For information on cGMPs, please visit: www.fda.gov.
Part
III: Quality Control Procedures
In this third segment of cGMP Demystified, we will dissect specific
guidelines pertaining to quality control procedures. This is
a major issue in regards to cGMPs because these standards were
established mostly due to quality concerns over these dietary
supplements. Without it, it is difficult to gauge the purity
and content of the dietary supplement. The FDA requires those
who manufacture, package, label or hold dietary supplement have
their quality control personnel follow these procedures.
The final rule requires manufacturers
of dietary supplements to:
Have their Quality Control Operations conducted by Quality Control
personnel
Have their QC personnel review and approve documentation
for in-meeting specifications to ensure identity, purity, strength
and composition of dietary supplement are verified
Have their QC personnel review and approve documentation
for in-meeting specifications to ensure finished batches are
consistent with specifications and free of contamination
Have their QC personnel review and approve documentation
for in-meeting specifications to ensure final batch testing Guidelines for Operations of
Material Reviews & Dispositions:
Conduct all required material reviews and make all required
dispositions
Establish and follow written procedures before conducting a
review and making a regulation or disposition decision
Provide signatures of those who conducted material review, quality
control procedure or any other qualified individual who provided
information on the review or disposition
Guidelines for Operations of Equipment,
Instruments and Control:
Review all processes for calibrating instruments and controls
Analyze periodically all records for calibrated instruments
and controls
Assess all records for inspections and electronic equipment
Guidelines for Components, Packaging
and Labeling:
Sets product labeling with proper requirements
Review all records for packaging and labeling operations
Ensure the finish packaging conforms to specifications
Requires material review or disposition if any problems with
packaging
or labeling
Approving or rejecting of re-packaging or re-labeling for any
returned or distributed dietary supplement
Guidelines for Returned Dietary Supplements:
Conduct review and make disposition needed on all returned products
Determine whether further testing is needed to comply with product
specifications
Approving or rejecting of any salvaged returned products
Approving or rejecting of any reprocessed returned products
Determine whether reprocessed returned products can be approved
or rejected to be re-released
Guidelines for Product Complaints:
Make and keep records of all product complaints
Establish and follow written procedures for material review
and disposition decisions
Requires written documentation to perform review, rejection
or approval of product complaint
Document any follow-up following material review or disposition
Have their Quality Control Operations conducted by Quality Control
personnel