Difference between revisions of "Template:LIMSpec/Production management"

From LIMSWiki
Jump to navigationJump to search
m (17.6)
m (Labeling)
 
(4 intermediate revisions by the same user not shown)
Line 29: Line 29:
  |-  
  |-  
   | style="padding:5px; width:500px;" |
   | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/part-106 21 CFR Part 106.6]<br />
[https://www.law.cornell.edu/cfr/text/21/part-111 21 CFR Part 111.255–260]<br />
[https://www.law.cornell.edu/cfr/text/21/part-114 21 CFR Part 114.100 (b)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.105 21 CFR Part 211.105 (b)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.105 21 CFR Part 211.105 (b)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.130 21 CFR Part 211.130 (e)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.130 21 CFR Part 211.130 (e)]<br />
Line 43: Line 46:
[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://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 6.1.1]<br />
[https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf Codex Alimentarius CXC 1-1969, Ch.1, 7.1.1]<br />
[https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf Codex Alimentarius CXC 1-1969, Ch.1, 8.1]<br />
[https://eur-lex.europa.eu/eli/dir/2003/94/oj 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 />
[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 11]<br />
[https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 4.2.1.1]<br />
[https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 4.18.1]<br />
[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 4.2.1.1]<br />
[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 4.18.1]<br />
[https://laws-lois.justice.gc.ca/eng/regulations/SOR-2018-108/index.html Safe Food for Canadians Regulations SOR/2018-108 Division 3, 48 (3)]<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, 2.3.1–2]<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, 2.3.1–2]<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, 2.3.1–2]<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, 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]
Line 51: Line 66:
  |-  
  |-  
   | style="padding:5px; width:500px;" |
   | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/part-106 21 CFR Part 106.6]<br />
[https://www.law.cornell.edu/cfr/text/21/part-106 21 CFR Part 106.100 (e)]<br />
[https://www.law.cornell.edu/cfr/text/21/part-111 21 CFR Part 111.205–210]<br />
[https://www.law.cornell.edu/cfr/text/21/part-114 21 CFR Part 114.100 (b)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.186 21 CFR Part 211.186]<br />
[https://www.law.cornell.edu/cfr/text/21/211.186 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://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://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.6.2]<br />
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 9.2.1]<br />
[https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf Codex Alimentarius CXC 1-1969, Ch.1, 7.1.2]<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 />
[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 10.1]<br />
[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 11]<br />
[https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 4.2.1.1]<br />
[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 4.2.1.1]<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, 2.3.1–2]<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, 2.3.1–2]<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, 2.3.1–2]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.22–23]
[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="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;" |
   | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/part-106 21 CFR Part 106.100 (e)]<br />
[https://www.law.cornell.edu/cfr/text/21/part-111 21 CFR Part 111.123 (a)]<br />
[https://www.law.cornell.edu/cfr/text/21/part-114 21 CFR Part 114.100 (c)]<br />
[https://www.law.cornell.edu/cfr/text/21/part-117 21 CFR Part 117.150 (d)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.100 21 CFR Part 211.100]<br />
[https://www.law.cornell.edu/cfr/text/21/211.100 21 CFR Part 211.100]<br />
[https://www.law.cornell.edu/cfr/text/21/211.186 21 CFR Part 211.186]<br />
[https://www.law.cornell.edu/cfr/text/21/211.186 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://www.govinfo.gov/app/details/FR-1996-07-25/96-17837/summary 61 FR 38806, 9 CFR Part 417.3]<br />
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 9.2.4]<br />
[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 10.3–4]<br />
[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 10.3–4]<br />
[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 10.2]<br />
[https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 4.2.1.2]<br />
[https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 4.3.x]<br />
[https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 5.11]<br />
[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 4.2.1.2]<br />
[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 4.3.x]<br />
[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 5.11]<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, 2.3.1–2]<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, 2.3.1–2]<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, 2.3.1–2]<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]
Line 69: Line 114:
  |-
  |-
   | style="padding:5px; width:500px;" |
   | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/part-111 21 CFR Part 111.123 (a)]<br />
[https://www.law.cornell.edu/cfr/text/21/part-114 21 CFR Part 114.100 (c)]<br />
