all incoming APIs, excipients, and additives received at the facility’s warehouse or designated receiving dock. It includes:

• Initial checks on container integrity, labeling, and quantity verification.
• Cross-checking against Purchase Orders (POs), supplier documentation, and relevant Certificates of Analysis (CoAs).
• Segregation of materials based on inspection findings (quarantine, acceptance, or rejection) and subsequent record updates.

Warehouse personnel, QA, Quality Control (QC), and Procurement staff must comply with these procedures to ensure correct handling and traceability of each received batch. Any special handling requirements (e.g., temperature-sensitive APIs, hazardous additives) must align with additional, item-specific SOPs or guidelines.

3. Responsibilities

• Warehouse Personnel:
  • Unload the shipment and perform preliminary inspections on all containers (drums, bags, carboys, or other packaging types).
  • Record receipt details in the Raw Material Receiving Register (Annexure-1), highlighting any deviations (damage, mismatch, missing documents).
  • Label and segregate suspect or damaged batches, preventing cross-contamination or accidental usage.
  • Notify QA and Procurement promptly if significant discrepancies or issues arise.
• Quality Assurance (QA) Team:
  • Define acceptance criteria for APIs, excipients, and additives, including labeling and minimum documentation checks (CoAs, batch labels, etc.).
  • Authorize movement to quarantine or rejection zones based on inspection outcomes, test results, or labeling issues.
  • Oversee any deviations, non-conformance reports, and final approval for usage or disposal of materials that fail to meet GMP requirements.
• Quality Control (QC) Team:
  • Perform sampling and testing if QA deems it necessary or if routine incoming checks are required (identification, assay, impurity profile).
  • Communicate results to QA, triggering acceptance, extended quarantine, or rejection if findings deviate from agreed specifications.
• Procurement Department:
  • Provide accurate PO details to the Warehouse, specifying product name, batch requirements, packaging types, and regulatory or labeling guidelines.
  • Address supplier-related issues when repeated or serious inconsistencies in shipments occur (wrong batches, incomplete CoAs, etc.).
  • Coordinate with suppliers regarding replacements, credits, or additional documentation if shipments are rejected.

4. Accountability

The Warehouse Manager ensures consistent application of this SOP, verifying that staff follow all established steps during the receipt of APIs, excipients, and additives. The QA Manager has final authority over material acceptance or rejection based on initial inspection data or QC tests. Any revisions to this SOP must be reviewed and approved by QA management to maintain regulatory compliance and product safety.

5. Procedure

5.1 Pre-Receipt Preparations

Proper planning ensures smooth inspection and facilitates traceability for incoming raw materials, especially when dealing with diverse categories like APIs, excipients, and additives.

1. PO and Documentation Review
   1. Procurement provides the Warehouse with the final PO for each shipment, detailing product name, batch or lot numbers, quantity, supplier, and any special instructions. Verify the completeness of this information before the shipment arrives.
   2. Ensure that any unique guidelines for labeling or handling—for example, labeling required by pharmacopeial standards—are clearly indicated. If specialized packaging or temperature controls are necessary, confirm readiness in the warehouse.
2. Inspection Area and Equipment
   1. Maintain a clean receiving area with sufficient space for segregating new shipments. Mark sections or pallets if multiple deliveries are expected simultaneously.
   2. Prepare labeling supplies (color-coded “Hold,” “Quarantine,” or “Rejected” tags) and ensure forklift trucks, dollies, or other handling equipment are in good working condition.
   3. If materials are temperature-sensitive or hazardous, confirm that recommended storage conditions and necessary protective gear (PPE) are available.

5.2 Receiving the Shipment

As soon as APIs, excipients, or additives arrive, Warehouse Personnel unload them and conduct preliminary checks to confirm basic compliance with the PO.

1. Unloading and Visual Inspection
   1. Unload each pallet or container (drum, bag, carboy, etc.) carefully, ensuring no further damage occurs. Keep products from the same batch together, if possible, to simplify traceability.
   2. Look for visible abnormalities: damaged packaging, leakage, torn bags, compromised seals. Any container showing serious damage is immediately isolated and marked “Hold—Damaged” until QA review.
2. Cross-Checking with PO Documents
   1. Confirm that the material name on labels matches the PO line item. For APIs, check that the batch number and potency (if stated) align with the PO. For excipients and additives, ensure the correct grade or specification is indicated.
   2. Note any shortages, overages, or mismatches in the Raw Material Receiving Register (Annexure-1). Contact Procurement and QA if the discrepancy is significant. Minor shortages may still warrant remarks in the log but might be managed by Procurement’s standard processes.
3. Label Accuracy
   1. Check labels for required details:
      • Product name (API, excipient, additive)
      • Batch/Lot number
      • Manufacturer or supplier name
      • Net weight or volume
      • Expiry or retest date, if applicable
   2. If critical details are missing or inconsistent with the PO, flag the items for QA review. Minor label smudges or partial info can sometimes be resolved, but major omissions typically result in quarantining those materials.

