Shawndouglas: Updated for 2022.

2022-05-05T20:29:21Z

Updated for 2022.

Shawndouglas: Created as needed.

2019-09-19T22:37:03Z

Created as needed.

New page

{|
| STYLE="vertical-align:top;"|
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
|-
! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
|-
| style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/58.105 21 CFR Part 58.105 (a)] 
[https://www.law.cornell.edu/cfr/text/21/211.80 21 CFR Part 211.80] 
[https://www.law.cornell.edu/cfr/text/21/225.102 21 CFR Part 225.102] 
[https://www.law.cornell.edu/cfr/text/21/226.102 21 CFR Part 226.102] 
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-4-1] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.3] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.10.1] 
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.2]
| style="background-color:white;" |'''11.1''' The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.
|-
| style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.80 21 CFR Part 211.80] 
[https://www.law.cornell.edu/cfr/text/21/225.102 21 CFR Part 225.102] 
[https://www.law.cornell.edu/cfr/text/21/226.102 21 CFR Part 226.102] 
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-4-2] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.10.1]
| style="background-color:white;" |'''11.2''' The system shall maintain the links between component parts of a batch and track the batch throughout the system.
|-
| style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.80 21 CFR Part 211.80] 
[https://www.law.cornell.edu/cfr/text/21/225.102 21 CFR Part 225.102] 
[https://www.law.cornell.edu/cfr/text/21/226.102 21 CFR Part 226.102] 
[https://www.law.cornell.edu/cfr/text/21/820.65 21 CFR Part 820.65] 
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-4-3]
| style="background-color:white;" |'''11.3''' The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-4-4]
| style="background-color:white;" |'''11.4''' The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.
|-
| style="padding:5px; width:500px;" |[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-15]
| style="background-color:white;" |'''11.5''' The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.
|-
|}
|}

← Older revision		Revision as of 20:29, 5 May 2022
Line 13:		Line 13:
	[https://www.law.cornell.edu/cfr/text/21/225.102 21 CFR Part 225.102]<br />		[https://www.law.cornell.edu/cfr/text/21/225.102 21 CFR Part 225.102]<br />
	[https://www.law.cornell.edu/cfr/text/21/226.102 21 CFR Part 226.102]<br />		[https://www.law.cornell.edu/cfr/text/21/226.102 21 CFR Part 226.102]<br />
	[https://www.astm.org/~~Standards/E1578~~.~~htm~~ ASTM E1578-18 E-4-1]<br />		[https://www.astm.org/e1578-18.html ASTM E1578-18 E-4-1]<br />
	[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.3]<br />		[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.3]<br />
	[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.10.1]<br />		[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.10.1]<br />
	[~~http~~://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.2]		[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.2]
	\| style="background-color:white;" \|'''11.1''' The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.		\| style="background-color:white;" \|'''11.1''' The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.
	\|-		\|-
Line 23:		Line 23:
	[https://www.law.cornell.edu/cfr/text/21/225.102 21 CFR Part 225.102]<br />		[https://www.law.cornell.edu/cfr/text/21/225.102 21 CFR Part 225.102]<br />
	[https://www.law.cornell.edu/cfr/text/21/226.102 21 CFR Part 226.102]<br />		[https://www.law.cornell.edu/cfr/text/21/226.102 21 CFR Part 226.102]<br />
	[https://www.astm.org/~~Standards/E1578~~.~~htm~~ ASTM E1578-18 E-4-2]<br />		[https://www.astm.org/e1578-18.html ASTM E1578-18 E-4-2]<br />
	[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.10.1]		[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.10.1]
	\| style="background-color:white;" \|'''11.2''' The system shall maintain the links between component parts of a batch and track the batch throughout the system.		\| style="background-color:white;" \|'''11.2''' The system shall maintain the links between component parts of a batch and track the batch throughout the system.
Line 32:		Line 32:
	[https://www.law.cornell.edu/cfr/text/21/226.102 21 CFR Part 226.102]<br />		[https://www.law.cornell.edu/cfr/text/21/226.102 21 CFR Part 226.102]<br />
	[https://www.law.cornell.edu/cfr/text/21/820.65 21 CFR Part 820.65]<br />		[https://www.law.cornell.edu/cfr/text/21/820.65 21 CFR Part 820.65]<br />
	[https://www.astm.org/~~Standards/E1578~~.~~htm~~ ASTM E1578-18 E-4-3]		[https://www.astm.org/e1578-18.html ASTM E1578-18 E-4-3]
	\| style="background-color:white;" \|'''11.3''' The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.		\| style="background-color:white;" \|'''11.3''' The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.astm.org/~~Standards/E1578~~.~~htm~~ ASTM E1578-18 E-4-4]		\| style="padding:5px; width:500px;" \|[https://www.astm.org/e1578-18.html ASTM E1578-18 E-4-4]
	\| style="background-color:white;" \|'''11.4''' The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.		\| style="background-color:white;" \|'''11.4''' The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.
	\|-		\|-

Template:LIMSpec/Batch and lot management - Revision history

Shawndouglas: Updated for 2022.

Shawndouglas: Created as needed.