[https://www.law.cornell.edu/cfr/text/21/part-117 21 CFR Part 117.150 (d)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.22 21 CFR Part 211.22]<br />
[https://www.law.cornell.edu/cfr/text/21/211.22 21 CFR Part 211.22]<br />
[https://www.law.cornell.edu/cfr/text/21/211.192 21 CFR Part 211.192]<br />
[https://www.law.cornell.edu/cfr/text/21/211.192 21 CFR Part 211.192]<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/21/820.70 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://www.govinfo.gov/app/details/FR-1996-07-25/96-17837/summary 61 FR 38806, 9 CFR Part 417.3]<br />
[https://eur-lex.europa.eu/eli/dir/2003/94/oj 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://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 4.2.1.2]<br />
[https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 4.3.x]<br />
[https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 5.11]<br />
[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 4.2.1.2]<br />
[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 4.3.x]<br />
[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 5.11]<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, 2.3.1–2]<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, 2.3.1–2]<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, 2.3.1–2]<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 82: Line 140:
[https://www.law.cornell.edu/cfr/text/21/212.50 21 CFR Part 212.50]<br />
[https://www.law.cornell.edu/cfr/text/21/212.50 21 CFR Part 212.50]<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/21/820.80 21 CFR Part 820.80 (c)]<br />
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 4]
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 4]<br />
[https://www.iso.org/standard/44001.html ISO/TS 22002-1:2009, 14.3]
   | 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="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.
  |-
  |-
Line 89: Line 148:
  |-  
  |-  
   | style="padding:5px; width:500px;" |
   | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/part-106 21 CFR Part 106.6]<br />
[https://www.law.cornell.edu/cfr/text/21/part-106 21 CFR Part 106.80]<br />
[https://www.law.cornell.edu/cfr/text/21/part-106 21 CFR Part 106.100 (f-6)]<br />
[https://www.law.cornell.edu/cfr/text/21/part-117 21 CFR Part 117.420]<br />
[https://www.law.cornell.edu/cfr/text/21/211.122 21 CFR Part 211.122 (c)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.122 21 CFR Part 211.122 (c)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.184 21 CFR Part 211.184]<br />
[https://www.law.cornell.edu/cfr/text/21/211.184 21 CFR Part 211.184]<br />
Line 100: Line 163:
[https://www.law.cornell.edu/cfr/text/21/820.80 21 CFR Part 820.80 (b)]<br />
[https://www.law.cornell.edu/cfr/text/21/820.80 21 CFR Part 820.80 (b)]<br />
[https://www.law.cornell.edu/cfr/text/21/820.120 21 CFR Part 820.120 (b)]<br />
[https://www.law.cornell.edu/cfr/text/21/820.120 21 CFR Part 820.120 (b)]<br />
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.6.1]<br />
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.9.2]<br />
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 5.4.4]<br />
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.5.1]<br />
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 9.5.1–2]<br />
[https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8]<br />
[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, I, K - FSM 14.1.1]<br />
[https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2]<br />
[https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.3]<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, D, I, K - GMP 17]<br />
[https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 4.5.2]<br />
[https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 4.18.1]<br />
[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 4.5.2]<br />
[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 4.18.1]<br />
[https://www.iso.org/standard/44001.html ISO/TS 22002-1:2009, 9.3]<br />
[https://www.iso.org/standard/44001.html ISO/TS 22002-1:2009, 14.2]<br />
[https://www.iso.org/standard/60969.html ISO/TS 22002-4:2013, 4.6.3]<br />
[https://www.iso.org/standard/60969.html ISO/TS 22002-4:2013, 4.11.2]<br />
[https://www.iso.org/standard/66126.html ISO/TS 22002-6:2016, 4.6.3]<br />
[https://www.iso.org/standard/66126.html ISO/TS 22002-6:2016, 4.11.2]<br />
[https://laws-lois.justice.gc.ca/eng/regulations/SOR-2018-108/index.html Safe Food for Canadians Regulations SOR/2018-108 Part 5, 90]<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, 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. Any related specifications for those materials should be able to be linked to the received materials.
  |-  
  |-  
   | style="padding:5px; width:500px;" |
   | style="padding:5px; width:500px;" |
Line 110: Line 194:
[https://www.law.cornell.edu/cfr/text/21/225.42 21 CFR Part 225.42]<br />
[https://www.law.cornell.edu/cfr/text/21/225.42 21 CFR Part 225.42]<br />
[https://www.law.cornell.edu/cfr/text/21/226.42 21 CFR Part 226.42]<br />
[https://www.law.cornell.edu/cfr/text/21/226.42 21 CFR Part 226.42]<br />
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.5.3]<br />
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 9.5.3]<br />
[https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8]<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, D, I, K - GMP 17]<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, 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.
  |-  
  |-  
   | style="padding:5px; width:500px;" |
   | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/part-106 21 CFR Part 106.6]<br />
[https://www.law.cornell.edu/cfr/text/21/part-106 21 CFR Part 106.70]<br />
