Template:LIMSpec/Production management - Revision history

Shawndouglas: Labeling

2022-12-02T15:09:08Z

Labeling

← Older revision		Revision as of 15:09, 2 December 2022
Line 200:		Line 200:
	[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 14.7 and 14.22]<br />		[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 14.7 and 14.22]<br />
	[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.35]		[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.35]
	\| style="background-color:white;" \|'''17.13''' The system shall be capable of recording the changing quantity of inventoried non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, ~~labelling~~, containers, and packaging materials), including batch and lot numbers and, if applicable, details of disposition after completion of production.		\| style="background-color:white;" \|'''17.13''' The system shall be capable of recording the changing quantity of inventoried non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, labeling, containers, and packaging materials), including batch and lot numbers and, if applicable, details of disposition after completion of production.
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Shawndouglas: Added 17.17 (was originally going to be 19.8)

2022-12-01T23:11:47Z

Added 17.17 (was originally going to be 19.8)

← Older revision		Revision as of 23:11, 1 December 2022
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	[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 14.29–30]		[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 14.29–30]
	\| style="background-color:white;" \|'''17.16''' The system should allow a completed production batch that has been rejected for use or a returned production batch to be flagged in the system for reprocessing or reworking if it meets relevant criteria.		\| style="background-color:white;" \|'''17.16''' The system should allow a completed production batch that has been rejected for use or a returned production batch to be flagged in the system for reprocessing or reworking if it meets relevant criteria.
			\|-
			\| style="padding:5px; width:500px;" \|
			[https://www.law.cornell.edu/cfr/text/21/part-112 21 CFR Part 112.145]<br />
			[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 4.11.8.x]<br />
			[https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02005R2073-20200308 E.U. Commission Reg. No. 2073/2005 Article 5]<br />
			[https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, I - FSM 19.2]<br />
			[https://www.iso.org/standard/44001.html ISO/TS 22002-1:2009, 11.5]<br />
			[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf SQF FSC 9, Food Manufacturing, Part B, 2.4.8]<br />
			[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_PetFood_v3-2-Final-w-Links.pdf SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.8]<br />
			[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.8]
			\| style="background-color:white;" \|'''17.17''' The system shall support environmental testing protocols for testing the production environment on a scheduled, reportable basis. That support shall include facility and sampling site management functionality that allows for highlighting specific test points in the facility, as well as support for offsite and randomized testing. The system should also allow associated samples, methods, tests, reports, and other documents to clearly indicate they correspond to specific environmental testing protocols.
	\|-		\|-
	\|}		\|}
	\|}		\|}

Shawndouglas: Updated for food and bev update

2022-12-01T22:42:09Z

Updated for food and bev update

Show changes

Shawndouglas: 17.12

2022-11-19T20:54:21Z

17.12

← Older revision		Revision as of 20:54, 19 November 2022
Line 102:		Line 102:
	[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 14.4, 14.15, and 14.21]<br />		[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 14.4, 14.15, and 14.21]<br />
	[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.32–33]		[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.32–33]
	\| style="background-color:white;" \|'''17.12''' The system shall be capable of documenting the receipt of non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, medical devices, labeling, and packaging materials), including information such as manufacturer, date of receipt, lot numbers, reference numbers, certificates of conformity, shelf life or expiration date, storage location, status of examination, and status of approval for use.		\| style="background-color:white;" \|'''17.12''' The system shall be capable of documenting the receipt of non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, medical devices, labeling, and packaging materials), including information such as manufacturer, date of receipt, lot numbers, reference numbers, certificates of conformity, shelf life or expiration date, storage location, status of examination, and status of approval for use. Any related specifications for those materials should be able to be linked to the received materials.
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Shawndouglas: 17.12

