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==2. Standards and regulations affecting food and beverage labs==
==Sandbox begins below==
Societies around the world have grown to expect and depend on high-quality, nutritious foods and beverages, whether coming directly from a farm or being produced by a food and beverage manufacturer. With the history of food and beverage safety having a somewhat checkered past until the early twentieth century<ref name="DouglasImportance22">{{cite web |url=https://www.limswiki.org/index.php/LIMS_FAQ:What_is_the_importance_of_a_food_and_beverage_testing_laboratory_to_society? |title=LIMS FAQ:What is the importance of a food and beverage testing laboratory to society? |author=Douglas, S. |work=LIMSwiki |date=August 2022 |accessdate=02 December 2022}}</ref>, this expectation hasn't always been easy to meet. However, with better understanding of food safety and greater efforts to standardize and regulate it, governments and producers have improved food quality and safety into the twenty-first century. Yet any assurances coming from these efforts to standardize and regulate are dependent upon rigorous and validated methods not only in the production facility but also in any [[laboratory]] making analyses for the facility.
[[File:Battery Manufacturing Lab (50954228316).jpg|right|500px]]


This chapter will briefly examine the standards, regulations, guidance, and other factors globally driven by not only the demand for safer foods and beverages, but also that in many cases dictate what and how quality activities are conducted towards ensuring food safety around the world inside and outside the food and beverage laboratory.
'''Title''': ''LIMS Selection Guide for Manufacturing Quality Control''


'''Edition''': First Edition


===2.1 Globally recognized food safety standards===
'''Author for citation''': Shawn E. Douglas
Like other industries, the food and beverage industry depends on well-defined and -justified standards to better ensure the quality of their products. Implementing and maintaining conformance to internationally recognized and benchmarked food safety standards benefits the food and beverage organization in a number of ways<ref name="PavlovićWhat17">{{cite web |url=https://www.ideagen.com/thought-leadership/blog/what-is-brc-global-food-safety-standard-explained |title=What is BRC? Global food safety standard explained |author=Pavlović, A. |work=Ideagen Blog |publisher=Ideagen Limited |date=26 June 2017 |accessdate=10 November 2022}}</ref><ref name="PJBRCGS20">{{cite web |url=https://www.pjfsc.com/Downloads/BRC-Overview.pdf |format=PDF |title=BRCGS - British Retail Consortium Global Standard |publisher=Perry Johnson Food Safety Consulting, Inc |date=April 2020 |accessdate=10  November 2022}}</ref>:


*It increases customer confidence through the organization's audited certification to the standard, taking the place of customers' own auditing methods to ensure quality and authenticity, in turn reducing time and costs.
'''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International]
*It drives organizations to better monitor their activities for non-conformities, identify root causes, and develop preventative controls, while clearly reporting such efforts to customers, further reducing the need for customer audits.
*It better ensures a rigorous and comprehensive approach to product safety, quality, integrity, and legality, in many cases meeting or exceeding local, state, federal, and/or international legislative requirements.
*It drives organizations to better vet their suppliers and service providers for meeting required food safety management practices.
*It enables organizations to better demonstrate auditable compliance with modern food safety management practices.
*It allows organizations to limit product recalls, reduce customer complaints, and better protect their brand.


As such, food and beverage researchers and manufacturers adopt standards from one or more organizations around the world, not only to benefit their operations but also meet or exceed regulatory requirements for their industry. What follows are some of the more critical standards and guidelines that apply to the food, beverage, and feed industries.
'''Publication date''': To be determined


====2.1.1 British Retail Consortium (BRC) Global Standard for Food Safety (GSFS)====
In 1998, the [[wikipedia:British Retail Consortium|British Retail Consortium]] (BRD) published the first edition of its Global Standard for Food Safety (GSFS), going on to become an internationally recognized standard of best practices in food manufacturing, storage, and distribution, and the first food safety standard to be recognized by the Global Food Safety Initiative (GFSI; discussed later). The standard covers stakeholder buy-in on continual improvement, food safety plan development, food quality management system development, manufacturing and storage site standardization, product and process control, personnel management, risk management, and trade product management.<ref name="PavlovićWhat17" /><ref name="PJBRCGS20" /><ref name="EagleFood19">{{cite web |url=https://vertassets.blob.core.windows.net/download/45fe7af4/45fe7af4-0500-4163-bd2b-5dd34e824bfd/eagle_wp_food_safetyquality_regulations_guide_a4_en.pdf |format=PDF |title=Food Safety and Quality Regulations: A Guide to Global Standards |publisher=Eagle Product Inspection |date=May 2019 |accessdate=10 November 2022}}</ref><ref name="BRCGSFS8_18">{{cite web |url=https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf |format=PDF |title=Global Standard Food Safety |author=British Retail Consortium |publisher=British Retail Consortium |date=August 2018 |accessdate=10 November 2022}}</ref> The standard is implemented by an organization through gap assessment, documentation development, consultation and assessment, internal auditing, and resolving non-conformances to the standard.<ref name="PJBRCGS20" />


