum holding time, chloride, 40 CFR 136: median 28 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement maximum holding time, total residual chlorine, 40 CFR 136: median 15 minute across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement maximum holding time, cyanide, 40 CFR 136: median 14 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement maximum holding time, fluoride, 40 CFR 136: median 28 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement maximum holding time, orthophosphate analysis, 40 CFR 136: median 48 hour across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement maximum holding time, sulfite, 40 CFR 136: median 15 minute across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement maximum holding time after extraction, phenols, 40 CFR 136: median 40 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement maximum holding time after extraction, phthalate esters, 40 CFR 136: median 40 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement maximum holding time after extraction, nitrosamines, 40 CFR 136: median 40 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement maximum holding time after extraction, PCBs, 40 CFR 136: median 1 year across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement maximum holding time after extraction, nitroaromatics and isophorone, 40 CFR 136: median 40 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement maximum holding time after extraction, polynuclear aromatic hydrocarbons, 40 CFR 136: median 40 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement maximum holding time after extraction, haloethers, 40 CFR 136: median 40 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement maximum holding time after extraction, chlorinated hydrocarbons, 40 CFR 136: median 40 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement maximum holding time after extraction, alkylated phenols, 40 CFR 136: median 40 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement maximum holding time, adsorbable organic halides (AOX), 40 CFR 136: median 6 month across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement maximum holding time after acetylation, chlorinated phenolics, 40 CFR 136: median 30 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement maximum holding time after extraction, pesticides, 40 CFR 136: median 40 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement time to preservation, grab sample, 40 CFR 136 Table II: median 15 minute across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement maximum holding time without pH adjustment, acrolein, 40 CFR 136: median 3 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement time to preservation, diphenylnitrosamine, 40 CFR 136: median 24 hour across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement time to preservation, trace level mercury (EPA Method 1631), 40 CFR 136: median 48 hour across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement time to laboratory filtration, dissolved trace level mercury, 40 CFR 136: median 24 hour across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement maximum holding time, total or dissolved trace level mercury, 40 CFR 136: median 90 day across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement calibration RSE acceptance limit where method sets no criterion, 40 CFR 136: median 20 percent across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement method detection limit confidence level, 40 CFR 136: median 99 percent across 1 source, read 24 October 2026.

Lab Standards Requirements, requirement maximum holding time, acrolein without pH adjustment, 40 CFR 136: median 3 day across 1 source, read 24 October 2026.

Cite as: "BioBricks Lab Standards Requirements", updated 2026-10-27, https://biobricks.org/datasets/lab-standards-requirements/.

Embed this figure (plain HTML, no scripts)

3 to 90 day

42 published figures, Lab Standards Requirements, across 2 sources, read 24 October 2026

Source: BioBricks Lab Standards Requirements

Download the CSV (93 rows, computed 2026-10-27)

Get a vendor shortlistCompare synthesis prices