SOP Library

334 Standard Operating Procedures

B Manufacturing 62

B-103 Small Parts Cleaning and General Sanitation
Rev 8 5 pg
B-104 Floor Drain Cleaning and Sanitizing Procedure
Rev 2 8 pg
B-105 Preparation of Cleaning and Sanitizing Chemicals for Production and Warehouse
Rev 2 15 pg
B-106 Cleaning Methods for Organic Processing Equipment
Rev 0 3 pg
B-108 Reprocessing Rework Procedure
Rev 7 7 pg
B-111 Cleaning of Manufacturing-Production Areas and Equipment
Rev 14 25 pg
B-112 Issuance of Master Case Labels
Rev 5 4 pg
B-201 Tooling Control and Cleaning
Rev 5 6 pg
B-207 NP-250 Rotary Tablet Press
Rev 4 10 pg
B-211 Fitz Mill Grinder
2 pg
B-212 Deduster Vibration Machine
Rev 4 3 pg
B-215 Digital Caliper Usage and Cleaning
Rev 4 3 pg
B-301 Oscillating Grinder
Rev 4 3 pg
B-302 Blender Magnet Cleaning Procedure
Rev 1 3 pg
B-303 Vibrating Sifter
2 pg
B-312 V-Blenders
Rev 4 4 pg
B-313 IMB Ribbon Blenders
Rev 2 4 pg
B-401 Liquid Mixing Tank
Rev 2 3 pg
B-402 Wilden Transfer Pump
Rev 0 3 pg
B-507 Encapsulation Machine Model NJP-2000 and NJP-3200
Rev 5 28 pg
B-601 Digital Cap Torque Tester
Rev 2 5 pg
B-602 Rx-4 Automatic Tablet Capsule Counter
Rev 0 4 pg
B-603 Insight Throat Metal Detector
Rev 0 3 pg
B-604 Slat Counter
Rev 0 5 pg
B-605 Vibratory Filler
Rev 0 4 pg
B-606 Viking Masek ST560 8 Lane Stick Packing Machine
5 pg
B-607 Automatic Cottoner
Rev 4 2 pg
B-608 Induction Sealer
Rev 4 3 pg
B-609 Semi-Automatic Labeler
Rev 4 3 pg
B-610 Inline Labeler
Rev 5 5 pg
B-611 In-Line Capper
Rev 4 4 pg
B-612 Video Jet Printer
Rev 4 4 pg
B-613 Heat Tunnel
Rev 4 3 pg
B-614 DPP 260H Blister Pack Machine
Rev 4 4 pg
B-615 Accumulation Table
Rev 4 2 pg
B-616 Conveyor Operation and Cleaning
2 pg
B-617 Machine Vision Cameras
2 pg
B-618 Inline Rotary Chuck Capper
Rev 0 4 pg
B-621 Powder Fillers
Rev 16 6 pg
B-627 Automatic Neckbander - Body Sleever
Rev 4 4 pg
B-629 Inline Metal Detector
Rev 6 15 pg
B-630 Manual Metal Detector
Rev 5 3 pg
B-631 Bottle Unscrambler
Rev 3 3 pg
B-633 Automatic Spindle Capper
Rev 4 5 pg
B-636 Side Seal Shrink Wrapper
Rev 2 5 pg
B-703 Solid Coating Pan
Rev 61144 3 pg
B-704 Perforated Pan Coating
Rev 2 6 pg
B-801 Checkweigher and Metal Detection Combination Unit
7 pg
B-802 Gummy Counter
Rev 0 4 pg
B-901 Blending Procedure - Powders
Rev 12 10 pg
B-902 Compression Procedure
Rev 6 6 pg
B-903 Encapsulation Procedure
Rev 6 6 pg
B-904 Packaging Procedure
Rev 10 13 pg
B-905 Quality Inspection Process
Rev 3 22 pg
B-906 Gummy Manufacturing Process
Rev 1 11 pg
B-908 Weighing and Blending Procedure - Liquids
Rev 1 9 pg
B-909 Liquid Encapsulation Procedure
Rev 1 7 pg
B-910 Weighing and Dispensing Procedure
Rev 4 10 pg
B-911 Continuous Gummy Manufacturing Process
Rev 0 14 pg
C-201-F1 Unplanned Deviation Initiation Form blackmaca 062024
C-201-F2 Unplanned Deviation Investigation Form blackmaca
QS-108-F1 CAPA Initiation Form

D Laboratory Operations and Specifications 183

D-101 Laboratory Housekeeping
Rev 4 3 pg
D-102 Laboratory Notebook, Equipment Use Logs, Data Handling, and Data Review
Rev 7 10 pg
D-103 Analytical Method Validation and Verification
Rev 8 16 pg
