SOP Library
334 Standard Operating Procedures
A General and Personnel 16
A-101 Numeric Data Entry and Rounding
A-102 Emergency Services Procedure
A-103 Understanding Safety Data Sheets
A-104 Emergency Preparedness
A-106 Documentation Guidelines for cGMP Records
A-107 Workplace Safety Procedure
A-108 Good Manufacturing Practices and Personal Hygiene
A-109 Quality - General Responsibility and Authority
A-110 Authorization to Work Procedure
A-112 Near Miss Reporting Process
A-113 Training Procedure
A-114 Employee Signature Recording
A-116 Ensuring Identity Purity Strength and Composition of Solid Dosage Finished Products
A-117 Personnel Qualifications
A-118 Management Review of Quality Metrics
A-119 Ensuring the Identity Purity Strength and Composition of Liquid Form Finished Product
B Manufacturing 62
B-103 Small Parts Cleaning and General Sanitation
B-104 Floor Drain Cleaning and Sanitizing Procedure
B-105 Preparation of Cleaning and Sanitizing Chemicals for Production and Warehouse
B-106 Cleaning Methods for Organic Processing Equipment
B-108 Reprocessing Rework Procedure
B-111 Cleaning of Manufacturing-Production Areas and Equipment
B-112 Issuance of Master Case Labels
B-201 Tooling Control and Cleaning
B-207 NP-250 Rotary Tablet Press
B-211 Fitz Mill Grinder
B-212 Deduster Vibration Machine
B-215 Digital Caliper Usage and Cleaning
B-301 Oscillating Grinder
B-302 Blender Magnet Cleaning Procedure
B-303 Vibrating Sifter
B-312 V-Blenders
B-313 IMB Ribbon Blenders
B-401 Liquid Mixing Tank
B-402 Wilden Transfer Pump
B-507 Encapsulation Machine Model NJP-2000 and NJP-3200
B-601 Digital Cap Torque Tester
B-602 Rx-4 Automatic Tablet Capsule Counter
B-603 Insight Throat Metal Detector
B-604 Slat Counter
B-605 Vibratory Filler
B-606 Viking Masek ST560 8 Lane Stick Packing Machine
B-607 Automatic Cottoner
B-608 Induction Sealer
B-609 Semi-Automatic Labeler
B-610 Inline Labeler
B-611 In-Line Capper
B-612 Video Jet Printer
B-613 Heat Tunnel
B-614 DPP 260H Blister Pack Machine
B-615 Accumulation Table
B-616 Conveyor Operation and Cleaning
B-617 Machine Vision Cameras
B-618 Inline Rotary Chuck Capper
B-621 Powder Fillers
B-627 Automatic Neckbander - Body Sleever
B-629 Inline Metal Detector
B-630 Manual Metal Detector
B-631 Bottle Unscrambler
B-633 Automatic Spindle Capper
B-636 Side Seal Shrink Wrapper
B-703 Solid Coating Pan
B-704 Perforated Pan Coating
B-801 Checkweigher and Metal Detection Combination Unit
B-802 Gummy Counter
B-901 Blending Procedure - Powders
B-902 Compression Procedure
B-903 Encapsulation Procedure
B-904 Packaging Procedure
B-905 Quality Inspection Process
B-906 Gummy Manufacturing Process
B-908 Weighing and Blending Procedure - Liquids
B-909 Liquid Encapsulation Procedure
B-910 Weighing and Dispensing Procedure
B-911 Continuous Gummy Manufacturing Process
C-201-F1 Unplanned Deviation Initiation Form blackmaca 062024
C-201-F2 Unplanned Deviation Investigation Form blackmaca
QS-108-F1 CAPA Initiation Form
C Record Management 20
C-101 Format of SOPs and Forms
C-103 Batch Production Record Review and Release of Finished Product
C-104 Master Batch Record and Issuance of Batch Production Record
C-105 Protocol and Report Documentation Requirements
C-106 Redzone Security
C-107 Redzone Reviewer Activities
C-108 Redzone Administration Activities
C-111 Redzone General Use
C-201 Deviation and Investigation Procedure Rev 10
