Standard Operating Procedure for Storage of Raw Materials in Holding Area Before Quarantine

Department	Warehouse / Quality Assurance / Procurement
SOP No.	SOP/RM/026/2025
Supersedes	SOP/RM/026/2022
Page No.	Page 1 of 15
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

This Standard Operating Procedure (SOP) describes a structured method for storing newly received raw materials in a designated holding area prior to formal quarantine. In many pharmaceutical or life science facilities, the holding area serves as a preliminary staging location where materials undergo basic verification before being moved into official quarantine. By following this SOP, the organization:

• Ensures that raw materials do not mix with approved stock or fully quarantined items until basic checks (e.g., quantity, obvious damage) are confirmed.
• Maintains orderly and traceable movement of incoming shipments, reducing confusion and potential GMP infractions.
• Preserves material identity while preventing cross-contamination or accidental use of unverified or suspect items.
• Supports efficient transitions from arrival, to short-term holding, and finally to quarantine or rejection if warranted.

Properly controlling the flow of raw materials through a dedicated holding area upholds product safety, quality, and regulatory compliance. This approach also clarifies roles and responsibilities across Warehouse, QA, and Procurement departments.

2. Scope

This SOP applies to all raw materials—active pharmaceutical ingredients (APIs), excipients, chemicals, packaging components, and any other items—received at the facility. It covers:

• Procedures for directing materials into a holding area after initial unloading.
• Documentation and labeling practices to ensure each incoming batch is clearly identifiable.
• Criteria for transferring materials from the holding area to official quarantine or rejection zones.
• Special handling instructions for high-risk, temperature-sensitive, or hazardous materials, if relevant.

All Warehouse Personnel, Quality Assurance (QA), Quality Control (QC), and Procurement staff must follow this SOP during the receiving process when utilizing a holding area before official quarantine.

3. Responsibilities

• Warehouse Personnel:
  • Unload and place incoming materials in the dedicated holding area once they arrive, ensuring proper labeling and traceability.
  • Conduct basic checks (container count, visible packaging integrity) and record details in the Raw Material Receiving Register (Annexure-1).
  • Prevent mixing or cross-contact between different batches, manufacturers, or previously held stock in the holding area.
  • Coordinate with QA if any anomalies (e.g., damaged packaging, suspicious labeling) are observed prior to quarantine clearance.
• Quality Assurance (QA) Team:
  • Define acceptance criteria and basic checks for materials in the holding area (e.g., correct labeling, minimal damage, matching PO details).
  • Authorize the release of materials from the holding area to the formal quarantine zone based on initial verification or required sampling protocols.
  • Oversee or confirm rejection for shipments with glaring discrepancies that do not need further quarantine evaluation.
  • Monitor the holding area process to ensure GMP compliance, providing final sign-off for any transitions to official quarantine or rejection.
• Quality Control (QC) Team:
  • Collaborate with QA to determine if immediate sampling in the holding area is necessary for particularly high-risk or newly introduced materials.
  • Review any test results from rapid ID checks or preliminary tests (e.g., color, odor) if performed before formal quarantine. Communicate findings to QA for further actions.
• Procurement Department:
  • Ensure that the Purchase Order (PO) and supplier instructions clearly state packaging, labeling, and minimum acceptance criteria so that Warehouse staff can identify issues in the holding area.
  • Facilitate communication with suppliers if repeated or significant problems are uncovered in the holding area (e.g., consistent labeling errors, missing documents) prior to official quarantine checks.

4. Accountability

The Warehouse Manager ensures that staff accurately follow these guidelines for placing raw materials in the holding area and preventing any unauthorized usage. The QA Manager has final authority over acceptance or rejection of materials that fail basic holding area checks. Any changes to this SOP must be reviewed and approved by QA management to preserve GMP standards and organizational policies.

5. Procedure

5.1 Preparing the Holding Area

A well-maintained holding area ensures safe, organized short-term storage of newly arrived raw materials until they can be fully assessed and moved to official quarantine or rejection.

1. Location and Setup
   1. Select a designated section of the warehouse that is physically or visually distinct from both active inventory and the formal quarantine zone. Mark the floor or use signage to label it “Holding Area.”
   2. Ensure the space is large enough to accommodate typical shipment volumes without crowding. Provide easy access for forklifts or manual transport equipment.
   3. Maintain cleanliness and, if needed, environmental controls (e.g., temperature, humidity) if the raw materials are sensitive or regulated (like cold chain items). The holding area must meet minimal GMP housekeeping standards.
2. Equipment and Labeling Supplies
   1. Keep an adequate supply of color-coded or designated “Hold” labels, markers, and tape in the area so that staff can promptly mark any arrivals as “Awaiting QA Check” or “Hold—Pending Quarantine.”
   2. Set up shelving, pallets, or racking to separate different shipments or batches. If the materials might contain hazardous substances, keep spill kits or absorbent materials on hand in the immediate vicinity.
3. Staff Training and Access Control
   1. Ensure all warehouse staff are trained on the use and purpose of the holding area, including instructions to never commingle holding area items with approved or rejected materials.
   2. Restrict access to the holding area if handling high-risk or valuable items. Use physical barriers or signage to prevent unauthorized entry until QA or QC complete initial checks.

