cGMP in Manufacturing, Packing, Labeling, or Holding
Operation for Dietary Supplements
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Personnel (Requirements, Written Procedures,
Prevention of microbial contamination from sick or infected personnel, Hygienic
practices, Qualification requirements, Supervisor requirements, and Records
requirements.
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Physical Plant and Ground (Sanitation
requirements, Written procedures, Design and construction requirements, and
Records)
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Equipment and Utensils (Requirements, Written
Procedures, Automated, Mechanical, or Electronic Equipment, and Records)
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Production and Process Control System
Requirements (Implementation, System Design, QC Operations, Specifications,
Responsibilities, Determination, Establishment, Sample Collection, Reserve
Sampling, Material Review and Disposition Decision, Treatments for In-Process
Adjustments and Reprocessing for Deviation or Unanticipated Occurrence, and
Records)
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Production and Process Control System
Requirements for Quality Control (Instruction, Responsibilities, Operations,
Lab Operations, Material Review, Disposition Decision, Equipment, Instrument,
Controls, Components, Packaging, and Labeling, MMR, Batch Production Records,
and Manufacturing Operations, Returns, Reprocessing, Reworking, and Complaints
processing and Records.
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Production and Process Control System Requirements
for Components, Packaging, and Labels, and for Product That You Receive for
Packaging or Labeling.
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Production and Process Control System Requirements
for Master Manufacturing Record
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Production and Process Control System Requirements
for the Batch Production Record
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Production and Process Control System Requirements
for Laboratory Operations
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Production and Process Control System Requirements
for Manufacturing Operations
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Production and Process Control System Requirements
for Packaging and Labeling Operations
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Holding and Distributing
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Returned Dietary Supplements
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Product Complaints
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Records and Recordkeeping