C-202 Material Review Board
C-403 Change Control Procedure
C-501 Document Control
C-502 Record Storage, Retention, And Destruction REV 6
C-601 New Product Approval Process
C-603 New Product Realization Process
C-604 National Drug Code (NDC) Coding
C-605 Product Quotation Process
C-706 Finished Product Expiration Dating
C-707 Critical Control Point Specifications
C-708 Printed Packaging Compliance Procedure
D Laboratory Operations and Specifications 183
D-101 Laboratory Housekeeping
D-102 Laboratory Notebook, Equipment Use Logs, Data Handling, and Data Review
D-103 Analytical Method Validation and Verification
D-104 QC Laboratory Glassware Cleaning
D-105 Out of Specification - Out of Trend Investigation
D-106 Analytical Standards
D-108 Estimation of Measurement Uncertainty
D-109 Qualitative Standards
D-110 Verification and Validation of Cleaning Processes
D-111 Allergen Testing for Production Equipment
D-113 Microbiological Media Validation
D-114 Laboratory Raw Data Definition and Management
D-115 Environmental Monitoring of Air and Surfaces
D-116 ATP Testing for Production Equipment
D-117 Laboratory Purchases and Receiving
D-118 Laboratory Quality Assurance Activities Plan (Proficiency Testing)
D-119 Sales - Laboratory Sample Submission
D-120 Laboratory Management Structure and Position Requirements
D-121 Management - Laboratory
D-122 Laboratory Operations
D-123 Control of Laboratory Electronic Documentation
D-124 Laboratory Management System Manual
D-125 Microbiological Method Suitability
D-126 Non-Conforming Results in the QC Laboratory
D-127 Product Specific HPLC Method Optimization
D-129 Internal Customer Feedback and Continual Improvement Procedure – Laboratory Services
D-201 QC Laboratory Sample Receipt and Control
D-202 Outsourced Testing Procedure
D-203 Raw Material and Finished Product Non-GMP Testing
D-301 Standardized Botanical Raw Materials
D-302 Using Raw Materials at Risk
D-303 Recertification of Raw Materials
D-304 Reserve Sample Handling Storage and Disposal - Raw Materials
D-305 Reclassifying Raw Materials
D-306 Finished Product Qualification and Reduced Testing
D-307 Declaration Claims and Allergen Requirements for Raw Materials and Finished Products
D-401 New Product Documentation Requirements
D-403 Calculations for Ingredient Addition Verification for Finished Products
D-404 Finished Product Reserve Samples
D-501 Stability Program for Finished Products
D-602 Labeling and Expiration Dating of Laboratory Chemicals and Microbiology Inventory
D-603 Chemical Waste Disposal
D-701 Ascorbic Acid Determination by HPLC with UV-Vis Spectroscopy
D-702 Density Determination of Liquids
D-703 Disintegration Testing
D-705 Friability Testing
D-706 Use and Calibration of pH Meters
D-708 Use of a Top Loading Balance
D-709 Semi-Quantitative Determination of Nitrates using MQuant Nitrate Test Test-Strips
D-710 Use of the Wrist Action Shaker
D-711 Calibration and Operation of the VK-200 Hardness Tester
D-712 Weight Variation of Dietary Supplements
D-713 Methylcobalamin Determination by HPLC using UV-Vis Spectroscopy
D-714 Use and Calibration of Digital Refractometer
D-715 Microbial Limit Testing using the Neogen Petrifilm System
D-717 Determination of the Related Compounds of Glycerin by GC-FID
D-718 Determination of L-Carnitine by HPLC UV
D-719 Amino Acid Determination using OPA and FMOC Derivitivization coupled with HPLC and UV-Vis
