Standard Operating Procedure for Conducting Risk Assessments on Newly Procured Raw Materials

Department	Quality Assurance / Procurement / Quality Control
SOP No.	SOP/RM/024/2025
Supersedes	SOP/RM/024/2022
Page No.	Page 1 of 15
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a clear and systematic approach for conducting risk assessments on newly procured raw materials. As the pharmaceutical or life-science industry frequently onboards new raw materials from different suppliers, it is crucial to evaluate any potential risks they pose to product quality, regulatory compliance, and patient safety. These risk assessments help the organization:

• Identify potential hazards in material sourcing, handling, and usage.
• Implement preventative measures or additional testing to mitigate identified risks.
• Strengthen supplier management and oversight by employing a robust, data-driven review process.
• Maintain compliance with Good Manufacturing Practice (GMP) and other regulatory guidelines.

By following this SOP, the organization ensures that each newly introduced raw material is rigorously evaluated, properly documented, and ultimately integrated with minimal impact on existing processes.

2. Scope

This SOP applies to all newly procured raw materials received at the facility, including but not limited to active pharmaceutical ingredients (APIs), excipients, intermediates, chemicals, and specialized components. It covers:

• Initial review of supplier qualifications and documentation.
• Detailed risk assessment steps considering quality, safety, and regulatory factors.
• Implementation of risk control measures (e.g., additional testing, supplier audits, protective packaging) based on assessment outcomes.
• Documentation and retention of risk assessment results for audit and continuous improvement.

All personnel involved in Procurement, Quality Assurance (QA), Quality Control (QC), and Warehouse activities must be familiar with this SOP. It is relevant whenever the organization introduces a new raw material or a significant change (e.g., new grade, new manufacturing site) that necessitates a formal risk assessment.

3. Responsibilities

• Procurement Department:
  • Identify new raw materials and suppliers, obtaining relevant documents (e.g., Certificates of Analysis (CoAs), Safety Data Sheets (SDS), supplier audits, manufacturing flow charts) for the risk assessment.
  • Ensure the supplier is added to or updated on the Approved Vendor List (AVL) contingent on QA approval.
  • Coordinate with suppliers if further information is required (e.g., stability data, manufacturing process overviews).
• Quality Assurance (QA) Team:
  • Lead the risk assessment process, defining criteria for scoring or classifying potential hazards (e.g., chemical, microbial, regulatory).
  • Review and approve the final risk assessment conclusions, specifying any necessary controls or additional tests.
  • Oversee the final acceptance or rejection of newly introduced raw materials, ensuring compliance with GMP.
  • Maintain records of all risk assessment activities for traceability and audits.
• Quality Control (QC) Team:
  • Provide scientific input on material properties, potential testing requirements, and laboratory capabilities to address identified risks.
  • Conduct recommended tests (e.g., expanded impurity profiles, microbial checks, heavy metals screening) if the risk assessment concludes they are necessary.
  • Communicate test outcomes to QA for final decision-making on risk acceptance or mandatory mitigations.
• Warehouse Personnel:
  • Implement any special handling or segregation measures indicated by the risk assessment (e.g., temperature controls, separate quarantine areas, protective labeling).
  • Record the raw material arrival and initial condition in the Raw Material Receiving Register (Annexure-1), referencing any risk-based instructions from QA.

4. Accountability

The QA Manager is accountable for ensuring this SOP is consistently applied and for authorizing the final disposition (acceptance, partial acceptance with controls, or rejection) of the new material. The Procurement Manager ensures that necessary supplier and material information is gathered upfront, and the QC Manager manages any lab tests requested by QA. Warehouse Management is responsible for implementing risk-based handling and storage instructions.

5. Procedure

5.1 Initiating the Risk Assessment

The process begins when Procurement identifies a new raw material or a significant change in an existing material (e.g., new manufacturer, revised grade). QA then initiates the formal risk assessment.

1. Material Identification
   1. Procurement lists the material name, grade, manufacturer, intended use, and potential classification (e.g., hazardous chemical, sterile excipient). Provide any existing CoA, SDS, or pre-qualification documents from the supplier.
   2. QA reviews this initial data to categorize the material into a risk category (e.g., “High Risk” for sterile or potent compounds, “Medium Risk” for standard excipients, “Low Risk” for commonly used chemicals with proven supply history).
2. Supplier Qualification
   1. If the supplier is new or flagged for prior quality issues, QA may request an on-site audit or remote documentation check. Procurement ensures that the supplier is aware of the organization’s expectations and compliance requirements.
   2. Any outstanding audit findings or corrective actions from previous supply arrangements must be documented. High-risk or critical materials might require a more extensive qualification process, including sample testing before full shipment acceptance.
3. Risk Assessment Plan
   1. QA determines the scope of the risk assessment. Factors include:
      • Material complexity (e.g., multiple steps in manufacturing or advanced processing).
      • Potential impact on final product quality or stability.
      • Regulatory classification (e.g., controlled substance, special environmental hazard).
      • History of supply chain issues, such as counterfeiting or adulteration risks.
   2. QA selects team members from Procurement, QC, and Warehouse if input is needed on packaging logistics, shipping conditions, or advanced testing capabilities.

