STANDARD OPERATING PROCEDURE
Title: Destruction of Unusable stocks
Process Owner: SOP No.: Version No.:
Regulatory Affairs RA-PHI-013 001
Next Revision Due: Effectivity Date: Page:
14 January 2027 15 January 2024 Page 4 of 4
1. Objective
To establish a standardized procedure for the proper identification, documentation,
handling, and destruction of unusable pharmaceutical stocks—including expired,
damaged, recalled, or temperature-excursion-affected cold chain products—in
compliance with FDA and DENR regulations.
2. Scope
This SOP applies to all unusable pharmaceutical stocks under the custody of the drug
distributor, including prescription, over-the-counter (OTC), and cold chain products that
are no longer fit for human use. It applies to all warehouse and logistics operations and
involves coordination with FDA- and DENR-accredited service providers.
3. Abbreviations
FDA Food and Drug Administration (Philippines)
Department of Environment and Natural
DENR
Resources
GDP Good Distribution Practice
GSP Good Storage Practice
CCP Cold Chain Product
CDO Certificate of Disposal
MSDS Material Safety Data Sheet
PPE Personal Protective Equipment
SOP Standard Operating Procedure
4. Definition
Products deemed unfit for sale or human use due to expiration,
Unusable Stocks damage, contamination, recall, or improper storage (including
temperature excursions).
Cold Chain Pharmaceutical products that require storage between 2°C and 8°C
Products (CCP) throughout their life cycle.
The irreversible process of rendering pharmaceutical products
Destruction unusable, typically through incineration, chemical disintegration, or
other approved methods.
A third-party waste management provider accredited by DENR and
Accredited Hauler
FDA to handle and dispose of pharmaceutical waste.
Certificate of Official document issued by the waste disposal provider confirming
Disposal (CDO) the destruction of regulated pharmaceutical waste.
5. Process Flow
STANDARD OPERATING PROCEDURE
Title: Destruction of Unusable stocks
Process Owner: SOP No.: Version No.:
Regulatory Affairs RA-PHI-013 001
Next Revision Due: Effectivity Date: Page:
14 January 2027 15 January 2024 Page 4 of 4
Identification → Quarantine → Documentation → Coordination with Hauler →
Disposal → Issuance of CDO → Archiving
6. Description of Process
6.1 Identification of Unusable Stocks
Routinely identify expired, damaged, recalled, or temperature-excursion-affected
products, including cold chain items.
Perform monthly inventory checks and segregate unusable items immediately.
Tag unusable stock as “FOR DISPOSAL – DO NOT USE”.
6.2 Quarantine and Segregation
Store unusable stocks in a secure, clearly labeled Quarantine Area with
restricted access.
CCPs that are compromised must be stored separately in a dedicated sealed
container or quarantine refrigerator pending disposal.
6.3 Documentation
Fill out the Disposal Request Form, listing:
o Product name
o Batch/Lot number
o Quantity
o Expiration date
o Reason for disposal (e.g., expired, damaged, cold chain failure)
Maintain a Disposal Logbook for internal tracking.
6.4 Coordination with Accredited Waste Disposal Provider
Contact a DENR- and FDA-accredited hauler for pick-up and destruction.
Provide the completed Disposal Request Form and necessary records (product
certificates, MSDS if applicable).
Schedule transport in compliance with RA 6969 (Toxic Substances and
Hazardous and Nuclear Wastes Control Act).
6.5 Handling and Transport
Ensure proper PPE is worn by warehouse staff during handover.
CCPs must be transported in leak-proof, temperature-insulated containers to
prevent contamination or hazard.
Ensure items are handed over with official documentation and acknowledged with
delivery receipts.
6.6 Destruction and Issuance of Certificate of Disposal
STANDARD OPERATING PROCEDURE
Title: Destruction of Unusable stocks
Process Owner: SOP No.: Version No.:
Regulatory Affairs RA-PHI-013 001
Next Revision Due: Effectivity Date: Page:
14 January 2027 15 January 2024 Page 4 of 4
The waste hauler performs disposal via approved methods such as:
o Incineration (for expired/damaged CCPs and general pharmaceuticals)
o Chemical neutralization (if applicable)
Obtain Certificate of Disposal (CDO) from the waste handler.
File the CDO with the supporting records and maintain for at least 5 years.
6.7 Review and Audit
Conduct semi-annual audits of disposal records.
Investigate frequent or large-volume disposals to assess systemic issues (e.g.,
overstocking, cold chain lapses).
7. Responsibilities
Warehouse Identifies and segregates unusable stocks; initiates disposal
Pharmacist process; reviews documentation.
Warehouse Ensures proper quarantine and storage of unusable products;
Supervisor coordinates with waste hauler.
Logistics Manages transport scheduling and documentation handover to
Coordinator hauler.
Accredited Waste Transports and disposes unusable stocks in compliance with FDA
Hauler and DENR regulations; issues CDO.
QA/Compliance Verifies completeness of disposal documentation and ensures
Officer audit readiness.
8. References
Administrative Order Adoption and Implementation of the World Health
No. 2013-0027 Organization Annex 5 Guide to Good Distribution Practices
(GDP) for Pharmaceutical Products, and Annex 9 Guide to
Good Storage Practices for Pharmaceuticals.
FDA Circular No. 2021- Revised Guidelines on the Cold Chain Management for
003 Pharmaceutical Products and Establishments
FDA Advisory No. 2022 - Compliance to Administrative No. 2013-0027 or the rules on
1895 the “Adoption and Implementation of the World Health
Organization Annex 5 Guide to Good Distribution Practices
(GDP) for Pharmaceutical Products, and Annex 9 Guide to
Good Storage Practices for Pharmaceuticals.
WHO TRS 957 Annex 5 Good Distribution Practices
WHO TRS 1025 Annex 7 Good Storage and Distribution Practices for medical
products
STANDARD OPERATING PROCEDURE
Title: Destruction of Unusable stocks
Process Owner: SOP No.: Version No.:
Regulatory Affairs RA-PHI-013 001
Next Revision Due: Effectivity Date: Page:
14 January 2027 15 January 2024 Page 4 of 4
WHO TRS 908 Annex 9 Good Storage Practices
WHO TRS 961 Annex 9 Guidelines for storage and transport of time and
temperature sensitive pharmaceutical products
Republic Act (RA) 6969 Toxic Substances and Hazardous and Nuclear Wastes
Control Act of 1990
9. History
Version 001 : Document newly established
10. Publication and Distribution
Publication: E-mail
Distribution: Email
Prepared by: Approved by:
