chemicals, and other production-critical substances. It covers:

• Safety measures for handling heavy drums, delicate bags, and liquid-filled carboys.
• Inspection and verification steps to ensure that container integrity, labeling, and quantities match the Purchase Order (PO) and supplier documents.
• Quarantine and labeling requirements to segregate and manage suspect or non-conforming materials.
• Documentation of all receiving activities, including any sampling or advanced checks.

All Warehouse Personnel, QA, and Procurement staff involved in receiving, inspecting, and approving raw materials in these packaging formats must adhere to this SOP. Where specific instructions differ based on container type (e.g., metal vs. plastic drums, small vs. large bags), follow the relevant sub-procedures.

3. Responsibilities

• Warehouse Personnel:
  • Unload incoming drums, bags, or carboys safely and inspect them for signs of damage, leakage, or labeling errors.
  • Record batch numbers, quantities, and packaging conditions in the Raw Material Receiving Register (Annexure-1).
  • Segregate suspect materials or those failing to meet PO requirements and inform QA.
  • Label or store materials properly (e.g., “Quarantine,” “Approved”) based on QA authorization.
• Quality Assurance (QA) Team:
  • Review any discrepancies, label mismatches, or damage reports. Decide whether to quarantine, reject, or accept shipments with minor issues.
  • Oversee deviation or non-conformance reports in case of repeated or serious problems.
  • Specify sampling or advanced testing needs to ensure raw material quality before final release to production.
• Procurement Department:
  • Provide accurate POs with detailed packaging instructions (e.g., specific type of drum, bag weight, carboy volume).
  • Verify that suppliers follow required labeling, seal, or tamper-evident practices for each container type.
  • Coordinate with suppliers to resolve repeated packaging issues or documented shortages or overages.
• Quality Control (QC) Team:
  • Perform sampling and testing where QA deems it necessary, especially for new or high-risk materials.
  • Alert QA if test results indicate contamination, adulteration, or mismatch, prompting potential quarantine or rejection.

4. Accountability

The Warehouse Manager ensures thorough application of this SOP during daily receiving operations. QA Management holds final authority for accepting or rejecting any materials that do not meet established standards. Any revisions to this SOP must be approved by QA to ensure ongoing compliance with GMP and company policies.

5. Procedure

5.1 Pre-Receipt Preparations

Adequate planning reduces delays and safety risks when receiving materials in drums, bags, or carboys.

1. Documentation and PO Verification
   1. Procurement supplies the latest approved PO details, including exact container types (e.g., 25-kg bags, 200-liter drums, 50-liter carboys), expected quantities, and any special handling instructions.
   2. Ensure any relevant shipping documents (packing lists, CoAs, SDS) are readily available or easily accessible once the shipment arrives.
2. Equipment and Safety Measures
   1. Check the receiving area for cleanliness and for the presence of necessary handling equipment (forklifts, drum dollies, bag lifters) in good working order. Make sure designated areas for quarantining suspect items are free and labeled.
   2. Provide appropriate PPE (e.g., gloves, safety shoes, aprons, goggles) to staff, especially if handling hazardous materials. If the environment requires specific temperature or humidity controls, confirm they’re active.
3. Staff Briefing
   1. Before the shipment arrives, Warehouse Personnel review the expected container count, packaging format, and any known hazards. They should also be aware of typical red flags for packaging damage or labeling errors.
   2. Arrange a short meeting with QA or QC if the material is high-risk or requires immediate sampling on arrival. Confirm roles and responsibilities for each container type (who handles drums vs. who inspects bags, etc.).

5.2 Unloading Drums, Bags, and Carboys

Careful unloading is vital to prevent damage, spillage, or contamination, especially when dealing with heavy drums or fragile bags.

1. Vehicle Inspection
   1. Examine the delivery truck’s interior for cleanliness or possible spillage that might contaminate your materials. Cross-check seal numbers if the supplier uses tamper-evident seals on the truck or container.
   2. If anything appears off—like an unsealed container, chemical odor, or stained cargo area—note it in the receiving log and alert QA to assess potential contamination.
2. Safe Handling Procedures
   1. Use forklifts or drum handlers for large or heavy drums. For bags, ensure staff do not exceed manual lifting limits, employing mechanical aids or team lifts for heavier loads.
   2. For liquids in carboys, keep them upright during offloading to avoid leakage. If a carboy is dented or sees signs of potential rupture, label it “Suspect—Damaged Packaging” and segregate it immediately.
3. Organized Placement
   1. Arrange each container type separately in the inspection area—group drums together, stack or place bags on pallets, line up carboys in a stable upright position. This helps efficient counting and label checking.
   2. Keep fragile packaging away from high-traffic zones to prevent accidental punctures or tears. Mark or barricade the area if needed, especially for hazardous materials requiring restricted access.

