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==Introduction== | ==Introduction== | ||
Numerous regulations, standards, and | |||
==Blah blah== | |||
Numerous regulations, standards, recommendations, and guidelines make clear that incident management and corrective action must be addressed by businesses in multiple industries, not only within their workflows and processes but also within the information systems they use to better manage those workflows and processes. Examples include: | |||
* 9 CFR Part 417 - Hazard Analysis and Critical Control Point (HACCP) Systems[https://www.govinfo.gov/app/details/FR-1996-07-25/96-17837/summary 61 FR 38806, 9 CFR Part 417.3] | * 9 CFR Part 417 - Hazard Analysis and Critical Control Point (HACCP) Systems[https://www.govinfo.gov/app/details/FR-1996-07-25/96-17837/summary 61 FR 38806, 9 CFR Part 417.3] | ||
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* ASTM E1578-18 - Standard Guide for Laboratory Informatics[https://www.astm.org/e1578-18.html ASTM E1578-18 E-9-5] | * ASTM E1578-18 - Standard Guide for Laboratory Informatics[https://www.astm.org/e1578-18.html ASTM E1578-18 E-9-5] | ||
* BRC Global Standard Food Safety[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.4.3][https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 5.6.1.2][https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 9.3.5] | * BRC Global Standard Food Safety[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.4.3][https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 5.6.1.2][https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 9.3.5] | ||
* CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition[https://www.cdc.gov/labs/BMBL.html CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition] | |||
[https://www.cdc.gov/labs/BMBL.html CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition] | * E.U. Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 13] | ||
* FDA HACCP Principles & Application Guidelines[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 5] | |||
* GFSI Benchmarking Requirements, Version 2020[https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22] | |||
[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 13] | * NYSDOH ELAP Medical Marijuana Microbiology Guidance[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf NYSDOH ELAP Medical Marijuana Microbiology Guidance] | ||
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 5] | * NIST 800-53, Rev. 5 - Security and Privacy Controls for Information Systems and Organizations[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-6(1)][https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IR-4(1) and IR-5][https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, SI-2 and SI-4] | ||
[https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22] | * SQF Institute Food Safety Code, Food Manufacturing, Pet Food Manufacturing, and Manufacture of Food Packaging[https://www.sqfi.com/docs/sqfilibraries/code-documents/edition-9/code-pdfs/20227fmin_foodmanufacturing_v3-2-final-w-links.pdf SQF FSC 9, Food Manufacturing, Part B, 2.5.3][https://www.sqfi.com/docs/sqfilibraries/code-documents/edition-9/code-pdfs/20227fmin_petfood_v3-2-final-w-links.pdf SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3][https://www.sqfi.com/docs/sqfilibraries/code-documents/edition-9/code-pdfs/20227fmin_foodpackaging_v3-2-final-w-links.pdf SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3] | ||
[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf NYSDOH ELAP Medical Marijuana Microbiology Guidance] | * WHO Technical Report Series, #986, Annex 2 - WHO good manufacturing practices for pharmaceutical products: Main principles[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)][https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 5.0] | ||
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-6(1)] | |||
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IR-4(1) and IR-5] | |||
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, SI-2 and SI-4] | |||
[https://www.sqfi.com/docs/sqfilibraries/code-documents/edition-9/code-pdfs/20227fmin_foodmanufacturing_v3-2-final-w-links.pdf SQF FSC 9, Food Manufacturing, Part B, 2.5.3] | |||
[https://www.sqfi.com/docs/sqfilibraries/code-documents/edition-9/code-pdfs/20227fmin_petfood_v3-2-final-w-links.pdf SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3] | |||
[https://www.sqfi.com/docs/sqfilibraries/code-documents/edition-9/code-pdfs/20227fmin_foodpackaging_v3-2-final-w-links.pdf SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3] | |||
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)] | |||
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 5.0] | |||
==Conclusion== | ==Conclusion== | ||
Revision as of 00:07, 22 February 2024
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[[File:|right|400px]] Title: How can a LIMS help a food and beverage laboratory better handle incident management and corrective action?
Author for citation: Shawn E. Douglas
License for content: Creative Commons Attribution-ShareAlike 4.0 International
Publication date: February 2024
Introduction
Blah blah
Numerous regulations, standards, recommendations, and guidelines make clear that incident management and corrective action must be addressed by businesses in multiple industries, not only within their workflows and processes but also within the information systems they use to better manage those workflows and processes. Examples include:
- 9 CFR Part 417 - Hazard Analysis and Critical Control Point (HACCP) Systems61 FR 38806, 9 CFR Part 417.3
- 21 CFR Part 225 - Current Good Manufacturing Practice for Medicated Feeds 21 CFR Part 225.58 (d)21 CFR Part 225.158
- 42 CFR Part 493, Subpart K - Quality System for Nonwaived [Clinical] Testing 42 CFR Part 493.128242 CFR Part 493.1289
- A2LA C211 - Specific Checklist, Combined ISO-IEC 17025-2017 and Veterinary Laboratory Accreditation ProgramA2LA C211 4.8 and 4.11
- ASTM E1578-18 - Standard Guide for Laboratory InformaticsASTM E1578-18 E-9-5
- BRC Global Standard Food SafetyBRC GSFS, Issue 8, 3.4.3BRC GSFS, Issue 8, 5.6.1.2BRC GSFS, Issue 8, 9.3.5
- CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th EditionCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition
- E.U. Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human useE.U. Commission Directive 2003/94/EC Article 13
- FDA HACCP Principles & Application GuidelinesFDA Hazard Analysis Critical Control Point Principle 5
- GFSI Benchmarking Requirements, Version 2020GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22
- NYSDOH ELAP Medical Marijuana Microbiology GuidanceNYSDOH ELAP Medical Marijuana Microbiology Guidance
- NIST 800-53, Rev. 5 - Security and Privacy Controls for Information Systems and OrganizationsNIST 800-53, Rev. 5, AU-6(1)NIST 800-53, Rev. 5, IR-4(1) and IR-5NIST 800-53, Rev. 5, SI-2 and SI-4
- SQF Institute Food Safety Code, Food Manufacturing, Pet Food Manufacturing, and Manufacture of Food PackagingSQF FSC 9, Food Manufacturing, Part B, 2.5.3SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3
- WHO Technical Report Series, #986, Annex 2 - WHO good manufacturing practices for pharmaceutical products: Main principlesWHO Technical Report Series, #986, Annex 2, 2.1 (f, j)WHO Technical Report Series, #986, Annex 2, 5.0
Conclusion
References