D-720 Caffeine, Theacrine, and Theobromine Determination using HPLC and UV-Vis Detection
D-721 Cholecalciferol (Vitamin D) Determination by HPLC using UV-Vis Spectroscopy
D-722 Organoleptic Analysis
D-723 Synephrine Determination by HPLC using UV-Vis Spectroscopy
D-724 Particle Size Determination
D-725 Loss on Drying
D-726 Creatine Determination by HPLC coupled with UV-VIS Spectroscopy
D-727 Raspberry Ketone and Zingerone Determination by HPLC using UV-Vis Spectroscopy
D-728 Water Soluble Determination by HPLC using UV-Vis Spectroscopy
D-729 Determination of Tributyrin by GC-FID
D-730 Determination of EPA and DHA by GC-FID
D-731 5-Hydroxytryptophan Determination by HPLC using UV-Vis Spectroscopy
D-732 Determination of Gingerols, Gingerdiones, and Shogaols by HPLC-UV
D-733 Determination of Chondroitin, N-Acetylglucosamine, and Glucosamine by HPLC-UV
D-734 Determination of Phytosterols by GC-FID
D-735 Arginine and Methionine Determination by HPLC coupled with UV-Vis Spectroscopy
D-736 L-Citrulline Determination by HPLC with UV-Vis Detection
D-737 Specific Gravity Determination Using a Pycnometer
D-738 Choline Determination by HPLC using UV-Vis Spectroscopy
D-739 Mangiferin Determination by HPLC-UV
D-740 Monacolin K Determination by HPLC using UV-Vis Spectroscopy
D-741 Chlorogenic Acid Determination by HPLC using UV-Vis Spectroscopy
D-742 TLC Identification of Botanicals
D-743 Coenzyme Q10 (Ubidecarenone) Determination by HPLC using UV-Vis Detection
D-744 Lowry Protein Determination
D-745 Phenylethylamine and Hordenine Determination by HPLC using UV-Vis Spectroscopy
D-746 Identification by Mass Spectroscopy
D-747 Determination of Total Tocotrienols by HPLC-UV
D-748 Hydroxycitric Acid Determination by HPLC using UV-Vis Spectroscopy
D-749 General Method for Determination of Water Soluble Vitamins and Similar Compounds by HPLC using UV-Vis Spectroscopy
D-750 Yohimbine Alkaloid Determination by HPLC and UV-Vis Spectroscopy
D-751 Baicalin, Hesperidin, and Naringin Determination By HPLC with UV-Vis Spectroscopy
D-752 Cordycepic Acid (Mannitol) Determination by HPLC with RI Detection
D-753 Diindoylmethane Determination by HPLC coupled with UV-VIS Spectroscopy
D-754 Residual Solvents by Headspace GC
D-755 Withanolides Determination by HPLC with UvVis Spectroscopy
D-756 Rosmarinic Acid Determination by HPLC using UV-Vis Spectroscopy
D-757 Determination of EGCG by HPLC-UV
D-758 Salidroside Determination by HPLC using Uv-Vis Spectroscopy
D-759 Melatonin Determination by HPLC using UV-Vis Spectroscopy
D-760 B-Hydroxy-B-Methylbutyrate and B-Hydroxybutyrate Determination by HPLC using UV-Vis Spectroscopy
D-762 Sennosides A and B Determination using UV-Vis Spectroscopy
D-763 Nobiletin Determination by HPLC using UV-Vis Spectroscopy
D-764 Monacolin K Determination by HPLC with UVVis Spectroscopy
D-765 Berberine and Dihydroberberine Determination by HPLC using UV-Vis Spectroscopy
D-766 Corosolic Acid Determination by HPLC using UV-Vis Spectroscopy
D-767 Salicilin Determination by HPLC using UV-Vis Spectroscopy
D-768 Methylsulfonylmethane Determination by GC using FLame Ionization Detection
D-770 Apoaequorin Determination by HPLC using UVVIS Spectroscopy
D-771 Ribose Determination by UV-Vis Spectroscopy
D-772 Total Polysaccharide Determination by UV-VIS Spectroscopy
D-773 Determination of Mogroside V by HPLC-UV
D-774 Determination of Chrysin & 3,3-Diindolymethane by HPLC-UV
