FDA Resources & Industry Standards
At BatchWize we love to learn & share! The following links may be helpful in determining your product’s specific regulatory requirements. If you have a question, please contact us. We’ll be happy to assist you directly or introduce you to one of our strategic partners.
21 CFR Part 820
Quality System Regulation
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820
21 CFR Part 210
Part 210—Current Good Manufacturing Practice In Manufacturing, Processing, Packing, Or Holding Of Drugs; General
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-210
21 CFR Part 211
Part 211—Current Good Manufacturing Practice For Finished Pharmaceuticals
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211
21 CFR Part 207
Part 207—Requirements For Foreign And Domestic Establishment Registration And Listing For Human Drugs, Including Drugs That Are Regulated Under A Biologics License Application, And Animal Drugs, And The National Drug Code
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-207
21 CFR Part 11
Part 11—Electronic Records; Electronic Signatures
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11
21 Chapter 1, Subchapter G
Cosmetics, See 21 CFR 700, 701, 710, 720, 740
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-G
21 CFR 110
Part 110—Current Good Manufacturing Practice In Manufacturing, Packing, Or Holding Human Food
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-110
21 CFR part 117
Part 117—Current Good Manufacturing Practice, Hazard Analysis, And Risk–Based Preventive Controls For Human Food
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-117
FDA Q&A Document
Questions and Answers on Dietary Supplements
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-117
QSIT Inspection Guide
Guide To Inspections of Quality Systems
https://www.fda.gov/files/Guide-to-Inspections-of-Quality-Systems.pdf
Q7 FDA Guidance
Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Guidance for Industry
https://www.fda.gov/files/drugs/published/Q7-Good-Manufacturing-Practice-Guidance-for-Active-Pharmaceutical-Ingredients-Guidance-for-Industry.pdf
Q13 FDA Guidance
Q13 Continuous Manufacturing of Drug Substances and Drug ProductsGuidance for Industry
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q13-continuous-manufacturing-drug-substances-and-drug-products
Q14 FDA Guidance
Q14 Analytical Procedure Development
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q14-analytical-procedure-development
Cannabis Resource Page
FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD)
https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd
Cannabis Resource Page
FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD)
https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd
Industry Guidance Cannabis
FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds
https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/fda-regulation-and-quality-considerations-cannabis-and-cannabis-derived-compounds
2 CFR Part 600
Part 600—Biological Products: General
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-600
21 CFR Part 111
Dietary Supplements
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-111
For additional information, see Dietary Supplements Guidance Documents & Regulatory Information.
21 CFR Part 106
Infant Formula
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-106
For additional information, see Infant Formula Guidance Documents & Regulatory Information.
21 CFR Part 113
Low-acid Canned Foods
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-113
For additional information, see Acidified & Low-Acid Canned Foods Guidance Documents & Regulatory Information.
21 CFR Part 114
Acidified Foods
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-114
For additional information, see Acidified & Low-Acid Canned Foods Guidance Documents & Regulatory Information.
21 CFR Part 129
Bottled Water
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-129
For additional information, see Bottled Water/Carbonated Soft Drinks Guidance Documents & Regulatory Information.
Food Safety Modernization Act (FSMA)
https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/food-safety-modernization-act-fsma