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Good Manufacturing Practices (GMP) for Natural Products

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Good Manufacturing Practices (GMP) for Natural Products

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Scientific Publications on Natural Products, including Food, Medicine and Dietary Supplements: With a focus on Good Manufacturing Practices (GMP) for Natural Products, Quality Management Systems, and Good Agricultural and Collection Practices (GACP)

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    1. A Field Guide to Herbal Dietary Supplements, AHPA-ERB Foundation, http://www.ahpafoundation.org/fieldguide.pdf
    2. A Harvester’s Handbook to Wild Medicinal Plant Collection in Kosovo (2003). Lonner J. and Thomas M. Source: http://www.gowildconsulting.com/wp-content/uploads/2011/02/harvesters_handbook.pdf
    3. AHPA-AHP Good Agricultural and Collection Practice for Herbal Raw Materials, December 2006. (Updated draft 2016)
    4. AHPA Botanical Identity References Compendium, http://www.botanicalauthentication.org/index.php/Main_Page
    5. AHPA Guidance Policies, http://www.ahpa.org/Portals/0/PDFs/Policies/AHPA_Guidance_Policies.pdf
    6. Aspects of sustainable wild plant collection (2012) Rodina K, WWF Hungary/TRAFFIC
    7. Biological Diversity Act 2002 (India)
    8. BRC’s Global Standard for Food Safety
    9. Canadian Herb, Spice and Natural Health Product Coalition (CHSNC) Good Agriculture and Collection Practices (GACP). Kehler C. Source: https://www.cotr.bc.ca/webs_media/Creston/_docManager/docs/Good%20Agricultural%20and%20Collection%20Practices(1).pdf
    10. Canadian Horticultural Council OFFS (CanadaGAP)
    11. Code of Good Agricultural Practices of Georgia (2007). Ministry of Agriculture of Georgia. Source: http://iwlearn.net/iw-projects/633/reports/aret-code-of-good-agriculture-practices-of-georgia
    12. Code of hygienic practices for spices and dried aromatic herbs. (2014) Codex Alimentarius Commission, CAC/RCP 42-1995
    13. Codex Alimentarius Commission Recommended International Code of Practice – General Principles of Food Hygiene CAC/RCP1-1969, Rev. 4 -2003
    14. Current good manufacturing practice in manufacturing, packaging, labeling or holding operations for dietary supplements (21 CFR 111)
    15. Current good manufacturing practice, hazard analysis and risk-based preventive controls for human food (21 CFR 117)
    16. Development of a Good Agricultural Practice Approach. November 5, 2003. Source: http://www.fao.org/prods/GAP/archive/GAPCONCEPT12_en.pdf.
    17. Development of Good Wildcrafting Practices and Wildcrafter Certification for Medicinal Plants. (2006) Howe A. Source:  http://www.bestlibrary.org/best_teachers/files/Wildcraftingfinalreport.pdf
    18. Dietary Supplement Ingredient Database, https://dietarysupplementdatabase.usda.nih.gov/
    19. Dietary Supplement Label Database, https://ods.od.nih.gov/factsheets/DietarySupplements-HealthProfessional/
    20. Dietary supplement laboratory quality assurance program: the first five exercises. Phillips MM, Rimmer CA, Wood LJ, Lippa KA, Sharpless KE, Duewer DL, Sander LC, Betz JM.  J AOAC Int 2011;94:803-14. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3173719/
    21. Dietary Supplement Online Wellness Library (OWL), Council for Responsible Nutrition (CRN), http://www.supplementowl.org/
    22. EFSIS Safe & Legal: https://www.saiglobal.com/assurance/food-safety/SafeandLegal.htm
    23. Ensuring the Compliance of Raw Herbal Materials stemmed from China with European Good Agricultural and Collection Practice. Philippe A. et al. Chinese Herbal Medicine, (2011) 3(4): 251-256
