Standard Operating Procedure for Receiving Raw Materials from Different Manufacturers of the Same API

Department	Warehouse / Quality Assurance / Procurement
SOP No.	SOP/RM/022/2025
Supersedes	SOP/RM/022/2022
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) details the method for receiving raw materials of the same Active Pharmaceutical Ingredient (API) from multiple manufacturers. Different manufacturers may present variations in packaging, labeling, or quality attributes, making it crucial to maintain stringent checks. By following this SOP, the organization ensures:

• Compliance with Good Manufacturing Practices (GMP) when handling and storing multiple batches of the same API from different vendors.
• Accurate documentation and segregation of each manufacturer’s batch to prevent mix-ups.
• Proper verification of materials against Purchase Orders (POs) and approved vendor criteria.
• Timely communication with Procurement and Quality Assurance (QA) about any discrepancies or manufacturer-specific concerns.

This procedure supports traceability and consistency in the production process, reducing the risk of cross-contamination and ensuring reliable product quality regardless of the API’s source.

2. Scope

This SOP applies to all raw materials, specifically the same API, arriving from multiple approved manufacturers for use in production. It covers:

• Verification of approved vendor status for each source manufacturer.
• Inspection and documentation of incoming batches, ensuring distinct identification and labeling for each manufacturer’s supply.
• Storage and segregation protocols to prevent unintended mixing of batches from different vendors.
• Communication channels for resolving discrepancies in labeling, documentation, or quality attributes across different manufacturers.

Warehouse personnel, QA, Quality Control (QC), and Procurement staff must adhere to this SOP whenever multiple manufacturers supply the same API to the facility.

3. Responsibilities

• Warehouse Personnel:
  • Receive and identify API materials from each manufacturer, verifying distinct batch numbers and labeling.
  • Record each batch in the Raw Material Receiving Register, linking it to the respective manufacturer and Purchase Order (PO).
  • Isolate or quarantine suspicious or mislabeled items until QA reviews them.
  • Follow storage guidelines to keep different manufacturers’ batches separate and clearly identified.
• Quality Assurance (QA) Team:
  • Approve manufacturers listed on the Approved Vendor List (AVL) and define specific acceptance criteria for each supplier if needed.
  • Review any deviations or non-conformances reported by Warehouse or QC when multiple manufacturer batches show labeling or quality discrepancies.
  • Authorize release or rejection of incoming materials based on compliance with GMP standards and internal quality specifications.
• Quality Control (QC) Team:
  • Perform sampling and testing on selected batches to confirm identity, purity, and compliance with relevant quality standards.
  • Compare test results across different manufacturers if variations in specifications are known or suspected, alerting QA to major differences.
• Procurement Department:
  • Ensure each manufacturer is properly approved before placing orders, adhering to company and regulatory criteria.
  • Update relevant POs with manufacturer-specific details and communicate any known changes in packaging or labeling to Warehouse and QA.
  • Manage supplier relations, addressing repeated or serious discrepancies in shipments from any manufacturer.

4. Accountability

The Warehouse Manager is responsible for ensuring each received batch of the API is distinctly accounted for, accurately labeled, and segregated by manufacturer. The QA Manager has final authority over accepting or rejecting shipments if a vendor or batch fails GMP or internal quality requirements. Any modifications to this SOP must be reviewed and approved by QA management.

5. Procedure

5.1 Pre-Arrival Preparations

Planning and awareness of each API source facilitates prompt, organized receiving and inspection.

1. Vendor Verification
   1. Procurement confirms each manufacturer of the API is on the Approved Vendor List (AVL). If a new manufacturer is introduced, QA must perform a vendor qualification process before shipments arrive.
   2. Review any manufacturer-specific instructions or known differences in labeling, packaging, or test specifications. Communicate these to Warehouse personnel in advance.
2. PO and Documentation Readiness
   1. Procurement provides POs clearly indicating which manufacturer is supplying each batch, expected quantity, and other relevant details (e.g., grade, potency).
   2. Gather necessary forms (e.g., Raw Material Receiving Register, relevant annexures, sampling logs) to record distinct manufacturer batches without confusion.
3. Area and Equipment Check
   1. Ensure the receiving area is ready with designated spots or shelves to place distinct manufacturer batches. Clearly label these sections to avoid mixing.
   2. Verify that forklift trucks, pallet jacks, or container trolleys are functioning. Maintain cleanliness to prevent cross-contamination when switching from one manufacturer’s batch to another.

5.2 Receiving Shipments from Different Manufacturers

Warehouse Personnel carefully offload and identify each batch upon arrival, referring to the PO to confirm the correct manufacturer and quantity.