5.3 Segregation and Initial Documentation

Ensuring materials do not mix with existing stock and capturing accurate records are fundamental steps before final QA disposition.

1. Labeling and Temporary Storage
   1. Attach a “Hold” or “Awaiting Quarantine” label to each container, referencing the date, PO number, and batch number. Place the items in a designated holding area if used (per the company’s “Holding Area Before Quarantine” SOP) or directly in the quarantine zone if that is the standard procedure.
   2. Keep questionable or damaged items physically separated from seemingly compliant items. This reduces the chance of cross-contamination or accidental usage of suspect materials.
2. Raw Material Receiving Register Entry
   1. Log all relevant data in Annexure-1: date, supplier, material name, batch number, PO reference, quantity, and any remarks about packaging condition or labeling anomalies.
   2. Ensure each entry is signed or initialed by Warehouse Personnel to maintain accountability and traceability. If using an electronic system (WMS/ERP), finalize digital records with proper user IDs and timestamps.
3. Notification to QA/Procurement
   1. For shipments with repeated or severe inconsistencies, Warehouse staff promptly inform QA and Procurement. Provide pictures if needed, particularly if serious damage or labeling fraud is suspected.
   2. Procurement may contact the supplier for clarifications or corrections (revised CoAs, missing documents) if the mismatch is related to documents or labeling. QA decides if the shipment remains on “Hold” or can proceed to standard quarantine.

5.4 Quality Assurance Review and Quarantine Process

QA verifies the initial inspection data and may require sampling, advanced testing, or direct quarantining of the materials prior to final release.

1. Documentation and CoA Check
   1. QA examines the supplier’s Certificate of Analysis, ensuring it references the correct batch number, manufacturing date, and meets pharmacopeial or internal specification requirements. If missing or heavily flawed, QA might quarantine or reject the batch pending additional verification from the supplier.
   2. If the CoA includes essential test parameters (e.g., assay, impurity profile for APIs; microbial limits for excipients), QA confirms alignment with internal standards. Large or suspicious deviations prompt further QC testing or immediate rejection.
2. Sampling and QC Testing
   1. Where mandated by routine checks, risk-based criteria, or suspicion of adulteration, QC performs sampling per the company’s Sampling SOP and logs it in Annexure-2 (Sampling Log). Tests may include identity (IR, HPLC, or other appropriate method), purity, microbial load, or heavy metals screening.
   2. QC communicates results to QA. Materials that pass specifications are officially quarantined or can be released if the facility uses a concurrent testing approach. Failures in test parameters lead to extended quarantine or direct rejection.
3. Approval for Quarantine or Rejection
   1. Once QA confirms the materials meet all acceptance criteria based on label review, CoA alignment, and any required testing, the lot is moved from “Hold” to the official quarantine zone (if full QC release testing is pending) or approved storage (if immediate release is allowed by skip-lot or risk-based approach).
   2. Conversely, if the materials are severely compromised (unacceptable test results, mislabeled beyond remediation, or physically contaminated), QA instructs a “Rejected” label. Warehouse places them in a segregated reject area awaiting final disposal or return to vendor procedures.

5.5 Handling Special Cases and Discrepancies

Some materials or situations may require tailored solutions beyond routine checks.

1. Temperature-Sensitive Materials
   1. For API or additives that need cold chain management, confirm temperature loggers or data accompany the shipment. If data suggests temperature excursions, QA might hold the lot in a temperature-controlled quarantine space pending additional stability or potency checks.
   2. Record the temperature tracker data in the receiving register or attach it to the batch file. If the log reveals significant deviations, QA and Procurement decide whether to reject the lot or request supplementary data from the supplier.
2. Hazardous or Controlled Substances
   1. Ensure designated hazard labels or controlled substance documentation is present. If insufficient or missing, isolate these items and alert QA to decide if they remain in quarantine or must be rejected outright for regulatory non-compliance.
   2. Follow local legal or DEA-like guidelines for any controlled material, ensuring locked storage even during quarantine. Security or EHS may require extra measures (like restricted access or sealed containers).
3. Partial Shipments or Overages
   1. If the quantity delivered does not match the PO (shortage or overage), note it in the receiving register and inform Procurement. Minor differences might be acceptable, but significant variances typically prompt QA to hold the shipment until the discrepancy is resolved or corrected by the supplier.
   2. Excess material that is not on the PO can be rejected outright or accepted after formal confirmation with Procurement if it’s deemed safe and needed. QA decides how to label or re-label the additional items to prevent confusion.
4. Recurring Supplier Issues
   1. Multiple incidents of mislabeled or poorly packaged shipments from the same supplier may trigger a deviation or non-conformance report. Procurement and QA review the supplier’s AVL status or demand corrective actions from the vendor.
   2. Document all relevant events, referencing each shipment’s batch number or invoice. This ensures robust traceability and accountability for repeated problems.

