Batch Production Records: must document:
A) The date when each step was performed.
B) Identify by initials or signature the person who performed each step.
C) The results of any tests or examinations that were conducted.
D) All of the above.
Personnel: QC
A) Management must identify who is responsible for Quality Control operations.
B) Each QC person must be qualified to perform QC operations.
C) Each QC person must have QC responsibilities distinct and separate from other responsibilities.
D) All of the above.
Specifications: Specification Verification
A) All established specifications must be verified in some way.
B) For products with multiple active ingredients an analysis must be conducted for every active ingredient for every batch manufactured.
C) Specifications must be established, but there is no need to verify established specifications.
D) None of the above.
Supplement returns:
A) Do not require a material review.
B) Do not need to be segregated until QC completes a material review and conducts a disposition decision.
C) May be approved for reprocessing without QC approval.
D) None of the above.
Complaints Handling
A) Companies must have a written procedure for the handling of complaints.
B) Quality Control must make the decision whether to investigate a complaint.
C) Quality Control must review and approve the investigation findings and follow up.
D) All of the above.
Reference standards
A) Criteria must be used in selecting reference standard materials employed for performing tests and examinations.
B) Compendial reference standards must always be employed for tests and examinations of dietary supplements.
C) Non-compendial reference standards do not need to be thoroughly characterized before use to ensure identity, strength, strength, purity and quality.
D) None of the above.
Packaging and Labeling
A) Label reconciliation is not required if the packaging equipment has electronic “vision systems” to verify that the correct labels were applied to the product.
B) Label reconciliation must always be done.
C) Labeling can only be done under the direct supervision of Quality Control.
D) None of the above.
Test Methods must be
A) Appropriate/scientifically valid for each established specification for which testing or examination is required to determine whether the specification is met.
B) Identified as suitable for use by the manufacturer.
C) Be accurate, precise, and specific for its intended purpose and consistently do what it is intended to do.
D) All of the above.
Expiration Dating:
A) Part 111 includes requirements for expiration dating.
B) If you use an expiration date on a product label you should have stability data to support that date.
C) You do not need to have a written stability testing program to assess product stability requirements if you use product expiration dates.
D) None of the above.
Physical Plant and Grounds: You must
A) Have adequate space for equipment and holding materials.
B) Have floors, walls, and ceilings that can be adequately cleaned and kept in good repair.
C) Have adequate ventilation and environmental control equipment that minimize odors and vapors.
D) All of the above.
