Standard Operating Procedure for Tablet Printing Process

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the systematic and controlled process for tablet printing to ensure the quality and legibility of printed information on tablets in compliance with the pharmaceutical industry standards and regulations.

2. Scope

This SOP applies to all personnel involved in the tablet printing process, including operators, technicians, and quality assurance staff.

3. Responsibilities

• Printing Operator: Responsible for setting up and operating the tablet printing equipment as per the defined procedure.
• Quality Assurance (QA) Staff: Responsible for ensuring that the tablet printing process is performed according to this SOP and all required quality checks are performed.
• Production Supervisor: Responsible for overseeing the tablet printing process and ensuring compliance with this SOP.

4. Procedure

4.1 Preparation of Tablet Printing Equipment:

• Before starting the tablet printing process, the printing equipment should be cleaned and sanitized as per the cleaning SOP.
• Verify that the printing machine is calibrated and set to the correct settings for the specific tablet batch.
• Ensure that the appropriate printing plates or stamps with the correct product information are available and in good condition.

4.2 Tablet Printing Process:

• Carefully load the tablets into the printing machine’s feed system, ensuring that the tablets are properly aligned.
• Set the printing machine to the correct printing parameters, including pressure, speed, and temperature, as specified in the batch record.
• Start the tablet printing process, and periodically check the printed tablets for any defects or irregularities.

4.3 In-Process Quality Checks:

• During the tablet printing process, perform regular checks to ensure the legibility and accuracy of the printed information on the tablets.
• If any defects are observed, immediately stop the printing process, investigate the root cause, and take corrective actions as necessary.

5. Abbreviations

SOP: Standard Operating Procedure
QA: Quality Assurance

6. Documents

The following documents are relevant to this SOP:

• Tablet Printing Equipment Cleaning and Sanitization SOP
• Batch Record for the specific tablet printing job

7. References

No specific references are required for this SOP as it is based on internal company procedures and industry best practices.

8. SOP Version

This is version 1.0 of the SOP for Tablet Printing Process, effective as of [Insert Date].