[https://www.law.cornell.edu/cfr/text/21/part-111 21 CFR Part 111.113]<br />
[https://www.law.cornell.edu/cfr/text/21/part-111 21 CFR Part 111.123 (b)]<br />
[https://www.law.cornell.edu/cfr/text/21/part-114 21 CFR Part 114.100 (d)]<br />
[https://www.law.cornell.edu/cfr/text/21/part-120 21 CFR Part 120.10]<br />
[https://www.law.cornell.edu/cfr/text/21/part-123 21 CFR Part 123.6]<br />
[https://www.law.cornell.edu/cfr/text/21/211.122 21 CFR Part 211.122 (e)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.122 21 CFR Part 211.122 (e)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.125 21 CFR Part 211.125 (d)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.125 21 CFR Part 211.125 (d)]<br />
Line 124: Line 219:
[https://www.law.cornell.edu/cfr/text/21/820.90 21 CFR Part 820.90]<br />
[https://www.law.cornell.edu/cfr/text/21/820.90 21 CFR Part 820.90]<br />
[https://www.law.cornell.edu/cfr/text/21/820.160 21 CFR Part 820.160]<br />
[https://www.law.cornell.edu/cfr/text/21/820.160 21 CFR Part 820.160]<br />
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.8.1]<br />
[https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf Codex Alimentarius CXC 1-1969, Ch.1, 7.2.2]<br />
[https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02005R2073-20200308 E.U. Commission Reg. No. 2073/2005 Article 7]<br />
[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 23]<br />
[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 24.1]<br />
[https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 5.7.1]<br />
[https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 5.10]<br />
[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 5.7.1]<br />
[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 5.10]<br />
[https://laws-lois.justice.gc.ca/eng/regulations/SOR-2018-108/index.html Safe Food for Canadians Regulations SOR/2018-108 Division 5, 82–84]<br />
[https://laws-lois.justice.gc.ca/eng/regulations/SOR-2018-108/index.html Safe Food for Canadians Regulations SOR/2018-108 Part 5, 90]<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, 2.4.5]<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, 2.4.7]<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, 2.4.5]<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, 2.4.7]<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, 2.4.5]<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, 2.4.7]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (g)]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (g)]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 14.4, 14.26, and 14.28]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 14.4, 14.26, and 14.28]<br />
Line 133: Line 245:
   | style="padding:5px; width:500px;" |
   | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/part-7/subpart-C 21 CFR Part 7 Subpart C]<br />
[https://www.law.cornell.edu/cfr/text/21/part-7/subpart-C 21 CFR Part 7 Subpart C]<br />
[https://www.law.cornell.edu/cfr/text/21/part-117 21 CFR Part 117.139]<br />
[https://www.law.cornell.edu/cfr/text/21/211.192 21 CFR Part 211.192]<br />
[https://www.law.cornell.edu/cfr/text/21/211.192 21 CFR Part 211.192]<br />
[https://www.law.cornell.edu/cfr/text/21/part-507 21 CFR Part 507.38]<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://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.11.2]<br />
[https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf Codex Alimentarius CXC 1-1969, Ch.1, 7.5]<br />
[https://eur-lex.europa.eu/eli/dir/2003/94/oj 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://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02005R2073-20200308 E.U. Commission Reg. No. 2073/2005 Article 7]<br />
[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]<br />
[https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 5.9.2]<br />
[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 5.9.2]<br />
[https://www.iso.org/standard/44001.html ISO/TS 22002-1:2009, 15.x]<br />
[https://www.iso.org/standard/60969.html ISO/TS 22002-4:2013, 4.12]<br />
[https://www.iso.org/standard/66126.html ISO/TS 22002-6:2016, 4.12]<br />
[https://laws-lois.justice.gc.ca/eng/regulations/SOR-2018-108/index.html Safe Food for Canadians Regulations SOR/2018-108 Division 5, 82–84]<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, 2.6.3]<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, 2.6.3]<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, 2.6.3]<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]
Line 141: Line 268:
  |-  
  |-  
   | style="padding:5px; width:500px;" |
   | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/part-111 21 CFR Part 111.520]<br />
[https://www.law.cornell.edu/cfr/text/21/211.165 21 CFR Part 211.165 (f)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.165 21 CFR Part 211.165 (f)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.204 21 CFR Part 211.204]<br />
[https://www.law.cornell.edu/cfr/text/21/211.204 21 CFR Part 211.204]<br />
[https://www.law.cornell.edu/cfr/text/21/212.71 21 CFR Part 212.71 (d)]<br />
[https://www.law.cornell.edu/cfr/text/21/212.71 21 CFR Part 212.71 (d)]<br />
[https://www.law.cornell.edu/cfr/text/21/820.90 21 CFR Part 820.90 (b-2)]<br />
[https://www.law.cornell.edu/cfr/text/21/820.90 21 CFR Part 820.90 (b-2)]<br />
[https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02005R2073-20200308 E.U. Commission Reg. No. 2073/2005 Article 7]<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, 2.4.6]<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, 2.4.6]<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, 2.4.6]<br />
[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.
  |-  
  |-  
|}
|}
|}
|}