D-104 QC Laboratory Glassware Cleaning
4 pg
D-105 Out of Specification - Out of Trend Investigation
Rev 2 17 pg
D-106 Analytical Standards
Rev 8 7 pg
D-108 Estimation of Measurement Uncertainty
Rev 0 11 pg
D-109 Qualitative Standards
Rev 6 10 pg
D-110 Verification and Validation of Cleaning Processes
Rev 3 6 pg
D-111 Allergen Testing for Production Equipment
Rev 7 9 pg
D-113 Microbiological Media Validation
Rev 7 11 pg
D-114 Laboratory Raw Data Definition and Management
2 pg
D-115 Environmental Monitoring of Air and Surfaces
Rev 11 26 pg
D-116 ATP Testing for Production Equipment
Rev 0 7 pg
D-117 Laboratory Purchases and Receiving
Rev 0 7 pg
D-118 Laboratory Quality Assurance Activities Plan (Proficiency Testing)
Rev 0 8 pg
D-119 Sales - Laboratory Sample Submission
Rev 0 10 pg
D-120 Laboratory Management Structure and Position Requirements
5 pg
D-121 Management - Laboratory
Rev 0 26 pg
D-122 Laboratory Operations
Rev 0 16 pg
D-123 Control of Laboratory Electronic Documentation
Rev 0 4 pg
D-124 Laboratory Management System Manual
Rev 0 27 pg
D-125 Microbiological Method Suitability
Rev 4 19 pg
D-126 Non-Conforming Results in the QC Laboratory
Rev 0 8 pg
D-127 Product Specific HPLC Method Optimization
Rev 1 5 pg
D-129 Internal Customer Feedback and Continual Improvement Procedure – Laboratory Services
Rev 0 4 pg
D-201 QC Laboratory Sample Receipt and Control
Rev 8 9 pg
D-202 Outsourced Testing Procedure
Rev 6 3 pg
D-203 Raw Material and Finished Product Non-GMP Testing
3 pg
D-301 Standardized Botanical Raw Materials
Rev 1 3 pg
D-302 Using Raw Materials at Risk
Rev 1 9 pg
D-303 Recertification of Raw Materials
Rev 5 6 pg
D-304 Reserve Sample Handling Storage and Disposal - Raw Materials
Rev 4 3 pg
D-305 Reclassifying Raw Materials
Rev 3 7 pg
D-306 Finished Product Qualification and Reduced Testing
Rev 3 11 pg
D-307 Declaration Claims and Allergen Requirements for Raw Materials and Finished Products
Rev 2 5 pg
D-401 New Product Documentation Requirements
Rev 12 10 pg
D-403 Calculations for Ingredient Addition Verification for Finished Products
Rev 6 10 pg
D-404 Finished Product Reserve Samples
Rev 8 3 pg
D-501 Stability Program for Finished Products
Rev 9 8 pg
D-602 Labeling and Expiration Dating of Laboratory Chemicals and Microbiology Inventory
Rev 9 7 pg
D-603 Chemical Waste Disposal
6 pg
D-701 Ascorbic Acid Determination by HPLC with UV-Vis Spectroscopy
Rev 1 9 pg
D-702 Density Determination of Liquids
Rev 5 5 pg
D-703 Disintegration Testing
Rev 8 7 pg
D-705 Friability Testing
Rev 4 4 pg
D-706 Use and Calibration of pH Meters
Rev 6 8 pg
D-708 Use of a Top Loading Balance
Rev 6 6 pg
D-709 Semi-Quantitative Determination of Nitrates using MQuant Nitrate Test Test-Strips
Rev 2 7 pg
D-710 Use of the Wrist Action Shaker
Rev 5 3 pg
D-711 Calibration and Operation of the VK-200 Hardness Tester
Rev 6 6 pg
D-712 Weight Variation of Dietary Supplements
Rev 8 6 pg
D-713 Methylcobalamin Determination by HPLC using UV-Vis Spectroscopy
Rev 2 8 pg
D-714 Use and Calibration of Digital Refractometer
Rev 2 7 pg
D-715 Microbial Limit Testing using the Neogen Petrifilm System
Rev 14 43 pg
