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Dietary Supplement GMP (Good Manufacturing Practices)

Dietary Supplement GMP (Good Manufacturing Practices)

Dietary Supplement GMP (Good Manufacturing Practices)

 

The U.S. Food and Drug Administration’s (FDA) final regulation on good manufacturing practices (GMPs) for dietary supplements (21 CFR 111) established stringent requirements for companies involved with the manufacturing, packaging, labeling and holding of dietary supplements.

Under the rule, manufacturers are required to evaluate the identity, purity, quality, strength, and composition of their dietary ingredients and dietary supplements. GMPs are crucial to the supplement industry’s ability to deliver safe, accurately labeled products to the consumer and in achieving the public health benefits noted by Congress in the preamble to the Dietary Supplement Health and Education Act of 1994.

 

Good Manufacturing Practices GMP for Dietary Supplements

NaturPro Scientific offers Compliance Audits for Good Manufacturing Practices GMP for Dietary Supplements

 

 

FDA Guidance for Industry on Dietary Supplement GMP:

Guidance for Industry: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements;

Table of Contents

 

  1. Introduction
  2. Discussion
    1. Compliance Dates for the Dietary Supplement Current Good Manufacturing Practice Rule (DS CGMP Rule) and the Interim Final Rule
    2. Organization for the DS CGMP Rule
  3. Subpart A – General Provisions
    1. Coverage of the DS CGMP Rule
    2. How the DS CGMP Rule Applies to Specific Types of Operations
    3. How the DS CGMP Rule Applies to Contractors
    4. Terms Used in the DS CGMP Rule and In This Document
    5. Other Applicable Statutory Provisions and Regulations
  4. Written Procedures Required by the DS CGMP Rule
  5. Records Required by the DS CGMP Rule
  6. Subpart B – Personnel
  7. Subpart C – Physical Plant And Grounds
  8. Subpart D – Equipment And Utensils
  9. Subpart E – Requirement To Establish A Production And Process Control System
    1. General Requirements of Subpart E
    2. Requirements to Establish Specifications
    3. Requirements to Determine Whether Specifications Are Met
    4. Specific Requirements Regarding Specifications for Dietary Ingredients and Other Components
    5. Representative and Reserve Samples
  10. Subpart F – Production and Process Control: Requirements For Quality Control
  11. Subpart G – Production and Process Control: Requirements For Components, Packaging, And Labels And For Product That Is Received For Packaging Or Labeling As A Dietary Supplement
    1. Requirements for Components
    2. Requirements for Packaging and Labels
    3. Requirements for Received Product
    4. Requirements for Rejected Components, Packaging, Labels and Received Product
  12. Subpart H – Production and Process Control: Requirements for a Master Manufacturing Record
  13. Subpart I – Production and Process Control: Requirements for a Batch Production Record
  14. Subpart J – Production and Process Control: Requirements for Laboratory Operations
  15. Subpart K – Production and Process Control: Requirements for Manufacturing Operations
  16. Subpart L – Production and Process Control: Requirements for Packaging and Labeling Operations
  17. Subpart M – Holding and Distributing
  18. Subpart N – Returned Dietary Supplements
  19. Subpart O – Product Complaints
  20. Subpart P –Records and Recordkeeping
  21. References

 

 

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