5.2 Gathering Information and Preliminary Checks

QA compiles all relevant data about the new raw material to perform an informed evaluation. This includes manufacturing details, supplier reliability, and prior usage data (if any).

1. Supplier-Provided Documents
   1. Procurement confirms receipt of an updated CoA, SDS, and any other technical files from the supplier (e.g., allergen statements, BSE/TSE declarations, if applicable).
   2. Check that the CoA references the correct batch/lot number and test methods, verifying these methods are acceptable to the organization’s QC department.
2. Internal Reference Standards
   1. QC or QA reviews any existing monographs or pharmacopeial references for the raw material. Compare the typical specification ranges with those stated by the new supplier. Large discrepancies in expected results raise red flags.
   2. If the organization already uses a similar raw material from another source, reference the historical data or in-house quality specification to gauge potential differences (e.g., color, granule size) that could affect production processes.
3. Supplier Reliability and Performance
   1. Check the supplier’s track record—any prior deviations, shipping delays, or repeated minor labeling errors might indicate a moderate risk. A new supplier with no proven record is automatically classified as higher risk until proven stable.
   2. Review the Approved Vendor List (AVL) to confirm the supplier’s current status, any conditions for temporary or probationary approval, and if they were recommended by a reliable partner or third-party audit.

5.3 Performing the Formal Risk Assessment

QA leads a structured evaluation, assessing each dimension of potential risk: material properties, supplier reliability, manufacturing process, and regulatory considerations.

1. Risk Factors and Scoring
   1. Develop or use an existing risk matrix with criteria such as:
      • Probability of hazard occurrence (e.g., contamination, labeling errors).
      • Severity of impact on product quality or safety (e.g., possible cross-contamination, introduction of allergens).
      • Detectability (likelihood that QC tests will catch the issue before product release).
   2. Assign a numeric score or qualitative rating (low, medium, high) to each factor. Summarize the overall risk level and highlight critical hazards that demand immediate attention or controls.
2. Material Handling and Process Compatibility
   1. Evaluate how the new raw material will integrate into existing manufacturing lines. Potential considerations:
      • Will new equipment or adaptors be required? (e.g., specialized bins or feeders for certain powders)
      • Does the material’s flowability or moisture sensitivity pose a new risk to blending or compression steps?
   2. Identify any extra validation or cleaning requirements to prevent cross-contact in multi-product facilities. If the raw material is a known allergen or a potent compound, advanced containment or cleaning steps might be required.
3. Regulatory and Stability Concerns
   1. Check whether the new material is subject to special regulatory conditions (e.g., restricted use, cold-chain logistics). If so, ensure the facility meets or can meet these conditions (temperature, humidity, special storage times).
   2. Review stability data. Some materials degrade quickly or can form dangerous byproducts if not stored properly. Factor this into the risk score—materials requiring rigorous temperature controls or short shelf-life might be higher risk.

5.4 Implementing Risk Control Measures

Based on the risk assessment outcomes, QA may define additional measures or restrictions to mitigate identified hazards, ensuring safe integration of the new raw material.

1. Supplier Controls
   1. If a moderate or high risk is linked to supplier reliability, Procurement coordinates with the vendor to reinforce packaging seals, labeling clarity, or shipping conditions (e.g., temperature monitors). QA might request more frequent CoA verifications or external lab testing.
   2. For particularly high-risk materials, QA can require supplier audits or provide detailed packaging guidelines to reduce contamination or labeling mishaps.
2. Receiving and Storage Modifications
   1. Warehouse Personnel follow new or more stringent protocols for receiving, such as performing a partial or full container count, immediate sampling for ID tests, or a separate quarantine area if cross-contamination is a concern.
   2. Store the material in a temperature- or humidity-controlled environment if recommended by the risk assessment. Implement color-coded or labeled racks to alert staff to special handling needs.
3. Enhanced Testing at QC
   1. QC might add new test parameters or increase sampling frequency for early batches from the new supplier. This ensures consistent quality and detects unexpected impurities or adulteration in time.
   2. QA can adjust the skip-lot strategy (if employed) so that initial shipments face 100% testing, eventually relaxing if repeated shipments meet all specs without deviations.

5.5 Documentation and Final Approval

Thorough records preserve the rationale behind risk classification, selected controls, and acceptance or rejection decisions. Proper traceability supports audits and future reviews.

