Is the QA and QC program review the same as the yearly SOP review?

No. USP 797 Section 17 separately says SOPs must be reviewed initially and at least every 12 months by the designated person(s), and that review must be documented. They run on the same clock, but they are two reviews.

Does the pharmacist in charge have to do the review?

The chapters assign it to the designated person(s). In a small pharmacy that may be the same pharmacist as the PIC, but your SOP should name who does it in writing.

What does the written QA and QC program have to include?

USP 797 Section 18 and USP 795 Section 12 say it must establish a system of adherence to procedures, prevention and detection of errors and other quality problems, evaluation of complaints and adverse events, and appropriate investigations and corrective actions.

Can we review the program more often than every 12 months?

Yes. 12 months is the longest gap the chapters allow. Your SOP can set a shorter cycle.

How often must the Designated Person review the QA and QC program under USP 797?

At least once every 12 months. USP 797 Section 18 and USP 795 Section 12 both say the overall QA and QC program must be reviewed at least once every 12 months by the designated person(s). Your SOP decides how the review is run and recorded; confirm the wording in your licensed chapters and with your state board.

The short answer is 12 months. The harder part is knowing what the program has to cover so the yearly review means something. Here is what USP 797 and USP 795 say, and where your SOP takes over.

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The interval: at least once every 12 months

USP 797 Section 18 (Category 1, 2, and 3 CSPs) says: “The overall QA and QC program must be reviewed at least once every 12 months by the designated person(s).”

USP 795 Section 12 uses the same wording for nonsterile compounding, so a pharmacy that does both sterile and nonsterile work has a 12-month clock on each program.

“At least” means 12 months is the longest gap the chapters allow, not a target. Your SOP can set a shorter cycle. Putting the review on a fixed month in your calendar keeps it from drifting.

Who does the review

Both chapters assign the review to the designated person(s). That is the USP compounding role, which may or may not be the same person as your pharmacist in charge. For the role itself, read What is a designated person under USP 797?.

If your facility names more than one designated person, your SOP decides who signs the QA and QC review for each program.

What the written QA and QC program has to establish

USP 797 Section 18 and USP 795 Section 12 both say the designated person(s) must ensure formal, written QA and QC programs that establish a system of:

Adherence to procedures.
Prevention and detection of errors and other quality problems.
Evaluation of complaints and adverse events.
Appropriate investigations and corrective actions.

Related requirements the yearly review sits next to

Complaints: USP 797 Section 18.2 and USP 795 Section 12.2 say a designated person(s) must review all complaints to decide whether a complaint points to a potential quality problem with the preparation. USP 795 Section 12.2 also lists what each complaint record must hold.

Adverse events: USP 797 Section 18.3 and USP 795 Section 12.3 say adverse events potentially associated with preparation quality must be reported under your SOPs and the laws of your jurisdiction.

Out-of-specification results: USP 797 Section 12 says any out-of-specification results must be investigated, with a corrective action plan implemented and documented as part of the QA and QC program.

Deviations: USP 797 Section 17 says a designated person(s) must follow up to make sure corrective actions are taken when problems, deviations, failures, or errors are found, and the corrective action must be documented.

Records: USP 797 Section 20 and USP 795 Section 14 say documentation must include information on complaints and adverse events, including corrective actions taken.

Do not mix it up with the SOP review

USP 797 Section 17 has a separate rule: SOPs must be reviewed initially and at least every 12 months by the designated person(s) to make sure they reflect current practices, and that review must be documented.

So a sterile compounding pharmacy has two yearly reviews on the same clock: the SOP review and the overall QA and QC program review. You can run them together, but keep both visible in the record.

The QA and QC review rule itself does not prescribe a format. Your SOP decides how you record it; a dated, signed record you can hand an inspector is the conservative choice.

Your SOP and state board

Your state board decides which USP edition it enforces and may add its own requirements. Check that locally, and read Which USP edition does our state board actually enforce? if you are not sure.

Ask Compounding AI Pro with your QA and QC SOP in hand, and it answers with the USP sections cited. Start Free Demo if you are not in the product yet.

FAQ

How often must the QA and QC program be reviewed by a designated person?: At least once every 12 months. USP 797 Section 18 and USP 795 Section 12 both say the overall QA and QC program must be reviewed at least once every 12 months by the designated person(s).
Is the QA and QC program review the same as the yearly SOP review?: No. USP 797 Section 17 separately says SOPs must be reviewed initially and at least every 12 months by the designated person(s), and that review must be documented. They run on the same clock, but they are two reviews.
Does the pharmacist in charge have to do the review?: The chapters assign it to the designated person(s). In a small pharmacy that may be the same pharmacist as the PIC, but your SOP should name who does it in writing.
What does the written QA and QC program have to include?: USP 797 Section 18 and USP 795 Section 12 say it must establish a system of adherence to procedures, prevention and detection of errors and other quality problems, evaluation of complaints and adverse events, and appropriate investigations and corrective actions.
Can we review the program more often than every 12 months?: Yes. 12 months is the longest gap the chapters allow. Your SOP can set a shorter cycle.

Educational information only. Not legal advice. Not an inspection-outcome guarantee. Keep a current USP Compendium subscription. PIC judgment and your board still govern.