With increase demand on GMP &Regulatories requirements, there is a high probability of occurrence of deviation, such deviation is required to be documented. the pharmaceutical manufacturing organization has recognized the need for having SOP for handling deviation. however best the compliance is there always is a modification or temporary change to the approved procedure, process, or system.
Definition of Deviation:
The Deviation is any modification or temporary change in any approved procedure, documentation, or specifications.
21CFR 211.100 states that there will be written procedures for production & process control to assure. however, if there is a deviation from written procedures, it will be documented and justified.
The deviation report is a one-time use document that will modify documents contained within or referenced by the batch records.
It does not permanently change existing specifications, SOPs or other batch records documents. These documents could be revised according to the document change control procedure if required.
Types of deviations:
Deviation could be process or procedure-related. The following types of deviation can be found in a manufacturing process:
Planned vs. Unplanned deviations:
Prior to execution, a planned deviation is a suggested change to any approved procedure, document, or specification an example of the use of WFI instead of purified water to rinse cleaned equipment.
An Unplanned deviation is an unexpected event that requires a change to any approved procedure, documents, or specifications. it is usually discovered after that fact eg. a sudden change in temperature/humidity in the manufacturing area, failed key parameters, or temperature variation outside the specified range during a drying cycle. Unplanned Deviation is further classified as minor, major, and critically based on the event and the impact on the product quality, efficacy, and purity.
Temporary vs. permanent deviation:
The deviation could be temporary or permanent, depending upon the impact. If the deviation occurs only once, it should be viewed as a one-time occurrence. if the deviation is going to result in permanent changes in approved procedure, document, or specification, then it is a permanent change and will require detailed follow-up corrective action to implement the required change, including employee training.
Lot-specific vs. multiple lot deviations
The deviation is usually lot-specific for a given drug substance/ product, but can also involve multiple lots.
Product-specific vs. multiple products deviations:
The deviation is generally product-specific, but in some cases, it can be involved more than one substance. eg. a sudden failure of the water system, impacting multiple products, which might have used suspect- quality water for equipment cleaning or product manufacture.