====2.1.2 Codex Alimentarius====
To be written...
The [[wikipedia:Codex Alimentarius|Codex Alimentarius]] is a collection of internationally recognized food and feed standards and guidelines developed as a joint venture between the United Nation's Food and Agricultural Organization (FAO) and the [[World Health Organization]] (WHO).<ref name="EagleFood19" /> The Codex "is intended to guide and promote the elaboration and establishment of definitions and requirements for foods to assist in their harmonization and in doing so to facilitate international trade."<ref name="FAOCodexAbout">{{cite web |url=https://www.fao.org/fao-who-codexalimentarius/about-codex/en/#c453333 |title=About Codex Alimentarius |publisher=Food and Agricultural Organization |date=2022 |accessdate=10 November 2022}}</ref> Scope of the standards is broad, covering food hygiene; food additives and contaminants, including pesticides and drugs; packaging and labelling; sampling and analysis methods; and import and export inspection and certification.<ref name="FAOCodexAbout" /> It's not unusual for governments to approach the FAO seeking help with harmonizing national legal frameworks of food safety with the Codex Alimentarius.<ref name="FOAFood22">{{cite web |url=https://www.fao.org/food-safety/food-control-systems/policy-and-legal-frameworks/food-laws-and-regulations/en/ |title=Food laws & regulations |publisher=Food and Agricultural Organization |date=2022 |accessdate=10 November 2022}}</ref> Among the Codex, some of the more broadly useful standards include General Principles of Food Hygiene (CXC 1-1969)<ref name="FAOCodes22">{{cite web |url=https://www.fao.org/fao-who-codexalimentarius/codex-texts/codes-of-practice/en/ |title=Codes of Practice |work=Codex Alimentarius |publisher=Food and Agricultural Organization |date=2022 |accessdate=10 November 2022}}</ref>, General Standard for Contaminants and Toxins in Food and Feed (CXS 193-1995), and General Methods of Analysis for Contaminants (CXS 228-2001).<ref name="FAOContam22">{{cite web |url=https://www.fao.org/fao-who-codexalimentarius/thematic-areas/contaminants/en/ |title=Contaminants |work=Codex Alimentarius |publisher=Food and Agricultural Organization |date=2022 |accessdate=10 November 2022}}</ref>


====2.1.3 Global Food Safety Initiative (GFSI)====
The table of contents for ''LIMS Selection Guide for Manufacturing Quality Control'' is as follows:
The [[wikipedia:Global Food Safety Initiative|GFSI]] is a collection of private organizations that has developed a set of benchmarking requirements for improving food safety management programs, with a goal of making them balanced enough to be broadly applicable while remaining relevant to different countries and regions of the world.<ref name="EagleFood19" /> Previously known as the GFSI Guidance Document<ref name="GFSIRelease17">{{cite web |url=https://mygfsi.com/press_releases/gfsi-releases-new-edition-of-benchmarking-requirements/ |title=GFSI Releases New Edition of Benchmarking Requirements |publisher=Global Food Safety Initiative |date=28 February 2017 |accessdate=10 November 2022}}</ref>, the GFSI Benchmarking Requirements act as a set of criteria and professional framework for food safety management programs to fulfill, formally allowing an organization to be recognized and certified by the GFSI. Certification to the GFSI Benchmarking Requirements "demonstrates an organization’s serious commitment to food safety to customers and potential customers across the world."<ref name="EagleFood19" /> An organization seeks out a third-party certification program owner (CPO) and undergoes the auditing process, which is driven and supported by the GFSI Benchmarking Requirements.<ref name="GFSICert22">{{cite web |url=https://mygfsi.com/how-to-implement/certification/ |title=Certification |publisher=Global Food Safety Initiative |date=2022 |accessdate=10 November 2022}}</ref> GFSI is also responsible for ensuring CPOs and certification bodies meet the necessary requirements.


====2.1.4 Hazard analysis and critical control points (HACCP)====
The [[wikipedia:Hazard analysis and critical control points|hazard analysis and critical control points]] or HACCP system has been adopted and integrated in various ways over the years<ref name="WeinrothHist18">{{Cite journal |last=Weinroth |first=Margaret D |last2=Belk |first2=Aeriel D |last3=Belk |first3=Keith E |date=2018-11-09 |title=History, development, and current status of food safety systems worldwide |url=https://academic.oup.com/af/article/8/4/9/5087923 |journal=Animal Frontiers |language=en |volume=8 |issue=4 |pages=9–15 |doi=10.1093/af/vfy016 |issn=2160-6056 |pmc=PMC6951898 |pmid=32002225}}</ref>, but at its core, the system directs organizations to focus on key areas or "critical control points" (CCPs) of vulnerability and hazard within the production process and mitigate their impact on overall food safety.<ref name="EagleFood19" /> Though the seeds of HACCP go back to the 1970s, it wasn't until the mid-1990s that it began finding its way into formal regulatory structures in the United States, first codified as 9 CFR Parts 304, 308, 310, 320, 327, 381, 416, and 417 in July 1996.<ref name="WeinrothHist18" /><ref name="61FR38806">{{cite web |url=https://www.govinfo.gov/app/details/FR-1996-07-25/96-17837/summary |title=61 FR 38806 - Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems |work=Federal Register |publisher=U.S. Government Publishing Office |date=25 July 1996 |accessdate=10 November 2022}}</ref> HACCP also found its way into other standards benchmarked by the GFSI.<ref name="WeinrothHist18" /> The concept of HACCP has perhaps changed slightly over the years, but the main principles remain<ref name="EagleFood19" />:


