Different Types of Deviations in Pharmaceuticals

Deviation management is an important part of pharmaceutical documentation. A lot of FDA warning letters are issued due to the improper handling of the deviations. Deviations are the departure of any process or procedure from a documented or expected value. Deviation may be in the form of value, process, or procedure that is different from the standard or guideline.

According to the occurrence, deviations are of the following two types.

1. Planned Deviation

Planned deviations are also known as controlled deviations. These are pre-planned deviations and we know these before occurrence. These deviations are temporary and approved before the execution of the manufacturing process. Planned deviations are planned for a specific time or number of batches to avoid any situation without any harm to the product quality.
Example: Change in batch size due to unavailability of raw material

2. Unplanned Deviation

Unplanned deviations cannot be controlled and can occur at any time, so these are also known as uncontrolled deviations. These deviations occur due to equipment breakdown or malfunction, human errors, or utility failures.
Example: Equipment breakdown due to interrupted power supply
Related: Difference between Incidence and Deviation

On the basis of the impact of the deviation on the product, deviations are of the following three types.

A. Minor Deviation

When a deviation occurs but it doesn’t have any impact on product quality, it is categorized as a minor deviation. Minor deviations don’t have any impact on the good manufacturing practices (GMP) system.
Example: Spillage of raw material during dispensing

B. Major Deviation

When any deviation has a considerable impact on product quality or the GMP system, it is categorized as a major deviation.
Example: FBD breakdown during drying of batch granules

C. Critical Deviation

When any deviation has a considerable impact on the quality of the product or GMP system, it is categorized as a critical deviation.
Example: Use of expired raw material in batch manufacturing

Deviation Identification Flowchart

Difference between Planned and Unplanned Deviations

1. Planned deviation are preapproved while unplanned deviation occurs suddenly and are never approved before execution.
2. Planned deviations don’t require any root cause analysis while unplanned deviations require root cause analysis.
3. Planned deviations don’t require corrective and preventive actions while unplanned deviations require CAPA.

FAQs on Deviations in Pharmaceuticals

Q1. How are deviations classified based on their severity?

Answer: On the basis of severity, deviations are classified as Minor, Major, and Critical deviations.

Q2. What are the common causes of deviations in pharmaceutical production?

Answer: Equipment breakdown and human errors are the common causes of deviations in pharmaceuticals.

Q3. What is the impact of deviations on pharmaceutical products?

Answer: Deviations always have a negative impact on the quality and safety of products. Deviation may lead to batch failure, rejection, and product recall.

Q4. What regulatory guidelines govern the handling of deviations in pharmaceuticals?

Answer: FDA 21 CFR Part 211. 160 and FDA 21 CFR Part 211. 192 have instructions to handle the deviations and EU GMP Guide Part 1 and EU GMP Guide Part II (APIs) have instructions on root cause analysis of deviations.