D-717 Determination of the Related Compounds of Glycerin by GC-FID
Rev 2 4 pg
D-718 Determination of L-Carnitine by HPLC UV
Rev 2 6 pg
D-719 Amino Acid Determination using OPA and FMOC Derivitivization coupled with HPLC and UV-Vis
Rev 4 9 pg
D-720 Caffeine, Theacrine, and Theobromine Determination using HPLC and UV-Vis Detection
10 pg
D-721 Cholecalciferol (Vitamin D) Determination by HPLC using UV-Vis Spectroscopy
Rev 8 10 pg
D-722 Organoleptic Analysis
Rev 4 2 pg
D-723 Synephrine Determination by HPLC using UV-Vis Spectroscopy
Rev 4 8 pg
D-724 Particle Size Determination
Rev 7 5 pg
D-725 Loss on Drying
Rev 6 8 pg
D-726 Creatine Determination by HPLC coupled with UV-VIS Spectroscopy
Rev 5 7 pg
D-727 Raspberry Ketone and Zingerone Determination by HPLC using UV-Vis Spectroscopy
Rev 6 8 pg
D-728 Water Soluble Determination by HPLC using UV-Vis Spectroscopy
Rev 2 10 pg
D-729 Determination of Tributyrin by GC-FID
Rev 2 8 pg
D-730 Determination of EPA and DHA by GC-FID
Rev 1 11 pg
D-731 5-Hydroxytryptophan Determination by HPLC using UV-Vis Spectroscopy
Rev 5 8 pg
D-732 Determination of Gingerols, Gingerdiones, and Shogaols by HPLC-UV
Rev 3 9 pg
D-733 Determination of Chondroitin, N-Acetylglucosamine, and Glucosamine by HPLC-UV
Rev 6 12 pg
D-734 Determination of Phytosterols by GC-FID
Rev 1 9 pg
D-735 Arginine and Methionine Determination by HPLC coupled with UV-Vis Spectroscopy
Rev 5 8 pg
D-736 L-Citrulline Determination by HPLC with UV-Vis Detection
Rev 5 7 pg
D-737 Specific Gravity Determination Using a Pycnometer
Rev 5 5 pg
D-738 Choline Determination by HPLC using UV-Vis Spectroscopy
Rev 5 8 pg
D-739 Mangiferin Determination by HPLC-UV
Rev 0 4 pg
D-740 Monacolin K Determination by HPLC using UV-Vis Spectroscopy
Rev 3 7 pg
D-741 Chlorogenic Acid Determination by HPLC using UV-Vis Spectroscopy
Rev 5 8 pg
D-742 TLC Identification of Botanicals
Rev 3 15 pg
D-743 Coenzyme Q10 (Ubidecarenone) Determination by HPLC using UV-Vis Detection
Rev 2 7 pg
D-744 Lowry Protein Determination
Rev 3 12 pg
D-745 Phenylethylamine and Hordenine Determination by HPLC using UV-Vis Spectroscopy
Rev 4 8 pg
D-746 Identification by Mass Spectroscopy
Rev 2 6 pg
D-747 Determination of Total Tocotrienols by HPLC-UV
Rev 1 10 pg
D-748 Hydroxycitric Acid Determination by HPLC using UV-Vis Spectroscopy
Rev 4 7 pg
D-749 General Method for Determination of Water Soluble Vitamins and Similar Compounds by HPLC using UV-Vis Spectroscopy
Rev 5 10 pg
D-750 Yohimbine Alkaloid Determination by HPLC and UV-Vis Spectroscopy
Rev 3 9 pg
D-751 Baicalin, Hesperidin, and Naringin Determination By HPLC with UV-Vis Spectroscopy
Rev 2 11 pg
D-752 Cordycepic Acid (Mannitol) Determination by HPLC with RI Detection
Rev 0 4 pg
D-753 Diindoylmethane Determination by HPLC coupled with UV-VIS Spectroscopy
Rev 3 7 pg
D-754 Residual Solvents by Headspace GC
Rev 2 17 pg
D-755 Withanolides Determination by HPLC with UvVis Spectroscopy
Rev 0 7 pg
D-756 Rosmarinic Acid Determination by HPLC using UV-Vis Spectroscopy
Rev 1 8 pg
D-757 Determination of EGCG by HPLC-UV
Rev 4 8 pg
D-758 Salidroside Determination by HPLC using Uv-Vis Spectroscopy