5.3 Visual Inspection and Label Verification

Warehouse Personnel ensure each drum, bag, or carboy matches the PO description and is labeled according to GMP and supplier requirements.

1. Package Integrity
   1. For drums, look for dents, rust, or compromised seals on the lids. Note any leaks or chemical residue on surfaces that suggest spillage or tampering.
   2. For bags, check for tears, dampness, or any sign of infestation (in the case of natural excipients). Seals or stitching should be intact without loose threads or suspicious re-sealing evidence.
   3. For carboys, verify that caps and seals are unbroken, no cracks in plastic or glass, and no color changes in the liquid, if visible.
2. Label Accuracy
   1. Ensure each container’s label has:
      • Material name (matching the PO)
      • Batch or lot number
      • Net weight or volume
      • Manufacturer or supplier name
      • Expiry or retest date (if applicable)
      • Any hazard symbols or handling instructions
   2. If labels are missing or heavily damaged, mark those items “Hold—Label Issue” and alert QA. Minor label smudges might be acceptable, but QA decides if re-labeling is possible without risking GMP compliance.
3. Quantity Verification
   1. Count the total number of drums, bags, or carboys, comparing to the PO’s indicated quantity. Shortages or overages must be noted in the Raw Material Receiving Register (Annexure-1) and communicated to Procurement and QA if significant.
   2. Weigh random samples if the PO states a specific net weight per bag or drum. Substantial deviations might signal supplier error or potential adulteration/tampering.

5.4 Recording Findings and Quarantine Actions

Any suspicious or damaged packaging must be isolated to prevent its accidental use, while accurate records ensure traceability.

1. Raw Material Receiving Register Entry
   1. In Annexure-1, log each container type (drum, bag, carboy) with the corresponding batch, quantity, and arrival date. Include remarks such as “Damaged Drum Lid,” “Torn Bag,” or “Leaking Carboy” where applicable.
   2. Sign or initial each entry for accountability. If using an electronic Warehouse Management System (WMS), finalize the record with your user ID and accurate timestamps.
2. Quarantine Labeling
   1. Mark any suspect container with a “Quarantine” or “Hold” label, referencing the batch number and reason for quarantine (e.g., “Dented Drum,” “Missing Label,” “Leaking Liquid”).
   2. Relocate quarantined items to a secure area to prevent mixing with standard stock. Document the quarantine location in both physical logs and digital systems for easy QA retrieval.
3. Immediate Communication
   1. If multiple containers are compromised or if a single container’s defect could endanger staff or the environment (e.g., spillage of a toxic substance), alert QA immediately and follow any relevant spill or emergency SOP.
   2. Procurement must be notified if repeated or significant discrepancies are discovered (e.g., large shortage, shipping damage). They coordinate with the supplier for possible replacements or credits.

5.5 QA Review and Sampling

QA determines if the material can be released, needs sampling for further checks, or must be rejected due to packaging issues or suspicious labeling.

1. QA Decision
   1. QA reviews the Warehouse’s inspection findings and, if necessary, physically inspects quarantined items to confirm whether the packaging damage or labeling discrepancy warrants rejection.
   2. Minor cosmetic defects might be resolved by re-labeling or verifying net weight, but QA must ensure GMP compliance. Serious contamination or tampering triggers immediate rejection to prevent cross-contamination or adulteration risk.
2. QC Sampling and Testing (If Required)
   1. If QA requests identity or purity tests, QC collects samples per the established Sampling SOP. They log the activity in Annexure-2 (Sampling Log), referencing the container type and batch number.
   2. QC communicates test results back to QA. Passing results allow standard release, while failing or suspicious results lead to further investigation or outright rejection, especially if contamination is suspected.
3. Final Release or Rejection
   1. After verifying container integrity, label accuracy, and QC results (if needed), QA approves the batch for usage or storage. The Warehouse updates the inventory system from “Quarantine” to “Approved.”
   2. Rejected batches remain segregated with a “Rejected” label. Procurement coordinates with the supplier for return or disposal, ensuring full documentation of the reasons (damage, incorrect labeling, poor packaging, etc.).

5.6 Storage and Safety Requirements

Proper storage for each container type ensures ongoing material integrity and compliance with GMP.