2022-11-18T23:36:56Z

17.12

← Older revision		Revision as of 23:36, 18 November 2022
Line 102:		Line 102:
	[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 14.4, 14.15, and 14.21]<br />		[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 14.4, 14.15, and 14.21]<br />
	[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.32–33]		[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.32–33]
	\| style="background-color:white;" \|'''17.12''' The system shall be capable of documenting the receipt of non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, medical devices, labeling, and packaging materials), including information such as manufacturer, date of receipt, lot numbers, reference numbers, certificates of conformity, storage location, status of examination, and status of approval for use.		\| style="background-color:white;" \|'''17.12''' The system shall be capable of documenting the receipt of non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, medical devices, labeling, and packaging materials), including information such as manufacturer, date of receipt, lot numbers, reference numbers, certificates of conformity, shelf life or expiration date, storage location, status of examination, and status of approval for use.
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Shawndouglas: 17.6

2022-11-17T00:00:12Z

17.6

← Older revision		Revision as of 00:00, 17 November 2022
Line 48:		Line 48:
	[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (a) and (f–g)]<br />		[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (a) and (f–g)]<br />
	[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.25–30]		[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.25–30]
	\| style="background-color:white;" \|'''17.6''' The system shall be able to create a batch production record capable of recording complete information regarding batch production and control details such as, but not limited to, a unique batch or production run number, formulation, specific labeling and packaging, production steps, in-process and laboratory control results, the unique identifier of any equipment used, persons performing and/or supervising operational steps, and the results of any pre-process or post-production inspections.		\| style="background-color:white;" \|'''17.6''' The system shall be able to create a batch production record capable of recording complete information regarding batch production and control details such as, but not limited to, a unique batch, lot, or production run number; formulation; specific labeling and packaging; production steps; in-process and laboratory control results; the unique identifier of any equipment used; persons performing and/or supervising operational steps; and the results of any pre-process or post-production inspections.
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Shawndouglas: Wording tweaks

2022-11-16T21:02:05Z

Wording tweaks

← Older revision		Revision as of 21:02, 16 November 2022
Line 102:		Line 102:
	[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 14.4, 14.15, and 14.21]<br />		[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 14.4, 14.15, and 14.21]<br />
	[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.32–33]		[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.32–33]
	\| style="background-color:white;" \|'''17.12''' The system shall be capable of documenting the receipt of non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, medical devices, labeling, and packaging materials), including information such as manufacturer, date of receipt, lot numbers, reference numbers, storage location, status of examination, and status of approval for use.		\| style="background-color:white;" \|'''17.12''' The system shall be capable of documenting the receipt of non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, medical devices, labeling, and packaging materials), including information such as manufacturer, date of receipt, lot numbers, reference numbers, certificates of conformity, storage location, status of examination, and status of approval for use.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|		\| style="padding:5px; width:500px;" \|
Line 112:		Line 112:
	[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 14.7 and 14.22]<br />		[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 14.7 and 14.22]<br />
	[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.35]		[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.35]
	\| style="background-color:white;" \|'''17.13''' The system shall be capable of recording the changing quantity of inventoried non-sample, -standard, and -reagent materials (e.g., ~~forumlated~~ drugs, drug components, labelling, containers, and packaging materials), including batch and lot numbers and, if applicable, details of disposition after completion of production.		\| style="background-color:white;" \|'''17.13''' The system shall be capable of recording the changing quantity of inventoried non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, labelling, containers, and packaging materials), including batch and lot numbers and, if applicable, details of disposition after completion of production.
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Shawndouglas: Updated for 2022.

2022-05-05T20:34:21Z

Updated for 2022.

Shawndouglas: Created as needed.

