A standard operating procedure (SOP) is a written set of instructions describing step-wise how a routine activity is to be performed. When the standard operating procedure is followed exactly, it ensures consistency of the operation being performed exactly as desired, and this makes sure that the desired quality is attained.
A standard operating procedure must contain a straightforward description of the task to be carried out, in simple language, and cover all the major steps in performing the task. The SOP must be written by persons who have sufficient knowledge and experience with the task being described.
SOPs must be written in clear language using the active tense. (For example, “Switch on the equipment..” and not “The equipment is switched on…”
The SOP must be detailed enough to allow someone with even limited knowledge or experience with the task, to perform the task as desired without any supervision. However, it must not involve unnecessarily lengthy descriptions. For example, in some processing SOP, if equipment operation is involved, and that procedure is a very long one and is available in the equipment operating manual, that procedure may just be referenced in the SOP instead of repeating all those instructions in the SOP.
Any abbreviations or acronyms used in the standard operating procedure must be explained at the beginning of the SOP.
SOPs must be prepared by the respective departments, and then reach QA for a review for checking if it complies with cGMP. After QA approval, the SOP must be signed, dated, and authorized for issue by senior personnel of the concerned department.
If a need is felt to amend or change any particular in an existing SOP being used, it must go through the change control procedure specified as part of QA.
Contents of standard operating procedure:
Title page
Table of contents
Procedures
1. Scope
2. Method summary
3. Definitions
4. Health and safety warnings
5. Cautions
6. Interferences
7. Personnel qualification/responsibility
8. Equipment/supplies
9. Procedure in steps
10. Calibration/standardization
11. Sample collection, handling, and preservation
12. Troubleshooting
13. Data entry, calculation, and report writing
QA/QC section
References section
Common SOPs in a manufacturing unit:
Organization and personnel
1. Personnel qualifications and experience
2. Personnel hygiene, responsibilities, movement control
3. Personnel training
Facilities and equipment
1. Facility safety procedures
2. Facility maintenance and cleaning
3. Qualification and validation of critical systems (examples – water system, HVAC, etc.)
4. Equipment cleaning and maintenance; logbooks
5. Qualification of equipment
Materials management
1. Receiving and storage of materials
2. Sampling of materials
3. Control of accepted and rejected materials
4. Warehousing of finished products
5. Distribution of approved products
Production o Work instructions
1. Operation of equipment
2. All production processes
3. All packing processes
4. BMR entry and checking
5. Personnel safety
6. Control of contamination and cross-contamination
7. Process deviations reports and investigation
8. Control of packaging and labeling
Quality Assurance
1. Document control, including SOPs
2. MFR and BMR
3. Process validations
4. Review of batch records and batch release
5. Change control
6. GMP training
7. Corrective and Preventive Action (CAPA)
Quality Control
1. Laboratory safety
2. Analytical methods
3. Sampling and testing of in-process and final goods
4. Calibration of analytical equipment/instruments
5. Maintenance of analytical equipment/instruments
6. Analytical method validation
7. Environmental monitoring
8. Approval or rejection of materials
9. Investigation of Out of Specifications (OOS) results
10. Stability testing
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