SOSCLEANROOM | COMPLIANCE EDUCATION
Understand the Standards. Make Informed Decisions.
Explore educational guides to USP <795>, USP <797>, and USP <800>, with supporting context for ISO cleanroom classifications and EU GMP Annex 1. Use them to frame questions, evaluate documentation, and support your own approved procedures.
Core pharmacy compounding resources
Choose the guide that matches your work.
The three USP chapters address different risks and may apply together. These overviews explain the subject matter and provide a starting point for discussions with your quality team—not a substitute for reviewing the governing chapter.
Nonsterile compounding
USP <795>
Standards for preparing compounded nonsterile preparations, with attention to personnel, components, processes, equipment, records, and beyond-use dating.
Useful for: pharmacy teams evaluating nonsterile compounding practices and operational controls.
Sterile compounding
USP <797>
Standards for compounded sterile preparations, including personnel qualification, facilities and engineering controls, aseptic practices, cleaning, monitoring, and documentation.
Useful for: sterile compounding teams planning procedures, training, and contamination-control practices.
Hazardous drug handling
USP <800>
Standards aimed at minimizing hazardous drug exposure, including containment, engineering controls, work practices, PPE, decontamination, spill response, and documentation.
Useful for: personnel who receive, prepare, administer, transport, or otherwise handle hazardous drugs.
USP <795> and <797> address different types of compounding. Hazardous drug handling may introduce additional obligations under USP <800> and other applicable requirements; determine your facility's specific obligations with qualified personnel.
Related controlled-environment frameworks
ISO classification and EU GMP Annex 1 are not interchangeable.
Different frameworks address different questions. Understanding their scope can prevent an air-cleanliness classification from being mistaken for a broader regulatory or sterility determination.
ISO 14644-1
Provides a method for classifying air cleanliness by airborne particle concentration. An ISO class alone does not establish sterile processing suitability or full compliance with pharmacy or GMP requirements.
ISO's official standard overview ↗EU GMP Annex 1
Provides GMP guidance for sterile medicinal product manufacture in the European regulatory context, including contamination-control strategy, cleanroom grades, and process controls.
European Commission Annex 1 source ↗For a practical comparison, read ISO Standards vs. Annex 1 or begin with Cleanrooms 101.
Using these resources responsibly
A practical path from guidance to a site-specific decision
01 SCOPE
Identify the activity
Define the process, materials, patient or product risks, facility type, and jurisdiction before selecting a framework.
02 SOURCE
Consult the official text
Use the publisher's current requirements, any applicable laws, and the interpretation of the authority having jurisdiction.
03 CONTROL
Apply approved SOPs
Your responsible quality or clinical team determines site controls, risk assessments, validation, training, and records.
04 VERIFY
Qualify exact products
Review manufacturer specifications, lot documentation, sterile status, and application suitability for the exact SKU when relevant.
Primary references
Go to the standards owners for definitive requirements.
SOSCleanroom's guides explain concepts in plain language. The official publishers control standards text, editions, errata, and notices. Some complete standards require paid access or a subscription.
United States Pharmacopeia (USP)
Official chapter resources, notices, and access to USP–NF.
USP Compounding Resources ↗International Organization for Standardization
ISO 14644-1 and other controlled-environment standards.
ISO 14644-1 Overview ↗European Commission
Official EU GMP Annex 1 publication and implementation information.
EU GMP Annex 1 ↗Documentation and product selection
Need source documentation for a product?
SOSCleanroom can help customers locate manufacturer-origin documentation when available, such as Technical Data Sheets (TDS), Safety Data Sheets (SDS), Certificates of Analysis or Conformance (CoA/CoC), and applicable sterility or lot records.
For an accurate request, include: exact manufacturer part number or SOS SKU, product configuration, the document required, and a lot/batch number for any lot-specific record.
Common questions
What these guides can—and cannot—tell you
Are these the official USP chapters?
No. They are SOSCleanroom educational summaries. Obtain and consult the official USP–NF chapter text and current USP notices when establishing binding requirements.
Does using an ISO-classified room establish USP <797> compliance?
No. An ISO air-cleanliness class is only one characteristic. Applicable sterile-compounding requirements can also involve facilities, personnel, procedures, environmental controls, training, and documented quality oversight.
Can buying a product from SOSCleanroom make a facility compliant?
No. Facility compliance depends on the applicable requirements and verified implementation of the overall program. Product selection must be evaluated for intended use, with manufacturer evidence where applicable.
Do requirements and enforcement vary by jurisdiction?
They can. Work with your responsible personnel and relevant regulatory authorities to determine which standards, laws, and policies apply to your activity and location.
Questions about a specific material or document?
Our team can help with availability, manufacturer documentation requests, and product identification. Your organization's qualified personnel remain responsible for regulatory interpretation and final approval for use.
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Editorial scope: general educational resources for cleanroom and compounding procurement. This page does not reproduce proprietary standards text, establish a manufacturer's product claims, or represent approval by USP, ISO, the European Commission, or any regulatory body. Refer to the official publisher for the current edition and to your own approved quality procedures.