2019-09-19T22:48:14Z

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/21/211.103 21 CFR Part 211.103] [https://www.law.cornell.edu/cfr/text/21/226.40 21 CFR Part 226.40 (d)] [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.4 and 16.20]
| style="background-color:white;" |'''17.1''' The system should be able to calculate and record theoretical and actual percentage of yield at various phases of processing, manufacturing, and packaging.
|-
| style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/211.103 21 CFR Part 211.103]
| style="background-color:white;" |'''17.2''' The system should provide a means for verification and approval of yield calculations before release for reporting.
|-
| style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/820.20 21 CFR Part 820.20] 
[https://www.law.cornell.edu/cfr/text/21/820.40 21 CFR Part 820.40] 
[https://www.law.cornell.edu/cfr/text/21/820.186 21 CFR Part 820.186] 
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf E.U. Commission Directive 2003/94/EC Article 11] 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 1.0]
| style="background-color:white;" |'''17.3''' The system shall be able to maintain a production facility's quality system in a specific quality system record, in accordance with regulations and guidance such as 21 CFR Part 820.20 and 820.40 (U.S.), E.U. Commission Directive 2003/94/EC Article 11 (E.U.), and WHO Technical Report Series, #986, Annex 2, 1.0 (global).
|-
| style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/820.30 21 CFR Part 820.30] [https://www.law.cornell.edu/cfr/text/21/820.120 21 CFR Part 820.120 (e)]
| style="background-color:white;" |'''17.4''' The system shall be able to create a design control document capable of recording the details surrounding device development, including control number, physical and performance requirements, final output, review, verification, approval, transfer, changes, and complete design history.
|-
| style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/820.181 21 CFR Part 820.181] [https://www.law.cornell.edu/cfr/text/21/820.184 21 CFR Part 820.184]
| style="background-color:white;" |'''17.5''' The system shall be able to create a device master and device history record capable of recording all information described in 21 CFR Part 820.181 and 820.184.
|-
| style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.105 21 CFR Part 211.105 (b)] 
[https://www.law.cornell.edu/cfr/text/21/211.130 21 CFR Part 211.130 (e)] 
[https://www.law.cornell.edu/cfr/text/21/211.134 21 CFR Part 211.134 (c)] 
[https://www.law.cornell.edu/cfr/text/21/211.188 21 CFR Part 211.188] 
[https://www.law.cornell.edu/cfr/text/21/211.20 21 CFR Part 211.20 (d)] 
[https://www.law.cornell.edu/cfr/text/21/211.50 21 CFR Part 211.50 (c)] 
[https://www.law.cornell.edu/cfr/text/21/225.102 21 CFR Part 225.102] 
[https://www.law.cornell.edu/cfr/text/21/225.202 21 CFR Part 225.202] 
[https://www.law.cornell.edu/cfr/text/21/226.80 21 CFR Part 226.80] 
[https://www.law.cornell.edu/cfr/text/21/226.102 21 CFR Part 226.102] 
[https://www.law.cornell.edu/cfr/text/21/820.60 21 CFR Part 820.60] 
[https://www.law.cornell.edu/cfr/text/21/820.70 21 CFR Part 820.70 (a)] 
[https://www.law.cornell.edu/cfr/text/21/820.80 21 CFR Part 820.80 (c)] 
[https://www.law.cornell.edu/cfr/text/21/820.120 21 CFR Part 820.120 (d)] 
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf E.U. Commission Directive 2003/94/EC Article 9.1] 
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 2 and 4] 
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 7] 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (a) and (f–g)] 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.25–30]
| style="background-color:white;" |'''17.6''' The system shall be able to create a batch production record capable of recording complete information regarding batch production and control details such as, but not limited to, a unique batch or production run number, formulation, specific labeling and packaging, production steps, in-process and laboratory control results, the unique identifier of any equipment used, persons performing and/or supervising operational steps, and the results of any pre-process or post-production inspections.