#Conduct a hazard analysis.
<!--:[[LII:LIMS Selection Guide for Manufacturing Quality Control/Introduction to manufacturing laboratories|1. Introduction to manufacturing laboratories]]//-->
#Identify CCPs.
:[[User:Shawndouglas/sandbox/sublevel9|1. Introduction to manufacturing laboratories]]
#Establish critical limits for those CCPs.
::1.1 Manufacturing labs, then and now
#Establish monitoring procedures for those CCPs.
::1.2 Laboratory roles and testing in the industry
#Establish corrective action for failed limits.
:::1.2.1 R&D roles and testing
#Establish verification procedures.
:::1.2.2 Pre-manufacturing and manufacturing roles and testing
#Establish record keeping and documentation procedures.
:::1.2.3 Post-production regulation and security roles and testing
:::1.2.4 Tangential laboratory work
::1.3 Safety and quality in the manufacturing industry


====2.1.5 International Featured Standards (IFS)====
<!--:[[LII:LIMS Selection Guide for Manufacturing Quality Control/Standards and regulations affecting manufacturing labs|2. Standards and regulations affecting manufacturing labs]]//-->
The IFS framework is made up of a group of eight food and non-food standards, covering various processes along the food supply chain. IFS Management, who is responsible for the standards, notes that "IFS does not specify what these processes must look like but merely provides a risk-based assessment"<ref name="IFSHome">{{cite web |url=https://www.ifs-certification.com/index.php/en/ |title=IFS: Global Safety and Quality Standards |publisher=IFS Management GmbH |accessdate=10 November 2022}}</ref> or "uniform evaluation system"<ref name="EagleFood19" /> for them. Organizations such as food manufacturers and logistics providers can certify to the standards. Some of the more relevant to food and beverage laboratories include IFS Food (for food manufacturers), IFS Global Markets Food (for food retailers), IFS PACsecure 2 (for packaging manufactures), and IFS Global Markets PACsecure (for packaging suppliers).<ref name="IFSStandards">{{cite web |url=https://www.ifs-certification.com/index.php/en/standards |title=IFS Standards |publisher=IFS Management GmbH |accessdate=10 November 2022}}</ref>
:[[User:Shawndouglas/sandbox/sublevel10|2. Standards and regulations affecting manufacturing labs]]
::2.1 Globally recognized manufacturing standards
:::2.1.1 Food and beverage
:::2.1.2 Materials
:::2.1.3 Pharmaceutical and medical devices
:::2.1.4 Other industries
::2.2 Regulations and laws around the world
:::2.2.1 Food and beverage
:::2.2.2 Materials
:::2.2.3 Pharmaceutical and medical devices
:::2.3.4 Other industries
::2.3 Other influencing factors
:::2.3.1 Good manufacturing practice (GMP) and current good manufacturing practice (cGMP)
:::2.3.2 Standards and Scientific Advice on Food and Nutrition (SSA)


====2.1.6 International Organization for Standardization (ISO) 22000====
<!--:[[LII:LIMS Selection Guide for Manufacturing Quality Control/Choosing laboratory informatics software for your manufacturing lab|3. Choosing laboratory informatics software for your manufacturing lab]]//-->
The [[wikipedia:ISO 22000|ISO 22000]] series of standards addresses how a food safety management system should be set up and operated, and how organizations can be certified to the standard by a third-party auditor.<ref name="ISO22000">{{cite web |url=https://www.iso.org/iso-22000-food-safety-management.html |title=ISO 22000 Food safety management |publisher=International Organization for Standardization |accessdate=10 November 2022}}</ref> ISO 22000 is based off the [[ISO 9000]] family of [[quality management system]] standards and, like other standards, incorporates elements of HACCP.<ref name="WeinrothHist18" /> The standard claims to be advantaged compared to other standards due to its comprehensive applicability across an entire organization, and across the entire food chain.<ref name="ISO22000Home">{{cite web |url=https://committee.iso.org/home/tc34sc17 |title=ISO/TC34/SC17 |publisher=International Organization for Standardization |accessdate=10 November 2022}}</ref> Major standards applicable to manufacturers with laboratories include:
:[[User:Shawndouglas/sandbox/sublevel11|3. Choosing laboratory informatics software for your manufacturing lab]]
::3.1 Evaluation and selection
:::3.1.1 Technology considerations
::::3.1.1.1 Laboratory informatics options
:::3.1.2 Features and functions
::::3.1.2.1 Base features
::::3.1.2.2 Specialty features
:::3.1.3 Cybersecurity considerations
:::3.1.4 Regulatory compliance considerations
:::3.1.5 System flexibility
:::3.1.6 Cost considerations
::3.2 Implementation
:::3.2.1 Internal and external integrations
::3.3 MSW, updates, and other contracted services
::3.4 How a user requirements specification fits into the entire process (LIMSpec)


*ISO/TS 22002-1:2009 ''Prerequisite programmes on food safety — Part 1: Food manufacturing''<ref name="ISO22002-1">{{cite web |url=https://www.iso.org/standard/44001.html |title=ISO/TS 22002-1:2009 Prerequisite programmes on food safety — Part 1: Food manufacturing |publisher=International Organization for Standardization |date=December 2009 |accessdate=10 November 2022}}</ref>
<!--::[[LII:LIMS Selection Guide for Manufacturing Quality Control/Resources for selecting and implementing informatics solutions|4. Resources for selecting and implementing informatics solutions]]//-->
*ISO/TS 22002-4:2013 ''Prerequisite programmes on food safety — Part 4: Food packaging manufacturing''<ref name="ISO22002-4">{{cite web |url=https://www.iso.org/standard/60969.html |title=ISO/TS 22002-4:2013 Prerequisite programmes on food safety — Part 4: Food packaging manufacturing |publisher=International Organization for Standardization |date=December 2013 |accessdate=10 November 2022}}</ref>
:[[User:Shawndouglas/sandbox/sublevel12|4. Resources for selecting and implementing informatics solutions]]
*ISO/TS 22002-6:2016 ''Prerequisite programmes on food safety — Part 6: Feed and animal food production''<ref name="ISO22002-6">{{cite web |url=https://www.iso.org/standard/66126.html |title=ISO/TS 22002-6:2016 Prerequisite programmes on food safety — Part 6: Feed and animal food production |publisher=International Organization for Standardization |date=April 2016 |accessdate=10 November 2022}}</ref>
::4.1 LIMS vendors
::4.2 Consultants
::4.3 Professional
:::4.3.1 Trade organizations
:::4.3.2 Conferences and trade shows
::4.4 LIMSpec