1. Risk Assessment Report
   1. QA compiles a written or electronic report summarizing:
      • Material description, supplier background, and intended use in production.
      • All identified risks, with assigned severity and probability ratings.
      • Chosen risk control measures, referencing any additional testing or packaging changes.
      • Deadlines or follow-ups for verifying the effectiveness of these controls.
   2. QA and Procurement sign off on the final report. The document is stored according to company retention policies, typically 5–7 years or as mandated by local regulations.
2. Raw Material Receiving Register and WMS Entry
   1. Upon arrival, Warehouse updates the Raw Material Receiving Register (Annexure-1) with references to the risk category or relevant instructions (“High Risk—Test Immediately” or “Medium Risk—Standard Quarantine”).
   2. Maintain an entry in the WMS or ERP system noting any extra steps. Example: “Material X from Supplier Y: High Risk—Mandatory ID test for each batch.”
3. Final Acceptance and Release
   1. Following completion of recommended testing or controls, QA issues final approval to use the new raw material in manufacturing. The Warehouse then moves it from “Quarantine” to “Approved Storage,” labeling it as per normal SOP guidelines.
   2. If the risk assessment or test results indicate the material is unsafe or non-compliant, QA rejects the shipment. Procurement arranges return or disposal, and the rejection rationale is documented thoroughly.

5.6 Ongoing Monitoring and Reassessment

Risk assessments can be revised over time, especially if significant changes occur in the supplier’s process, the facility’s usage of the material, or regulatory updates.

1. Periodic Review
   1. QA sets a schedule for reviewing high-risk materials, especially after a set number of batches or months of satisfactory performance. If no issues arise, QA may downgrade them to a lower risk status, relaxing certain controls.
   2. Conversely, if new hazards emerge or test failures occur, QA upgrades the risk status and intensifies testing or demands further supplier audits.
2. CAPA for Emerging Issues
   1. If repeated minor deviations pop up (labeling errors, partial shipping mix-ups), a CAPA plan might address potential process weaknesses. For example, adjusting forklift or handling procedures, revising sampling frequency, or re-training staff on container checks.
   2. Procurement assists QA by contacting the supplier with concerns, ensuring they address the root causes (e.g., packaging lines, sealing issues) in their environment.
3. Regulatory and Internal Policy Updates
   1. If new regulations impose stricter standards for a raw material or production step, QA reopens the risk assessment to incorporate those requirements. Additional testing or supplier verifications might be mandated.
   2. Communicate changes to Warehouse, QC, and Procurement so they can adjust procedures, reorder strategies, or storage capacities as required.

5.7 Deviation and Non-Conformance Handling

If any misalignment occurs between planned risk controls and actual events (e.g., missing tests, incorrectly followed quarantine rules), a formal deviation or non-conformance record is opened.

1. Reporting Deviations
   1. Warehouse, QA, or QC staff noticing unapproved short-cuts, labeling changes, or missed risk-based tests raise a deviation ticket. The reference to the material’s risk assessment helps track if the recommended measures were bypassed.
   2. QA leads the investigation, determining whether the short-cut introduced real risk to product safety or final product compliance.
2. Root Cause Analysis and Corrective Actions
   1. If the deviation stems from insufficient training or unclear instructions, QA updates SOP language or organizes re-training sessions. If a supplier consistently fails to adhere to certain packaging or labeling instructions, Procurement might re-negotiate or delist them from the AVL.
   2. Log the outcome in the deviation record, implementing CAPA steps for future shipments and ensuring no repeated breakdowns occur in risk management.
3. Closure and Records
   1. Once all corrective actions are verified and no further vulnerabilities remain, QA closes the deviation. Keep the final documentation accessible for regulatory audits or internal reviews.
   2. Summaries of significant risk-related deviations can feed into annual product quality review processes, improving overall risk awareness across the facility.

6. Abbreviations

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

7. Documents

1. Raw Material Receiving Register (Annexure-1)
2. Sampling Log (Annexure-2)
3. Purchase Orders (PO), Supplier Invoices, and Shipping Documents
4. CoAs, SDS, Audit Reports from Supplier
5. Deviation / Non-Conformance Reports (if required)
6. Risk Assessment Forms or Templates

8. References

• 21 CFR Part 211 – Current GMP for Finished Pharmaceuticals (US FDA)
• EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
• ICH Q9 – Quality Risk Management
• Company-Specific Quality, Procurement, 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	Risk Category	Remarks
01/02/2025	ABC Chemicals	API-X	X-98765	PO-12345	100 kg	Medium	Risk Assessment Pending
02/02/2025	XYZ Pharma	Excipient-Y	Y-2025-001	PO-67890	150 kg	High	New Supplier, Additional Testing Required

Annexure-2: Sampling Log

Date	Material Name	Batch Number	Sampling Personnel	QC Test Performed	Result	Remarks
01/02/2025	API-X	X-98765	John Doe	Extended ID Test	Pass	Risk Assessment Recommendation
02/02/2025	Excipient-Y	Y-2025-001	Jane Smith	Heavy Metals, Impurity Profile	Pending	Initial Data for Risk Mitigation

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 framework for risk assessment on new raw materials
01/02/2025	2.0	Refined Risk Scoring Methods	Standardization of Document	QA Head	All	All	Added structured approach to vendor qualification, expanded sampling recommendations