Rev 1 6 pg
D-759 Melatonin Determination by HPLC using UV-Vis Spectroscopy
Rev 2 7 pg
D-760 B-Hydroxy-B-Methylbutyrate and B-Hydroxybutyrate Determination by HPLC using UV-Vis Spectroscopy
Rev 2 9 pg
D-762 Sennosides A and B Determination using UV-Vis Spectroscopy
Rev 3 9 pg
D-763 Nobiletin Determination by HPLC using UV-Vis Spectroscopy
Rev 1 7 pg
D-764 Monacolin K Determination by HPLC with UVVis Spectroscopy
Rev 0 6 pg
D-765 Berberine and Dihydroberberine Determination by HPLC using UV-Vis Spectroscopy
Rev 2 10 pg
D-766 Corosolic Acid Determination by HPLC using UV-Vis Spectroscopy
Rev 2 7 pg
D-767 Salicilin Determination by HPLC using UV-Vis Spectroscopy
Rev 1 7 pg
D-768 Methylsulfonylmethane Determination by GC using FLame Ionization Detection
Rev 2 9 pg
D-770 Apoaequorin Determination by HPLC using UVVIS Spectroscopy
Rev 2 24 pg
D-771 Ribose Determination by UV-Vis Spectroscopy
Rev 3 7 pg
D-772 Total Polysaccharide Determination by UV-VIS Spectroscopy
Rev 3 7 pg
D-773 Determination of Mogroside V by HPLC-UV
Rev 22 7 pg
D-774 Determination of Chrysin & 3,3-Diindolymethane by HPLC-UV
7 pg
D-775 Determination of Rebaudioside A and Rebaudioside M by HPLC-UV
Rev 2 7 pg
D-776 Cannabinoid Determination and Identification by HPLC
Rev 2 12 pg
D-777 Elemental Analysis by ICP-MS
Rev 8 37 pg
D-778 Limit of Citrinin by LC-MS CURRENT
Rev 2 9 pg
D-779 Determination of B-Caryophyllene by GC-FID
Rev 1 5 pg
D-780 Determination of Quercetin by HPLC using UV-Vis Spectroscopy
Rev 3 7 pg
D-781 Determination of N-Acetyl Tyrosine by HPLC-UV
Rev 2 7 pg
D-782 Determination of Cynaropicrin by HPLC using UV-Vis Spectroscopy
6 pg
D-783 Determination of Lidocaine and Phenoxyethanol by HPLC using UV-Vis Spectroscopy
Rev 1 7 pg
D-784 Determination of Trimethylglycine (Betaine) by HPLC-UV
Rev 2 7 pg
D-785 Beta Carotene Determination by HPLC using UV-Vis Spectroscopy
8 pg
D-786 Determination of Lipid Soluble Vitamins - Retinyl Acetate, Tocopheryl Acetate, Tocopheryl Succinate, Menoquininone-7
Rev 1 8 pg
D-787 Determination of Dehydroepiandrosterone and Piperine by HPLC using UV-VIS Spectroscopy
8 pg
D-788 Determination of Levodopa by HPLC using UV-Vis Spectroscopy
7 pg
D-789 Determination of D-Biotin by HPLC using UVVIS Spectroscopy
Rev 2 8 pg
D-790 Quantification of Procyanidins (Acid Butanol Method) by Visible Light Spectroscopy
Rev 1 6 pg
D-791 Quantification of Polyphenols (Folin-Ciocalteu Method) by Visible Light Spectroscopy
Rev 1 5 pg
D-792 Thymoquinone Determination by HPLC with UV-Vis Spectroscopy
Rev 1 8 pg
D-793 Cryogenic Grinding of Chewable Gels
Rev 0 3 pg
D-794 Use and Calibration of an Analog Brix Meter
Rev 1 7 pg
D-796 Determination of Salicylic Acid and its Organic Impurities by HPLC-UV
Rev 1 11 pg
D-797 Determination of a-Lipoic Acid by HPLC-UV
Rev 1 7 pg
D-798 Pterostilbene Determination by HPLC with UV-Vis Spectroscopy
Rev 1 9 pg
D-799 a-Mangostin Determination by HPLC with UV-Vis Spectroscopy
Rev 1 8 pg
D-801 Agilent 7890 GC Operation Maintenance and Qualification
Rev 1 20 pg
D-802 LC-MS Operation Maintenance and Qualification
Rev 1 18 pg
