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AHPA GACP-GMP Guidance Document

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AHPA GACP-GMP Guidance Document GOOD AGRICULTURAL AND COLLECTION PRACTICES AND GOOD MANUFACTURING PRACTICES FOR BOTANICAL MATERIALS CONTAINS NON-BINDING RECOMMENDATIONS May 2021 (Revised) Prepared by the American Herbal Products Association This version replaces a document of the same title published in 2017. This version includes an Appendix regarding the control of the inadvertent presence of pyrrolizidine alkaloids in certain botanicals used in food and supplement products. This document is the property of the American Herbal Products Association (AHPA) and is for AHPA purposes only. Unless given prior approval from AHPA, it shall not be reproduced, circulated, or quoted, in whole or in part, outside of AHPA, its Committees, and its members. Cite as: American Herbal Products Association. May 2021. Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials. Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials Contents Acknowledgements ............................................................................................................... 1 Preface .................................................................................................................................. 1 Introduction .......................................................................................................................... 2 Disclaimers ............................................................................................................................ 4 D1. Definitions ...................................................................................................................... 5 BQ2. Botanical identity and quality ...................................................................................... 14 BQ2.1 General considerations ............................................................................................... 14 BQ2.2 Identity ........................................................................................................................ 15 BQ2.3 Physical characteristics ............................................................................................... 18 BQ2.4 Chemical characteristics ............................................................................................. 19 BQ2.5 Contaminants .............................................................................................................. 19 C3. Cultivation ..................................................................................................................... 22 C3.1 Propagation material ..................................................................................................... 22 C3.2 Cultivation site ............................................................................................................... 23 C3.3 Fertilizer use .................................................................................................................. 26 C3.4 Irrigation ........................................................................................................................ 28 C3.5 Crop maintenance and protection ................................................................................ 28 C3.6 Other considerations ..................................................................................................... 30 WC4. Wild collection ........................................................................................................... 32 WC4.1 Permits and permissions ............................................................................................ 32 WC4.2 Collection site ............................................................................................................. 33 WC4.3 Sustainability .............................................................................................................. 34 WC4.4 Identification .............................................................................................................. 37 WC4.5 Other considerations ................................................................................................. 37 GF5. General farm standards ............................................................................................... 39 GF5.1 General considerations ............................................................................................... 39 GF5.2 Farm buildings ............................................................................................................. 40 GF5.3 Farm equipment .......................................................................................................... 41 GF5.4 Farm personnel ........................................................................................................... 43 GF5.5 Records ........................................................................................................................ 43 © AHPA May 2021 i Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials H6. Harvest of cultivated and wild collected plants .............................................................. 44 H6.1 Harvest conditions ........................................................................................................ 44 H6.2 Harvest quality .............................................................................................................. 45 H6.3 Harvest documentation and samples ........................................................................... 47 PH7. Post-harvest handling .................................................................................................. 50 PH7.1 Handling immediately after harvest ........................................................................... 50 PH7.2 Separating the desired plant part ............................................................................... 51 PH7.3 Washing and cleaning ................................................................................................. 51 PH7.4 Dehydration ................................................................................................................ 52 FP8. Further processing and handling .................................................................................. 57 FP8.1 Special preparation ...................................................................................................... 57 FP8.2 Size reduction .............................................................................................................. 57 FP8.3 Extraction ..................................................................................................................... 59 FP8.4 Packing, packaging, and storage .................................................................................. 60 FP8.5 Shipping ....................................................................................................................... 63 FF9. Food facility and farm mixed-type facility requirements ............................................... 65 FF9.1 Regulations................................................................................................................... 65 FF9.2 Personnel ..................................................................................................................... 65 FF9.3 Plant and grounds ........................................................................................................ 67 FF9.4 Sanitary operations ...................................................................................................... 68 FF9.5 Sanitary facilities and controls ..................................................................................... 69 FF9.6 Equipment and utensils ............................................................................................... 71 DI10. Recommendations for dietary ingredient processors .................................................. 73 DI10.1 Regulations ................................................................................................................. 73 DI10.2 Component controls .................................................................................................. 74 DI10.3 Processing operations and finished product controls ............................................... 75 DI10.4 Laboratory operations................................................................................................ 77 DI10.5 Personnel ................................................................................................................... 77 DI10.6 Equipment .................................................................................................................. 78 DI10.7 Quality management ................................................................................................. 78 Appendix 1: Covered produce subject to 21 CFR Part 112 ..................................................... 80 © AHPA May 2021 ii Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials §112.1 What food is covered by this part? ........................................................................... 80 §112.2 What produce is not covered by this part? ............................................................... 81 §112.3 What definitions apply to this part? .......................................................................... 82 Appendix 2: Farms exempt from 21 CFR Part 112 ................................................................
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