====2.1.8 Safe Quality Food (SQF) Program====
<!--::[[LII:LIMS Selection Guide for Manufacturing Quality Control/Taking the next step|5. Taking the next step]]//-->
The SQF Program, headlined by the SQF Institute and recognized by the GFSI, is a food "safety-plus-quality" management certification mechanism that covers the food supply chain from farm to fork.<ref name="EagleFood19" /> Those who wish to be certified to SQF must comply with SQF Code, which covers a variety of topics, from aquaculture and farming to food packaging and food and feed manufacturing.<ref name="SQFCode">{{cite web |url=https://www.sqfi.com/resource-center/sqf-code-edition-9-downloads/ |title=SQF Code – Edition 9 Downloads |publisher=SQF Institute |date=24 May 2021 |accessdate=10 November 2022}}</ref> Like other standards, the organization wanting to be accredited finds a certified third-party auditor to administer program certification.
:[[User:Shawndouglas/sandbox/sublevel13|5. Taking the next step]]
::5.1 Conduct initial research into a specification document tailored to your lab's needs
::5.2 Issue some of the specification as part of a request for information (RFI)
::5.3 Respond to or open dialogue with vendors
:::5.3.1 The value of demonstrations
::5.4 Finalize the requirements specification and choose a vendor


<!--::[[LII:LIMS Selection Guide for Manufacturing Quality Control/Closing remarks|6. Closing remarks]]//-->
:[[User:Shawndouglas/sandbox/sublevel14|6. Closing remarks]]


===2.2 Regulations and laws around the world===
<!--::[[LII:LIMS Selection Guide for Manufacturing Quality Control/Blank LIMSpec template for manufacturing labs|Appendix 1. Blank LIMSpec template for manufacturing labs]]//-->
The safety and quality of food is a high priority for most countries around the world, though how that safety and quality is regulated and legislated varies, sometimes significantly. The following subsections briefly address the primary regulations and legislation enacted in seven major countries and supranational unions around the world. (It is beyond the scope of this FAQ to address them all.) Similarities among the countries may be seen in their goals, but it should be noted that differences—significant and nuanced—exist among them all in regards to regulatory approaches to sampling, testing, risk, and importing<ref name="BuzbyFood03">{{cite web |url=https://www.ers.usda.gov/amber-waves/2003/november/food-safety-and-trade-regulations-risks-and-reconciliation/ |title=Food Safety and Trade: Regulations, Risks, and Reconciliation |author=Buzby, J.C.; Mitchell, L. |work=Amber Waves |publisher=U.S. Department of Agriculture, Economic Research Service |date=01 November 2003 |accessdate=13 November 2022}}</ref><ref name="GAOFoodSafety05">{{cite web |url=https://www.gao.gov/products/gao-05-212 |title=Food Safety: Experiences of Seven Countries in Consolidating Their Food Safety Systems |author=U.S. Government Accountability Office |date=February 2005 |accessdate=13 November 2022}}</ref><ref name="WhitworthReport22">{{cite web |url=https://www.foodsafetynews.com/2022/02/report-finds-food-testing-policies-different-between-countries/ |title=Report finds food testing policies different between countries |author=Whitworth, J. |work=Food Safety News |date=22 February 2022 |accessdate=13 November 2022}}</ref>, which should not be surprising given the cultural, political, and functional differences across regions and nations of the world.<ref name="BuzbyFood03" />
:[[User:Shawndouglas/sandbox/sublevel15|Appendix 1. Blank LIMSpec template for manufacturing labs]]
::A1. Introduction and methodology
::A2. Primary laboratory workflow
::A3. Maintaining laboratory workflow and operations
::A4. Specialty laboratory functions
::A5. Technology and performance improvements
::A6. Security and integrity of systems and operations
::A7. Putting those requirements to practical use and caveats
::A8. LIMSpec in Microsoft Word format


