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SOP on Raw Material Cleaning Procedure

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1. Purpose:

The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for cleaning and sanitizing raw materials used in the manufacturing process.

2. Scope:

This SOP is applicable to all raw materials received and used in the manufacturing process.

3. Responsibilities:

The Quality Control (QC) department is responsible for implementing the cleaning procedure and ensuring the effectiveness of the cleaning process. The Production department is responsible for ensuring that all raw materials received are cleaned and sanitized before use.

4. Procedure:

4.1. Inspection of Raw Materials

Raw materials received should be inspected visually for any signs of damage, discoloration, or contamination before cleaning. Any contaminated or damaged raw materials should be rejected and disposed of in accordance with established procedures.

See also  SOP for Raw Material Dispensing Procedure

4.2. Cleaning Procedure

i. Gather cleaning equipment and materials, including cleaning solutions, disinfectants, and protective gear.

ii. segregate the raw materials according to their category or type.

iii. Remove any excess dirt, debris, or packaging from the raw materials.

iv. Rinse the raw materials with water to remove any loose or adhering particles.

v. Soak the raw materials in a cleaning solution or disinfectant, depending on the material type and nature.

vi. Scrub the raw materials with a soft bristle brush or cloth to remove any stubborn dirt or grime.

vii. Rinse

the raw materials thoroughly with clean water to remove all the cleaning solutions.

See also  SOP on Raw Material Sampling Plan Procedure

viii. Sanitize the raw materials with a disinfectant or sanitize water, depending on the material type and nature.

ix. Dry the raw materials in a clean and controlled environment.

4.3. Recording and Documentation

Record all the cleaning activities and make sure they are well documented in the relevant documentation.

5. References:

ISO 9001:2015, ISO 22000:2018, cGMP, HACCP Manual.

6. Attachments:

Nil.

7. Revision History:

Rev. No. Date of Revision Details of Revision Revised By

1 [Date] This is the initial version. [Name]
2 [Date] Updated with changes suggested by quality assurance. [Name]

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
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  • Good Distribution Practice
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  • Powder & Granules
  • Purchase Departments
  • Quality Assurance
  • Quality Control
  • Raw Material Stores
  • Regulatory Affairs
  • Tablet Manufacturing
  • Rectal Dosage Forms
  • Transdermal Patches
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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

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