1. Unloading and Label Verification
   1. Unload each container or pallet, referencing the PO. Confirm the manufacturer name or brand is as expected. Any container labeled with an unapproved manufacturer name must be quarantined immediately.
   2. Compare batch numbers and expiration or retest dates with the details on the PO. If no mismatch arises, proceed with standard inspection. If discrepancies appear, notify QA and segregate those containers.
2. Physical Inspection
   1. Check the packaging integrity—torn shrink-wrap, dented drums, or suspicious tampering could affect material safety. Mark suspect items “Hold” and alert QA for further assessment.
   2. Ensure manufacturer-specific labeling is present, especially if the organization expects certain design or text from a known brand. Missing brand-specific details might signal potential counterfeiting or non-conformance.
3. Cross-Referencing With PO and Supplier Documents
   1. Verify that the packing list or invoice indicates the correct manufacturer. If the PO references “Manufacturer X” but the shipment’s label reads “Manufacturer Y,” isolate the material and contact Procurement.
   2. Record key details (manufacturer name, batch number, quantity) in the Raw Material Receiving Register (Annexure-1), ensuring each line item is associated with the correct PO line. Include remarks for any anomalies.

5.3 Storage and Segregation by Manufacturer

Keeping different manufacturers’ API batches clearly separated prevents accidental mixing or usage confusion.

1. Dedicated Storage Zones
   1. Assign distinct storage areas or racks for each manufacturer, labeling them with the manufacturer’s name or code. If the same API from multiple vendors must be placed in one zone, separate them by clearly demarcated sections or shelves.
   2. Ensure these areas align with the required storage conditions (temperature, humidity) outlined for the API. Do not stack multiple manufacturers’ batches on top of each other without physical barriers or clear labeling.
2. Quarantine Protocol
   1. Until QA or QC performs any necessary sampling or standard release tests, store new batches in the quarantine area. Label them “Quarantine—[Manufacturer Name], Batch [Number].”
   2. Only once QA issues release approval should the batch move to the final designated area or be used in production. Maintain the distinction between each vendor’s batch throughout the storage life cycle.
3. Record Updates
   1. For each batch, log the storage location and date in the inventory management system or manual logs, referencing the manufacturer.
      • E.g., “Manufacturer X, Batch [Number], stored on Rack B, Shelf 3.”
   2. Sign off or digitally confirm each movement or location update. QA can then trace the exact location for any sampling or recall procedures if needed.

5.4 Quality Checks and Sampling

Different manufacturers might exhibit slight variations in API characteristics, requiring consistent testing and documentation to confirm each batch’s suitability.

1. QC Test Requirements
   1. Consult internal guidelines or monographs for each manufacturer’s batch. Some companies implement rigorous ID checks (FTIR, HPLC) for new or high-risk vendors, while trusted vendors may follow skip-lot or reduced testing protocols.
   2. QA confirms the sampling plan, specifying the frequency or type of tests needed (assay, impurity profile, microbial, etc.). If prior data from a manufacturer suggests consistent quality, QA may reduce sampling frequency, pending risk assessments.
2. Sampling Procedure
   1. QC staff follow the Sampling Log (Annexure-2) and relevant SOPs, ensuring the sample container is properly labeled with the manufacturer’s name, batch number, and date.
      • Take care not to mix equipment or utensils between different manufacturers’ batches.
   2. After sampling, re-seal the container and return it to the designated quarantine area if the final QC release is pending.
3. Data Comparison Across Manufacturers
   1. Where feasible, QC compares results (e.g., assay, impurity levels) for different manufacturers of the same API to check for outlier values or sudden variations that might indicate supply chain issues.
   2. Any anomalies, such as an unusually high impurity in one manufacturer’s batch, must be flagged for QA. Procurement may consult the vendor or request additional data to ensure no adulteration or process deviation occurred.

5.5 Handling Discrepancies

Even small divergences in packaging, labeling, or test outcomes may necessitate further evaluation to confirm no mix-ups or substandard quality.