====2.2.1 Food Safety Act 1990 and Food Standards Act 1999 - ''United Kingdom''====
<!---Place all category tags here-->
The [[wikipedia:Food Safety Act 1990|Food Safety Act of 1990]] and [[wikipedia:Food Standards Agency|Food Standards Act of 1999]] represent the core of food safety regulation in the United Kingdom, though there are other pieces of legislation that also have an impact.<ref name="SBCFood22">{{cite web |url=https://www.scarborough.gov.uk/home/business-licensing-and-grants/food-hygeine/food-safety-regulations |title=Food safety regulations |publisher=Scarborough Borough Council |date=10 November 2022 |accessdate=10 November 2022}}</ref><ref name="FSAKey22">{{cite web |url=https://www.food.gov.uk/about-us/key-regulations |title=Key regulations |publisher=Food Standards Agency |date=30 August 2022 |accessdate=10 November 2022}}</ref> The Food Safety Act of 1990 encourages entities to "not include anything in food, remove anything from food, or treat food in any way which means it would be damaging to the health of people eating it"; serve or sell food that is of a quality that "consumers would expect"; and ensure food is labeled, advertised, and presented clearly and truthfully.<ref name="SBCFood22" /><ref name="FSAKey22" /> The Food Standards Act of 1999 later created the UK's Food Standards Agency (FSA) "to protect public health from risks which may arise in connection with the consumption of food (including risks caused by the way in which it is produced or supplied) and otherwise to protect the interests of consumers in relation to food."<ref name="FSA99Sec1">{{cite web |url=https://www.legislation.gov.uk/ukpga/1999/28/section/1 |title=1999 c. 28, The Food Standards Agency, Section 1 |work=legislation.gov.uk |accessdate=10 November 2022}}</ref> One of the ways the FSA does this is through enforcing food safety regulation at the local level, including within food production facilities, as well as setting ingredient and nutrition labelling policy.<ref name="FSAAbout">{{cite web |url=https://www.gov.uk/government/organisations/food-standards-agency |title=Food Standards Agency |work=Gov.uk |accessdate=13 November 2022}}</ref> Regulations and guidance from the FSA address not only labelling but also radioactivity monitoring, meat processing, manure management, ''Salmonella'' testing, temperature control, dairy hygiene, and more.<ref name="FSAGuidReg">{{cite web |url=https://www.gov.uk/search/guidance-and-regulation?organisations%5B%5D=food-standards-agency&parent=food-standards-agency |title=Guidance and regulation: Food Standards Agency (FSA) |work=Gov.uk |accessdate=13 November 2022}}</ref>
 
====2.2.2 Food Safety and Standards Act of 2006 - ''India''====
This act was enacted in 2006 to both consolidate existing food-related law and to establish the Food Safety and Standards Authority of India (FSSAI), which develops regulations and standards of practice for the manufacture, storage, distribution, and packaging of food.<ref name="PRSImplement">{{cite web |url=https://prsindia.org/policy/report-summaries/implementation-food-safety-and-standards-act-2006 |title=Implementation of Food Safety and Standards Act, 2006 |work=PRS Legislative Research |accessdate=13 November 2022}}</ref><ref name="FSSAIFood">{{cite web |url=https://fssai.gov.in/cms/food-safety-and-standards-act-2006.php |title=Food Safety and Standards Act, 2006 |publisher=Food Safety and Standards Authority of India |accessdate=13 November 2022}}</ref> However, an audit of FSSAI by the Comptroller and Auditor General of India (CAG) in December 2017 revealed some deficiencies in the FSSAI's activities, including an overall "low quality" of food testing laboratories in the country.<ref name="PRSImplement" /> Nonetheless, the FSSAI remains the primary regulatory watchdog, developing standards and guidelines for food and enforcing those standards. This includes setting limits for food additives, contaminants, pesticides, drugs, heavy metals, and more, as well as defining quality control mechanisms, accreditation requirements, sampling and analytical techniques, and more.<ref name="FSSAIFood" />
 
====2.2.3 Food Safety Law - ''China''====
The [[wikipedia:Food safety in China|Food Safety Law]] is described as "the fundamental law regulating food safety in China."<ref name="UNEPFood15">{{cite web |url=https://leap.unep.org/countries/cn/national-legislation/food-safety-law-2015 |title=Food Safety Law (2015) |author=Food and Agriculture Organization of the United Nations |work=Law and Environment Assistance Platform |publisher=United Nations Environmental Programme |date=24 April 2015 |accessdate=13 November 2022}}</ref> Enacted in 2009 and revised in 2015, the Law "builds up the basic legal framework for food safety supervision and management" and  "introduces many new regulatory requirements," including "not only general requirements applicable to food and food additives, but also specific requirements for food-related products and other product categories."<ref name="UNEPFood15" /> Among these activities, the Law describes how food testing laboratories shall conduct their activities, from accreditation and sampling to testing and reporting.<ref name="USDAChina15">{{cite web |url=https://apps.fas.usda.gov/newgainapi/api/report/downloadreportbyfilename?filename=Amended%20Food%20Safety%20Law%20of%20China_Beijing_China%20-%20Peoples%20Republic%20of_5-18-2015.pdf |format=PDF |title=China's Food Safety Law (2015) |author=Foreign Agriculture Service Staff |publisher=U.S. Department of Agriculture |work=GAIN Repo |date=18 May 2015 |accessdate=13 November 2022}}</ref>
 
