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 any deviations observed during production.
   5. Document the in-process controls and results of quality checks performed during production.
2. Completion of Batch Record:
   1. Ensure that all sections of the batch record are completed accurately and legibly.
   2. Review the batch record for completeness and accuracy before submitting it for approval.
   3. Sign and date the completed batch record to certify that all information is accurate and complete.

4.3 Review and Approval

1. Submit the completed batch record to the quality assurance department for review.
2. The quality assurance personnel should review the batch record for completeness, accuracy, and compliance with SOPs and regulatory requirements.
3. Any discrepancies or deviations should be investigated, documented, and resolved before approving the batch record.
4. Once the batch record is approved, it should be signed and dated by the quality assurance personnel.

4.4 Record Maintenance

1. Store the approved batch records in a secure location to prevent loss or damage.
2. Maintain batch records for a period specified by regulatory requirements or company policy.
3. Ensure that batch records are easily accessible for audits and inspections.

5) Abbreviations, if any

N/A

6) Documents, if any

1. Batch record templates
2. Calibration records
3. Quality control checklists

7) Reference, if any

GMP Guidelines for Documentation in Pharmaceutical Manufacturing

8) SOP Version

Version 1.0