Change Control is an integral part of any Quality system of an FDA regulated product. This includes protocols, master records and every SOP in the plant.
As a general rule, Standard Operating Procedures (SOPs) should be reviewed and revised every two years. However, realities of ever-changing workplaces and the convenience of paperless systems means that SOPs may be updated more frequently.To remain GMP compliant, there must be a procedure in place for changing and reviewing SOPs.
When a change needs to be made to an SOP, a request should be made to the Quality Department. The draft changes should also be submitted for comment to all affected personnel. Once the change is approved, it should be determined if additional training is needed. The date and justification of the change should be included in the SOP.
Reasons for changing an SOP include:
- New equipment
- New software
- New vendors or products
- Revised FDA regulations
- Staff suggestion to make a procedure more efficient
When the Quality team reviews the SOP, it should be determined if any other changes are required. Once the review is complete, the date of the review should be recorded.