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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: May 2023

Manufacturing endeavors and quality control have a long yet twisted history together, with standards, guidelines, best practices, and regulations all shaping how the two relate to each other. Consumer safety and higher quality weren't always goals of manufacturers, but today they are vital considerations towards the final end product during a time when a single product failure could ruin a manufacturer already competing in a highly competitive environment. Maintaining compliance with standards and regulations that guide safety and quality now requires more than paper notebooks and spreadsheets, particularly when it comes to laboratory analyses associated with that compliance. Manufacturing-based laboratories are continuing to adopt information management strategies that welcome solutions such as the laboratory information management system (LIMS) into the workflow of the manufacturer and its associated labs. However, selecting the right LIMS or other informatics solution is not a straightforward task.

This guide broadly examines the field of manufacturing across a variety of associated industries, discussing the evolution of the manufacturing-based lab and the activities it undertakes in the pursuit of safer, higher-quality products. It will look at examples of standards and regulations that impact these labs and how laboratory informatics solutions can best be utilized to maintain compliance with those standards and regulations. It will give acquisition advice and considerations while also providing a useful user requirements document in the form of LIMSpec. By the end, the reader should have a clearer idea of the challenges that affect manufacturing-based labs and how properly acquired and implemented software solutions, like the LIMS, can have a positive impact.

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

1.1.1 From apothecary to small-scale manufacturing laboratory

1.1.2 From small-scale private manufacturing lab to larger-scale industrial manufacturing lab

1.1.3 The rise of the industrial research lab within large-scale manufacturing, and today's manufacturing landscape

1.2 Laboratory roles and activities in the industry

1.2.1 R&D roles and activities

1.2.2 Pre-manufacturing and manufacturing roles and activities

1.2.3 Post-production regulation and security roles and activities

1.2.4 Tangential laboratory work

1.3 Safety and quality in manufacturing industries

2. Standards and regulations affecting manufacturing labs

2.1 Globally recognized manufacturing standards

2.1.1 Food and beverage

2.1.1.2 British Retail Consortium (BRC) Global Standard for Food Safety (GSFS)

2.1.1.2 Codex Alimentarius

2.1.1.3 Global Food Safety Initiative (GFSI)

2.1.1.4 Hazard analysis and critical control points (HACCP)

2.1.1.5 International Featured Standards (IFS)

2.1.1.6 International Organization for Standardization (ISO) 22000

2.1.1.7 Safe Quality Food (SQF) Program

2.1.2 Materials

2.1.2.1 American Society of Civil Engineers (ASCE) materials standards

2.1.2.2 ASTM International Volume 15.04

2.1.2.3 Canadian Standards Association (CSA) A3000 series

2.1.2.4 International Organization for Standardization (ISO) 10993

2.1.2.5 Metal Powder Industries Federation (MPIF) Standard 35 family

2.1.3 Pharmaceutical and medical devices

2.1.3.1 ASTM International Volume 14.01

2.1.3.2 European Pharmacopoeia standards

2.1.3.3 International Organization for Standardization (ISO) 10993, 13485, and 16142-2

2.1.3.4 United States Pharmacopeia and National Formulary (USP-NF) standards

2.1.4 Other industries and standards

2.1.4.1 British Standards Institution (BSI) standards

2.1.4.2 Global Standard's Global Organic Textile Standard (GOTS)

2.1.4.3 International Organization for Standardization (ISO) 9001

2.1.4.4 Underwriter Laboratories (UL) standards

2.2 Regulations and laws around the world

2.2.1 Food and beverage

2.2.2.1 Food Safety Act 1990 and Food Standards Act 1999 - United Kingdom

2.2.2.2 Food Safety and Standards Act of 2006 - India

2.2.2.3 Food Safety Law - China

2.2.2.4 Food Sanitation Act and Food Safety Basic Act - Japan

2.2.2.5 Food Safety Modernization Act (FSMA) and other acts - United States

2.2.2.6 General Food Law Regulation (GFLR) - European Union

2.2.2.7 Safe Food for Canadians Act (SFCA) - Canada

2.2.2 Materials

2.2.2.1 21 CFR Part 175 and 176 - United States

2.2.2.2 Building Standard Law - Japan

2.2.2.3 The Furniture and Furnishings (Fire) (Safety) Regulations 1988 - United Kingdom

2.2.2.4 National Environment Protection (Used Packaging Materials) Measure 2011 - Australia

2.2.2.5 Surface Coating Materials Regulations (SOR/2016-193) - Canada

2.2.3 Pharmaceutical and medical devices

2.2.3.1 Current Good Manufacturing Practice (cGMP) regulations - United States and other countries

2.2.3.2 Drugs and Cosmetics Act of 1940 - India

2.2.3.3 Food and Drugs Act - Canada

2.2.3.4 Pharmaceutical Affairs Act (PAA) and Medical Devices Act (MDA) - South Korea

2.2.3.5 Pharmaceutical and Medical Device Act (PMD Act) - Japan

2.3.4 Other industries and regulations

2.3.4.1 Good manufacturing practice (GMP) and current good manufacturing practice (cGMP) - United States and other countries

2.3.4.2 Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) Regulation - European Union

2.3.4.3 Resolução de diretoria colegiada - RDC nº 529 - Brazil

2.3.4.4 Restriction of Hazardous Substances in Electrical and Electronic Equipment (RoHS) Directive - European Union

2.3.4.5 Road Vehicle Standards (RVS) legislation - Australia

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