Latest revision as of 15:09, 2 December 2022

Regulation, Specification, or Guidance Requirement
21 CFR Part 211.103
21 CFR Part 226.40 (d)
WHO Technical Report Series, #986, Annex 2, 16.4 and 16.20
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.
21 CFR Part 211.103 17.2 The system should provide a means for verification and approval of yield calculations before release for reporting.

21 CFR Part 820.20
21 CFR Part 820.40
21 CFR Part 820.186
E.U. Commission Directive 2003/94/EC Article 11
WHO Technical Report Series, #986, Annex 2, 1.0

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).
21 CFR Part 820.30
21 CFR Part 820.120 (e)
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.
21 CFR Part 820.181
21 CFR Part 820.184
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.

21 CFR Part 106.6
21 CFR Part 111.255–260
21 CFR Part 114.100 (b)
21 CFR Part 211.105 (b)
21 CFR Part 211.130 (e)
21 CFR Part 211.134 (c)
21 CFR Part 211.188
21 CFR Part 211.20 (d)
21 CFR Part 211.50 (c)
21 CFR Part 225.102
21 CFR Part 225.202
21 CFR Part 226.80
21 CFR Part 226.102
21 CFR Part 820.60
21 CFR Part 820.70 (a)
21 CFR Part 820.80 (c)
21 CFR Part 820.120 (d)
BRC GSFS, Issue 8, 6.1.1
Codex Alimentarius CXC 1-1969, Ch.1, 7.1.1
Codex Alimentarius CXC 1-1969, Ch.1, 8.1
E.U. Commission Directive 2003/94/EC Article 9.1
FDA Hazard Analysis Critical Control Point Principle 2 and 4
FDA Hazard Analysis Critical Control Point Principle 7
GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11
IFS Food 7, Part 2, 4.2.1.1
IFS Food 7, Part 2, 4.18.1
IFS PACsecure 2, Part 2, 4.2.1.1
IFS PACsecure 2, Part 2, 4.18.1
Safe Food for Canadians Regulations SOR/2018-108 Division 3, 48 (3)
SQF FSC 9, Food Manufacturing, Part B, 2.3.1–2
SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1–2
SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1–2
WHO Technical Report Series, #986, Annex 2, 2.1 (a) and (f–g)
WHO Technical Report Series, #986, Annex 2, 15.25–30

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.

