Change control and Deviation are two familiar words in Pharmaceutical and both are the parts of Quality Management System (QMS). Every body should know the basic things about these two so Let us know what is the difference between these two……
What is Change control :
1. Any planned permanent or temporary departure or modification or addition or deletion from an approved/qualified process/policy/document/system/material/method/equipment etc. is called as change and the document which is required to capture all the activities is called change control.
2. Change control can be Permanent or Temporary.
3. Change control is of two types Major and Minor.
4. Example of Change control are Change in Batch size, Manufacturing process, Formulation, Artwork related changes, Change in raw materials, packing materials, Change in documents like Specification, Standard test Procedure and Standard Operating procedure etc.
5. Change control can be raised before initiating any change either Permanent or temporary.
6.Change control can be closed within 90 days after approval and if required extension shall be taken.
7.Trending of the Change control shall be done on Quarterly basis.
8. The initiator who want to change in approved procedure or document has to raise change control.
What is Deviation :
1. Any unwanted event that represents a departure from approved processes or procedures or instruction or specification or established standard or from what is required. Deviations can occur during manufacturing, packing, sampling and testing of drug products.
2. Deviation can be Planned or Unplanned
3. Deviation is of three types Minor, Major and Critical
4. Example of deviation are Temperature and RH of area goes out of limit during manufacturing, Typographical error observed in approved documents, Standard operating procedure not followed, Breakdown of equipment, Spillage of material during unloading, Instrument calibration results goes out of limit etc.
5. Deviation shall be raised within 24 hours of the occurrence (An Incident or event)
6. Deviation can be closed or investigation of deviation shall be closed within 30 days and if required extension can be taken.
7. Similar types of deviation reported earlier should be reviewed in order to check its recurrence.
8. From deviation root cause CAPA shall be raised and if required change control can be initiated.
9. Trending of the Deviation shall be done on Quarterly basis.
10. The person or the department identifying the occurrence of deviation has to raise deviation.
For Change control procedure Refer https://pharmaceuticalupdates.com/2020/05/16/change-control-procedure/
For Deviation Procedure refer https://pharmaceuticalupdates.com/2019/02/22/procedure-for-handling-of-deviations-in-pharmaceuticals/