Standard Operating Procedure for Maintaining Equipment Logbooks

1) Purpose

The purpose of this SOP is to provide guidelines for the proper maintenance of equipment logbooks to ensure accurate tracking and documentation of equipment usage, maintenance, and calibration activities in the production of ocular dosage forms.

2) Scope

This SOP applies to all equipment used in the production of ocular dosage forms within the pharmaceutical manufacturing facility, including eye drops, ointments, gels, and inserts.

3) Responsibilities

The responsibilities include documenting equipment usage, maintenance, and calibration activities, reviewing logbook entries for completeness and accuracy, and ensuring logbooks are properly maintained and stored. Production staff and maintenance personnel are responsible for recording equipment activities, and quality assurance personnel are responsible for reviewing and approving logbook entries.

4) Procedure

4.1 Preparation

1. Ensure all personnel involved in maintaining equipment logbooks are trained in proper documentation practices.
2. Verify that logbook templates are up-to-date and approved for use.
3. Ensure that logbooks are readily available at the equipment location.

4.2 Logbook Entries

1. Recording Equipment Usage:
   1. Document the date and time of equipment usage.
   2. Record the name of the operator and the purpose of equipment use.
   3. Note any deviations or issues encountered during equipment operation.
   4. Record the batch number or production lot number associated with the equipment usage.
2. Recording Maintenance Activities:
   1. Document the date