====2.2.4 Food Sanitation Act and Food Safety Basic Act - ''Japan''====
The Food Sanitation Act of 1947 and the Food Safety Basic Act of 2003 represent the most important pieces of food-related legislation in Japan, though there are others. The Food Sanitation Act was originally enacted "to prevent sanitation hazards resulting from eating and drinking by enforcing regulations and other measures necessary from the viewpoint of public health, to ensure food safety and thereby to protect citizens' health."<ref name="JLTFood47">{{cite web |url=https://www.japaneselawtranslation.go.jp/en/laws/view/3687/en |title=Food Sanitation Act (Act No. 233 of 1947) |work=Japanese Law Translation |date=24 December 1947 |accessdate=13 November 2023}}</ref> The Food Safety Basic Act recognized the effects of "internationalization" and changing dietary habits, as well as scientific and technological shifts in food production, as a primary driver for modernizing food safety and sustainability in the country, and it also created the Food Safety Commission of Japan.<ref name="FSCFoodSafe03">{{cite web |url=https://www.fsc.go.jp/english/basic_act/fs_basic_act.pdf |format=PDF |title=Food Safety Basic Act |publisher=Food Safety Commission of Japan |date=23 May 2003 |accessdate=13 November 2022}}</ref> Between the two pieces of legislation, standards and specifications for food and food additives, as well as associated tools and packaging, are addressed, as are inspection standards, production standards, hygiene management, and individual food and ingredient safety.<ref name="BMFoodJapan18">{{cite web |url=https://resourcehub.bakermckenzie.com/en/resources/asia-pacific-food-law-guide/asia-pacific/japan/topics/food-product-and-safety-regulation |title=Japan: Food product and safety regulation |work=Asia Pacific Food Law Guide |author=Baker McKenzie |date=2018 |accessdate=13 November 2022}}</ref>
 
====2.2.5 Food Safety Modernization Act (FSMA) and other acts - ''United States''====
The [[wikipedia:FDA Food Safety Modernization Act|Food Safety Modernization Act]] of the United States was signed into law in January 2011, giving the US Food and Drug Administration (FDA) more regulatory authority to address the way food is grown, harvested, and processed.<ref name="WeinrothHist18" /><ref name="FDAFood22">{{cite web |url=https://www.fda.gov/animal-veterinary/animal-food-feeds/food-safety-modernization-act-and-animal-food |title=Food Safety Modernization Act and Animal Food |publisher=U.S. Food and Drug Administration |date=20 October 2022 |accessdate=15 November 2022}}</ref> It has been described by the FDA as "the most sweeping reform of our food safety laws in more than 70 years."<ref name="FDAFood22" /> The FSMA, at its base, has five key aspects, addressing preventive controls, inspection and compliance, safety of food imports, mandatory recall response, and food partnership enhancement.<ref name="FDAFood22" /> However, FSMA continues to evolve, with additional rules getting added since its enactment, including rules about record management, good manufacturing practice (GMP) for human food and animal feed, and laboratory accreditation (referred to as the [[LII:FDA Food Safety Modernization Act Final Rule on Laboratory Accreditation for Analyses of Foods: Considerations for Labs and Informatics Vendors|LAAF Rule]]).<ref name="FDAFSMA22">{{cite web |url=https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-rules-guidance-industry#rules |title=FSMA Rules & Guidance for Industry |publisher=U.S. Food and Drug Administration |date=20 October 2022 |accessdate=15 November 2022}}</ref>
 
Another important regulatory body in the US is the Food Safety and Inspection Service (FSIS), which is overseen by the US Department of Agriculture (USDA). The FSIS and its authority to regulate are derived from three different acts: the Federal Meat Inspection Act of 1906, the Poultry Products Inspection Act of 1957, and the Egg Products Inspection Act of 1970.<ref name="USDAOurHist18">{{cite web |url=https://www.fsis.usda.gov/about-fsis/history |title=Our History |author=Food Safety and Inspection Service |publisher=U.S. Department of Agriculture |date=21 February 2018 |accessdate=15 November 2022}}</ref> The FSIS has developed its own regulatory requirements for meat, poultry, and egg products, including for inspections, imports and exports, labeling, and laboratory testing.<ref name="9CFR412">{{cite web |url=https://www.ecfr.gov/current/title-9/chapter-III/subchapter-E/part-412 |title=9 CFR Part 412 - Label Approval |work=Code of Federal Regulations |date=31 October 2022 |accessdate=15 November 2022}}</ref><ref name="FSISFedReg">{{cite web |url=https://www.fsis.usda.gov/policy/federal-register-rulemaking/federal-register-rules |title=Federal Register Rules |publisher=Food Safety and Inspection Service |accessdate=15 November 2022}}</ref><ref name="NALFoodSafe">{{cite web |url=https://www.nal.usda.gov/human-nutrition-and-food-safety/food-safety-standards |title=Food Safety Standards |author=National Agricultural Library |publisher=U.S. Department of Agriculture |accessdate=16 November 2022}}</ref>
 
====2.2.6 General Food Law Regulation (GFLR) - ''European Union''====
The GFLR was enacted across the European Union in 2002 as part of Regulation (EC) No 178/2002, and it is described as "the foundation of food and feed law" for the EU.<ref name="EUGeneral">{{cite web |url=https://food.ec.europa.eu/horizontal-topics/general-food-law_en |title=General Food Law |work=Food Safety |publisher=European Commission |accessdate=14 November 2022}}</ref> Along with setting requirements and procedures for food and feed safety, the GFLR also mandated the creation of the European Food Safety Authority (EFSA), an independent body assigned to developing sound scientific advice about and providing support towards the goals of food, beverage, and feed safety in the EU.<ref name="WeinrothHist18" /><ref name="EUGeneral" /> As such, the EFSA develops broad and sector-specific guidance<ref name="EFSAGuidance">{{cite web |url=https://www.efsa.europa.eu/en/methodology/guidance |title=Guidance and other assessment methodology documents |publisher=European Food Safety Authority |accessdate=14 November 2022}}</ref>, as well as other rules related to scientific assessment of food safety matters, e.g., Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs.<ref name="EU2073-2005">{{cite web |url=https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32005R2073 |title=Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs |work=EUR-Lex |date=03 August 2020 |accessdate=15 November 2022}}</ref> The EFSA also develops food classification standardization tools such as the Standard Sample Description (SSD2) data model, to better ensure an appropriate "format for describing food and feed samples and analytical results that is used by EFSA’s data providers."<ref name="EFSAFoodClass">{{cite web |url=https://www.efsa.europa.eu/en/data/data-standardisation |title=Food classification standardisation – The FoodEx2 system |publisher=European Food Safety Authority |accessdate=14 November 2022}}</ref>
 