21 CFR Part 106.6
21 CFR Part 106.100 (e)
21 CFR Part 111.205–210
21 CFR Part 114.100 (b)
21 CFR Part 211.186
21 CFR Part 212.50 (b)
21 CFR Part 225.102
21 CFR Part 226.102
BRC GSFS, Issue 8, 3.6.2
BRC GSFS, Issue 8, 9.2.1
Codex Alimentarius CXC 1-1969, Ch.1, 7.1.2
FDA Hazard Analysis Critical Control Point Principle 7
GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.1
GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11
IFS Food 7, Part 2, 4.2.1.1
IFS PACsecure 2, Part 2, 4.2.1.1
SQF FSC 9, Food Manufacturing, Part B, 2.3.1–2
SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1–2
SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1–2
WHO Technical Report Series, #986, Annex 2, 15.22–23

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.

21 CFR Part 106.100 (e)
21 CFR Part 111.123 (a)
21 CFR Part 114.100 (c)
21 CFR Part 117.150 (d)
21 CFR Part 211.100
21 CFR Part 211.186
21 CFR Part 212.50 (b)
61 FR 38806, 9 CFR Part 417.3
BRC GSFS, Issue 8, 9.2.4
E.U. Commission Directive 2003/94/EC Article 10.3–4
GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.2
IFS Food 7, Part 2, 4.2.1.2
IFS Food 7, Part 2, 4.3.x
IFS Food 7, Part 2, 5.11
IFS PACsecure 2, Part 2, 4.2.1.2
IFS PACsecure 2, Part 2, 4.3.x
IFS PACsecure 2, Part 2, 5.11
SQF FSC 9, Food Manufacturing, Part B, 2.3.1–2
SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1–2
SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1–2
WHO Technical Report Series, #986, Annex 2, 2.1 (a–b)
WHO Technical Report Series, #986, Annex 2, 4.0

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.

21 CFR Part 111.123 (a)
21 CFR Part 114.100 (c)
21 CFR Part 117.150 (d)
21 CFR Part 211.22
21 CFR Part 211.192
21 CFR Part 820.70 (b)
21 CFR Part 820.75
61 FR 38806, 9 CFR Part 417.3
E.U. Commission Directive 2003/94/EC Article 10.3
IFS Food 7, Part 2, 4.2.1.2
IFS Food 7, Part 2, 4.3.x
IFS Food 7, Part 2, 5.11
IFS PACsecure 2, Part 2, 4.2.1.2
IFS PACsecure 2, Part 2, 4.3.x
IFS PACsecure 2, Part 2, 5.11
SQF FSC 9, Food Manufacturing, Part B, 2.3.1–2
SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1–2
SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1–2
WHO Technical Report Series, #986, Annex 2, 2.1 (a–b, f)
WHO Technical Report Series, #986, Annex 2, 4.0

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.

21 CFR Part 211.110
21 CFR Part 212.50
21 CFR Part 820.80 (c)
FDA Hazard Analysis Critical Control Point Principle 4
ISO/TS 22002-1:2009, 14.3

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.
21 CFR Part 211.111 17.11 The system shall provide a means to track the amount of time between production processes.

21 CFR Part 106.6
21 CFR Part 106.80
21 CFR Part 106.100 (f-6)
21 CFR Part 117.420
21 CFR Part 211.122 (c)
21 CFR Part 211.184
21 CFR Part 212.20 (b)
21 CFR Part 212.40 (c) and (e)
21 CFR Part 225.42
21 CFR Part 226.40 (b)
21 CFR Part 226.42
21 CFR Part 606.120 (b)
21 CFR Part 820.60
21 CFR Part 820.80 (b)
21 CFR Part 820.120 (b)
BRC GSFS, Issue 8, 3.6.1
BRC GSFS, Issue 8, 3.9.2
BRC GSFS, Issue 8, 5.4.4
BRC GSFS, Issue 8, 3.5.1
BRC GSFS, Issue 8, 9.5.1–2
Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8
GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1
GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2
GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.3
GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17
IFS Food 7, Part 2, 4.5.2
IFS Food 7, Part 2, 4.18.1
IFS PACsecure 2, Part 2, 4.5.2
IFS PACsecure 2, Part 2, 4.18.1
ISO/TS 22002-1:2009, 9.3
ISO/TS 22002-1:2009, 14.2
ISO/TS 22002-4:2013, 4.6.3
ISO/TS 22002-4:2013, 4.11.2
ISO/TS 22002-6:2016, 4.6.3
ISO/TS 22002-6:2016, 4.11.2
Safe Food for Canadians Regulations SOR/2018-108 Part 5, 90
WHO Technical Report Series, #986, Annex 2, 14.4, 14.15, and 14.21
WHO Technical Report Series, #986, Annex 2, 15.32–33

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.