D-803 Calibration Verification and Operation of the Brookfield DV1 Digital Viscometer
Rev 2 7 pg
D-804 Data and Audit Trail Review in Agilent Open Labs Software
Rev 3 6 pg
D-805 Calibration Verification and Operation of the AquaLab 4TE
Rev 1 5 pg
D-806 Use of a Mechanical Pipette
Rev 1 6 pg
D-807 HPLC Operation Maintenance and Qualification Rev03
Rev 3 16 pg
D-808 Use of OpenLab for HPLC and GC Data Acquisition and Reporting
Rev 2 19 pg
D-809 Use and Calibration of Conductivity Meter
Rev 1 3 pg
D-810 Easy C1 Titrator Operation Maintenance and Qualification
Rev 0 14 pg
D-811 Creating Instrument Method Files using Chromeleon Series 7.X Series Software
4 pg
D-812 Creating Processing Method Files Using Chromeleon 7.X Software
Rev 4 5 pg
D-813 HPLC Data Handling and Naming Conventions Using Chromeleon 7.X Software
Rev 5 5 pg
D-814 HPLC Column Tracking and Maintenance
Rev 7 4 pg
D-815 Lab Computer System Access and Backup
Rev 5 3 pg
D-821 DicksonOne Data Loggers
Rev 4 4 pg
D-823 Identification by FTIR and Calibration-Preventative Maintenance Procedures
Rev 2 11 pg
D-824 Operation and Cleaning of the Autoclaves in the QC Laboratory
Rev 8 10 pg
D-825 Calibration, Verification, and Operation of a Multiwave Go Microwave System
Rev 2 6 pg
D-826 Calibration, Use, and Cleaning of Inline pH Meters
4 pg
D-827 Calibration and Use of Brix Refractometers
Rev 7 6 pg
D-828 Use of Balances in the QC Laboratory
Rev 8 9 pg
D-901 Raw Material Life Cycle and CoA Challenge Process
Rev 8 8 pg
D-902 Establishment of Specifications
Rev 1 20 pg
D-903 Conversion Factors used in Analytical Determinations and New Product Formulation
Rev 2 7 pg
D-1001 Determination of Isoflavones in Raw Materials and Finished Products by HPLC-UV
8 pg
D-1002 Determination of Ethylene Glycol and Diethylene Glycol by GC-FID
5 pg
D-1003 Determination of Amino Acids by LC-MS
13 pg
D-1004 Determination of Squalene by GC-FID
6 pg
D-1006 Determination of Methylcobalamin and Cyanocobalamin by LC-MS
12 pg
D-1007 Determination of Astaxanthin and Fucoxanthin in Raw Materials by HPLC-UV
10 pg
D-1011 Determination of Ginsenosides by HPLC-UV
8 pg
D-1012 Determination of Huperzine A, Theacrinem Caffeine, and Methylliberine by HPLC-UV
10 pg
D-1013 Determination of Phenylcapsaicin in Raw Materials by HPLC -UV
7 pg
D-1014 Determination of Paraxanthine in Raw Materials & Finished Products by HPLC-UV
8 pg
D-1015 Determining Phage Titer
Rev 0 10 pg
D-1016 Microbial Identification via Biolog Microstation
22 pg
D-1017 Determination of Lutein & Zeaxanthin by HPLC-UV
7 pg
D-1018 Determination of 5-Hydroxytryptophan, Tryptophan & Melatonin by HPLC-UV
8 pg
D-1019 Determination of Vitamin K1 by HPLC-UV
6 pg
D-1020 Determination of Apigenin by HPLC-UV
7 pg
D-1021 Determination of Rhaponticin and Desoxyrhaponticin by HPLC-UV
7 pg
D-1022 Determination of Water Soluble Vitamins by LC-MS
15 pg
D-1023 Determination of Beta Carotene by Visible Spectroscopy
5 pg
D-1024 Determination of Mannose by HPLC-UV
11 pg
D-1025 Determination of Ascorbyl Palmitate by HPLC-UV
10 pg
D-1026 Total Saponins Assay
4 pg
D-1027 Ninhydrin Testing for Boron Chelate 5%
3 pg