D-775 Determination of Rebaudioside A and Rebaudioside M by HPLC-UV
D-776 Cannabinoid Determination and Identification by HPLC
D-777 Elemental Analysis by ICP-MS
D-778 Limit of Citrinin by LC-MS CURRENT
D-779 Determination of B-Caryophyllene by GC-FID
D-780 Determination of Quercetin by HPLC using UV-Vis Spectroscopy
D-781 Determination of N-Acetyl Tyrosine by HPLC-UV
D-782 Determination of Cynaropicrin by HPLC using UV-Vis Spectroscopy
D-783 Determination of Lidocaine and Phenoxyethanol by HPLC using UV-Vis Spectroscopy
D-784 Determination of Trimethylglycine (Betaine) by HPLC-UV
D-785 Beta Carotene Determination by HPLC using UV-Vis Spectroscopy
D-786 Determination of Lipid Soluble Vitamins - Retinyl Acetate, Tocopheryl Acetate, Tocopheryl Succinate, Menoquininone-7
D-787 Determination of Dehydroepiandrosterone and Piperine by HPLC using UV-VIS Spectroscopy
D-788 Determination of Levodopa by HPLC using UV-Vis Spectroscopy
D-789 Determination of D-Biotin by HPLC using UVVIS Spectroscopy
D-790 Quantification of Procyanidins (Acid Butanol Method) by Visible Light Spectroscopy
D-791 Quantification of Polyphenols (Folin-Ciocalteu Method) by Visible Light Spectroscopy
D-792 Thymoquinone Determination by HPLC with UV-Vis Spectroscopy
D-793 Cryogenic Grinding of Chewable Gels
D-794 Use and Calibration of an Analog Brix Meter
D-796 Determination of Salicylic Acid and its Organic Impurities by HPLC-UV
D-797 Determination of a-Lipoic Acid by HPLC-UV
D-798 Pterostilbene Determination by HPLC with UV-Vis Spectroscopy
D-799 a-Mangostin Determination by HPLC with UV-Vis Spectroscopy
D-801 Agilent 7890 GC Operation Maintenance and Qualification
D-802 LC-MS Operation Maintenance and Qualification
D-803 Calibration Verification and Operation of the Brookfield DV1 Digital Viscometer
D-804 Data and Audit Trail Review in Agilent Open Labs Software
D-805 Calibration Verification and Operation of the AquaLab 4TE
D-806 Use of a Mechanical Pipette
D-807 HPLC Operation Maintenance and Qualification Rev03
D-808 Use of OpenLab for HPLC and GC Data Acquisition and Reporting
D-809 Use and Calibration of Conductivity Meter
D-810 Easy C1 Titrator Operation Maintenance and Qualification
D-811 Creating Instrument Method Files using Chromeleon Series 7.X Series Software
D-812 Creating Processing Method Files Using Chromeleon 7.X Software
D-813 HPLC Data Handling and Naming Conventions Using Chromeleon 7.X Software
D-814 HPLC Column Tracking and Maintenance
D-815 Lab Computer System Access and Backup
D-821 DicksonOne Data Loggers
D-823 Identification by FTIR and Calibration-Preventative Maintenance Procedures
D-824 Operation and Cleaning of the Autoclaves in the QC Laboratory
D-825 Calibration, Verification, and Operation of a Multiwave Go Microwave System
D-826 Calibration, Use, and Cleaning of Inline pH Meters
D-827 Calibration and Use of Brix Refractometers
D-828 Use of Balances in the QC Laboratory
D-901 Raw Material Life Cycle and CoA Challenge Process
D-902 Establishment of Specifications
D-903 Conversion Factors used in Analytical Determinations and New Product Formulation
D-1001 Determination of Isoflavones in Raw Materials and Finished Products by HPLC-UV
D-1002 Determination of Ethylene Glycol and Diethylene Glycol by GC-FID
D-1003 Determination of Amino Acids by LC-MS
D-1004 Determination of Squalene by GC-FID
