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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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Revised SOPs for Raw Material Warehouse V 2.0

SOP for Unloading and Moving Raw Materials to the Quarantine Area – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to establish a systematic, GMP-compliant method for unloading raw materials from transport vehicles and transferring them to the quarantine area. Proper unloading and movement of materials are critical steps that help maintain product quality, prevent cross-contamination, and ensure compliance with regulatory standards. By adhering to this SOP, the organization can:

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Raw Material Warehouse V 2.0

SOP for Assigning Goods Receipt Note (GRN) Number to Received Materials – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to establish a clear and consistent method for assigning a Goods Receipt Note (GRN) number to incoming raw materials. A Goods Receipt Note serves as the official record of goods received against a specific Purchase Order (PO), documenting quantities, conditions, and any observed discrepancies. Proper GRN assignments help maintain a robust audit trail, support financial accuracy, and ensure seamless coordination among the Warehouse, Procurement, and Finance Departments. This SOP also provides guidelines to prevent duplicate entries, reduce errors in stock reconciliation, and enhance traceability throughout the material lifecycle.

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Raw Material Warehouse V 2.0

SOP for Checking Batch Number, Manufacturing Date, and Expiry Date at Receipt – V 2.0

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This Standard Operating Procedure (SOP) outlines the steps for verifying and documenting the batch number, manufacturing date, and expiry date of raw materials at the time of receipt. Accurate identification and confirmation of these details ensure that only materials meeting the company’s quality standards and shelf-life requirements enter production or storage. By adhering to this SOP, the organization complies with Good Manufacturing Practices (GMP), maintains product integrity, and upholds regulatory obligations. Additionally, it facilitates efficient inventory rotation (First-Expiry-First-Out or FEFO), prevents the risk of expired or unsuitable materials being used, and supports robust traceability in the event of recalls or deviations.

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Raw Material Warehouse V 2.0

SOP for Receiving and Handling of Controlled Substances in Raw Material Stores – V 2.0

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This Standard Operating Procedure (SOP) outlines a comprehensive method for the receipt and handling of controlled substances within the raw material stores. Controlled substances require stringent security measures, documentation, and regulatory compliance to prevent misuse, theft, or unauthorized access. By adhering to this SOP, the organization ensures compliance with national and international regulations governing controlled substances, upholds Good Manufacturing Practice (GMP) requirements, and maintains accurate records for audit readiness. Additionally, this SOP provides guidelines for safeguarding materials from contamination or mix-ups and implementing secure storage conditions that maintain product integrity.

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Raw Material Warehouse V 2.0

SOP for Sampling at Receiving Stage for Preliminary Inspection – V 2.0

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This Standard Operating Procedure (SOP) describes the preliminary sampling process for raw materials at the time of receipt. Preliminary sampling is intended to perform basic identification tests, check for physical integrity, and quickly screen for gross contamination or mismatch. By adhering to this SOP, the organization ensures that only compliant materials proceed to full quality testing or storage, minimizing the risk of using substandard or incorrect raw materials in production. This procedure also streamlines quarantine decisions, accelerates the resolution of obvious discrepancies, and maintains regulatory compliance.

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Raw Material Warehouse V 2.0

SOP for Physical and Visual Inspection of Incoming Raw Materials – V 2.0

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This Standard Operating Procedure (SOP) describes the process for conducting a detailed physical and visual inspection of all incoming raw materials. Physical and visual inspections are essential components of the receiving process, ensuring that materials are free from obvious damage, contamination, or labeling discrepancies before they enter the organization’s storage or manufacturing areas. By adhering to this SOP, the company ensures Good Manufacturing Practice (GMP) compliance, reduces the risk of using compromised or adulterated materials, and maintains a safe, efficient production environment. Regular and meticulous inspections uphold product quality, regulatory compliance, and internal standards by detecting early any anomalies that could affect final product integrity.

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Raw Material Warehouse V 2.0

SOP for Handling and Reporting Shortages in Raw Material Shipments – V 2.0

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This Standard Operating Procedure (SOP) sets forth a clear, GMP-compliant method for identifying, documenting, and resolving shortages in raw material shipments. A shortage occurs when the quantity of delivered materials is less than the quantity stated on the Purchase Order (PO) or indicated in the supplier’s shipping documents. By consistently following these guidelines, the organization can:

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Raw Material Warehouse V 2.0

SOP for Receiving Bulk Shipments of Raw Materials – V 2.0

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This Standard Operating Procedure (SOP) outlines the procedure for safely and effectively receiving bulk shipments of raw materials. Bulk shipments typically arrive in large containers—such as tankers, silos, totes, or super-sacks—requiring specialized handling and unloading equipment. By following these guidelines, the organization ensures that:

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Raw Material Warehouse V 2.0

SOP for Checking Raw Material Shipment against Approved Purchase Order (PO) – V 2.0

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This Standard Operating Procedure (SOP) outlines the method for verifying that incoming raw materials match the specifications and quantity stated in an approved Purchase Order (PO). Checking against the approved PO ensures that the correct material, batch number, and quantities are delivered, supporting accurate inventory management and upholding Good Manufacturing Practice (GMP) requirements. By following this SOP, the organization can minimize risks like receiving incorrect materials, incomplete shipments, or mislabeled products that could affect final product quality and regulatory compliance.

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Raw Material Warehouse V 2.0

SOP for Inspection of Double-Checked and Double-Bagged Raw Materials – V 2.0

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This Standard Operating Procedure (SOP) provides the method for inspecting raw materials that arrive with double-checked packaging and are double-bagged. Double-checked packaging typically signifies an additional layer of quality control performed by the supplier or an intermediary, while double-bagging offers extra protection against contamination, moisture, or damage. This SOP ensures that:

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Raw Material Warehouse V 2.0

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Standard Operating Procedures V 1.0

  • Aerosols
  • Analytical Method Development
  • Bioequivalence Bioavailability Study
  • Capsule Formulation
  • Clinical Studies
  • Creams
  • Data Integrity
  • Dental Dosage Forms
  • Drug Discovery
  • Environment, Health and Safety
  • Formulation Development
  • Gels
  • Good Distribution Practice
  • Good Warehousing Practices
  • In-Process Control
  • Injectables
  • Liquid Orals
  • Liposome and Emulsion Formulations
  • Lotions
  • Lyophilized Products
  • Maintenance Dept.
  • Medical Devices
  • Metered-Dose Inhaler
  • Microbiology Testing
  • Nanoparticle Formulation
  • Nasal Spray Formulations
  • Nebulizers
  • Ocular (Eye) Dosage Forms
  • Ointments
  • Otic (Ear) Dosage Forms
  • Pharmacovigilance
  • Powder & Granules
  • Purchase Departments
  • Quality Assurance
  • Quality Control
  • Raw Material Stores
  • Regulatory Affairs
  • Tablet Manufacturing
  • Rectal Dosage Forms
  • Transdermal Patches
  • Vaginal Dosage Forms
  • Validations and Qualifications

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NEW! Revised SOPs – V 2.0

  • Aerosols V 2.0
  • Analytical Method Development V 2.0
  • API Manufacturing V 2.0
  • BA-BE Studies V 2.0
  • Biosimilars V 2.0
  • Capsules V 2.0
  • Creams V 2.0
  • Elixers V 2.0
  • Ointments V 2.0
  • Raw Material Warehouse V 2.0
  • Tablet Manufacturing V2.0

New Publication: A must for All.

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