====2.2.7 Safe Food for Canadians Act (SFCA) - ''Canada''====
In November 2012, the SFCA was enacted to place regulatory "focus on prevention to ensure a food that is imported, exported or shipped from one province to another, is manufactured, stored, packaged and labelled in a way that does not present a risk of contamination."<ref name="ManitobaSafe">{{cite web |url=https://www.gov.mb.ca/agriculture/food-safety/at-the-food-processor/safe-food-for-canadians-act.html |title=Safe Food for Canadians Act |publisher=Manitoba Government |accessdate=15 November 2022}}</ref><ref name="JLWSafeFood19">{{cite web |url=https://laws-lois.justice.gc.ca/eng/acts/s-1.1/index.html |title=Safe Food for Canadians Act (S.C. 2012, c. 24) |work=Justice Laws Website |publisher=Government of Canada |date=17 June 2019 |accessdate=15 November 2022}}</ref> Though Canadian Food Inspection Agency (CFIA) enforcement of the SFCA's regulations didn't start until January 2019<ref name="ManitobaSafe" />, the consolidation of 14 sets of existing food regulations by the SFCA has managed to improve consistency, reduce administrative burden, and enable food business innovation.<ref name="GoCUnder18">{{cite book |last=Canadian Food Inspection Agency |year=2018 |title=Understanding the Safe Food for Canadians Regulations: A handbook for food businesses |url=https://inspection.canada.ca/food-safety-for-industry/toolkit-for-food-businesses/sfcr-handbook-for-food-businesses/eng/1481560206153/1481560532540?chap=0 |publisher=Government of Canada |isbn=9780660269856}}</ref> An interpretive guide published by the CFIA, ''Understanding the Safe Food for Canadians Regulations: A handbook for food businesses'', summarizes and explains some of the nuances of the SFCA and its 16 parts on matters such as trade, licensing, preventive controls, packaging and labeling, and traceability.<ref name="GoCUnder18" />
 
 
===2.3 Other influencing factors===
Several other organized efforts towards better food quality are worth mentioning, often influencing the development of standards and regulations of other entities around the world.
 
====2.3.1 Good manufacturing practice (GMP) and current good manufacturing practice (cGMP)====
As a broad concept, [[good manufacturing practice]] or GMP is an organized set of standards and guidelines that allow manufacturers of most any product to better ensure their products are consistently produced and packaged to a consistent level of quality. GMP tends to cover most every step of production, from planning recipes and choosing starting materials to training personnel and documenting processes.<ref name="ISPEGMP">{{cite web |url=https://ispe.org/initiatives/regulatory-resources/gmp |title=Good Manufacturing Practice (GMP) Resources |publisher=International Society for Pharmaceutical Engineering, Inc |accessdate=15 November 2022}}</ref> The concept of GMP is often spoken of in terms of pharmaceutical and medical device manufacturing<ref name="ISPEGMP" /><ref name="WHOMedicines15">{{cite web |url=https://www.who.int/news-room/questions-and-answers/item/medicines-good-manufacturing-processes |title=Medicines: Good manufacturing practices |publisher=World Health Organization |date=20 November 2015 |accessdate=15 November 2022}}</ref>, though it is applicable to most any other production industry<ref name="CEReg07">{{cite web |url=https://www.controleng.com/articles/regulated-or-not-know-good-manufacturing-practices-gmp/ |title=Regulated or not? Know good manufacturing practices (GMP) |author=''Control Engineering'' Staff |work=Control Engineering |date=14 July 2007 |accessdate=15 November 2022}}</ref><ref name="FDAGMPCosm22">{{cite web |url=https://www.fda.gov/cosmetics/cosmetics-guidance-documents/good-manufacturing-practice-gmp-guidelinesinspection-checklist-cosmetics |title=Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist for Cosmetics |publisher=U.S. Food and Drug Administration |date=25 February 2022 |accessdate=15 November 2022}}</ref>, including the food and beverage industry.<ref name="FDAGoodMan17">{{cite web |url=https://www.who.int/news-room/questions-and-answers/item/medicines-good-manufacturing-processes |title=Good Manufacturing Practices for the 21st Century for Food Processing (2004 Study) Section 1: Current Food Good Manufacturing Practices |publisher=U.S. Food and Drug Administration |date=27 December 2017}}</ref><ref>{{Cite book |last=Manning |date=2013-01-11 |title=Food & Drink - Good Manufacturing Practice: A Guide to its Responsible Management |url=http://doi.wiley.com/10.1002/9781118318225 |language=en |publisher=Wiley-Blackwell |place=Oxford, UK |doi=10.1002/9781118318225 |isbn=978-1-118-31822-5}}</ref>
 
