Standard Operating Procedure Template for Laboratory Equipment

SOP is essential document that includes written instructions, it must be followed for the good laboratory management system. It covers all the activities of the laboratory (Safety, Technical, Hygiene, Administration). A well written SOP should be concise, detailed and clear so that it can be read and understood easily. The key elements of a well written SOP are consistency and accuracy, a good SOP provides Total Quality System of the laboratory.

Part 211- CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

Subpart F - Production and Process Controls

Sec. 211.100 Written procedures; deviations.

(a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in this subpart. These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit. (b) Written production and process control procedures shall be followed in the execution of the various production and process control functions and shall be documented at the time of performance. Any deviation from the written procedures shall be recorded and justified.

(Source : FDA Title 21, subchapter C - DRUGS)

 

SOP sample template

1. Title

Use, operation and maintenance of the equipment, name for the tests/methods.

2. Purpose/Objective
Include the objective of the tests/procedure, instrument or equipment operation.

3. Scope

Describe the process briefly. Persons who follow the SOP.  

4. References

A list of related documents such as reference SOPs, equipment manuals, work instructions and other guided documents.

5. Responsibilities and Ownership

Persons responsible for the tasks/methods or processes, operator of the equipment.

6. Health and Safety/ Warnings and dangers

Include the possible risks, warnings while performing the tasks or using the equipment.

7. Equipment and materials

The specific materials, equipment used should be included.

8. Procedure

Step by step instructions to operate the equipment and methods/procedure.  

9. Maintenance

Persons responsible for Cleaning and maintenance of the equipment.

10. Records and Documentation

Include any forms, documents eg. User log, Maintenance records

11. Attachments

Include list of forms, Tables, images etc. related to the equipment or the procedure of the tests/methods.

12. Revisions/ SOP change records
Record the Updates and changes made in the SOP by including a table or a section.

13. Approval
Include Technical and Management Approval