1. Drums
   1. Stack drums in a stable arrangement (no more than recommended height). Use pallets or drum racks if needed to avoid direct floor contact. Keep lids or bungs sealed until official usage or sampling is authorized.
   2. For flammable or hazardous liquids, store in designated sections with fire prevention systems. Post signage (e.g., “Flammable—No Smoking”) to warn staff. Secure drum trolleys or dollies to prevent rolling accidents.
2. Bags
   1. Stack or shelve bagged materials in a manner preventing tears or compression. If the bags are large or heavy, do not exceed the recommended stacking limit. Place the heaviest bags at the bottom layers for stability.
   2. Keep moisture-sensitive powders in a dry environment with controlled humidity. If the bag has an inner liner, ensure it remains sealed until official usage, sampling, or repackaging as per SOPs.
3. Carboys
   1. Store carboys upright on level surfaces. If possible, secure them in racks or use secondary containment trays to catch potential leaks. Label each carboy’s side for easy identification.
   2. Follow temperature or light-exposure requirements if the liquid is sensitive (e.g., photosensitive solutions). Keep pathways clear to reduce accidental knocks or tip-overs.
4. Labeling During Storage
   1. Affix status labels (“Quarantine,” “Approved,” or “Rejected”) clearly on each container or on pallet racks. This helps staff quickly see which materials are safe to move or use.
   2. When consolidating multiple containers of the same batch, ensure no mixing with a different batch or another container type. Maintain strict batch segregation to uphold GMP traceability.

5.7 Deviations, Non-Conformances, and CAPA

Inconsistent or faulty packaging, repeated damage, or labeling errors trigger formal documentation and potential supplier review.

1. Deviation Reporting
   1. QA or the Warehouse Manager initiates a deviation or non-conformance report for critical issues with drums, bags, or carboys. This includes persistent leaking, repeated mislabeling, or advanced deterioration observed upon receipt.
   2. Include all relevant data: batch number, container type, supplier details, photos, and any potential root cause (rough shipping, poor sealing, etc.). Keep QA updated on the investigation status.
2. Root Cause Analysis
   1. Analyze whether the issue arises from supplier errors (defective drums, sub-par bag quality) or internal handling mistakes (improper forklift usage, inadequate offloading procedures). QA, Procurement, and Warehouse staff collaborate on the investigation.
   2. Document findings in the deviation file, referencing previous incidents if it’s a recurring pattern. Identify potential improvements or re-training needs.
3. Corrective and Preventive Actions (CAPA)
   1. Based on the root cause, propose CAPA steps such as changing supplier packaging requirements, refining forklift operator training, or enforcing stricter QA checks for certain materials or container sizes.
   2. Monitor CAPA effectiveness over time, verifying that new shipments show fewer incidents of packaging damage or labeling confusion.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• PO: Purchase Order
• SDS: Safety Data Sheet
• CAPA: Corrective and Preventive Action
• WMS: Warehouse Management System
• ERP: Enterprise Resource Planning

7. Documents

1. Raw Material Receiving Register (Annexure-1)
2. Sampling Log (Annexure-2) if sampling is performed
3. Purchase Orders (PO), Supplier Packing Lists, Invoices
4. Certificates of Analysis (CoAs), SDS
5. Deviation or Non-Conformance Reports (if needed)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
• ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• Company-Specific Procurement, Warehouse, and QA Policies

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Raw Material Receiving Register

Date	Supplier Name	Material Name	Batch Number	PO Number	Packaging Type (Drum/Bag/Carboy)	Quantity	Remarks
01/02/2025	ABC Chemicals	API-X	X-2025-D1	PO-34567	Drum (200 L)	10 Drums	No Visible Damage
02/02/2025	XYZ Supplies	Excipient-Y	Y-2025-B5	PO-45678	Bags (25 kg)	50 Bags	2 Torn Bags, QA Hold

Annexure-2: Sampling Log

Date	Material Name	Batch Number	Packaging Type	Sampling Personnel	QC Test Performed	Result	Remarks
01/02/2025	API-X	X-2025-D1	Drum	John Doe	ID, Assay	Pass	Standard QC Release
02/02/2025	Excipient-Y	Y-2025-B5	Bag	Jane Smith	Visual, Purity	Pending	Torn Bags Quarantined

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head	All	All	Established guidelines for receiving raw materials in various container types
01/02/2025	2.0	Expanded Safety and Segregation Steps	Standardization of Document	QA Head	All	All	Added detailed instructions for different packaging formats (drums, bags, carboys)