[Company]

Quality Manual

Company

Quality Manual

In compliance with

Dietary Supplement Current Good Manufacturing Practices (cGMPs 21 CFR part 111, 2007)

Document Number: QM01-00

Effective Date: MM-DD-YYYY

Table of Contents

Section / Content / Page
Cover Page / 1
Revision and Approval Record / 2
Quality Policy / 3
Table of Contents / 4
Chapter 1 / General Provisions / 8
1.1. / Purpose and Applications / 8
1.2. / Definitions / 8
Chapter 2 / Personnel / 11
2.1. / Written Procedure Requirements / 11
2.2. / Preventing Microbial Contamination and Hygienic Practices / 11
2.3. / Personnel Qualification Requirements / 12
2.4. / Supervisor Requirements / 13
2.5. / Record Requirements / 13
Chapter 3 / Physical Plant and Grounds / 14
3.1. / Sanitation Requirements / 14
3.2. / Written Procedure Requirements / 16
3.3. / Design and Construction Requirements / 16
3.4. / Record Requirements / 18
Chapter 4 / Equipment and Utensils / 19
4.1. / Written Procedure Requirements / 19
4.2. / Equipment and Utensils / 19
4.3. / Automated, Mechanical, or Electronic Equipment / 22
4.4. / Record Requirements / 22
Chapter 5 / Production and Process Control System / 24
5.1. / Implement a Production and Process Control System / 24
5.2. / Design Requirements / 24
5.3. / Requirements for Quality Control Operations / 24
5.4. / Requirements for Specifications / 24
5.5. / Responsibility for Determining whether Established Specifications Are Met / 25
5.6. / What We Must Do to Determine whether Specifications Are Met / 26
5.7. / What Must We Do If Established Specifications Are Not Met / 28
5.8. / Representative Sample Collection Requirements / 28
5.9. / Reserve Sample Requirements / 29
5.10. / Material Review and Disposition Decision Responsibilities / 30
5.11. / Treatments, In-Process Adjustments, and Reprocessing Requirements / 30
5.12. / Record Requirements / 30
Chapter 6 / Quality Control Requirements / 32
6.1. / Written Procedure Requirements / 32
6.2. / Quality Control Personnel Responsibilities / 32
6.3. / Quality Control Operation Requirements for Laboratory Operations / 33
6.4. / Quality Control Operation Requirements for Material Review and Disposition Decision / 33
6.5. / Quality Control Operation Requirements for Equipment, Instruments, and Controls / 34
6.6. / Quality Control Operation Requirements for Components, Packaging, and Labels / 34
6.7. / Quality Control Operation Requirements for the Master Manufacturing Record, the Batch Production Record, and Manufacturing Operations / 34
6.8. / Quality Control Operation Requirements for Packaging and Labeling Operations / 36
6.9. / Quality Control Operation Requirements for Returned Dietary Supplements / 36
6.10. / Quality Control Operation Requirements for Product Complaints / 37
6.11. / Record Requirements / 37
Chapter 7 / Receiving Operations / 39
7.1. / Written Procedure Requirements / 39
7.2. / Components of Dietary Supplements / 39
7.3. / Packaging and Labels Received / 40
7.4. / Product Received for Packaging or Labeling / 40
7.5. / Rejected Components, Packaging, Labels, and Product Received for Packaging or Labeling / 41
7.6. / Record Requirements / 41
Chapter 8 / Master Manufacturing Record / 43
8.1. / Requirements to Establish a Master Manufacturing Record / 43
8.2. / Master Manufacturing Record Contents / 43
Chapter 9 / Batch Production Record / 45
9.1. / Requirements to Establish a Batch Production Record / 45
9.2. / Batch Production Record Content / 45
Chapter 10 / Laboratory Operations / 47
10.1. / Written Procedure Requirements / 47
10.2. / Laboratory Facility Requirements / 47
10.3. / Laboratory Control Process Requirements / 48
10.4. / Laboratory Method Requirements / 49
10.5. / Record Requirements / 49
Chapter 11 / Manufacturing Operations / 50
11.1. / Written Procedure Requirements / 50
11.2. / Design Requirements for Manufacturing Operations / 50
11.3. / Requirements for Sanitations / 50
11.4. / Precautions to Prevent Contamination / 50
11.5. / Rejected Dietary Supplements / 51
11.6. / Record Requirements / 51
Chapter 12 / Packaging and Label Operations / 52
12.1. / Written Procedure Requirements / 52
12.2. / Packaging and Labels / 52
12.3. / Filling, Assembling, Packaging, Labeling, and Related Operations / 52
12.4. / Repackaging and Relabeling / 53
12.5. / Packaged and Labeled Dietary Supplement Rejected for Distribution / 53
12.6. / Record Requirements / 53
Chapter 13 / Holding and Distribution / 54
13.1. / Written Procedure Requirements / 54
13.2. / Holding Components, Dietary Supplements, Packaging, and Labels / 54
13.3. / Holding In-Process Material / 54
13.4. / Holding Reserve Samples of Dietary Supplements / 54
13.5. / Distributing Dietary Supplements / 55
13.6. / Record Requirements / 55
Chapter 14 / Returned Products / 56
14.1. / Written Procedure Requirements / 56
14.2. / Receiving Returned Dietary Supplement / 56
14.3. / Disposition of Returned Dietary Supplement / 56
14.4. / Salvage of Returned Dietary Supplement / 56
14.5. / Reprocess of Returned Dietary Supplement / 56
14.6. / Investigation of Manufacturing Processes and Other Batches / 57
14.7. / Record Requirements / 57
Chapter 15 / Product Complaint / 58
15.1. / Written Procedure Requirements / 58
15.2. / Review and Investigation of a Product Complaint / 58
15.3. / Record Requirements / 58
Chapter 16 / Records and Recordkeeping / 60
16.1. / Requirements Apply to the Records That We Make and Keep / 60
16.2. / Records Made Available to FDA / 60

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