    24. FairWild Standard, Version 2.0 (2010).
    25. FairWild Standards Map. Source: http://search.standardsmap.org/assets/media/FairWild/English/AtAGlance_EN.pdf
    26. FDA Food Safety Modernization Act http://www.fda.gov/Food/GuidanceRegulation/FSMA/
    27. FDA Dietary Supplement Labeling Guide, http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm2006823.htm
    28. Field Techniques Used by Missouri Botanical Garden. Compiled by R. Liesner with suggestions from MO staff and others. Source: http://www.mobot.org/MOBOT/molib/fieldtechbook/pdf/handbook.pdf
    29. GAP Production of TCM Herbs in China (2010) Zhang B. et al. Planta Med 2010 76:1948-1955
    30. General guidelines for good agricultural practices: spices. International Organisation of Spice Trade Associations (IOSTA) (2013). Source: http://www.esa-spices.org/download/iosta-gap-final.pdf
    31. Global GAP, http://www.globalgap.org/uk_en/
    32. Good Agricultural and Collection Practices – Guidelines for the cultivation and collection of herbal medicines. (2012) Republic of Kenya.
    33. Good agricultural and collection practices for medicinal plants: Illustrated booklet for farmers and collectors. Source: http://www.dmapr.org.in/Downloads/Illustratedbooklet.pdf
    34. Good Agricultural and Wild Collection Practice (GACP) of Medicinal Plants in Europe, EUROPAM,( EHGA), c/o Veterinaerplatz, Vienna.
    35. Good Agricultural Practice (GAP) – Does It Ensure a Perfect Supply of Medicinal Herbs for Research and Drug Development? (2008) Leung PC and Cheng KF. Int J. App. Res. Nat. Prod. 1(2);1-8.
    36. Good Agricultural Practices and Good Handling Practices: Audit Verification Program. (2011) USDA Source: https://www.ams.usda.gov/sites/default/files/media/GAPGHP_Audit_Program_User%27s_Guide%5B1%5D.pdf
    37. Good Agricultural Practices and Good Handling Practices: Risk Mitigation in Edible Horticultural Production Systems (2015) Urbanowitz S and Bishop C. Source: https://www.unce.unr.edu/publications/files/ag/2015/cm1501.pdf
    38. Good agricultural practices for Artemisia (2014) ICAR Directorate of Medicinal and Aromatic Plants Research, Anand, Gujarat, India. Source: http://www.dmapr.org.in/publications/bulletine/artemisia%2016-1-15.pdf
    39. Good Agricultural Practices for Chinese Crude Drugs (Interim) (2002). Source: http://eng.sfda.gov.cn/WS03/CL0768/61642.html
    40. Good Agricultural Practices for Medicinal Plants (2009) National Medicinal Plant Board (NMPB), Department of AYUSH, India and World Health Organization Source: http://nmpb.nic.in/WriteReadData/links/8527013542Good%20Agricultural%20Practicies%20(GAPs)%20Booklet%20-%20Part%20-%20I.pdf
    41. Good Agricultural Practices for Plantago ovate Forsk. National Medicinal Plant Board (NMPB), Department of AYUSH, India and World Health Organization Source:
    42. Good agricultural practices for senna (2015) ICAR Directorate of Medicinal and Aromatic Plants Research, Anand, Gujarat, India. Source: http://www.dmapr.org.in/publications/bulletine/Good%20Agricultural%20Practices%20for%20Senna.pdf
    43. Good agricultural practices for small diversified farms, Carolina Farm Stewardship Association. Source: http://www.carolinafarmstewards.org/wp-content/uploads/2013/07/CFSA_GAPS-web.pdf
    44. Good agricultural practices for sustainable cocoa production: a guide for farmer training. Asare R and Sonii D. (2010) University of Copenhagen
    45. Good Practices for Plant Identification for the Herbal Industry (2004), Saskatchewan Herb and Spice Association, National Herb and Spice Coalition (Canada)
    46. Grocery Manufacturers Association (GMA-SAFE)
    47. Guidance for Implementing the International Standard for Sustainable Wild Collection of Medicinal and Aromatic Plants (ISSC-MAP). (2008) Leaman and Cunningham.
