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SOP for Inventory Management of Spare Parts

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SOP for Inventory Management of Spare Parts

Standard Operating Procedure for Inventory Management of Spare Parts

1) Purpose

The purpose of this SOP is to establish procedures for the management and control of spare parts inventory used in the maintenance and operation of equipment for manufacturing dental dosage forms, ensuring availability, traceability, and cost-effective management.

2) Scope

This SOP applies to all personnel involved in the procurement, storage, issuance, and inventory control of spare parts used for equipment used in dental pastes, gels, and mouthwashes manufacturing within the pharmaceutical industry.

3) Responsibilities

The Maintenance Department is responsible for overseeing the inventory management of spare parts. Maintenance technicians are responsible for requisitioning, recording usage, and ensuring proper storage and handling of spare parts.

See also  SOP for Weighing and Dispensing of Raw Materials

4) Procedure

4.1 Spare Parts Identification and Classification

4.1.1 Maintain an updated list of critical and non-critical spare parts required for equipment maintenance and operation.

4.1.2 Classify spare parts based on usage frequency, criticality, and availability from suppliers.

4.2 Procurement and Receiving

4.2.1 Initiate procurement of spare parts based on forecasted demand, historical usage, and equipment maintenance schedules.

4.2.2 Receive and inspect incoming spare parts to verify quantity, quality, and compliance with specifications.

4.3 Storage and Handling

4.3.1 Store spare parts in designated storage areas with appropriate environmental conditions, such as temperature and humidity

control, to prevent degradation.

See also  SOP for Risk Assessment of Equipment Use

4.3.2 Label and identify each spare part clearly with part number, description, and storage location.

4.4 Inventory Control

4.4.1 Maintain accurate inventory records of spare parts, including stock levels, reorder points, and consumption rates.

4.4.2 Conduct regular cycle counts and physical inventories to reconcile actual inventory levels with records.

4.5 Issuance and Usage

4.5.1 Issue spare parts based on approved requisitions and work orders from maintenance technicians.

4.5.2 Record all transactions related to spare parts issuance, usage, returns, and adjustments.

4.6 Obsolescence and Disposal

4.6.1 Monitor spare parts for obsolescence and determine appropriate disposal or return to suppliers for credit.

See also  SOP for Regulatory Submissions for Equipment Validation

4.6.2 Document and dispose of obsolete spare parts according to company policies and environmental regulations.

5) Abbreviations, if any

SOP – Standard Operating Procedure

6) Documents, if any

Spare Parts Inventory List

Purchase Orders

Inventory Reconciliation Reports

7) Reference, if any

Equipment manufacturer’s spare parts manuals and recommendations

Company-specific inventory management policies

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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