Regulators expect clarity, speed, and proof. You need all three. Therefore, this guide explains usp requirements in plain language. You will see what matters, why it matters, and how to comply. We cover USP 800, 797, and 795. We also explain testing, impurities, and water. Then we add tables, steps, and pitfalls. You can share this with QA, RA, and operations. Everyone will understand the same rules.
Finally, you leave with checklists, links, and next actions. Let’s make compliance predictable and audit-ready.
How does USP set standards?
The United States Pharmacopeia creates public standards for drug quality, purity, identity, and strength.
The USP–NF combines monographs and general chapters that manufacturers and pharmacies must follow. These standards support safety, consistency, and trust. They also align with regulators.
USP chapters define methods and acceptance criteria. Monographs define specific product expectations. Therefore, teams should map operations to these documents. They should also train staff on changes. Additionally, they must verify data integrity and documentation. Finally, they must keep procedures aligned with current USP monograph requirements and compendial updates.
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Where do the compounding standards differ?
| Area | USP 795 (Nonsterile) | USP 797 (Sterile) | USP 800 (Hazardous Drugs) |
|---|---|---|---|
|
Scope |
Nonsterile compounding |
Sterile compounding |
HD handling across settings |
|
Key Focus |
BUDs, documentation |
Asepsis, airflow, EM |
Containment, risk control |
|
Rooms |
Standard spaces |
Cleanroom, ante, buffer |
Negative pressure required |
|
Controls |
Hygiene, verification |
Pressure, HEPA, sampling |
C-PEC, C-SEC, PPE |
How do testing chapters reinforce usp requirements?
USP microbial and sterility testing
Start with definitions and clarity. USP 61 and USP 62 address microbial enumeration and specified microorganisms. Therefore, you must qualify methods, media, and recovery. You also must prove suitability with product matrices.
Then, USP 71 defines the sterility test. It includes membrane filtration and direct inoculation. Furthermore, USP 85 covers the endotoxin test using gel clot or kinetic methods.
Choose the method that fits product risk, route, and matrix.
Now align actions with risk and practicality. You should document sampling plans, incubation conditions, and acceptance criteria. Additionally, trend recoveries and deviations.
Next, verify disinfectants and contact times. Then, train staff on aseptic technique and contamination control.
Consider media fills for aseptic process simulation under USP 797 requirements. Finally, link failures to CAPA with clear root causes.
Your goal is reliable, repeatable, and defendable results. When you trend data well, you see issues early. You also protect patients and your brand.
Residual solvents and elemental impurities
Controls protect patients and products. USP 467 defines residual solvents limits for Class 1, 2, and 3.
Therefore, you must assess process solvents, cleaning agents, and supplier risks. You also must maintain validated methods and reference standards.
Next, USP 232 and USP 233 define elemental impurities assessment and testing. ICP-MS methods are common due to sensitivity and selectivity.
However, documentation decides success.
Create a justification summary that links sources, limits, and specs. Then confirm appropriate controls for catalysts, excipients, and water. Additionally, evaluate supplier changes quickly.
You should also trend results against lifecycle stages. Finally, retain certificates and calculations with clear traceability.
When teams explain the risk model, auditors gain confidence. They also see strong scientific rationale.
This reduces questions and protects release timelines.
Infobox — Quick Definitions
USP 71 sterility test: Detects viable contaminants in sterile products.
USP 85 endotoxin test: Detects pyrogenic bacterial endotoxins.
USP 467 residual solvents: Limits toxic and process-essential solvents.
USP 232/233 elemental impurities: Risk-based controls using modern instrumentation.
What actionable steps prove you meet usp requirements?
Matrix Mapping
First, map every SOP to specific USP–NF clauses. Then assign clear owners and due dates. Finally, record revisions, approvals, and effective dates.
Method Validation and Trending
Validate methods for USP microbial limits and impurities. Next, document suitability, accuracy, precision, and robustness. Then trend monthly results and review outliers.
Qualified Water Systems
Qualify USP purified water and WFI using lifecycle control. Define URS, IQ/OQ/PQ, and monitoring plans. Then trend bioburden, endotoxin, and conductivity continuously.
Sterility Test Readiness
Establish readiness for the USP 71 sterility test. Train staff and qualify media fills routinely. Also maintain sampling plans, incubation conditions, and acceptance criteria.