|-
| style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.186 21 CFR Part 211.186] 
[https://www.law.cornell.edu/cfr/text/21/212.50 21 CFR Part 212.50 (b)] 
[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.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 7] 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.22–23]
| style="background-color:white;" |'''17.7''' The system shall be able to create a master production and control record capable of recording complete information regarding master production and control details.
|-
| style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.100 21 CFR Part 211.100] 
[https://www.law.cornell.edu/cfr/text/21/211.186 21 CFR Part 211.186] 
[https://www.law.cornell.edu/cfr/text/21/212.50 21 CFR Part 212.50 (b)] 
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf E.U. Commission Directive 2003/94/EC Article 10.3–4] 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (a–b)] 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 4.0]
| style="background-color:white;" |'''17.8''' The system shall require a new or modified master production and control record to be validated, reviewed, and approved before being implemented into production, including allowing that record to be electronically signed by one or more authorized individuals upon approval. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.
|-
| style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.22 21 CFR Part 211.22] 
[https://www.law.cornell.edu/cfr/text/21/211.192 21 CFR Part 211.192] 
[https://www.law.cornell.edu/cfr/text/21/820.70 21 CFR Part 820.70 (b)] 
[https://www.law.cornell.edu/cfr/text/21/820.75 21 CFR Part 820.75] 
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf E.U. Commission Directive 2003/94/EC Article 10.3] 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (a–b, f)] 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 4.0]
| style="background-color:white;" |'''17.9''' The system shall require a new or modified production and control record to be validated, reviewed, and approved before being implemented in production. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.
|-
| style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.110 21 CFR Part 211.110] 
[https://www.law.cornell.edu/cfr/text/21/212.50 21 CFR Part 212.50] 
[https://www.law.cornell.edu/cfr/text/21/820.80 21 CFR Part 820.80 (c)] 
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 4]
| style="background-color:white;" |'''17.10''' The system shall be able to indicate if a sample consists of an in-process manufacturing material and track characteristics of the in-process material such as identity, strength, quality, purity, and approval status.
|-
| style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/211.111 21 CFR Part 211.111]
| style="background-color:white;" |'''17.11''' The system shall provide a means to track the amount of time between production processes.
|-
| style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.122 21 CFR Part 211.122 (c)] 
[https://www.law.cornell.edu/cfr/text/21/211.184 21 CFR Part 211.184] 
[https://www.law.cornell.edu/cfr/text/21/212.20 21 CFR Part 212.20 (b)] 
[https://www.law.cornell.edu/cfr/text/21/212.40 21 CFR Part 212.40 (c) and (e)] 
[https://www.law.cornell.edu/cfr/text/21/225.42 21 CFR Part 225.42] 
[https://www.law.cornell.edu/cfr/text/21/226.40 21 CFR Part 226.40 (b)] 
[https://www.law.cornell.edu/cfr/text/21/226.42 21 CFR Part 226.42] 
[https://www.law.cornell.edu/cfr/text/21/606.120 21 CFR Part 606.120 (b)] 
[https://www.law.cornell.edu/cfr/text/21/820.60 21 CFR Part 820.60] 
[https://www.law.cornell.edu/cfr/text/21/820.80 21 CFR Part 820.80 (b)] 
[https://www.law.cornell.edu/cfr/text/21/820.120 21 CFR Part 820.120 (b)] 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 14.4, 14.15, and 14.21] 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.32–33]
