Standard Operating Procedure for Recording Batch Information in Production

1) Purpose

The purpose of this SOP is to provide guidelines for the accurate and comprehensive recording of batch information during the production of ocular dosage forms to ensure traceability, quality control, and compliance with regulatory requirements.

2) Scope

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

3) Responsibilities

The responsibilities include documenting batch details, ensuring the accuracy of recorded information, reviewing batch records for completeness, and maintaining batch records for future reference. Production staff are responsible for recording batch information, and quality assurance personnel are responsible for reviewing and approving batch records.

4) Procedure

4.1 Preparation

1. Ensure all personnel involved in batch recording are trained in proper documentation practices.
2. Verify that batch record templates are up-to-date and approved for use.
3. Ensure that all required materials and equipment are available and meet quality specifications.

4.2 Batch Documentation

1. Recording Batch Information:
   1. Document the batch number, production date, and product name on the batch record.
   2. Record the quantities of raw materials used, including lot numbers and expiration dates.
   3. Document the equipment used for production, including equipment ID and calibration status.
   4. Record the processing parameters (e.g., temperature, pressure, mixing time) and