5.6 Document Completion and Reporting

Accurate records are essential to uphold GMP principles and ensure each batch can be traced from receipt to final disposition.

1. Raw Material Receiving Register Updates
   1. Warehouse Personnel finalize entries in Annexure-1 once QA authorizes movement from “Hold” to “Quarantine,” “Approved Storage,” or “Rejected.” Document the date, initials of QA’s sign-off, and any test references if QC was involved.
   2. If the material was rejected, indicate the reason under “Remarks” (e.g., “Failed ID test,” “Damaged packaging—possible contamination,” “Temperature excursion beyond specs”).
2. Sampling Log (If Testing Occurred)
   1. QC staff fill Annexure-2 with the date, batch number, and test outcomes (ID, assay, microbial, etc.). Attach or cross-reference laboratory reports for a thorough audit trail.
   2. Sign or initial each entry. QA references these results during final acceptance or rejection decisions.
3. Deviation / Non-Conformance Records
   1. If repeated or significant lapses happen, QA or Warehouse triggers a deviation record. Summaries of root causes, corrective actions, and final resolution are compiled.
   2. Procurement documents supplier communications in the material file or ERP/WMS system, especially if a corrective action plan is required from the vendor.
4. Supplier Feedback
   1. Procurement liaises with the supplier for partial shipments, mislabeled batches, or repeated labeling or CoA errors. Keep copies of emails or letters confirming any future improvements or clarifications in packaging/labeling protocols.
   2. Update the Approved Vendor List or supplier performance records if QA or management decides further actions (e.g., more frequent audits, adding skip-lot testing, or removing from AVL for non-compliance).

5.7 Storage and Ongoing Monitoring

For materials that pass initial inspection and move to quarantine or direct approval, ongoing compliance with labeling, environmental, and security requirements remains critical.

1. Quarantine Management
   1. All newly received materials that pass initial checks but require full QC release are stored in the quarantine zone, labeled per the quarantine SOP. Only QA can shift them to the approved storage area after final testing confirms compliance.
   2. Monitor quarantined stocks to avoid indefinite holding. If QC sampling is delayed, QA addresses it promptly to facilitate timely usage or final disposition of the batch.
2. Approved Storage
   1. For materials quickly verified (like common excipients or well-known additives from a trusted supplier) that skip-lot or reduced testing, label them “Approved” once QA signs off. Store them in standard inventory sections, ensuring batch segregation is maintained.
   2. Follow standard stock rotation (FEFO, FIFO) as relevant, adhering to any retest dates or expiry. Keep transparent traceability so each container’s origin and manufacturer are evident.
3. Temperature and Safety Controls
   1. For temperature-sensitive APIs and additives, maintain recommended storage conditions. Record temperature logs as part of standard QA checks or EHS protocols.
   2. Separate flammable or hazardous materials in designated areas with proper signage. Reinforce PPE rules for staff handling or sampling these materials to reduce health and safety risks.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• PO: Purchase Order
• CoA: Certificate of Analysis
• FEFO: First Expiry First Out
• FIFO: First In First Out
• CAPA: Corrective and Preventive Action
• AVL: Approved Vendor List
• WMS: Warehouse Management System
• ERP: Enterprise Resource Planning
• EHS: Environment, Health, and Safety

7. Documents

1. Raw Material Receiving Register (Annexure-1)
2. Sampling Log (Annexure-2), if sampling is performed
3. Purchase Orders (PO), Supplier Invoices, and Packing Lists
4. Certificates of Analysis (CoAs) and other Supplier Quality Documents
5. Deviation/Non-Conformance Reports (if applicable)
6. Internal SOPs for Quarantine, Rejection, and Disposal

8. References

• 21 CFR Part 211 – Current GMP for Finished Pharmaceuticals (US FDA)
• EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
• ICH Q7 – GMP Guide for Active Pharmaceutical Ingredients
• Company-Specific Procurement, QA, and Warehouse 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	Quantity Received	Remarks
01/02/2025	ABC Pharma Supply	API-X	X-2025-123	PO-98765	100 kg	No Discrepancy
02/02/2025	XYZ Chemical Co.	Excipient-Y	Y-2025-456	PO-54321	200 kg	Minor Label Variation

Annexure-2: Sampling Log

Date	Material Name	Batch Number	Sampling Personnel	QC Test Performed	Result	Remarks
01/02/2025	API-X	X-2025-123	John Doe	Identity, Assay	Pass	QC Release Approved
03/02/2025	Excipient-Y	Y-2025-456	Jane Smith	Impurity Profile	Pending	Further QA Review Required

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 and inspection of APIs, excipients, and additives
01/02/2025	2.0	Expanded Inspection Steps	Standardization of Document	QA Head	All	All	Clarified labeling checks, rework vs. rejection scenarios, and integrated temperature/hazardous considerations