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Vaginal Dosage Forms: SOP for Ring Forming Tool

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SOP for Ring Forming Tool

Operation and Maintenance of Ring Forming Tool

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the ring forming tool used in the manufacturing process of rings.

2) Scope

This SOP applies to all personnel involved in the operation, cleaning, and maintenance of the ring forming tool in the manufacturing facility.

3) Responsibilities

It is the responsibility of production operators, maintenance staff, and quality control personnel to follow this SOP to ensure proper operation and maintenance of the ring forming tool.

4) Procedure

4.1 Preparation

  1. Verify the availability of ring materials and batch records.
  2. Inspect the ring forming tool for cleanliness and proper functioning of forming dies, controls, and safety mechanisms.
  3. Ensure all safety protocols are followed, including using protective equipment.
See also  Vaginal Dosage Forms: SOP for Pest Control

4.2 Forming Process

  1. Set up the forming tool according to ring size and shape specifications.
  2. Feed the ring material into the forming dies and initiate the forming process.
  3. Monitor the forming process to ensure accurate shaping and sizing of rings.

4.3 Cleaning and Maintenance

  1. After completing the forming process, clean the tool thoroughly to remove any residues.
  2. Inspect and lubricate forming dies and components as per maintenance schedule.
  3. Document cleaning and maintenance activities in the logbook.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Ring forming tool specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for ring forming tool

See also  SOP for Risk Management

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

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