This document provides an overview of dietary supplement manufacturing and quality assurance/quality control processes at Bluebonnet Nutraceutical Ltd. in compliance with Current Good Manufacturing Practices regulations. It details the company's history and product lines. The manufacturing facility layout and processes are described, including receiving raw materials, mixing, blending, encapsulation, tablet production, coating, and finished product packaging. Quality control procedures involve testing raw materials, in-process materials, and finished products to ensure safety and specifications are met. Maintaining compliance with regulations through qualified personnel, documented processes, and calibration of equipment is emphasized.

1. Dietary Supplement Manufacturing and QA/QC Overview
In Compliance with cGMPs: 21 CFR Part 111 standards
BY
Mohammad Rafiqul (Rafiq) Islam, B.S. in Chemical Engineering
(Registered member of APEGA and ASQ)
Manufacturing and QA/QC Specialist at Bluebonnet Nutraceutical Ltd.
Sugarland, Texas
August, 2016

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Table of Contents
1.0 Objective………………………………………………………………………………………………………………………….5
2.0 Bluebonnet Corporation Background……………………………………………………………………………5
2.1 History…………………………………………………………………………………………………………………5
2.2 An award winning company………………………………………………………………………………..5
2.3 A broad and diversified product line……………………………………………………………………6
2.4 CGMP Certified Sugarland Manufacturing Facility ………………………………………………9
3.0 Sugarland Manufacturing Plant layout…………………………………………………………………………..11
4.0 Dietary Supplement and Market Prospect…………………………………………………………………….12
5.0 US FDA’s Dietary Supplement Regulation……………………………………………………………………..12
5.1 Fundamental of CGMP……………………………………………………………………………………….13
5.2 Basic Requirement of CGMP………………………………………………………………………………14
5.3 CGMP Directive-Code of Federal Regulation………………………………………………………15
5.4 Inspection of Dietary Supplement Manufacturers……………………………………………..38
5.5 Improving Compliance……………………………………………………………………………………….39
5.6 Continuous Compliance…………………………………………………………………………………….39
6.0 Production Documentation and Control Procedure……………………………………………………..40
6.1 Production Documentation……………………………………………………………………………….40
6.2 Suitability for Production ………………………………………………………………………………….40
6.3 Production Flow Chart ……………………………………………………………………………………..42
7.0 Manufacturing Processes and Raw Materials………………………………………………………………43
7.1 Preparing Production Planning…………………………………………………………………………43
7.2 Receiving Raw Materials…………………………………………………………………………………..43
7.3 Preliminary Check of Raw Materials…………………………………………………………………44
7.3.1 Quarantine……………………………………………………………………………………….44
7.3.2 Released…………………………………………………………………………………………..45
7.3.3 Rejected……………………………………………………………………………………………45
7.3.4 Stock of Raw Materials……………………………………………………………………..45

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7.3.5 Shelf Life…………………………………………………………………………………………..45
7.4 Classification of Raw Materials…………………………………………………………………………45
7.5 Handling and Storage of Raw Materials……………………………………………………………47
7.6 Dispensing Raw Materials………………………………………………………………………………..47
8.0 The Step-by-Step Manufacturing Processes………………………………………………………………..47
8.1 Weighing…………………………………………………………………………………………………………48
8.1.1 Importance of Weighing………………………………………………………………….48
8.1.2 Measure and Weigh of Raw Materials…………………………………………….48
8.2 Mixing and Blending……………………………………………………………………………………….49
8.3 Variable Parameter impacts on Blending………………………………………………………..49
8.4 Protect Sensitive Ingredients during Blending ……………………………………………….50
8.5 Pre-Blend of Raw Materials……………………………………………………………………………50
8.6 Blending Time and Level………………………………………………………………………………..50
8.7 Granulation……………………………………………………………………………………………………51
8.8 Equipment used in Mixing and Blending………………………………………………………..52
8.8.1 Fitz Mill………………………………………………………………………………………….52
8.8.2 Cross Flow Blender (50 cubic feet capacity)…………………………………..53
8.8.3 Cross Flow Blender (30 cubic feet capacity)…………………………………..54
8.8.4 V-shell Blender (V-Mixer); Type 5………………………………………………….54
8.8.5 Ribbon Blenders……………………………………………………………………………55
8.8.6 Pony Mixer…………………………………………………………………………………..56
8.9 Encapsulation…………………………..………………………………………………………………….56
8.9.1 Product type: Capsules…………………………………………………………………56
8.9.2 Capsule sizes produced………………………………………………………………..57
8.10 Equipment Used in Encapsulation……………………………………………………………..57
8.10.1 Schaefer STI Model Capsule Filling Machine………………………………57
8.10.2 GKF Capsylon 705………………………………………………………………………58

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8.11 Polishing and Inspection …………………………………………………………………………..58
8.11.1 Capsule Polishing Technique……………………………………………………..58
8.11.2 Capsule Manufacturing defects and Remedies………………………….59
8.12 Tablet Manufacturing……………………………………………………………………………….60
8.12.1 Direct Compression…………………………………………………………………..61
8.12.2 Manufacturing Defects and Remedies………………………………………62
8.13 Equipment Used in Tablet Manufacturing………………………………………………..63
8.13.1 Riddhi High Speed Rotary Tablet Press RDD3-16……………………….63
8.13.2 Riddhi High Speed Rotary Tablet Press RDD3-27……………………….64
8.14 Tablet Coating…………………………………………………………………………………………..64
8.14.1 Accela-Cota Tablet Coating System…………………………………………..65
9.0 Tablet / Capsules Testing…………………………………………………………………………………….67
10.0 Finished Product……………………………………………………………………………………………….68
10.1 Labeling and Shipping Finished Products …………………………………………………68
11.0 Personnel Hygiene Facilities……………………………………………………………………………..68
11.1 Statutory Requirement ……………………………………………………………………………69
11.2 Best Practice Requirement……………………………………………………………………….69
11.3 Cleaning Dirt off Clothing…………………………………………………………………………70
11.4 Emergency Shower and Eye Wash Station……………………………………………….70
12.0 Equipment Wash and Preparation…………………………………………………………………….71
13.0 Calibration of Measuring Equipment…………………………………………………………………72
14.0 Quality Systems………………………………………………………………………………………………..72
14.1 Quality Assurance (QA)…………………………………………………………………………….72
14.2 Responsibilities of Quality Control Personnel…………………………………….…...73
14.3 Quality Control (QC)……………….………………………………………………………………..74
14.4 Laboratory Testing……………………………………………………………………………………74
References……………………………………………………………………………………………………………….76