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SOP for Raw Material Record Keeping

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Purpose:
The purpose of this Standard Operating Procedures (SOP) for Raw Material Record Keeping is to outline the procedures for recording and logging of raw materials information.
Scope:
This SOP applies to all personnel involved in receiving, inspecting, and storing of raw materials.
Responsibility:
The quality assurance team shall ensure the implementation and maintenance of this SOP. The members of the production team shall be responsible for conducting RAW materials inspection and entering respective data in the records.
Procedure:
1. Receiving and Inspection Procedure
1.1 The receiving personnel shall verify the identity of the raw materials as per the purchase order.
1.2 Upon receipt of the raw materials, the personnel shall inspect for any damage and check for temperature, appearance, and odor of all raw materials.
1.3 The personnel shall also check the label informative details against the purchase order, such as batch number, expiry date, and storage condition.
2. Storage Procedure
2.1 The received raw materials shall proceed to the quarantine area.
2.2 The personnel shall ensure that the storage area meets the specified storage requirements for raw materials based on the product label.
2.3 The personnel shall place the material in the designated area based on FIFO (First In, First Out)
2.4 The personnel shall take RFQ (Request for Quality Analysis) samples from the received material and store them in a separate area.
3. Data / Records Entry
3.1 The data entry personnel must verify the data of each raw material in the Purchase Order.
3.2 The data entry personnel must create a record of the receipt of material, including the following information:
– Date of receipt
– Raw material name
– Batch Number
– Expiry/Re-test date
– Quantity received
– Supplier name
– Delivery note/invoice number
– Temperature
– Appearance
– Odor
3.3 “RFQ sample given” is marked “Yes” or “No” in the record.
3.4 Any observation made during receipt and inspection shall be noted with respective documentation to support.
3.5 In the case of discrepancies in the recorded data, the data entry personnel shall report these immediately to the quality assurance team leader.
4. Finalization And Review
4.1 The completed raw material records shall be signed by the responsible person, approved by the Quality Assurance Manager, and retained.
4.2 The raw material records shall be reviewed annually by the quality assurance team for their accuracy and compliance.
Conclusion:
The Raw Material Record Keeping Procedure will ensure that the raw materials are tracked, received, and documented correctly. It also assures that the quality and integrity of the received material are maintained throughout the whole process of storage and handling until final use.

See also  SOP for Raw Material Expiry Date Management Procedure
Raw Material Stores Tags:Efficient workflow in raw material stores, Quality control procedures for raw materials, Raw material SOP, Raw material store management, Raw material store SOP, SOP for raw material stores, SOP of raw material stores, Standard Operating Procedures for raw materials

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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
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  • Elixers V 2.0
  • Ointments V 2.0
  • Raw Material Warehouse V 2.0
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