SOP for inspection readiness IP NZ, SOP for IP privacy compliance NZ, SOP for IP safety reporting NZ, SOP for CAPA IP findings NZ, SOP for trial oversight IP NZ, SOP for accountability in IP management NZ”,
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Published on 22/12/2025

Investigational Product Management and Accountability SOP

Department	Clinical Research
SOP No.	CS/NZ-IP/209/2025
Supersedes	N.A.
Page No.	1 of 28
Issue Date	28/08/2025
Effective Date	05/09/2025
Review Date	05/09/2027

Purpose

The purpose of this SOP is to outline procedures for investigational product (IP) management and accountability in clinical trials conducted in New Zealand. It ensures compliance with Medsafe, Health and Disability Ethics Committees (HDEC), and ICH GCP requirements for receipt, labeling, storage, dispensing, reconciliation, and destruction of IP.

Scope

This SOP applies to all clinical trials using investigational medicinal products in New Zealand. It covers sponsor, investigator, and pharmacist responsibilities for IP lifecycle management, including handling, accountability, record-keeping, and audits.

Responsibilities

• Sponsor: Ensures appropriate labeling, packaging, distribution, and reconciliation of IP; provides training to site staff.
• Principal Investigator (PI): Maintains oversight of IP at the site, ensures accountability logs are complete, and delegates dispensing to qualified pharmacists.
• Pharmacist: Manages receipt, storage, dispensing, reconciliation, and destruction of IP in accordance with trial protocol and GCP.
• CRO: Provides oversight and support for IP management on behalf of the sponsor when delegated.
• Quality Assurance (QA): Conducts audits of IP accountability records and ensures CAPA implementation.

Accountability

The sponsor is accountable for ensuring compliance with all IP management requirements. The PI is accountable for site-level IP management and reconciliation. The pharmacist is accountable for daily operations and documentation.

Procedure

1. Receipt of IP

1. Verify shipment against shipping documents.
2. Document receipt in IP Accountability Log (Annexure-1).
3. Report discrepancies to sponsor immediately.

2. Storage of IP

1. Store IP under conditions defined in protocol and product labeling (e.g., temperature, humidity).
2. Maintain temperature logs and calibrate storage equipment regularly.
3. Restrict access to authorized personnel.

3. Dispensing of IP

1. Dispense IP only to eligible participants after consent and randomization.
2. Document dispensing in IP Dispensing Log (Annexure-2).
3. Ensure blinding procedures are maintained.

4. Accountability and Reconciliation

1. Record all receipts, dispensing, returns, and destruction of IP.
2. Reconcile IP inventory monthly and at trial close-out.

5. Return and Destruction

1. Return unused IP to sponsor or authorized destruction vendor.
2. Document destruction in IP Destruction Log (Annexure-3).

6. Documentation and Archiving

1. Maintain IP logs in ISF and TMF.
2. Archive IP documentation for at least 10 years post-trial.

Abbreviations

• IP: Investigational Product
• PI: Principal Investigator
• QA: Quality Assurance
• CRO: Contract Research Organization
• HDEC: Health and Disability Ethics Committees
• ISF: Investigator Site File
• TMF: Trial Master File
• CAPA: Corrective and Preventive Action
• GCP: Good Clinical Practice
• Medsafe: Medicines and Medical Devices Safety Authority

Documents

1. IP Accountability Log (Annexure-1)
2. IP Dispensing Log (Annexure-2)
3. IP Destruction Log (Annexure-3)

References

• Medsafe — Medicines and Medical Devices Safety Authority
• HDEC — Health and Disability Ethics Committees
• ICH E6(R2) Good Clinical Practice
• WHO Clinical Trial Standards

Version: 1.0

Approval

Prepared By	Checked By	Approved By
Name: Rajesh Kumar Date: 20/08/2025 Signature: __________	Name: Sunita Reddy Date: 22/08/2025 Signature: __________	Name: Dr. Meera Iyer Date: 28/08/2025 Signature: __________

Annexures

Annexure-1: IP Accountability Log

Date	Shipment No.	Quantity Received	Checked By	Remarks
05/08/2025	SHIP-2025-09	500 tablets	Neha Sharma	No discrepancies

Annexure-2: IP Dispensing Log

Date	Subject ID	Quantity Dispensed	Dispensed By	Remarks
12/08/2025	NZ-701	30 tablets	Pharmacist: Arjun Mehta	Initial dispense

Annexure-3: IP Destruction Log

Date	Quantity Destroyed	Method	Witness	Remarks
20/08/2025	120 tablets	Incineration	QA: Sunita Reddy	Batch expiry

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
28/08/2025	1.0	Initial SOP for investigational product management and accountability in New Zealand.	New SOP created for Medsafe, HDEC, and GCP compliance.	Head of Clinical Research

For more SOPs visit: Pharma SOP.