1. Label or Documentation Mismatches
   1. If the delivered batch numbers or labeling format do not match the PO or expected style for that manufacturer, Warehouse Personnel notify QA. The suspect lot is quarantined pending QA’s verification or supplier response.
   2. Procurement addresses repeated documentation failures with the vendor, ensuring future shipments correctly identify the manufacturer and batch.
2. Quality Variations
   1. Should QC tests reveal major deviations from typical potency or impurity ranges for that manufacturer, QA may instruct further confirmatory analyses or hold the shipment entirely in quarantine.
   2. If no resolution is possible, or if the material is definitively substandard, QA rejects the batch. Procurement then arranges return or disposal, updating supplier performance records accordingly.
3. Deviation and Non-Conformance Reports
   1. Any critical mismatch leading to potential risk of product quality results in a deviation report. QA investigates root causes, referencing relevant manufacturer details, and implements Corrective and Preventive Actions (CAPA).
   2. Procurement and Warehouse collaborate to rectify process steps or revise SOPs if the mismatch was internal, or to escalate issues to the supplier if the problem originated externally.

5.6 Final Acceptance or Rejection

Once the specified checks are completed, QA issues a decision, ensuring each manufacturer’s batch meets the same high-quality standard.

1. QA Approval
   1. QA reviews test data (if required), label accuracy, and overall compliance with GMP and internal specifications. If satisfied, they release the batch for production or transfer to final storage, maintaining the manufacturer’s distinction in the inventory system.
   2. Upon acceptance, Warehouse updates the inventory status from “Quarantine” to “Approved,” referencing the manufacturer name. Mark any specific storage or retest intervals as advised by QA.
2. Rejection Criteria
   1. If QA or QC identifies major issues—incorrect labeling, test failures, or suspect adulteration—the entire batch is rejected. Label containers “Rejected—[Reason]” and store them in a segregated reject area.
   2. Procurement negotiates credit, replacement, or disposal with the supplier, referencing the manufacturer’s batch number in all communications. Keep a record of these negotiations in the batch file or ERP/WMS system.

5.7 Documentation and Ongoing Supplier Evaluation

Keeping thorough records and periodically reviewing supplier performance ensures consistent quality even when multiple sources are used for the same API.

1. Raw Material Receiving Register
   1. Complete the entries in Annexure-1 with final remarks (“Approved,” “Rejected,” or “Pending Additional Data”) plus any relevant QA notes. Sign or initial each entry for accountability.
   2. Attach relevant CoAs, test summaries, or deviation records for quick reference during audits or recalls.
2. Electronic Inventory Updates
   1. In the Warehouse Management System (WMS) or ERP, label each batch with the manufacturer’s name or code, making it easy to track multiple vendor supplies of the same API.
   2. Ensure all returns, rejections, or reorder data is recorded promptly so future orders reflect accurate manufacturer preference or stock levels.
3. Supplier Performance Review
   1. Procurement and QA periodically evaluate suppliers providing the same API, comparing metrics like on-time delivery, batch acceptance rates, quality test outcomes, or deviation frequency.
   2. Based on the review, suppliers with recurring issues may be removed from the AVL or assigned a more rigorous testing regime. Suppliers with consistent positive performance may receive reduced sampling or simpler approval steps.
4. CAPA and Continuous Improvement
   1. Any patterns of discrepancy or confusion arising from multi-manufacturer usage trigger a CAPA plan, refining labeling, storage processes, or receiving checklists.
   2. Review and update this SOP as needed to incorporate best practices for handling multiple manufacturer supplies of the same API, ensuring clarity for Warehouse, QA, and QC personnel.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• API: Active Pharmaceutical Ingredient
• PO: Purchase Order
• AVL: Approved Vendor List
• 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/testing occurs at receipt
3. Purchase Orders (PO), Supplier Invoices, Packing Lists
4. Certificates of Analysis (CoAs), SDS, and other manufacturer-specific QC documents
5. Deviation or Non-Conformance Reports (if applicable)
6. Supplier Communication Records (for alignment on labeling or specification differences)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice (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
• Approved Vendor List (AVL) Documentation

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	Manufacturer Name	API Name	Batch Number	PO Number	Quantity Received	Remarks
01/02/2025	ABC Distributors	Manufacturer X	API-A	A-12345X	PO-111111	100 kg	No Discrepancy
02/02/2025	XYZ Chemicals	Manufacturer Y	API-A	A-67890Y	PO-222222	90 kg	Minor Label Variation, QA Review

Annexure-2: Sampling Log

Date	API Name	Manufacturer Name	Batch Number	Sampling Personnel	QC Test Performed	Result	Remarks
01/02/2025	API-A	Manufacturer X	A-12345X	John Doe	ID, Assay	Pass	N/A
02/02/2025	API-A	Manufacturer Y	A-67890Y	Jane Smith	Assay, Impurities	Pending	Sample from separate manufacturer

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 multi-manufacturer API receiving
01/02/2025	2.0	Enhanced Storage and Labeling Steps	Standardization of Document	QA Head	All	All	Included additional guidance on comparing test results across manufacturers