Standard Operating Procedure
Meridian Pharma Manufacturing Ltd

SOP: Incoming Raw Materials Inspection and Release

SOP No: QA-RM-007 Version: 2.1 Effective: 1 February 2026
Purpose
This Standard Operating Procedure defines the process for receiving, inspecting, and releasing incoming raw materials and packaging components at the Meridian Pharma Manufacturing facility. The purpose is to ensure that all materials meet defined quality specifications before use in manufacturing operations and to maintain full traceability in compliance with GMP requirements.
Scope
This procedure applies to all active pharmaceutical ingredients (APIs), excipients, and primary and secondary packaging materials delivered to the Swindon manufacturing site. It applies to all personnel involved in goods receipt, quality control testing, and material release activities.
Definitions
GMP: Good Manufacturing Practice — regulatory guidelines governing the manufacture of pharmaceutical products. CoA: Certificate of Analysis — document provided by the supplier confirming test results for a specific batch. Quarantine: A temporary hold status applied to materials pending inspection and approval. Release: The act of approving a material batch for use in manufacturing following satisfactory QC testing. Deviation: Any departure from approved procedures or specifications.
Roles and Responsibilities
Warehouse Operative: Receives deliveries, performs initial count and visual inspection, applies quarantine labels, and updates the ERP system. Quality Control Analyst: Collects samples, performs or co-ordinates laboratory testing, and updates the LIMS with results. QC Supervisor: Reviews test results against specifications and authorises material release or rejection. Quality Assurance Manager: Approves deviations and oversees the overall integrity of the process.
Procedure
  1. Upon delivery, the Warehouse Operative verifies the delivery note against the purchase order in the ERP system. Any discrepancies in quantity, product code, or supplier must be recorded immediately and escalated to the QC Supervisor.
  2. The Warehouse Operative performs a visual inspection of all outer packaging for signs of damage, contamination, or tampering. Damaged or suspect items are segregated and a Non-Conformance Report (NCR) is raised.
  3. All accepted pallets and containers are labelled with a Quarantine sticker (yellow) and moved to the designated Quarantine area. No materials may leave the Quarantine area without QC authorisation.
  4. The Warehouse Operative creates a goods receipt record in the ERP system, recording batch number, quantity, supplier, and date of receipt.
  5. The QC Analyst collects representative samples in accordance with the approved sampling plan (refer to SOP QA-SP-003). Samples are transferred to the QC laboratory with a completed Sample Request Form.
  6. The QC Analyst performs identity, purity, and specification testing in accordance with the approved test method. The supplier's CoA is reviewed and compared against internal specifications.
  7. The QC Supervisor reviews all test results and the CoA. If all results comply with specifications, the Supervisor authorises release by updating the ERP status to "Approved" and replacing the Quarantine label with a green Released label.
  8. If any result falls outside specification, the QC Supervisor initiates a deviation and places the batch on formal Reject status. The warehouse team moves the material to the Reject area. The Purchasing team is notified to arrange return or disposal with the supplier.
  9. The QC Analyst files all records (test results, CoA, sample forms) in the batch record folder and archives a digital copy in the LIMS.
Quality and Safety Notes
All personnel handling raw materials must wear appropriate PPE as specified in the material Safety Data Sheet (SDS). Materials must never be moved from Quarantine without written QC authorisation. Verbal instructions are not sufficient. Cold-chain materials (storage below 8°C) must be inspected and transferred to temperature-controlled storage within 30 minutes of delivery. Temperature excursions must be reported immediately. Any suspected counterfeit or adulterated material must be quarantined immediately and the QA Manager and Responsible Person notified without delay.
Revision History
Version Date Author Summary of Changes
1.0 14 Mar 2023 A. Patel Initial issue.
2.0 9 Jan 2025 S. Okonkwo Updated sampling plan reference; added cold-chain handling requirements.
2.1 20 Jan 2026 S. Okonkwo Revised ERP steps to reflect system upgrade; added digital LIMS archiving step.
Approval
Approved by: Dr Sarah Okonkwo Title: Quality Assurance Manager Date: 20 January 2026
Approver Signature