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SOP on Raw Material Inspection Procedure

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1.0 Purpose:

The purpose of this Standard Operating Procedure (SOP) is to establish the procedure for inspecting raw materials before accepting them for use in the manufacturing process. This SOP aims to ensure that all incoming raw materials meet the required quality standards and specifications.

2.0 Scope:

This SOP is applicable to all personnel involved in the receipt, inspection, and acceptance of raw materials in the manufacturing process.

3.0 Responsibilities:

The following personnel are responsible for implementing and following the Raw Material Inspection Procedure:

– Procurement Manager – Responsible for ensuring that raw materials are procured from approved suppliers and that all quality requirements are met.

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– Quality Control Manager – Responsible for inspecting all incoming raw material and approving or rejecting them based on the quality standards.

– Warehouse Supervisor – Responsible for receiving the raw materials and coordinating with the Quality Control Manager for inspection.

4.0 Procedure:

1. Upon receipt of raw materials, the Warehouse Supervisor will verify if the materials match the purchase order and delivery note. Any discrepancies shall be reported immediately to the Procurement Manager.

2. The Quality Control Manager will undertake a visual inspection of the incoming raw materials to ensure that they are free from damage, contamination, or any other visible defects.

3. The Quality

Control Manager will obtain a sample for testing as per the applicable quality control plan. The location and size of the sample and the testing method will be as per the approved testing procedure.

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4. The Quality Control Manager will conduct the necessary tests based on specifications and standards, such as physical, chemical, and microbiological tests.

5. Based on the results of inspection and testing, the Quality Control Manager will approve or reject the raw material. Approved raw materials will be issued to the production department for use, while rejected materials will be stored separately and returned to the supplier, if necessary.

6. Inspection records will be maintained in the warehouse for a specified period as per the organization’s policies.

5.0 Documentation:

All raw material inspection information shall be documented on the appropriate forms and logs, which should include:

See also  SOP for Raw Material Record Keeping

– Date of receipt of raw materials
– Details of the supplier, Purchase order, and delivery note
– Results of visual inspection and quality tests done
– Signature of the Quality Control Manager approving or rejecting the raw materials

6.0 Conclusion:

This SOP will ensure all incoming raw materials are inspected and approved as per organizational quality standards. This procedure will also ensure that only quality raw materials are used in the manufacturing process, leading to high-quality finished products.

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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
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