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Implementation of FDA’s Current Good Manufacturing Practices for Dietary Supplements. Current Good Manufacturing Practices (CGMP’s) for Dietary Supplements.
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Implementation of FDA’s Current Good Manufacturing Practices for Dietary Supplements
Current Good Manufacturing Practices (CGMP’s) for Dietary Supplements This final rule establishes the minimum CGMP’s to manufacturing, packing, labeling, or holding dietary supplements to ensure the quality of the dietary supplement.
CGMP’s The final rule is organized into 16 subparts that focus on specific aspects of the manufacturing process or addressing specific issues.
CGMP’s General Provisions SubpartA
Manufacture, package, label or hold a dietary supplement. Package, label or distribute manufactured by another firm. Sell in bulk to a distributor Imported or offered for import Who is Subject to this Part?§111.1
Other Statutory Provisions and Regulations?§111.5 In addition to these regulations, you must comply with other applicable statutory provisions and regulations related to dietary supplements.
CGMP’s Personnel Subpart B
Personnel Subpart B • Establish and follow written procedures • Microbial contamination • Qualified employees • Supervisor requirements • Record Keeping
CGMP’s Physical Plant and Grounds Subpart C
Physical Plant and GroundsSubpart C • Sanitation Requirements • Establish and follow written procedures • Design and Construction requirements • Record Keeping
CGMP’s Equipment and Utensils Subpart D
Equipment and Utensils Subpart D • Establish and follow written procedures • Requirements • Automated, Mechanical, Electrical • Record Keeping
CGMP’s Production and Process Controls Subpart E
Production and Process ControlsSubpart E • Implement a system of production and process controls • Design requirements • Quality Control Operations • Specifications • Responsibility of Specifications
Production and Process ControlsSubpart E • Are Specifications met • What to do if specifications are not met • Representative samples • Reserve sample requirements • Material reviews and disposition decisions
Production and Process ControlsSubpart E • Requirements to Treatments, In-process Adjustments and Reprocessing • Record Keeping
CGMP’s Control Requirements for Quality Control Subpart F
Controls Requirements for Quality Control Subpart F • Establish and follow written procedures for the quality control operations unit. • What Quality Control Personnel must do • Quality control for Laboratory operations • Material review and disposition decisions
Controls Requirements forQuality Control Subpart F • Quality control for equipment, instruments and controls • Quality control for components, packaging and labels before use • Quality control for master manufacturing record, batch record and manufacturing operations. • Quality control for Packaging and Labeling operations.
Controls Requirements for Quality Control Subpart F • Quality control for returned dietary supplements • Quality control for Product Complaints • Record Keeping
CGMP’s Requirements for Components, Packaging and Labeling Subpart G
Requirements for Components, Packaging, Labeling Subpart G • Establish and follow written procedures • Requirements to components • Requirements to packaging and labels received • Requirements to products received for packaging or labeling • Requirements for rejected packaging and labeling.
CGMP’s Master Manufacturing Record Subpart H
Master Manufacturing Record Subpart H • Prepare and follow a written master manufacturing record for each unique formulation of dietary supplement • What the master record must include
CGMP’s Batch Production Record Subpart I
Batch Production Record • A batch production record must be established every time you manufacture a batch • Batch production record must include:
CGMP’s Batch Laboratory Operations Subpart J
Requirements forLaboratory Operations • Establish and follow written procedures • Use adequate laboratory facilities • Requirements for Laboratory control processes • Methods for testing and examination
CGMP’s Manufacturing Operations Subpart K
Manufacturing Operations • Establish and follow written procedures for manufacturing operations • Ensure product specifications are consistent • Adequate sanitation principles • Prevent contamination • Appropriate disposition of rejected or unsuitable dietary supplements
CGMP’s Requirements for Packaging and Labeling Operations Subpart L
Requirements for Packaging and Labeling Operations • You must establish and follow written procedures for packaging and labeling operations • Condition of packaging will ensure quality of dietary supplements • Requirements for filling, assembling packaging, labeling and related procedures
Requirements for Packaging and Labeling Operations • Requirements for repackaging and relabeling • Packaged and labeled supplements rejected for distribution • Record Keeping
CGMP’s Holding and Distributing Subpart M
Holding and Distributing • Establish and follow written procedures for holding and distributing operations • Requirements to hold components, supplements, packaging and labels • Requirements for in-process materials • Requirements for reserve samples • Distribution requirements to protect against contamination and deterioration
CGMP’s Returned Dietary Supplement Subpart N
Returned Dietary Supplements • Establish and follow written procedures under this subpart • Identify and quarantine returned dietary supplements • Destroy and suitably dispose of dietary supplements • Salvaging a returned dietary supplement • Requirements for reprocessed dietary supplements
Returned Dietary Supplements • Investigation of manufacturing processes and other batches • Record Keeping
CGMP’s Product Complaints Subpart O
Product Complaints • You must establish and follow written procedures to fulfill the requirements of this subpart • Review and investigation of product complaints • Record Keeping
CGMP’s Record and Recordkeeping Subpart P
Records and Recordkeeping • Recordkeeping requirements • Records that must be made available to FDA
Petition to Request Exemption from 100 Percent Identity Testing of Dietary IngredientsInterim Final Rule (IFR) 72 FR 34959 June 25, 2007 Ref: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements
IFR • Requirement for 100 percent identity testing of dietary ingredients is found at Subpart E — Requirement to Establish a Production and Process Control System, § 111.75 ‘‘What must you do to determine whether specifications are met?’’ in the CGMP final rule. • 111.75(a)(1) Before you a component you must: (1) Conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient.
IFR • This identity testing requirement applies to a manufacturer who: • purchases a dietary ingredient from a dietary ingredient supplier • manufactures its own dietary ingredient for use in the manufacture of its dietary supplement.
IFR FDA will consider, on a case-by-case basis, a manufacturer’s conclusion, supported by appropriate data and information in the petition submission, that it has developed a system that it would implement as a sound, consistent means of establishing, with no material diminution of assurance compared to the assurance provided by 100 percent identity testing, the identity of the dietary ingredient before use.
IFR • The petition needs to set forth, at minimum: • Scientific Rationale for requested exemption • Supporting Data and information • Documenting and careful analysis of any variability or errors in incoming product • Alternative testing proposal
IFR • Under this IFR, firms will be granted exemption from the requirement of 100 percent identity testing only when • a manufacturer petitions the agency under §10.30 and • the agency grants such an exemption.
IFR • § 10.30 (21 CFR 10.30), the citizen petition process requires your petition to include: • The action requested (i.e., a request for an exemption from the requirements of § 111.75(a)(1)(i)); • A statement of grounds; • A section on environmental impact,
IFR • A statement certifying that, to the best of your knowledge and belief, your petition includes all information and views on which the petition relies, and that it includes representative data and information known to you which are unfavorable to the petition. • Identify any information in the petition that is confidential commercial or trade secret information • Should segregate such information from other information in your petition.