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SOP for Raw Material Inspection for Creams

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SOP for Raw Material Inspection for Creams

Standard Operating Procedure for Raw Material Inspection for Creams

1) Purpose

The purpose of this SOP is to define the procedures for the inspection and acceptance of raw materials used in creams production to ensure they meet quality specifications and comply with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in the receipt, inspection, sampling, and testing of raw materials used in creams production within the pharmaceutical manufacturing facility. It covers procedures from receipt of materials to their release for use in production.

3) Responsibilities

It is the responsibility of the quality control (QC) department, procurement personnel, and production supervisors to follow this SOP. QC personnel conduct inspections and testing, procurement ensures proper documentation and handling of materials, and production supervisors verify material acceptance for use.

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4) Procedure

4.1 Receipt of Raw Materials

4.1.1 Receive raw materials in designated receiving areas with controlled environmental conditions.

4.1.2 Verify received quantities against purchase orders and shipping documents.

4.1.3 Notify procurement of any discrepancies in quantity or condition of received materials.

4.2 Initial Inspection

4.2.1 Perform initial visual inspection of raw materials for signs of damage, contamination, or packaging integrity issues.

4.2.2 Check for compliance with labeling requirements, including batch numbers, expiration dates, and supplier information.

4.2.3 Reject materials

that do not meet visual inspection criteria and initiate rejection procedures.

4.3 Sampling

4.3.1 Collect representative samples from each received lot based on sampling plans and procedures.

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4.3.2 Use appropriate sampling tools and techniques to ensure sample integrity and representativeness.

4.3.3 Label samples accurately with identification information and transfer them to the QC laboratory for testing.

4.4 Testing

4.4.1 Perform quality control tests on raw materials according to approved test methods and specifications.

4.4.2 Conduct tests such as identity testing, assay, impurities, microbial limits, and any other relevant tests based on material specifications.

4.4.3 Record test results accurately in designated test records or electronic systems.

4.5 Material Acceptance or Rejection

4.5.1 Evaluate test results against acceptance criteria defined in material specifications.

4.5.2 Accept materials that meet all specifications and release them for use in production.

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4.5.3 Reject materials that fail to meet specifications and initiate rejection procedures, including notification to suppliers.

5) Abbreviations, if any

QC: Quality Control

SOP: Standard Operating Procedure

6) Documents, if any

Raw Material Specifications

Purchase Orders and Shipping Documents

Inspection and Testing Records

7) Reference, if any

USP (United States Pharmacopeia) Chapter on Pharmaceutical Excipients

ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

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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