Endotoxin Suitability and Interference
Define USP 85 method suitability and interference controls. Choose gel clot or kinetic methods appropriately. Then verify inhibition or enhancement before routine testing.
Reference Standards Traceability
Maintain USP reference standards with full traceability. Link certificates of analysis to each lot and test. Also control storage conditions, expiry, and usage logs.
Weekly Conductivity Review
Review USP 645 conductivity limits for purified water and WFI weekly. Record readings at critical points of use. Investigate excursions promptly and document corrective actions.
Where do facilities and handling practices tighten usp requirements?
Hazardous drug rooms requirements
You must control exposure at every step. USP 800 requirements mandate a negative pressure containment room for compounding. They also require a C-PEC within a C-SEC to protect workers and products. Consequently, airflow and pressure monitoring become daily priorities. Next, PPE, closed-system transfer devices, and deactivation procedures reduce contamination. They also lower waste handling risks.
However, paperwork matters equally. USP 800 hazardous drug handling requirements include an inventory, risk assessments, SOPs, and medical surveillance.
Nonsterile processes
- Nonsterile compounding needs discipline and traceability. USP 795 requirements define beyond-use dates based on formulation risk, water activity, and storage. Therefore, you must choose stable packaging and labels. You also must record formulas, lot numbers, and calculations.
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What records make audits smooth and defensible?
Audits reward clarity and completeness. Therefore, keep controlled SOPs, forms, and logs updated. Capture training, competency, and deviations with signatures and dates.
Then, cross-reference each record to the applicable chapter. Also link to change controls and CAPA. This shows a traceable story.
Now protect data integrity. Use ALCOA+ principles for every record. Additionally, back up EM results, calibration data, and calculations. Then, ensure version control for templates and batch records. Finally, conduct internal audits that simulate real inspections. Ask tough questions first. Detect gaps before inspectors do. With consistent documentation, you reduce friction, save time, and protect releases.
How should teams control water systems and conductivity limits?
Water drives product quality and cleaning. Therefore, define specifications for USP purified water and USP water for injection. Next, implement routine sampling with action and alert levels. Then, trend bioburden, endotoxin, and conductivity. Align with USP 645 conductivity limits for purified water and WFI. Additionally, maintain sanitary design, circulation, and temperature controls. Biofilm prevention starts with hydraulics and hygiene.
Furthermore, link utilities to risk. Justify point-of-use filters, sanitization cycles, and hold times. Then, document deviations and corrective actions quickly. Finally, qualify sensors and meters with traceable calibrations. Water issues spread quietly. However, strong trending and fast responses limit impact. Your products and audits both benefit.
FAQ — Quick Answers That Match Common Queries
What is USP–NF?
It is the combined compendium of standards published by USP.
How often do chapters change?
Updates occur regularly. Therefore, review change logs and adopt revisions.
Do USP standards equal approval?
No. They are public standards, not product approvals.
What defines a USP monograph?
It lists identity, strength, purity, and tests for a substance or product.
Are USP tests mandatory?
They are mandatory when referenced by law, contracts, or submissions.
Conclusion
You now understand the essentials behind usp requirements. You also know how USP 800, 797, and 795 shape daily work. Additionally, you can connect testing chapters to risk and evidence. Residual solvents and elemental impurities have clear paths. Water systems and documentation close the loop. Therefore, you can plan training, investments, and inspections with confidence.
Next, make your chapter matrix and update SOPs. Then trend data weekly and act quickly. Also audit yourself before others do. Finally, keep messaging honest and specific. Compliance is a habit, not a project. When teams repeat the right steps, everything gets easier. Audits become predictable. Products stay safe. Patients benefit most.
References
Ershad Moradi
Ershad Moradi, a Content Marketing Specialist at Zamann Pharma Support, brings 6 years of experience in the pharmaceutical industry. Specializing in pharmaceutical and medical technologies, Ershad is currently focused on expanding his knowledge in marketing and improving communication in the field. Outside of work, Ershad enjoys reading and attending industry related networks to stay up-to-date on the latest advancements. With a passion for continuous learning and growth, Ershad is always looking for new opportunities to enhance his skills and contribute to pharmaceutical industry. Connect with Ershad on Facebook for more information.
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