21 CFR Part 211.122 (e)
21 CFR Part 211.125 (d)
21 CFR Part 211.184
21 CFR Part 225.42
21 CFR Part 226.42
BRC GSFS, Issue 8, 3.5.3
BRC GSFS, Issue 8, 9.5.3
Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8
GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17
WHO Technical Report Series, #986, Annex 2, 14.7 and 14.22
WHO Technical Report Series, #986, Annex 2, 16.35

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.

21 CFR Part 106.6
21 CFR Part 106.70
21 CFR Part 111.113
21 CFR Part 111.123 (b)
21 CFR Part 114.100 (d)
21 CFR Part 120.10
21 CFR Part 123.6
21 CFR Part 211.122 (e)
21 CFR Part 211.125 (d)
21 CFR Part 211.184
21 CFR Part 225.42
21 CFR Part 226.42
21 CFR Part 606.100 (c)
21 CFR Part 820.80 (d–e)
21 CFR Part 820.90
21 CFR Part 820.160
BRC GSFS, Issue 8, 3.8.1
Codex Alimentarius CXC 1-1969, Ch.1, 7.2.2
E.U. Commission Reg. No. 2073/2005 Article 7
GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 23
GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1
IFS Food 7, Part 2, 5.7.1
IFS Food 7, Part 2, 5.10
IFS PACsecure 2, Part 2, 5.7.1
IFS PACsecure 2, Part 2, 5.10
Safe Food for Canadians Regulations SOR/2018-108 Division 5, 82–84
Safe Food for Canadians Regulations SOR/2018-108 Part 5, 90
SQF FSC 9, Food Manufacturing, Part B, 2.4.5
SQF FSC 9, Food Manufacturing, Part B, 2.4.7
SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.5
SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.7
SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.5
SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.7
WHO Technical Report Series, #986, Annex 2, 2.1 (g)
WHO Technical Report Series, #986, Annex 2, 14.4, 14.26, and 14.28
WHO Technical Report Series, #986, Annex 2, 15.44–45
WHO Technical Report Series, #986, Annex 2, 16.36
WHO Technical Report Series, #986, Annex 2, 17.18–19

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.

21 CFR Part 7 Subpart C
21 CFR Part 117.139
21 CFR Part 211.192
21 CFR Part 507.38
21 CFR Part 810 Subpart B
BRC GSFS, Issue 8, 3.11.2
Codex Alimentarius CXC 1-1969, Ch.1, 7.5
E.U. Commission Directive 2003/94/EC Article 13
E.U. Commission Reg. No. 2073/2005 Article 7
GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22
IFS Food 7, Part 2, 5.9.2
IFS PACsecure 2, Part 2, 5.9.2
ISO/TS 22002-1:2009, 15.x
ISO/TS 22002-4:2013, 4.12
ISO/TS 22002-6:2016, 4.12
Safe Food for Canadians Regulations SOR/2018-108 Division 5, 82–84
SQF FSC 9, Food Manufacturing, Part B, 2.6.3
SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.3
SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.3
WHO Technical Report Series, #986, Annex 2, 6.0
WHO Technical Report Series, #986, Annex 2, 14.32

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.

21 CFR Part 111.520
21 CFR Part 211.165 (f)
21 CFR Part 211.204
21 CFR Part 212.71 (d)
21 CFR Part 820.90 (b-2)
E.U. Commission Reg. No. 2073/2005 Article 7
SQF FSC 9, Food Manufacturing, Part B, 2.4.6
SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.6
SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.6
WHO Technical Report Series, #986, Annex 2, 14.29–30

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.

21 CFR Part 112.145
BRC GSFS, Issue 8, 4.11.8.x
E.U. Commission Reg. No. 2073/2005 Article 5
GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, I - FSM 19.2
ISO/TS 22002-1:2009, 11.5
SQF FSC 9, Food Manufacturing, Part B, 2.4.8
SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.8
SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.8

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.