D-1006 Determination of Methylcobalamin and Cyanocobalamin by LC-MS
D-1007 Determination of Astaxanthin and Fucoxanthin in Raw Materials by HPLC-UV
D-1011 Determination of Ginsenosides by HPLC-UV
D-1012 Determination of Huperzine A, Theacrinem Caffeine, and Methylliberine by HPLC-UV
D-1013 Determination of Phenylcapsaicin in Raw Materials by HPLC -UV
D-1014 Determination of Paraxanthine in Raw Materials & Finished Products by HPLC-UV
D-1015 Determining Phage Titer
D-1016 Microbial Identification via Biolog Microstation
D-1017 Determination of Lutein & Zeaxanthin by HPLC-UV
D-1018 Determination of 5-Hydroxytryptophan, Tryptophan & Melatonin by HPLC-UV
D-1019 Determination of Vitamin K1 by HPLC-UV
D-1020 Determination of Apigenin by HPLC-UV
D-1021 Determination of Rhaponticin and Desoxyrhaponticin by HPLC-UV
D-1022 Determination of Water Soluble Vitamins by LC-MS
D-1023 Determination of Beta Carotene by Visible Spectroscopy
D-1024 Determination of Mannose by HPLC-UV
D-1025 Determination of Ascorbyl Palmitate by HPLC-UV
D-1026 Total Saponins Assay
D-1027 Ninhydrin Testing for Boron Chelate 5%
E Materials Management 15
E-101 Warehouse and Inventory Control
E-204 Receiving Process for Raw Materials and Packaging Components
E-302 Distribution Procedure
E-401 Refrigerator Unit Requirements
E-501 Procedure for Returned Products
E-701 Packaging Components Sampling Procedure
E-702 Finished Product Sampling Procedure
E-703 Raw Material Sampling Procedure
E-704 AQL Statistical Sampling Plan
E-706 Pre-screening Bulk and Tapped Density of Key Materials
E-707 Compressed Air Microbial Testing
E-708 Creating New Packaging Component Specifications
E-801 Return of Materials and Destruction of Non-Hazardous Waste Materials R11 -
E-804 Handling and Storage of Probiotics
E-901 Shipping and Receiving Transport Inspection
F Facilities 7
F-502 Evoqua Purified Water System
F-503 Millipore Water System
F-505 Environmental Monitoring of Temperature and Humidity
F-506 Facility Maintenance and Sanitation
F-507 Warehouse Maintenance and Sanitation
F-508 Control of Glass, Brittle Plastics, and Ceramics
F-509 Powered Industrial Equipment Procedure
G Equipment 16
G-102 Equipment Profiles
G-103 Qualification of Equipment
G-104 Lockout Tagout Procedure
G-105 Lockout Tagout Devices
G-106 Emergency Removal of Safety Locks
G-108 Cherry Industrial Equipment Pallet Inverter
G-109 SOP G-109 Fall Protection
G-201 Calibration Program
G-202 Calibration Verification of Digital Temperature Devices
G-203 Calibration Verification of Digital Humidity Indicators
G-204 Calibration Verification of Digital and Analog Timers
G-205 Calibration Verification of Digital Micrometers
G-206 Verification of Digital Temperature and Humidity Recording Devices
G-207 Calibration and Operation of Scales and Load Cells
G-208 Analytical Calibration and Equipment Control
G-209 Calibration and Operation of the Sotax MT-50 Hardness Tester FORMATTED
H Audits 1
QS Quality System 14
QS-101 Complaints
QS-102 Adverse Events
QS-103 Pest Control Management
QS-106 Allergen Control
QS-107 Recall Procedure
QS-108 Corrective and Preventative Action (CAPA)
QS-109 Food Defense Plan
QS-111 Root Cause Analysis (RCA)
QS-112 Core Quality Systems and Quality Events
QS-113 Effectiveness Checks (EC)
QS-114 Quality Risk Management
QS-115 cGMP Electronic System Controls and Requirements
QS-116 cGMP Electronic Signatures
QS-117 Halal Assurance System (HAS)