SOP for Checking Compliance with Good Distribution Practices (GDP) at Receipt – V 2.0

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SOP for Checking Compliance with Good Distribution Practices (GDP) at Receipt – V 2.0

Standard Operating Procedure for Checking Compliance with Good Distribution Practices (GDP) at Receipt

Department Quality Assurance / Supply Chain
SOP No. SOP/RM/007/2025
Supersedes SOP/RM/007/2022
Page No. Page 1 of 14
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

This Standard Operating Procedure (SOP) establishes guidelines for ensuring compliance with Good Distribution Practices (GDP) at the point of raw material receipt. Adherence to GDP principles is vital to protect product integrity, maintain a robust supply chain, and meet regulatory requirements. By applying GDP controls during receiving operations, the organization can mitigate risks associated with temperature excursions, contamination, or mishandling in transit. Furthermore, consistent GDP checks strengthen traceability and documentation, which underpin high-quality operations and instill confidence in both regulators and consumers.

2. Scope

This SOP covers all aspects of receiving raw materials that are subject to Good Distribution Practices. It applies to every shipment, whether local or international, and includes active pharmaceutical ingredients (APIs), excipients, intermediates, and packaging materials critical to final product quality. The procedure integrates checks for temperature control, documentation accuracy, labeling, and product condition to comply with GDP guidelines. It involves personnel within Supply Chain, Quality Assurance (QA), Warehouse Operations, and any other relevant stakeholders responsible for overseeing the logistics and distribution channels for incoming goods.

3. Responsibilities

  • Warehouse Personnel:

    • Receive shipments and verify that incoming materials adhere to GDP requirements such as correct labeling, suitable containers, and intact seals.
    • Check temperature-controlled deliveries (e.g., cold chain shipments) for any evident excursions by reviewing data logger or temperature indicator records.
    • Record receiving information in the Raw Material Receiving Register, ensuring documentation completeness and accuracy.
    • Notify Quality Assurance if any deviations from GDP standards are detected, such as compromised packaging or missing transport records.
  • Quality Assurance (QA) Team:

    • Define and update GDP-related SOPs and acceptance criteria for incoming materials.
    • Review documentation (e.g., Certificates of Analysis, Temperature Data Logger printouts, shipping records) to ensure compliance with GDP guidelines.
    • Investigate and document deviations or non-conformances, including temperature excursions, damaged packaging, or missing distribution records.
    • Authorize final release or rejection of materials based on the outcome of GDP checks and overall compliance.
  • Supply Chain Department:

    • Coordinate with vendors and logistics service providers to establish and maintain GDP-compliant transport conditions (e.g., temperature ranges, humidity controls, packaging specifications).
    • Ensure that Purchase Orders (POs) incorporate GDP requirements and that shipping documents reflect accurate product handling instructions.
    • Collaborate with QA to address any repeated distribution issues and implement corrective actions or vendor improvements as needed.
  • Procurement Department:

    • Work with approved suppliers who can demonstrate compliance with GDP through relevant certifications and documented procedures.
    • Obtain all necessary shipping and regulatory documentation (e.g., Good Distribution Certificates, CoAs, SDS) before dispatch.
    • Notify Warehouse and QA if there are known potential distribution risks with certain shipments (e.g., extended transit times, special storage requirements).
  • Quality Control (QC) Team (If Applicable):

    • Provide guidance on sampling and testing if the distribution conditions could have compromised material quality (e.g., moisture or microbial contamination risk due to poor handling).
    • Support QA in verifying that distribution-related parameters (e.g., temperature labels) align with the product’s critical quality attributes.
    • Perform additional tests if GDP deviations are suspected to confirm material integrity or to validate disposal decisions.

4. Accountability

The Head of Quality Assurance (or an equivalent authorized person) retains ultimate accountability for verifying that this SOP is correctly implemented and updated in accordance with evolving GDP guidelines. The Warehouse Manager is responsible for day-to-day adherence to GDP standards at the receiving dock, while Procurement and Supply Chain ensure upstream compliance from approved vendors. Any deviations must be escalated to QA for documentation and resolution, following internal corrective and preventive action (CAPA) procedures.

See also  SOP for Acceptance Criteria for Receiving of Raw Materials - V 2.0

5. Procedure

5.1 Pre-Receipt Preparations

Before any shipment arrives, relevant personnel should have access to key information regarding the product’s GDP requirements. This involves prior communication with suppliers and transporters to ensure correct packaging, storage, and handling instructions are in place.

  1. Documentation Review

    1. Procurement and Supply Chain must provide any known transport or temperature requirements specified in the Purchase Order. This includes the recommended storage range (e.g., 2°C to 8°C for cold chain, or controlled room temperature for other items).
    2. Warehouse Personnel verify that they have the relevant documentation—such as shipping manifests, CoAs, and transport condition records—available for reference before the shipment arrives.
  2. Equipment and Area Readiness

    1. Confirm the availability and functionality of equipment like forklift trucks, temperature probes, or data loggers needed for immediate checks upon receipt.
    2. Clear the receiving area of any obstructions or unrelated materials to prevent cross-contamination and maintain proper GMP/GDP standards.
    3. If the shipment includes temperature-controlled items, ensure that refrigerated or frozen storage units are prepared and set to the correct operating temperatures.
  3. Risk Evaluation

    1. If the product is classified as high-risk (e.g., biologics, labile materials), QA may require an enhanced inspection protocol or sampling plan. Communicate these requirements to Warehouse personnel ahead of time.
    2. Review the supplier’s GDP history. If past shipments have shown repeated issues with temperature maintenance or incomplete paperwork, be prepared for a more thorough receipt inspection.

