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SOP for Handling and Storage of Raw Materials

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SOP for Handling and Storage of Raw Materials

Standard Operating Procedure for Handling and Storage of Raw Materials

1) Purpose

The purpose of this SOP is to ensure proper handling and storage of raw materials used in the manufacturing of dental dosage forms to maintain their quality and prevent contamination.

2) Scope

This SOP applies to all raw materials used in the manufacturing of dental pastes, gels, and mouthwashes within the pharmaceutical industry.

3) Responsibilities

The Warehouse Department is responsible for the proper handling and storage of raw materials. The Quality Assurance (QA) Department is responsible for monitoring and ensuring compliance with the SOP.

See also  SOP for Homogenization Equipment

4) Procedure

4.1 Receipt of Raw Materials

4.1.1 Verify the identity and quality of raw materials upon receipt.

4.1.2 Check the packaging for integrity and any signs of damage.

4.1.3 Record the receipt of raw materials in the inventory log.

4.2 Handling

4.2.1 Use appropriate personal protective equipment (PPE) when handling raw materials.

4.2.2 Follow specific handling instructions provided by the manufacturer.

4.2.3 Minimize exposure to air, light, and moisture to preserve material integrity.

4.3 Storage

4.3.1 Store raw materials in designated areas with appropriate environmental controls (e.g., temperature, humidity).

4.3.2 Label all storage containers clearly with the material name, batch number, and expiration date.

See also  SOP for Gowning Procedures for Equipment Handling

4.3.3 Rotate stock using the First-In-First-Out (FIFO) method to ensure older

materials are used first.

4.4 Documentation

4.4.1 Maintain records of all raw materials, including receipt, handling, and storage details.

4.4.2 Conduct regular inventory checks to ensure accuracy and compliance.

5) Abbreviations, if any

PPE – Personal Protective Equipment

FIFO – First-In-First-Out

6) Documents, if any

Inventory Log

Material Receipt Records

7) Reference, if any

Current Good Manufacturing Practices (cGMP) guidelines

8) SOP Version

Version 1.0

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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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