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SOP for Inspection and Testing of Incoming Raw Materials

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SOP for Inspection and Testing of Incoming Raw Materials

Standard Operating Procedure for Inspection and Testing of Incoming Raw Materials

1) Purpose

The purpose of this SOP is to establish procedures for the inspection and testing of incoming raw materials used in the manufacturing of dental dosage forms to ensure they meet quality standards and specifications.

2) Scope

This SOP applies to all incoming raw materials received for use in the production of dental pastes, gels, and mouthwashes within the pharmaceutical industry.

3) Responsibilities

The Quality Assurance (QA) Department is responsible for executing inspection and testing procedures. The Purchasing Department is responsible for coordinating with suppliers and ensuring compliance with this SOP.

See also  SOP for Equipment Decommissioning

4) Procedure

4.1 Receipt and Identification

4.1.1 Receive incoming raw materials in designated receiving areas and inspect accompanying documentation (e.g., packing list, certificates of analysis).

4.1.2 Verify material identification and quantity against purchase orders and specifications.

4.2 Visual Inspection

4.2.1 Conduct visual inspection of raw materials for any signs of damage, contamination, or discrepancies.

4.2.2 Reject any materials that do not meet visual inspection criteria or show signs of damage or tampering.

4.3 Sampling and Testing

4.3.1 Collect representative samples of raw materials for testing according to sampling plans and procedures.

4.3.2 Perform testing of samples using approved analytical methods and equipment to verify quality

parameters (e.g., identity, purity, potency).

See also  SOP for Periodic Review of Equipment Performance

4.3.3 Compare test results against established acceptance criteria and specifications.

4.4 Approval or Rejection

4.4.1 Record inspection and test results in designated quality control documents (e.g., batch records, testing logs).

4.4.2 Release approved materials for use in production or reject materials that do not meet specifications.

4.5 Storage and Handling

4.5.1 Store approved materials in designated storage areas under appropriate conditions (e.g., temperature, humidity).

4.5.2 Label materials with necessary identification and handling instructions.

4.6 Documentation

4.6.1 Maintain accurate records of all inspection, testing, and acceptance/rejection activities.

4.6.2 Archive documentation according to retention policies and regulatory requirements.

5) Abbreviations, if any

SOP – Standard Operating Procedure

See also  SOP for Inventory Management of Spare Parts

QA – Quality Assurance

6) Documents, if any

Material Inspection and Testing Records

Supplier Certificates of Analysis

Batch Records

7) Reference, if any

Current Good Manufacturing Practices (cGMP) guidelines

Pharmacopeial standards (e.g., USP, EP)

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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