    48. Guidance for Industry: Botanical Drug Products (2004) FDA.Source: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070491.pdf
    49. Guidance Manual for Organic Collection of Wild Plants (2005) Swiss Import Promotion Programme (SIPPO).
    50. Guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin. London, 20 February 2006. Doc. Ref. EMEA/HMPC/246816/2005 Source: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003362.pd
    51. Guidelines for good agricultural and hygiene practices for raw materials used for herbal and fruit infusions (GAHP). [Former EHIA Document], Version 6, 2014 Source: http://www.thie-online.eu/fileadmin/inhalte/Publications/HFI/2_2014-06_PU_GAHP_Version_6.pdf
    52. Guidelines for good agricultural and wild collection practices for medicinal and aromatic plants (2010). EUROPAM the European Herb Growers Association Brussels, November, 2010; EUROPAM GACP‐MAP 8.0
    53. Guidelines for identification and collection of medicinal plants in Bhutan. 2008.
    54. Guidelines for the Sustainable Harvesting of Traditional Medicinal Plants in Zimbabwe ( ). Khumalo SG, Frode A, Sola P. Research and Development Section Southern Alliance for Indigenous Resources (SAFIRE). Source: http://projects.nri.org/adappt/docs/HarvestingGuidelines.pdf
    55. Hand book of domestic medicine and common Ayurvedic remedies. Source: http://niimh.nic.in/ebooks/ayuhandbook/index.php
    56. Heavy metals: analysis and limits in herbal dietary supplements, http://www.naturalhealthresearch.org/wp-content/uploads/2013/02/09_1214_AHPA_Heavy-Metals-White-Paper-Revised.pdf
    57. Herbs of Commerce, American Herbal Products Association, Second Ed. (First Ed., 1992 available here: https://law.resource.org/pub/us/cfr/ibr/001/ahpa.herbs.1992.pdf )
    58. In search of comprehensive standards for nontimber forest products in the botanicals trade. PIERCE, A.R. and S.A. LAIRD. (2003). International Forestry Review 5(2):138-147.
    59. International Labour Organization: Labour Principles of the United Nations Global Compact
    60. International Standard for Sustainable Wild Collection of Medicinal and Aromatic Plants (ISSC-MAP) (2007) Version 1.0 Source: http://www.floraweb.de/map-pro/Standard_Version1_0.pdf
    61. ISO /TS 22003:2007 Food safety management systems – Requirements for bodies providing audit and certification of food safety management systems
    62. ISO 22000:2005 Food safety management systems – Requirements for any organization in the food chain
    63. ISO 9000:2005 Quality management systems – Fundamentals and vocabulary
    64. ISO 9001:2008 Quality management systems – Requirements
    65. ISO/IEC 17000:2004 Conformity assessment – Vocabulary and general principles
    66. ISO/IEC 17011:2004 Conformity assessment – General requirements for accreditation bodies accrediting conformity assessment bodies
    67. ISO/IEC 17021:2006 Conformity assessment – Requirements for bodies providing audit and certification of management systems
    68. ISO/IEC Guide 65:1996 General requirements for bodies operating product certification systems
    69. Legal and regulatory frameworks governing the growing, packing and handling of fresh produce in countries exporting to the U.S. (2010) Produce Safety Project, Pew Charitable Trust, Georgetown University. Source: http://www.pewtrusts.org/~/media/legacy/uploadedfiles/phg/content_level_pages/reports/psprptlegalregexportspdf.pdf
    70. National Advisory Committee on Microbiological Criteria for Foods Hazard Analysis and Critical Control Point Principles and Application Guidelines, August 1997.
    71. Office of Dietary Supplements, Background Information on Dietary Supplements, https://ods.od.nih.gov/factsheets/DietarySupplements-HealthProfessional/
    72. Pesticide Analytical Manual, Vol I, FDA. Source: http://www.fda.gov/downloads/Food/FoodScienceResearch/ucm113702.pdf
    73. Pesticide Analytical Manual, Vol II, FDA. Source: http://www.fda.gov/downloads/Food/FoodScienceResearch/ucm113721.pdf
    74. Pesticide chemicals in processed foods (21 CFR 170.19)
    75. Phytomedicine 101: plant taxonomy for preclinical and clinical medicinal plant researchers. Bennett, BC, Balick MJ.  J Soc Integr Oncol 2008;6:150-157.  https://www.ncbi.nlm.nih.gov/pubmed/19134447
    76. Quality assurance of cultivated and gathered medicinal plants. Mathe and Mathe, Source: http://www.mtk.nyme.hu/fileadmin/user_upload/kornyezet/Mathe/Quality_assurance.pdf
    77. Quality control methods for medicinal plant materials (1998) World Health Organization
    78. Recommendations for microbial limits in herbal products, American Herbal Products Association, http://www.ahpa.org/Portals/0/PDFs/Policies/14_0206_AHPA_micro_limits_comparisons.pdf
    79. Research and implementation of good agricultural practice for traditional Chinese medicinal materials in Jilin Province, China. (2014) Li C, Yan Z, Zhang L, Li Y. Ginseng Res. 38;227-232 Source: http://www.ginsengres.com/article/S1226-8453(14)00062-1/pdf
    80. Safe Quality Food, Edition 7.0. (SQF 2000 Levels 1, 2 & 3)
    81. Selection and authentication of botanical materials for the development of analytical methods. Applequist WL, Miller JS.  Anal Bioanal Chem 2013;405):4419-28. https://www.ncbi.nlm.nih.gov/pubmed/23224664
    82. Standard operating procedure for the collection and preparation of voucher plant specimens for use in the nutraceutical industry. Hildreth J, Hrabeta-Robinson E, Applequist W, Betz J, Miller J. Anal Bioanal Chem. 2007 Sep;389(1):13-7. Epub 2007 Jun 16.
