QA024: SOP FOR HANDLING AND DISPOSAL OF REJECTED MATERIAL, EXPIRED FINISHED PRODUCTS, NEAR-EXPIRY PRODUCTS, AND SAMPLES

OBJECTIVE:

The purpose of this SOP is to define a uniform and documented procedure for identification, segregation, control, and destruction of rejected materials, expired finished products, near-expiry products, stability samples, control samples, and various laboratory samples in order to prevent their unintended use and ensure compliance with Pharmaceuticals, and environmental regulations.

SCOPE:

This SOP is applicable to all rejected materials, expired finished products, near-expiry products, and samples generated at warehouse, manufacturing, quality control, and laboratory areas of the company.
It covers all dosage forms and materials such as raw materials, intermediates, bulk products, printed and primary packaging materials, stability samples, control samples, and other analytical samples.

RESPONSIBILITIES:

Head – Warehouse / Designee:

Shall identify, label, segregate, and maintain records of all rejected, expired, and near-expiry materials stored in the warehouse.

Head Quality Control (QC) / Designee:

Shall identify and initiate the disposal of stability samples, control samples, and various laboratory samples, ensuring proper labeling, segregation, and documentation in accordance with this SOP.

Head – Planning / Production:

Shall verify and coordinate the destruction of non-moving, rejected, expired, or near-expiry stock in consultation with QA and Warehouse.

Quality Assurance (QA):

shall obtain all necessary permissions and approvals from the Excise Department and other relevant government authorities before initiating destruction of materials.
Shall verify destruction records, cross-check the quantities proposed for destruction, witness the destruction process, and retain all associated certificates and documentation.

Head Human Resource (HR) & Administration / EHS:

Shall arrange for authorized waste management vendors and ensure that disposal or destruction is carried out in an environmentally safe manner at a government-approved facility.

Head Quality Assurance (QA) and Head – Finance:

Shall review and approve the Destruction Proposal prior to final authorization to ensure compliance and reconciliation.
Shall ensure compliance with corporate and regulatory policies.

Management Representative:

Shall provide final authorization for destruction of all critical, high-value, or large-quantity materials.

DEFINATIONS:

Rejected Material: Any material that fails to meet the defined specifications during receipt, sampling, testing, or production stages.
Expired Product: Product whose shelf life has exceeded the approved expiry date.
Near-Expiry Product: Product having less than six months (or as defined) of remaining shelf life.
Control Sample: A sample retained for comparison with the market sample during investigation.
Stability Sample: Product sample kept under defined conditions to evaluate shelf life.
Destruction Certificate: A controlled document evidencing destruction of specified quantities in presence of authorized personnel.
ETP: Effluent Treatment Plant for neutralization of liquid waste.
QRM: Quality Risk Management process for assessing and mitigating potential cross-contamination or misuse risks during handling of rejected or expired materials.

PROCEDURE:

Identification and Segregation:

The concerned department (Warehouse, Production and Laboratory) shall identify all materials or products that are rejected, expired, or near expiry.
Each identified item shall be labeled with a red “REJECTED” or “EXPIRED” status label as per SOP on labeling.
Materials shall be physically segregated and stored in a designated, access-controlled quarantine area clearly marked “REJECTED MATERIAL AREA.”
The segregation area shall be maintained with restricted access and monitored under CCTV where applicable.

Documentation and Record Control:

A Destruction logbook shall be raised by the initiating department. Each destruction activity shall be recorded in the Destruction Logbook.
The QA Department shall issue, review and approve the request after verifying supporting data (COA, expiry confirmation, etc.).
Batch number, product name, quantity, reason for destruction, and method of destruction shall be documented.
All records shall be archived for a minimum period of five (5) years from the date of destruction or as per regulatory requirement, whichever is higher.

Destruction Authorization:

For materials, up to 5 kg total quantity, internal destruction may be performed under QA supervision.
For quantities above 5 kg, prior written approval shall be obtained from the QA Head.
The process rejects generated after various stages of manufacturing shall be rejected inhouse after approval from Designee QA and the quantities shall be recorded in the Batch |Manufacturing Record (BMR) and Batch Packing Record (BPR).

Methods of Destruction (Internal Disposal ≤5 kg):

Printed Aluminum Foils: Deface by drilling or punching multiple holes to make them unusable.
Primary Packaging Components: Cut, crush, or shred using shredding equipment.
Printed Cartons/Leaflets/Shippers: Pass through paper shredder or tear manually.
Tablets: Remove packaging, defoil blisters/strips, collect tablets in a container, neutralize in twice the volume of 2% sodium hydroxide solution, and send neutralized slurry to ETP.
Capsules: Crush capsules, soak for 2–4 hours in water, neutralize with 2% NaOH, and send to ETP.
Liquids: Remove labels, pour liquid into container, neutralize with 2% NaOH, and send to ETP.
Raw Materials / Bulk Intermediates: Neutralize with 2% NaOH solution in container and dispose via ETP.

Disposal of Quantities > 5 kg:

The HR/ EHS Representative shall obtain permission from local Excise/Environmental authorities.
QA shall verify and seal the materials prior to dispatch for incineration.
HR/EHS shall arrange transportation to a government-approved hazardous waste facility (e.g., incinerator).
The vendor shall issue a Certificate of Incineration, which shall be verified and filed by QA.

Witness and Certification:

Destruction must be carried out in presence of at least two authorized persons (QA/EHS/HR + one from initiating department).
QA shall retain the original certificate; copies shall be distributed to initiating department, Finance, and HR/EHS.

Environment, Health and Safety Controls:

All personnel shall wear appropriate PPE (gloves, goggles, mask, apron, and shoes) during destruction activity.
Area hygiene shall be maintained; spills shall be immediately cleaned using neutralizing agent.
Neutralized liquid waste shall be routed through ETP and shall meet discharge standards before disposal.
Solid waste shall be handed over to approved hazardous-waste vendor only.
No burning, burying, or uncontrolled dumping shall be permitted.

Quality Risk Management (QRM):

QA shall perform a Risk Assessment for destruction activities to identify potential risks (cross-contamination, environmental impact, mix-up).
Appropriate controls and mitigations shall be implemented (segregation, labeling, double verification, PPE).
The QRM summary shall be attached with each lot destruction record.

Reconciliation:

The quantity proposed for destruction shall be verified against stock records.
Any discrepancy shall be investigated and recorded as per deviation SOP.
QA shall confirm reconciliation before destruction certificate approval.

Archival and Retention:

All original records (request forms, destruction logs, certificates, witness sheets, vendor certificates) shall be archived under QA control.
Retention period shall be minimum five years or as per regulatory requirement.

Training:

All concerned personnel (Warehouse, QA, QC, PPIC, EHS) shall be trained on this SOP before implementation.
Refresher training shall be conducted once every two years or upon major revision.

Frequency:

This activity shall be carried out as and when required based on identification of rejected, expired, or near-expiry materials, or as per periodic review (quarterly or bi-annual).

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