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Standard Operating Procedure for IP Labeling (For Clinical Trial Use)

Purpose

The purpose of this SOP is to outline the procedures for labeling investigational products (IP) intended for clinical trial use. Proper labeling ensures subject safety, product traceability, and compliance with international regulatory standards, while safeguarding blinding requirements where applicable.

Scope

This SOP applies to all investigational products including pharmaceuticals, biologics, comparators, and placebos used in clinical trials. It covers labeling at sponsor facilities, contract manufacturers, or at clinical trial sites where permitted, and is applicable to blinded and open-label studies.

Responsibilities

• Principal Investigator (PI): Ensures IP labeling complies with the protocol and regulations before dispensing to participants.
• Pharmacist/Authorized Designee: Performs labeling, verifies accuracy, and maintains label accountability logs.
• Study Coordinator: Ensures label-related records are filed in ISF and TMF.
• Sponsor/CRO: Provides approved label text, oversees regulatory compliance, and verifies blinding integrity.
• Quality Assurance Officer: Audits labeling and accountability during monitoring and inspections.

Accountability

The PI is accountable for ensuring that all IP labels meet ethical, regulatory, and trial-specific requirements. Sponsors are accountable for supplying correct label text and ensuring compliance across sites.

Procedure

1. Label Content
Include protocol number, trial reference code, subject identifier fields, dosing instructions, storage conditions, batch/lot number, expiry date, and “For Clinical Trial Use Only.”
Exclude any misleading promotional text.

2. Regulatory Requirements
Ensure compliance with local regulations (e.g., FDA 21 CFR, EMA Annex 13, CDSCO requirements).
Translate labels into local language(s) as per regulatory authority mandates.

3. Blinding Considerations
For blinded studies, labels must not reveal treatment allocation.
Maintain identical packaging for investigational and comparator products.

4. Labeling Process
Print labels using validated systems to prevent errors.
Verify accuracy against approved label master.
Affix labels securely and ensure legibility.
Record all labeled units in IP Labeling Log (Annexure-1).

5. Verification
Double-check by two authorized staff before release.
Document verification signatures in Label Verification Form (Annexure-2).

6. Re-labeling
Conduct re-labeling only after sponsor authorization.
Record re-labeling details in Re-labeling Log (Annexure-3).

7. Archiving
File all label templates, accountability logs, and verification records in ISF and TMF.
Retain for at least 5 years post-trial or as per regulations.

Abbreviations

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• IP: Investigational Product
• CRO: Clinical Research Organization
• ISF: Investigator Site File
• TMF: Trial Master File
• QA: Quality Assurance

Documents

1. IP Labeling Log (Annexure-1)
2. Label Verification Form (Annexure-2)
3. Re-labeling Log (Annexure-3)

References

• ICH E6(R2) – Good Clinical Practice
• US FDA – Labeling Guidance
• EMA – Annex 13 Clinical Trial IMP Labeling
• CDSCO – Clinical Trial Rules, 2019
• WHO – Guidelines on Investigational Products

Version: 1.0

Approval Section

Annexures

Annexure-1: IP Labeling Log

Annexure-2: Label Verification Form

Annexure-3: Re-labeling Log

Revision History

For more SOPs visit: Pharma SOP