In the pharmaceutical industry, a deviation is a difference between an observed value and an expected value for a product or process condition.
Deviations can also be a departure from a documented standard or procedure. Deviations can occur at any point during a product’s lifecycle, including the testing phase, manufacturing, final product acceptance, and post-market surveillance.
Deviations can be classified into three types:
- 𝐂𝐫𝐢𝐭𝐢𝐜𝐚𝐥
Affects the quality of a critical process parameter, equipment, or instrument.
The deviation will have a notable impact on the critical attributes of the product.
For Example: Usage of contaminated raw materials and solvents.
Integrity failure of high efficiency particulate air filters - 𝐌𝐚𝐣𝐨𝐫
The deviation will or may have a notable impact on critical attributes of the product.
For Example: Critical process and in process parameter failure.
Significant variation from standard output range. - 𝐌𝐢𝐧𝐨𝐫
The deviation will not have any direct impact on the quality of the product.
For Example: Weights not replaced properly after use.
Equipment and measuring device malfunction.
Deviations can impact system integrity, product quality, and public health and safety.
There are two main types of Devaition
- 𝐏𝐥𝐚𝐧𝐧𝐞𝐝 𝐃𝐞𝐯𝐚𝐢𝐭𝐢𝐨𝐧
These are pre-approved and intentional deviations from standard procedures or processes.
Examples include implementing a temporary manufacturing process change or using an alternative raw material. - 𝐔𝐧𝐩𝐥𝐚𝐧𝐧𝐞𝐝 𝐃𝐞𝐯𝐢𝐚𝐭𝐢𝐨𝐧
These can occur during the development, manufacturing, labeling, packing, sampling, testing, storage, and distribution of products.
For example, a customer complaint can trigger a deviation if a company’s standards don’t meet certain certification requirements - One tool to find out the root cause analysis for the deviations is fault tree analysis (FTA).
𝐖𝐡𝐞𝐧 𝐭𝐨 𝐑𝐚𝐢𝐬𝐞 𝐚 𝐃𝐞𝐯𝐚𝐢𝐭𝐢𝐨𝐧?
As soon a deviation occurs it should be immediately reported to Quality assurance (QA) within one working day from the time when the deviation has occurred or as per the Standard operating procedure (SOP).