    83. Standardization of herbal medicines – A review. Kunle O.F. et al, (2012) Int. J Biodiv and Conserv. 4(3) 101-112. Source: http://www.academicjournals.org/article/article1380017716_Kunle%20et%20al.pdf
    84. Suggested Good Agricultural and Collection Practices for North Carolina Medicinal Herbs (2016) Davis J. Source: http://content.ces.ncsu.edu/suggested-good-agricultural-and-collection-practices-for-north-carolina-medicinal-herbs
    85. Suggested guidelines for articles about botanical dietary supplements. Swanson CA. Am J Clin Nutr 2002;75:8-10, https://www.ncbi.nlm.nih.gov/pubmed/11756054
    86. The Ayurvedic Pharmacopoeia of India, 5 Volumes, Ministry of Health and Family Welfare, Govt. of India, New Delhi, 1989-2005
    87. The Chinese Approach to Medicinal Plants – Their Utilization and Conservation. Pen-Gen X. (1991) In: Akerle, O., V. Heywood, and H. Synge (eds.). Conservation of Medicinal Plants. Cambridge University Press, Cambridge, UK.
    88. The Drugs and Cosmetics Act and Rules (as amended up through 30 June 2005. New Delhi: Department of Health. 2005.Schedule T: Good Manufacturing Practices (GMPs) for Ayurveda, Siddha and Unani Medicines.
    89. The Global Food Safety Initiative: GFSI Guidance Document, 6th Version 6.3
    90. The Indian Forest Act, India, 1927
    91. The NIH analytical methods and reference materials program for dietary supplements. Betz JM., Fisher KD., Saldanha LG, Coates PM.  Anal Bioanal Chem 2007; 389:19-25.  https://www.ncbi.nlm.nih.gov/pubmed/17541565
    92. The Siddha Pharmacopoeia of India, Part I(1), Ministry of Health and Family Welfare, 
 of India, New Delhi, 2007
    93. The Unani Pharmacopoeia of India, Part-I, Ministry of Health and Family Welfare, Govt. of India, New Delhi
    94. Trainer’s manual on good agricultural and collection practices for medicinal plants: Source: http://www.dmapr.org.in/Downloads/Trainersmanual.pdf
    95. U.S. Customs & Border Protection, (C-TPAT)
    96. USDA (National Organic Program), https://www.ams.usda.gov/about-ams/programs-offices/national-organic-program
    97. USP Food Fraud Mitigation Guidance, http://www.usp.org/food/food-fraud-mitigation-guidance
    98. USP <2750> Manufacturing Practices for Dietary Supplements.
    1. USP <467> Residual Solvents
    2. USP <561> Articles of Botanical Origin
    3. Voluntary Sustainability Standards (Draft), United Nations Forum on Sustainability Standards Source: https://unfss.org/documentation/general-documentation/
    4. WHO guidelines on good agricultural and collection practices (GACP) for medicinal plants (2003). Source: http://apps.who.int/iris/bitstream/10665/42783/1/9241546271.pdf
    5. WHO Traditional Medicine Strategy 2002-2005. World Health Organization, Geneva.
    6. Wild Life (Protection) Act, India, 1972

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