| style="background-color:white;" |'''17.12''' The system shall be capable of documenting the receipt of non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, medical devices, labeling, and packaging materials), including information such as manufacturer, date of receipt, lot numbers, reference numbers, storage location, status of examination, and status of approval for use.
|-
| style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.122 21 CFR Part 211.122 (e)] 
[https://www.law.cornell.edu/cfr/text/21/211.125 21 CFR Part 211.125 (d)] 
[https://www.law.cornell.edu/cfr/text/21/211.184 21 CFR Part 211.184] 
[https://www.law.cornell.edu/cfr/text/21/225.42 21 CFR Part 225.42] 
[https://www.law.cornell.edu/cfr/text/21/226.42 21 CFR Part 226.42] 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 14.7 and 14.22] 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.35]
| style="background-color:white;" |'''17.13''' The system shall be capable of recording the changing quantity of inventoried non-sample, -standard, and -reagent materials (e.g., forumlated drugs, drug components, labelling, containers, and packaging materials), including batch and lot numbers and, if applicable, details of disposition after completion of production.
|-
| style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.122 21 CFR Part 211.122 (e)] 
[https://www.law.cornell.edu/cfr/text/21/211.125 21 CFR Part 211.125 (d)] 
[https://www.law.cornell.edu/cfr/text/21/211.184 21 CFR Part 211.184] 
[https://www.law.cornell.edu/cfr/text/21/225.42 21 CFR Part 225.42] 
[https://www.law.cornell.edu/cfr/text/21/226.42 21 CFR Part 226.42] 
[https://www.law.cornell.edu/cfr/text/21/606.100 21 CFR Part 606.100 (c)] 
[https://www.law.cornell.edu/cfr/text/21/820.80 21 CFR Part 820.80 (d–e)] 
[https://www.law.cornell.edu/cfr/text/21/820.90 21 CFR Part 820.90] 
[https://www.law.cornell.edu/cfr/text/21/820.160 21 CFR Part 820.160] 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (g)] 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 14.4, 14.26, and 14.28] 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.44–45] 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.36] 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.18–19]
| style="background-color:white;" |'''17.14''' The system shall prevent the internal release for distribution of a completed production batch until an authorized individual has determined the batch's conformance to final specifications and has approved it for release. If a batch is nonconforming, the system shall be able to clearly document it as such (so as to not distribute it) and provide a review and disposition process. Such approval, rejection, review, and disposition activities shall be documented.
|-
| style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/part-7/subpart-C 21 CFR Part 7 Subpart C] 
[https://www.law.cornell.edu/cfr/text/21/211.192 21 CFR Part 211.192] 
[https://www.law.cornell.edu/cfr/text/21/part-810/subpart-B 21 CFR Part 810 Subpart B] 
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf E.U. Commission Directive 2003/94/EC Article 13] 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 6.0] 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 14.32]
| style="background-color:white;" |'''17.15''' The system shall provide a means to track and record recall activities of manufactured product and devices based on lot, batch, or other identifier, including storage location, necessary disposition details, and reconciliation between distributed and recovered quantities.
|-
| style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.165 21 CFR Part 211.165 (f)] 
[https://www.law.cornell.edu/cfr/text/21/211.204 21 CFR Part 211.204] 
[https://www.law.cornell.edu/cfr/text/21/212.71 21 CFR Part 212.71 (d)] 
[https://www.law.cornell.edu/cfr/text/21/820.90 21 CFR Part 820.90 (b-2)] 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 14.29–30]
| style="background-color:white;" |'''17.16''' The system should allow a completed production batch that has been rejected for use or a returned production batch to be flagged in the system for reprocessing or reworking if it meets relevant criteria.
|-
|}
|}

