Controlled Substance Inventory Count Checklist [FREE PDF]

Controlled substance inventory counts are mandated by DEA regulations (21 CFR Part 1304) and must align with FDA 21 CFR Part 211 recordkeeping standards. Accurate biennial and perpetual inventories are essential to detect diversion, theft, or discrepancies before they escalate into regulatory violations. This checklist guides Quality Managers through each step of a compliant controlled substance count, from vault access verification to final reconciliation sign-off.

  • Industry: Pharmaceutical Manufacturing
  • Frequency: Monthly
  • Estimated Time: 45-60 minutes
  • Role: Quality Manager
  • Total Items: 36
  • Compliance: DEA 21 CFR Part 1304 - Recordkeeping and Reporting, FDA 21 CFR 211.68 - Automatic, Mechanical, and Electronic Equipment, FDA 21 CFR 211.188 - Batch Production and Control Records, FDA 21 CFR Part 11 - Electronic Records and Signatures, ICH Q7 Section 6 - Documentation and Records

Vault Access & Security Verification

Verify that physical access controls and security protocols are intact before initiating the count.

  • Is the controlled substance vault or cage secured with a DEA-compliant lock mechanism?
  • Are access logs for the vault current and accounted for prior to the count?
  • Is alarm system functionality confirmed active and operational?
  • Are video surveillance systems recording in the controlled substance storage area?
  • Have all unauthorized personnel been removed from the counting area prior to initiation?

Pre-Count Documentation Review

Confirm all perpetual inventory records and prior count documents are available and reviewed before the physical count begins.

  • Is the most recent perpetual inventory record available and reviewed?
  • Are all receiving receipts since the last count available for reconciliation?
  • Are dispensing or usage logs complete and signed for the period under review?
  • Are destruction or waste records available for all controlled substances disposed since last count?
  • Is the count form or electronic system validated and ready for data entry?

Physical Count Execution

Perform and document the actual physical count of all controlled substances on hand.

  • Were all controlled substances counted by two independent personnel simultaneously?
  • Is the total physical count recorded by substance name, NDC, lot number, and dosage form?
  • Were broken, damaged, or unusable units identified and segregated during the count?
  • Total number of dosage units counted (enter total across all substances)?
  • Were any substances found in locations other than their designated storage area?
  • Was a photo record taken of the counted inventory as evidence?

Reconciliation & Discrepancy Analysis

Compare physical count results against book inventory and document any discrepancies found.

  • Does the physical count match the perpetual inventory book balance for all substances?
  • Were any discrepancies identified during reconciliation?
  • If discrepancies exist, have they been documented with a deviation report number?
  • Discrepancy quantity (if applicable, enter total units unaccounted for)?
  • Has a root cause been identified for any discrepancy prior to closing this count?

Expiry & Physical Condition Inspection

Inspect all controlled substances for expiration dates, storage condition compliance, and physical integrity.

  • Are all controlled substances within their labeled expiration dates?
  • Are storage temperature conditions within required range for all substances?
  • Current storage area temperature at time of count?
  • Are all containers intact with no signs of tampering, breakage, or label damage?
  • Were any substances within 90 days of expiration identified and flagged?

Regulatory Reporting & Notification

Assess whether any findings from this count require mandatory regulatory reporting to DEA or FDA.

  • Is a DEA Form 106 required due to significant loss or theft discovered during this count?
  • Has a Biennial Inventory been conducted within the past 2 years as required?
  • Are all DEA order forms (DEA 222) for Schedule II substances accounted for and filed?
  • Have state pharmacy board requirements for controlled substance counts been satisfied for this jurisdiction?
  • Additional regulatory notes or observations requiring follow-up?

Count Completion & Sign-Off

Finalize the count record, obtain required signatures, and archive documentation per regulatory retention requirements.

  • Has the completed count record been reviewed and signed by both the counter and witness?
  • Has the count record been archived in the controlled substance master file?
  • Has the perpetual inventory been updated to reflect the confirmed count balance?
  • Have all open CAPAs from this count been assigned to a responsible owner with a due date?
  • Final inspector summary comments or count completion notes?

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Why Use This Controlled Substance Inventory Count Checklist [FREE PDF]?

This controlled substance inventory count checklist [free pdf] helps pharmaceutical manufacturing teams maintain compliance and operational excellence. Designed for quality manager professionals, this checklist covers 36 critical inspection points across 7 sections. Recommended frequency: monthly.

Ensures compliance with DEA 21 CFR Part 1304 - Recordkeeping and Reporting, FDA 21 CFR 211.68 - Automatic, Mechanical, and Electronic Equipment, FDA 21 CFR 211.188 - Batch Production and Control Records, FDA 21 CFR Part 11 - Electronic Records and Signatures, ICH Q7 Section 6 - Documentation and Records. Regulatory-aligned for audit readiness and inspection documentation.

Frequently Asked Questions

What is a Controlled Substance Inventory Count Checklist [FREE PDF]?

A Controlled Substance Inventory Count Checklist [FREE PDF] is a standardized inspection form used by quality manager to ensure consistent pharmaceutical manufacturing operations. It contains 41 inspection points organized into 7 sections. FREE controlled substance inventory count checklist. Ensure DEA & FDA 21 CFR 211 compliance. Download PDF for audits.

How often should I use this pharmaceutical manufacturing checklist?

This checklist is designed to be completed monthly. Regular use ensures compliance with DEA 21 CFR Part 1304 - Recordkeeping and Reporting and FDA 21 CFR 211.68 - Automatic, Mechanical, and Electronic Equipment and helps identify issues before they become problems.

Can I download this Controlled Substance Inventory Count Checklist [FREE PDF] as a PDF?

Yes, you can download this checklist as a FREE PDF for printing or offline use. The checklist includes 41 fields across 7 sections and typically takes 45-60 minutes to complete.

What compliance standards does this checklist cover?

This checklist helps ensure compliance with DEA 21 CFR Part 1304 - Recordkeeping and Reporting, FDA 21 CFR 211.68 - Automatic, Mechanical, and Electronic Equipment, FDA 21 CFR 211.188 - Batch Production and Control Records, FDA 21 CFR Part 11 - Electronic Records and Signatures, ICH Q7 Section 6 - Documentation and Records. Following these standards protects your organization and ensures best practices.

How do I complete this pharmaceutical manufacturing inspection checklist?

Begin by completing the header fields for Inspection Date & Time, Inspector Name, Witness Name, Storage Location / Vault ID, and DEA Schedule Being Counted. Work through each of the 7 sections, marking items Yes or No as applicable. Add notes for any issues found. The entire process takes approximately 45 to 60 minutes.

What are the key sections in this pharmaceutical manufacturing checklist?

This pharmaceutical manufacturing checklist is organized into 7 key sections: Vault Access & Security Verification, Pre-Count Documentation Review, Physical Count Execution, Reconciliation & Discrepancy Analysis, Expiry & Physical Condition Inspection, Regulatory Reporting & Notification, Count Completion & Sign-Off. Each section contains specific inspection points that quality manager must verify. The structured layout ensures nothing is missed during pharmaceutical manufacturing inspections and makes the process efficient, typically taking 45-60 minutes to complete.

Who should use this Controlled Substance Inventory Count Checklist [FREE PDF]?

This checklist is primarily designed for quality manager working in pharmaceutical manufacturing operations. However, it is also valuable for quality assurance teams, safety officers, compliance managers, and supervisors who need to verify that pharmaceutical manufacturing standards are being met. Organizations of all sizes can benefit from using this Controlled Substance Inventory Count Checklist [FREE PDF] to maintain consistency and accountability.

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