Standard Operating Procedure for Equipment Identification and Labeling
1) Purpose
The purpose of this SOP is to establish procedures for the identification and labeling of equipment used in the manufacturing of dental dosage forms. Proper identification and labeling ensure traceability, facilitate maintenance, and promote safe and efficient operation.
2) Scope
This SOP applies to all equipment used in the production, testing, and control of dental pastes, gels, and mouthwashes within the pharmaceutical industry. It includes new equipment as well as existing equipment requiring updated labels.
3) Responsibilities
The Engineering Department is responsible for creating and applying identification labels to equipment. The Quality Assurance (QA) Department is responsible for approving the labeling format and ensuring compliance with this SOP. All personnel are responsible for maintaining the visibility and legibility of equipment labels.
4) Procedure
4.1 Equipment Identification
4.1.1 Assign a unique identification number to each piece of equipment, ensuring no duplication of numbers.
4.1.2 Maintain a master list of equipment identification numbers, including details such as equipment type, manufacturer, model, and location.
4.2 Labeling Requirements
4.2.1 Ensure labels are durable, resistant to environmental conditions, and securely affixed to equipment in a visible location.
4.2.2 Labels should include the following information:
4.2.2.1 Equipment identification number
4.2.2.2 Equipment name and description
4.2.2.3 Manufacturer’s name
4.2.2.4 Serial number
4.2.2.5 Date of installation or last maintenance
4.3 Label Application
4.3.1 Clean the surface area where the label will be applied to ensure proper adhesion.
4.3.2 Affix the label to the equipment, ensuring it is straight, legible, and securely attached.
4.3.3 Verify the accuracy of the information on the label against the master list and equipment records.
4.4 Label Maintenance
4.4.1 Inspect labels regularly during routine maintenance checks to ensure they remain legible and intact.
4.4.2 Replace any damaged or faded labels promptly, following the same application procedure.
4.5 Record-Keeping
4.5.1 Maintain records of all labeled equipment, including a copy of the label information and the date of labeling.
4.5.2 Update the master list and equipment records whenever labels are replaced or updated.
5) Abbreviations, if any
SOP – Standard Operating Procedure
QA – Quality Assurance
6) Documents, if any
Master List of Equipment Identification Numbers
Equipment Labeling Records
Maintenance and Inspection Logs
7) Reference, if any
Manufacturer’s equipment manuals and specifications
Regulatory guidelines for equipment identification and traceability
8) SOP Version
Version 1.0