5.2 Receipt and Visual Inspection

Once the consignment arrives, Warehouse Personnel perform an initial inspection to confirm that it meets GDP requirements, focusing on temperature-sensitive indicators, packaging integrity, labeling accuracy, and correct product identification.

  1. Delivery Vehicle Check

    1. Inspect the exterior of the delivery vehicle for signs of damage, tampering, or conditions that could indicate poor handling (e.g., unsealed doors, presence of spilled chemicals).
    2. For temperature-sensitive shipments, confirm that the vehicle’s refrigeration unit is running (if applicable) and check the temperature gauge or data logger attached to the cargo area for correct temperature range.
  2. Documentation Cross-Check

    1. Match the number of boxes, pallets, or containers with the shipping manifest or packing list. Significant discrepancies must be reported to QA and Procurement immediately.
    2. Review any accompanying temperature or humidity logs provided by the transporter. If the logs show readings outside the established limits, flag the shipment for QA review and quarantine.
  3. Packaging and Labeling Verification

    1. Examine cartons, crates, or drums for visible damage (punctures, watermarks, broken seals). If seals are broken, record the observation in the receiving register for QA to investigate.
    2. Ensure labels include the correct product name, batch number, and any hazard symbols as required by GDP guidelines (e.g., temperature labeling for cold chain items, flammability labels, or other relevant hazard indicators).
  4. Immediate Temperature Check

    1. If the shipment is temperature-controlled, use calibrated infrared thermometers or data logger readouts to spot-check the internal temperature of containers upon opening. Note any deviations.
    2. Keep a record of these spot-checks, as QA may require them for further analysis or for evidence in the event of a temperature excursion claim with the supplier or transporter.

5.3 Quarantine and Documentation Verification

After the initial inspection, materials that pass the basic GDP checks may proceed to quarantine for further evaluation, including full document verification and possible QC sampling. If major discrepancies are noted, the consignment is quarantined until QA decides on the next steps.

  1. Quarantine Labeling

    1. Affix “Quarantine” labels to each container, noting the date, product name, and batch number. For temperature-sensitive items, store them in the appropriate temperature-controlled area with restricted access.
    2. Segregate any shipments with suspect temperatures or packaging in a designated area for further investigation. Clearly mark these as “On Hold for QA” to prevent unauthorized use.
  2. Document Validation

    1. Verify the Certificate of Analysis (CoA), ensuring the batch numbers match the labels on the containers and that the document is signed by the supplier’s authorized representative. Confirm the CoA date aligns with the product’s manufacturing date or re-test date, if applicable.
    2. Check for additional GDP documentation, such as distribution records or chain-of-custody forms indicating the product’s movement from the manufacturing site to the receiving warehouse. If these records are missing, QA must be informed for a risk assessment.
    3. Procurement or Supply Chain should provide any known temperature transit data or shipping validations relevant to the product’s recommended storage conditions (e.g., a shipping validation report for a product requiring 2°C–8°C). Compare these data with the actual conditions recorded during transit.
  3. Receiving Register Entry

    1. Complete or update the Raw Material Receiving Register (Annexure-1) with any significant findings, such as a new temperature reading, packaging anomalies, or missing documents.
    2. All relevant remarks—like “Minor tear in the outer box,” “Temperature logger indicates 15°C at time of receipt,” or “Seals intact”—must be included to build a traceable record. Warehouse Personnel sign or initial each entry to maintain accountability.
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5.4 Additional QC or QA Evaluations

Under GDP, materials showing potential distribution-related deviations (e.g., temperature excursions or questionable handling conditions) may need special testing or QA evaluation to ensure they remain within specification. This step is crucial for verifying product quality and ensuring compliance with local and international regulations.

  1. Enhanced Sampling Process

    1. If the product’s stability profile is significantly affected by temperature (e.g., biologics, certain APIs), QC might perform additional tests (potency assays, degradation product analysis) to confirm the item is still within specification.
    2. Document the sampling activities in the Sampling Log (Annexure-2), noting any special instructions from QA that address suspected GDP violations (e.g., “Sample extra units from the container showing high temperature reading”).
  2. Deviation Investigation

    1. In the event of a confirmed or suspected GDP breach (like a multi-hour temperature excursion or seal tampering), QA opens a deviation record. The record details the findings, potential impact on quality, and immediate corrective actions taken (like quarantine or testing).
    2. Supply Chain or Procurement may contact the transporter or supplier to gather more data about the shipping environment, request updated shipping validations, or negotiate returns if the material is compromised.
  3. Risk Assessment and CAPA

    1. QA leads a risk assessment, possibly in collaboration with QC and Supply Chain, to determine if the product can be salvaged or must be rejected. Factors include time out of temperature range, type of packaging, product susceptibility to thermal degradation, and test results.
    2. If corrective or preventive actions are needed (e.g., improved shipping containers, revised shipping routes), QA documents these in a CAPA plan and assigns responsibilities and deadlines.

