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).

 REFERENCE:

• EudraLex Volume 4 – EU-GMP Guidelines
•  WHO TRS No. 1019 Annex 2 – Pharmaceutical Quality System

RECORDS:

 REVISION HISTORY: