7.3 Quality Control, Product Verification, and Release Testing

7.3 Quality Control, Product Verification, and Release Testing

Quick Answer: A CNSP is released only after it meets the specifications in its master formulation, applicable monograph, SOPs, and law. Every preparation receives appropriate physical inspection and documentation review; additional weight, pH, yield, potency, or microbial tests are used when the formulation and risk require them. Do not apply a universal ±10% capsule rule or 95–105% yield rule to every CNSP.

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QA and QC

Quality assurance (QA) designs and monitors the system: SOPs, training, supplier qualification, equipment control, deviation review, and continual improvement. Quality control (QC) is product-focused: observations, measurements, tests, and documentation used to decide whether a specific preparation meets its specification. QC is planned, not merely “reactive.”

Technicians may perform or document authorized checks, but final verification and release authority follow state law, scope of practice, and facility policy.

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Universal Release Questions

Before release, confirm:

1. Identity and traceability: Correct prescription, patient, drug form, strength, component lots, and quantities.
2. Process: The approved master formulation was followed and deviations were resolved.
3. Appearance: Color, odor, texture, clarity, redispersibility, fill, and absence of foreign matter match the specification.
4. Container and label: Packaging is compatible and intact; route, directions, storage, auxiliary labels, and BUD are correct.
5. Quantity and reconciliation: Actual yield or count is documented and any unexplained loss or gain is investigated.
6. Authorization: Required checks and signatures are complete.

A failed or unexplained result triggers quarantine. Do not “average away” an outlier or rework a preparation without an approved investigation and procedure.

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Dosage-Form Checks

Solutions and Suspensions

A solution expected to be clear should have no unexpected cloudiness, precipitate, color change, or foreign material. A suspension should redisperse as the master formulation specifies, without hard caking, and its container must permit adequate shaking. pH, density, or assay is measured when the formulation specifies it.

Emulsions and Semisolids

Inspect for homogeneity, smoothness, air entrapment, unexpected crystals, leakage, and phase separation. Reversible creaming differs from cracking/breaking, an irreversible separation of the emulsion. A cracked product is quarantined and investigated rather than casually remixed.

Capsules and Molded Units

Inspect shell closure, cleanliness, damage, fill consistency, and count. Weight variation can reveal a filling problem, but sample size and limits come from an applicable monograph, validated master formulation, or facility SOP. USP <795> does not impose a blanket “10 capsules within ±10%, none beyond ±15%” rule on every compounded capsule.

Containers

Check closure engagement, leakage, pump or syringe function, dosing-device compatibility, tamper evidence when applicable, and child-resistant packaging or documented exception under law. Ensure an oral product cannot be mistaken for a parenteral product.

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Calculations Used in QC

Percent Yield

Percent yield = actual final yield / theoretical yield × 100

If theoretical yield is 40.0 g and actual yield is 38.6 g:

38.6 / 40.0 × 100 = 96.5%

The arithmetic does not establish acceptability. Compare 96.5% with the master-formulation or process specification and investigate unexplained loss. A 95–105% range may be a stated facility criterion for one formulation, but it is not a universal USP release range.

Weight Deviation

Weight deviation (%) = |individual weight − target weight| / target weight × 100

Use the target, sample plan, and acceptance rule specified for that formulation. Weight is a surrogate for content only when fill composition and mixing uniformity justify the inference; it does not directly assay potency.

Potency

USP <795> uses 90–110% of labeled strength as the general CNSP strength expectation unless an applicable monograph establishes another range. A specific formulation may require a narrower specification. Potency testing must use a suitable method capable of measuring the API in the actual matrix; physical inspection cannot establish potency.

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pH, Density, and Microbial Testing

Select objective tests from formulation risk and specification:

Ophthalmic preparations are sterile preparations governed by <797>, so do not treat “ophthalmic” as an ordinary nonsterile pH-testing example.

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MFR-to-CR Audit

Compare the Master Formulation Record (MFR) with the actual Compounding Record (CR):

• component names, forms, manufacturers, lots, expiration dates, and actual quantities;
• calculations, scale-up or overage, and independent checks;
• equipment IDs and required verification status;
• sequence, time, temperature, mixing, transfer, and deviations;
• actual yield, inspection, test results, and container;
• label, storage, BUD source and calculation;
• compounder and verifier identities and release authorization.

If a deviation could affect quality, quarantine the CNSP until the designated person completes an impact assessment and disposition.

Exam Decision Pattern

Calculate the requested value first, then compare it with the stated specification. If the question supplies no acceptance limit, do not invent one. Physical separation, wrong identity, a calculation mismatch, an unsupported BUD, or incomplete traceability requires hold and investigation.