← Older revision		Revision as of 20:34, 5 May 2022
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	[https://www.law.cornell.edu/cfr/text/21/820.40 21 CFR Part 820.40]<br />		[https://www.law.cornell.edu/cfr/text/21/820.40 21 CFR Part 820.40]<br />
	[https://www.law.cornell.edu/cfr/text/21/820.186 21 CFR Part 820.186]<br />		[https://www.law.cornell.edu/cfr/text/21/820.186 21 CFR Part 820.186]<br />
	[https://ec.europa.eu/~~health/sites/health~~/~~files~~/~~files~~/~~eudralex~~/~~vol-1/dir_2003_94/dir_2003_94_en.pdf~~ E.U. Commission Directive 2003/94/EC Article 11]<br />		[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 11]<br />
	[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 1.0]		[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 1.0]
	\| style="background-color:white;" \|'''17.3''' The system shall be able to maintain a production facility's quality system in a specific quality system record, in accordance with regulations and guidance such as 21 CFR Part 820.20 and 820.40 (U.S.), E.U. Commission Directive 2003/94/EC Article 11 (E.U.), and WHO Technical Report Series, #986, Annex 2, 1.0 (global).		\| style="background-color:white;" \|'''17.3''' The system shall be able to maintain a production facility's quality system in a specific quality system record, in accordance with regulations and guidance such as 21 CFR Part 820.20 and 820.40 (U.S.), E.U. Commission Directive 2003/94/EC Article 11 (E.U.), and WHO Technical Report Series, #986, Annex 2, 1.0 (global).
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	[https://www.law.cornell.edu/cfr/text/21/820.80 21 CFR Part 820.80 (c)]<br />		[https://www.law.cornell.edu/cfr/text/21/820.80 21 CFR Part 820.80 (c)]<br />
	[https://www.law.cornell.edu/cfr/text/21/820.120 21 CFR Part 820.120 (d)]<br />		[https://www.law.cornell.edu/cfr/text/21/820.120 21 CFR Part 820.120 (d)]<br />
	[https://ec.europa.eu/~~health/sites/health~~/~~files~~/~~files~~/~~eudralex~~/~~vol-1/dir_2003_94/dir_2003_94_en.pdf~~ E.U. Commission Directive 2003/94/EC Article 9.1]<br />		[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 9.1]<br />
	[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 2 and 4]<br />		[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 2 and 4]<br />
	[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 7]<br />		[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 7]<br />
Line 63:		Line 63:
	[https://www.law.cornell.edu/cfr/text/21/211.186 21 CFR Part 211.186]<br />		[https://www.law.cornell.edu/cfr/text/21/211.186 21 CFR Part 211.186]<br />
	[https://www.law.cornell.edu/cfr/text/21/212.50 21 CFR Part 212.50 (b)]<br />		[https://www.law.cornell.edu/cfr/text/21/212.50 21 CFR Part 212.50 (b)]<br />
	[https://ec.europa.eu/~~health/sites/health~~/~~files~~/~~files~~/~~eudralex~~/~~vol-1/dir_2003_94/dir_2003_94_en.pdf~~ E.U. Commission Directive 2003/94/EC Article 10.3–4]<br />		[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 10.3–4]<br />
	[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (a–b)]<br />		[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (a–b)]<br />
	[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 4.0]		[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 4.0]
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	[https://www.law.cornell.edu/cfr/text/21/820.70 21 CFR Part 820.70 (b)]<br />		[https://www.law.cornell.edu/cfr/text/21/820.70 21 CFR Part 820.70 (b)]<br />
	[https://www.law.cornell.edu/cfr/text/21/820.75 21 CFR Part 820.75]<br />		[https://www.law.cornell.edu/cfr/text/21/820.75 21 CFR Part 820.75]<br />
	[https://ec.europa.eu/~~health/sites/health~~/~~files~~/~~files~~/~~eudralex~~/~~vol-1/dir_2003_94/dir_2003_94_en.pdf~~ E.U. Commission Directive 2003/94/EC Article 10.3]<br />		[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 10.3]<br />
	[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (a–b, f)]<br />		[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (a–b, f)]<br />
	[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 4.0]		[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 4.0]
Line 135:		Line 135:
	[https://www.law.cornell.edu/cfr/text/21/211.192 21 CFR Part 211.192]<br />		[https://www.law.cornell.edu/cfr/text/21/211.192 21 CFR Part 211.192]<br />
	[https://www.law.cornell.edu/cfr/text/21/part-810/subpart-B 21 CFR Part 810 Subpart B]<br />		[https://www.law.cornell.edu/cfr/text/21/part-810/subpart-B 21 CFR Part 810 Subpart B]<br />
	[https://ec.europa.eu/~~health/sites/health~~/~~files~~/~~files~~/~~eudralex~~/~~vol-1/dir_2003_94/dir_2003_94_en.pdf~~ E.U. Commission Directive 2003/94/EC Article 13]<br />		[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 13]<br />
	[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 6.0]<br />		[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 6.0]<br />
	[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 14.32]		[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 14.32]