5.2 Receiving and Placing Materials in the Holding Area

Once materials arrive, Warehouse Personnel direct them to the holding area to perform initial checks and labeling before proceeding to the official quarantine process.

1. Unloading and Movement
   1. Unload the shipment from the delivery vehicle per standard receiving SOPs. Carefully handle all containers (drums, bags, carboys, boxes) to avoid damage. Group them by PO and batch number.
   2. Transport items directly to the designated “Holding Area” sign or zone, ensuring no items are inadvertently placed in general inventory or quarantine yet.
2. Labeling and Basic Documentation
   1. Attach “Hold” or “Awaiting Quarantine” labels to each batch, referencing:
      • Date of receipt
      • PO number
      • Batch/lot number
      • Manufacturer/supplier name
   2. Record these details in the Raw Material Receiving Register (Annexure-1), indicating the items are in the holding area. Sign or initial the entry to confirm accountability.
3. Initial Visual Checks
   1. Conduct a quick visual inspection for any glaring packaging flaws (e.g., torn bags, leaking drums). If major damage or mismatch with the PO is discovered, move those containers to “Suspect” status within the same holding area or a dedicated problem corner.
   2. Note any anomalies in the receiving register or electronic system. QA will evaluate if immediate quarantine, re-labeling, or rejection is needed.

5.3 Short-Term Storage in the Holding Area

Materials typically remain in the holding area for a limited time—often 24 to 72 hours—while awaiting QA’s approval to either move them to official quarantine or handle them in some other prescribed manner.

1. Segregation by PO/Batches
   1. Keep each PO’s items in separate, clearly labeled sections or pallets. Do not stack multiple POs’ containers together unless they share exactly the same batch details and are from the same supplier, which QA may still prefer to keep distinct.
   2. Use color-coded floor markings, pallet tags, or overhead signage to indicate distinct shipments. If multiple shipments arrive simultaneously, store them side by side with demarcated space in the holding area.
2. Environmental Conditions
   1. If the materials are sensitive to humidity or temperature, monitor the environment. Should they require refrigeration, keep them in a designated “cold chain” holding section or reefer unit if available, labeled as “Hold—Refrigerated.”
   2. Follow any hazardous material protocols, especially if the items are flammable or corrosive. For example, store them in a ventilated mini-cage or a portion of the holding area with restricted access.
3. Safety and Security
   1. Ensure that no raw material in the holding area is opened or used for sampling unless specifically authorized by QA or QC. If sampling is done in the holding area, follow strict GMP sampling SOP to avoid contamination or cross-contact with other batches.
   2. Lock or block off the holding area after standard receiving hours if the facility uses partial shifts or if the area is not continuously staffed. This prevents accidental movement or tampering.

5.4 Transition to Quarantine or Other Actions

The holding area is not a permanent storage location. Once QA or QC complete the necessary checks, each batch is either cleared for official quarantine, flagged for immediate rejection, or assigned another specialized route.

1. QA Authorization to Move to Quarantine
   1. After verifying PO alignment, basic label correctness, and no visible damage or major concerns, QA allows the batch to move from “Holding” to the designated official quarantine zone. Update the receiving register status from “Holding” to “In Quarantine.”
   2. Warehouse staff physically transfer the labeled containers to the quarantine area. Each container keeps its “Hold” label, which is replaced with “Quarantine” labeling as per the company’s normal quarantine SOP.
2. Immediate Rejection or Suspect Handling
   1. If QA identifies a serious discrepancy—like improper product identity, significant label mismatch, or extreme damage—QA can instruct Warehouse to direct the material to the “Rejected” area. The items skip formal quarantine as it’s evident they do not meet acceptance requirements.
   2. Record the rejection in the receiving system (Annexure-1) with a short note (e.g., “Rejection due to major labeling inconsistency”). Warehouse applies “Rejected” labeling to avoid any confusion in future handling.
3. Conditional Release or Rework
   1. In unusual instances where a small fix (e.g., re-labeling correct batch numbers) can salvage the shipment without a full quarantine, QA may choose a “rework” approach in the holding area. This is rarely used, but permissible if no product safety or integrity is compromised and the re-labeling is done under strict GMP controls.
   2. Upon completion of the rework, QA must sign off that the corrected material can proceed to formal quarantine or direct usage if immediate QC release is authorized. All rework activity is documented thoroughly.

5.5 Documentation and Final Record Update

Proper record-keeping ensures full traceability, supporting GMP standards and facilitating audits or any potential investigations.