5.5 Final Release or Rejection

Once all GDP checks, QC analyses, and documentation verifications are completed, QA authorizes a final decision about whether the incoming materials can be integrated into the inventory or must be rejected.

  1. Approval for Use

    1. If the materials meet GDP standards and in-house specifications, QA signs off on the release, and Warehouse Personnel affix “Approved” labels on the containers. The inventory management system is updated accordingly, moving the stock from “Quarantine” to “Approved.”
    2. Any special storage instructions (e.g., keep refrigerated, protect from light) must be prominently indicated in the warehouse management system and on container labels where applicable.
  2. Conditional Release

    1. Occasionally, QA may conditionally release a batch under enhanced monitoring if the GDP deviation is minor or can be remediated. For instance, if a temperature excursion was minimal and test results still confirm quality, QA might require frequent temperature checks or re-testing within a shorter retest interval.
    2. These conditions must be documented in an internal memo, ensuring Warehouse and QC are aware of the heightened oversight for that specific batch.
  3. Rejection and Disposal

    1. If GDP deviations are severe (e.g., extended temperature excursions, major contamination), QA instructs Warehouse Personnel to mark the goods as “Rejected.” The material is segregated in a designated reject area, pending return to the supplier or authorized disposal.
    2. All rejection details, including reason codes, relevant data loggers, photos, or test results, are attached to the batch record. Procurement liaises with the supplier regarding claims, credits, or replacements as per contractual agreements.
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5.6 Record-Keeping and Archiving

Thorough documentation is integral to GDP compliance. Accurate, retrievable records help demonstrate the integrity of goods at each stage of the distribution chain and provide evidence for audits or inspections.

  1. Raw Material Receiving Register

    1. Record all key data—shipment details, temperature checks, packaging observations—in the Raw Material Receiving Register (Annexure-1). Ensure each entry is dated, signed, and references any relevant PO or lot numbers.
    2. Update the register in real time or on the same day to maintain chronological accuracy, preventing data gaps or confusion.
  2. Sampling Log

    1. QC personnel maintain the Sampling Log (Annexure-2) for all test samples drawn from suspect or standard shipments. The log must include date, product name, batch number, and test results or references to laboratory reports.
    2. Ensure traceability by linking the sample ID in the log with the corresponding container or pallet ID. This link is essential for investigating any out-of-specification results or distribution issues.
  3. Deviation and CAPA Records

    1. Major distribution deviations must be captured in the deviation system, complete with root cause analyses, immediate containment measures, and assigned CAPA tasks. Timely documentation supports a strong GDP audit trail and fosters continual improvement.
    2. Maintain these records for the timeframe mandated by local regulations or internal policies (commonly 5 to 7 years), ensuring they are retrievable during inspections by health authorities or clients.
  4. Electronic Systems and Data Integrity

    1. If using electronic data logging for temperature or humidity, ensure the system meets data integrity guidelines (e.g., 21 CFR Part 11) with secure access controls, audit trails, and robust backup procedures.
    2. Regularly validate or calibrate electronic temperature monitoring devices to confirm accuracy, maintaining documentation of calibrations for audit references.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • GDP: Good Distribution Practice
  • QA: Quality Assurance
  • QC: Quality Control
  • PO: Purchase Order
  • CoA: Certificate of Analysis
  • SDS: Safety Data Sheet
  • CAPA: Corrective and Preventive Action
  • OOS: Out of Specification
  • GHS: Globally Harmonized System of Classification and Labeling of Chemicals
  • AVL: Approved Vendor List

7. Documents

  1. Raw Material Receiving Register (Annexure-1)
  2. Sampling Log (Annexure-2)

8. References

  • WHO Technical Report Series, No. 957, 2010 – Annex 5: WHO Good Distribution Practices for Pharmaceutical Products
  • EU GDP Guidelines (2013/C 343/01)
  • 21 CFR Part 211 – Current Good Manufacturing Practice (US FDA)
  • ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
  • Company-specific GDP and GMP 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 GDP Check PO Number Remarks
01/02/2025 ABC Pharma Supply API Alpha Batch A123 Compliant PO-10001 No Temperature Excursion
02/02/2025 Global Distributors Ltd. Excipient Z Lot EZ-098 Deviation PO-10002 Suspected Seal Tampering

Annexure-2: Sampling Log

Date Material Name Batch Number Sampling Personnel QC Test Performed Result
02/02/2025 API Alpha Batch A123 Jane Doe Assay, Identification Pass
03/02/2025 Excipient Z Lot EZ-098 John Smith Impurity Profile Pending

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 baseline procedures for GDP at receipt
01/02/2025 2.0 Expanded Guidance Standardization of Document QA Head All All Included enhanced steps for temperature checks and GDP deviations
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