Closely related is the term "current good manufacturing practice" or cGMP. Both "GMP" and "cGMP" are largely interchangeable, though the latter is preferred in most regulatory language of the United States. A more nuanced take says that cGMP essentially represents the newest, most updated technologies implemented towards the goals of meeting GMP requirements.<ref name="PSDiff21">{{cite web |url=https://www.pharmaspecialists.com/2021/10/difference-between-gmp-and-cgmp.html#gsc.tab=0 |title=Difference Between GMP and cGMP |work=Pharma Specialists |date=13 October 2021 |accessdate=15 November 2022}}</ref><ref name="MoravekTheDiff">{{cite web |url=https://www.moravek.com/the-differences-between-gmp-and-cgmp/ |title=The Differences Between GMP and cGMP |work=Moravek Blog |publisher=Moravek, Inc |date=January 2021 |accessdate=15 November 2022}}</ref> In the United States, cGMP—in the context of food—was first introduced in 1969 as 21 CFR Part 110, though the concept of cGMP was modernized in 2015, in 21 CFR Part 117. This led to not only broad food- and beverage-based cGMPs but also cGMPs specific to a type of ingestible, including dietary supplements, infant formula, low-acid canned food, and bottled water.<ref name="FDACurrentGood20">{{cite web |url=https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/current-good-manufacturing-practices-cgmps-food-and-dietary-supplements |title=Current Good Manufacturing Practices (CGMPs) for Food and Dietary Supplements |publisher=U.S. Food and Drug Administration |date=31 January 2020 |accessdate=15 November 2022}}</ref>
 
====2.3.2 Standards and Scientific Advice on Food and Nutrition (SSA)====
The WHO's Nutrition and Food Safety (NFS) Department envisions "a world free from all forms of malnutrition and foodborne diseases, within safe and supportive societies and healthy environments."<ref name="WHONFSHome">{{cite web |url=https://www.who.int/teams/nutrition-and-food-safety/overview |title=Nutrition and Food Safety - Vision and Mission |publisher=World Health Organization |accessdate=15 November 2022}}</ref> One way they attempt to make that vision a reality is through its SSA Unit, described as "the focal point for WHO’s work on international standard-setting in food safety and nutrition."<ref name="WHONFS_SSA">{{cite web |url=https://www.who.int/teams/nutrition-and-food-safety/standards-and-scientific-advice-on-food-and-nutrition |title=Nutrition and Food Safety - Standards and Scientific Advice on Food and Nutrition (SSA) |publisher=World Health Organization |accessdate=15 November 2022}}</ref> The SSA consists of a number of committees that develop scientific risk assessments and guidelines, which in turn make their way into the Codex Alimentarius and other national regulations and standards. These assessments and guidelines cover a variety of topics, including microbiological risk management, drug residues, food contaminates and additives, microplastics, and allergens, among others.<ref name="WHONFS_SSA" />
 
==References==
{{Reflist|colwidth=30em}}

Revision as of 21:44, 21 March 2023

Sandbox begins below

Battery Manufacturing Lab (50954228316).jpg

Title: LIMS Selection Guide for Manufacturing Quality Control

Edition: First Edition

Author for citation: Shawn E. Douglas

License for content: Creative Commons Attribution-ShareAlike 4.0 International

Publication date: To be determined


To be written...

The table of contents for LIMS Selection Guide for Manufacturing Quality Control is as follows:


1. Introduction to manufacturing laboratories
1.1 Manufacturing labs, then and now
1.2 Laboratory roles and testing in the industry
1.2.1 R&D roles and testing
1.2.2 Pre-manufacturing and manufacturing roles and testing
1.2.3 Post-production regulation and security roles and testing
1.2.4 Tangential laboratory work
1.3 Safety and quality in the manufacturing industry
2. Standards and regulations affecting manufacturing labs
2.1 Globally recognized manufacturing standards
2.1.1 Food and beverage
2.1.2 Materials
2.1.3 Pharmaceutical and medical devices
2.1.4 Other industries
2.2 Regulations and laws around the world
2.2.1 Food and beverage
2.2.2 Materials
2.2.3 Pharmaceutical and medical devices
2.3.4 Other industries
2.3 Other influencing factors
2.3.1 Good manufacturing practice (GMP) and current good manufacturing practice (cGMP)
2.3.2 Standards and Scientific Advice on Food and Nutrition (SSA)
3. Choosing laboratory informatics software for your manufacturing lab
3.1 Evaluation and selection
3.1.1 Technology considerations
3.1.1.1 Laboratory informatics options
3.1.2 Features and functions
3.1.2.1 Base features
3.1.2.2 Specialty features
3.1.3 Cybersecurity considerations
3.1.4 Regulatory compliance considerations
3.1.5 System flexibility
3.1.6 Cost considerations
3.2 Implementation
3.2.1 Internal and external integrations
3.3 MSW, updates, and other contracted services
3.4 How a user requirements specification fits into the entire process (LIMSpec)
4. Resources for selecting and implementing informatics solutions
4.1 LIMS vendors
4.2 Consultants
4.3 Professional
4.3.1 Trade organizations
4.3.2 Conferences and trade shows
4.4 LIMSpec
5. Taking the next step
5.1 Conduct initial research into a specification document tailored to your lab's needs
5.2 Issue some of the specification as part of a request for information (RFI)
5.3 Respond to or open dialogue with vendors
5.3.1 The value of demonstrations
5.4 Finalize the requirements specification and choose a vendor
6. Closing remarks
Appendix 1. Blank LIMSpec template for manufacturing labs
A1. Introduction and methodology
A2. Primary laboratory workflow
A3. Maintaining laboratory workflow and operations
A4. Specialty laboratory functions
A5. Technology and performance improvements
A6. Security and integrity of systems and operations
A7. Putting those requirements to practical use and caveats
A8. LIMSpec in Microsoft Word format