1. Raw Material Receiving Register Completion
   1. Warehouse Personnel finalize entries in Annexure-1 with final status transitions (from “Holding” to “Quarantine,” “Rejected,” or “Rework”). Note the exact date and time of each transition, plus relevant references (QA approval signature, rework SOP number, etc.).
   2. Attach or link any supplier communication or additional documentation if discovered or provided while materials were in the holding area.
2. Deviation or Non-Conformance Records
   1. If a pattern of repeated issues arises at the holding stage—such as frequent label mismatches or shipping damage—QA or Warehouse staff open a deviation. Summaries of these events feed into improvement or CAPA processes (e.g., forklift driver re-training, new signage, or updated supplier instructions).
   2. Close the deviation after investigating root causes and implementing solutions, ensuring the same type of shipping or labeling error does not persist in future deliveries.
3. ERP or WMS Updates
   1. If the facility uses an electronic system (ERP/WMS), reflect each container’s location and status changes (“Received, Holding,” then “Moved to Quarantine,” “Rejected,” or “Rework Completed”). Provide a digital trail for audits or management oversight.
   2. Sign or digitally confirm each action to guarantee data integrity, preventing any unauthorized or untraceable changes to material statuses.

5.6 Special Considerations

Some materials may require extra attention or particular handling protocols in the holding area to comply with safety, environmental, or regulatory guidelines.

1. Temperature-Sensitive or Hazardous Items
   1. If the raw material requires cold chain or sub-ambient conditions, a specialized holding sub-area (e.g., a walk-in cooler or freezer) must be available. Mark these items “Hold—Refrigerated” until QA decides on final storage or quarantine movement.
   2. For hazardous chemicals or flammables, ensure they remain in well-ventilated, designated sections that meet local EHS codes. Keep flammable signage and distance from ignition sources if mandated by company policy or local law.
2. Controlled Substances
   1. Follow local regulatory guidelines (e.g., DEA in the US) for receiving controlled substances. Typically, these items require locked cages or vaults. The holding area for a controlled substance must also be restricted-access with logs to track who enters or exits.
   2. QA or Security may require immediate count verification and advanced label checks, skipping normal holding times if special regulations demand immediate quarantine or ID test for authenticity.
3. High Value or High Risk Materials
   1. For extremely high-cost items or potent compounds, the holding area might include extra security measures (cameras, locked enclosures). Warehouse managers ensure minimal staff handle these items, with sign-offs for each movement.
   2. QA can expedite or prioritize such shipments to minimize holding time, ensuring risk-based decisions are made swiftly (like early sampling or ID testing) to free up the holding area and keep operations moving effectively.

5.7 Continuous Improvement and Review

The holding area concept aims to streamline receiving, but it requires periodic reassessment to ensure ongoing GMP compliance and operational efficiency.

1. Periodic SOP Evaluations
   1. QA, Warehouse Management, and Procurement periodically review this SOP, especially if expansions or reorganizations occur. If recurring bottlenecks or space constraints appear in the holding area, update the layout or capacity guidelines.
   2. Changes in regulatory expectations or corporate policy might necessitate re-labelling instructions, new signage, or adjusting the maximum allowable dwell time in the holding area before forced quarantine or rejection.
2. Documentation Audits
   1. On a set schedule (e.g., monthly or quarterly), QA or designated staff check the holding area logs to ensure each material has either moved to quarantine or is properly documented if still on “Hold.” This prevents indefinite storage or lost containers leading to GMP violations.
   2. Any container left in the holding area beyond the standard timeframe (e.g., 72 hours) triggers an internal alert, prompting QA or Procurement to resolve the matter swiftly (e.g., obtaining missing docs, re-labeling, or final rejection).
3. Training and Staff Feedback
   1. Warehouse staff should be able to identify any improvement opportunities in how goods flow through the holding area (e.g., adding more racks, clarifying color-coded signage). They provide feedback to management or QA for potential updates to this SOP.
   2. QA can conduct refresher training if new staff come onboard or if internal audits reveal confusion about labeling or record updates. Ensuring everyone understands the holding area’s purpose and procedures fosters consistent GMP compliance.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• PO: Purchase Order
• EHS: Environment, Health, and Safety
• WMS: Warehouse Management System
• ERP: Enterprise Resource Planning

7. Documents

1. Raw Material Receiving Register (Annexure-1)
2. Purchase Orders (PO), Invoices, and Packing Lists
3. Supplier CoAs and any additional shipping docs (temperature logs, if relevant)
4. Deviation / Non-Conformance Reports (if applicable)
5. Company-Specific Procedures for Quarantine and Rejection (References)

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
• Internal SOPs on Quarantine, Rejection, and Disposition of Raw Materials
• Company-Specific EHS and Security Guidelines

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	Holding Status	Remarks
01/02/2025	ABC Chemicals	API A	A-2025-01	PO-98765	200 kg	In Holding	Awaiting QA Check
02/02/2025	XYZ Pharma	Excipient B	B-2025-05	PO-54321	100 kg	Moved to Quarantine	QA Approved Transfer

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 procedure for holding area usage before formal quarantine
01/02/2025	2.0	Enhanced Guidance	Standardization of Document	QA Head	All	All	Added special considerations for temperature-sensitive and hazardous materials, plus expanded labeling instructions