RDC 430 Storage: Audit Evidence Checklist

In pharmaceutical storage, a sensor installed in an environment proves an instrument is present. Alone, it does not demonstrate that the location was mapped, that the measurement point represents the product, or that the team responds to excursions. This guide helps quality, maintenance, and storage personnel gather verifiable evidence, distinguishing applicable requirements from methods and resources that help demonstrate them.

What an audit must verify

• Whether RDC 430 applies to the audited activity and which storage conditions apply to products.
• Whether the thermal study justifies where to measure and how to interpret results.
• Whether calibration, qualification, records, and computerized systems have traceable evidence.
• Whether alerts, deviations, and contingencies lead to documented decisions about product disposition.

First confirm whether RDC 430 applies to the operation

RDC 430/2020 addresses good distribution, storage, and transport practices for pharmaceuticals. RDC 653/2022 amended provisions of the resolution. Before using an outdated checklist, review the official text and its amendments and evaluate the actual activity rather than assuming every hospital area with medications falls automatically within the same scope.

Also separate the regulatory requirement from the method of demonstrating it. The organization must prove it controls applicable storage conditions and maintains adequate records. A thermal study, qualification protocols, and data recovery tests are useful technical evidence; do not present each format or acronym, such as IQ/OQ/PQ, as a universal obligation without confirming the requirement applicable to your case.

Use thermal mapping to select measurement points

The thermal study must reveal how temperature and, when applicable, humidity vary across the storage space. A room average can hide a cold zone near the air intake or a hot spot near a door, light fixture, or equipment. The report must allow the auditor to understand test conditions, measurement positions, results, and conclusions.

Position routine sensors at points defined by the study, not where installation is most convenient. If a change in shelving, load, equipment, or airflow alters the environment, assess whether the study remains representative and document the justification to maintain or revise the points.

Evidence checklist, responsibilities, and corrective actions

Use the table as a self-assessment guide. A single document rarely suffices: link the procedure, the record from the period, and a test showing the control functions in routine operation.

Control	Expected evidence	Responsible party and action to close gaps
Thermal mapping	Protocol, test configuration and conditions, raw data, report, hot and cold spots identified, conclusion, and assessment of changes.	Quality and maintenance. Plan or update the study when actual configuration is not represented.
Sensor position	Floor plan or sketch with identifiers, positions justified by the study, and history of changes.	Maintenance executes; quality approves. Reposition or formally justify any divergence.
Traceable calibration	Certificates linked to each sensor identifier, range and calibration result, expiration, and procedure for out-of-specification results.	Metrology or designated responsible party. Calibrate, assess impact on prior data, and document the decision.
Installation, operational, and performance qualification	Requirements, approved protocols, results, acceptance criteria, deviations, and equipment or area release.	Quality and engineering. Complete missing tests and close deviations before relying on the system.
Record frequency and retention	Procedure with justified interval, applicable retention period, and test of search and export of a historical sample.	Quality and IT. Define documented criteria and test recovery, including after backup restoration.
Computerized system validation	User requirements, risk assessment, tests of functions used, change management, backup, and tested restoration.	Quality and IT. Evaluate the system as a process, including sensor, transmission, storage, access, and data output.
Audit trail and physical access	Test identifying who altered data or settings, when, and what changed; separately, records of access to the controlled room or area.	IT controls accounts and changes; area responsible controls physical access. Do not assume environmental monitoring performs both.
Deviations and escalation	Procedure, event record, investigation, product assessment, approved decision, corrective action, and test of contacts and escalation paths.	Quality coordinates; storage and maintenance respond. Simulate alerts and correct gaps in response or on-call coverage.
Contingency	Plan and test for power loss, communication failure, and refrigeration failure, with responsible parties, alternatives, and transfer criteria.	Maintenance, storage, and quality. Exercise the plan and document times, failures, and actions for each scenario.

Treat digital audit trail and physical access as separate controls

The audit trail records system events, such as configuration change, altered data, or responsible user, when those functions exist and have been tested. Physical control records who entered the room or restricted area. A temperature history does not prove who opened the door; a room access record does not prove system data remained intact.

Validate the end-to-end set. Include communication failure, later synchronization, export, and backup recovery. 21 CFR Part 11 is not an automatic requirement of RDC 430; the organization must separately assess which rules apply to its context.

Distinguish predictive alert from limit alarm

Consider this hypothetical example: at 2 AM, DROME Predict detects an abnormal pattern in the asset and issues a predictive alert before temperature exceeds the defined limit. Maintenance checks the equipment and quality monitors the trend. This early alert does not replace the deviation procedure or product assessment.

If temperature later exceeds the limit, the team records the excursion, identifies and segregates potentially affected lots, assesses duration and thermal history based on applicable product information, and documents the disposition decision. The predictive alert and limit alarm are distinct events, each with its own records and decisions.

Where sensors and DROME prediction fit in

The STE Satellite Sensor measures temperature; the STH measures temperature and humidity. The CTD Concentrator has battery backup for up to 12 hours and temporary data storage for up to 20 days. This can maintain records locally during a communication interruption, within those conditions, but does not mean continuous transmission or keep refrigeration running.

DROME Predict crosses more than 15 parameters from the same asset and can alert 30 to 60 minutes before a failure. This layer helps anticipate intervention but does not replace mapping, calibration, qualification, system validation, or quality procedures. Define who receives the alert, how they confirm receipt, and how they document the action.

Gather this evidence before the audit

• Activity scope and product matrix with their storage conditions.
• Thermal study, sensor sketch, and justification for current positions.
• Calibration certificates and equipment maintenance records.
• Qualification, validation, and change management protocols and reports.
• Record samples, retention policy, and recovery test.
• Audit trail test, physical access controls, and list of responsible parties.
• Recent deviations, product assessments, alert tests, and contingency exercises.

For each control, show the procedure, a real result, and the decision made when something went wrong.

Frequently asked questions

What does RDC 430 say about storage?

RDC 430/2020 establishes good practices for distribution, storage, and transport activities for pharmaceuticals. In an audit, the team must demonstrate how it maintains applicable storage conditions, records controls, and handles deviations. Read the resolution with its amendments and confirm whether the audited activity falls within the regulatory scope.

Does RDC 430 automatically apply to hospital pharmacy?

Not automatically. RDC 430 addresses distribution, storage, and transport activities for pharmaceuticals, but storing medications within a hospital is not, by itself, sufficient to define its application. Assess the activity, sanitary license, the organization's role, and other applicable standards before building your audit checklist.

Does the regulation mandate a single temperature recording interval?

Do not assume a single interval for all operations. Define recording frequency based on storage conditions required for products, environmental risk, and the approved procedure. Keep the justification, original data, and evidence that the team can retrieve and review records from the audited period.

Is 21 CFR Part 11 mandatory to comply with RDC 430?

No. 21 CFR Part 11 does not automatically become a Brazilian requirement because of RDC 430. The organization must validate the computerized system according to requirements applicable to its operation and document controls for access, integrity, changes, and retention. Foreign rules may apply if another relevant regulatory obligation exists.

What should be done when a temperature excursion occurs?

The team must follow the approved procedure: identify and segregate potentially affected products, record the excursion period and conditions, investigate the cause, and assess stability using applicable product information. Quality documents the disposition decision, approvals, and corrective and preventive actions.