What is validation in pharmaceutical industry?

Validation is the most important activity in the pharmaceutical industry. There are multiple types of validation in the pharmaceutical, such as Analytical Method Validation, Process Validation, Cleaning Validation, Equipment Validation, HVAC System Validation, Facility Validation, and Computer System Validation. In every industry validation is plays an important role to produce results in a consistent manner.

What is the Definition of validation in pharmaceutical industry?

The validation procedure authorizes documentary evidences that a particular process/method/activity will consistently produce a product with the expected result (predetermined requirements).

Importance of validation in pharmaceutical industry?

Any food and drug regulatory agency around the world does not only require products that meet its specifications, but they also require processes, procedures, intermediate inspection stages, and testing adoptions that are designed to produce similar, reproducible, consistent results that satisfy the regulatory and security requirements of the product being manufactured.

The process of validation allows for the development of such procedures. This is to ensure that the food and drug products are of a higher standard.

The definition of processes validation is to gather and evaluate data through the design phase and to the final stage of production, in order to establish scientific evidence that a process is able to consistently produce quality products.

A good validation system should ensure that every phase, every process, and every change has been adequately evaluated before implementation. Testing a sample of a final product does not equate to conclusive evidence that all of the products in a batch meet the specification.

Let’s go over different types of validation and their phase in the pharmaceutical industry. In this section, we will discuss different types of validation in more detail.

Types of Validation in pharmaceuticals:

Analytical Method Validation:

Analytical validation is designed to verify that the selected analytical method is capable of providing reliable results that are appropriate for the intended purpose. Different parameters are considered as part of the analytical method validation process. These are as follows:

  1. Accuracy
  2. Precision
  3. Reproducibility
  4. Repeatability
  5. Specification
  6. Linearity
  7. Range
  8. Limit of Detection
  9. Limit of Quantitation

Cleaning Validation:

Cleaning validation is a documented setup that provides a high degree of assurance that a particular system/piece of equipment is cleaned to a predetermined standard and within acceptable limits. Pharmaceutical products are contaminated by a variety of materials including lubricants, airborne materials, preparation residues, and microbes. Therefore, an appropriate cleaning procedure plays an important role in preventing contamination and cross-contamination.

Process Validation:

A process validation shows documented proof, which can provide a higher level of assurance a product will meet all the program’s specified quality characteristics and specifications consistently. Validation of the process also assures repeatability and decreases manufacturing errors, resulting in a higher level of output of a predetermined quality.

Process validation can be classified into four types based on the stage where the process is being evaluated:

  • Prospective Validation
  • Concurrent Validation
  • Retrospective Validation
  • Revalidation

Equipment Validation:

Equipment or instrument validation is a common process for every industrial instrument or equipment. There are three main phases for equipment validation in pharma and are as follows:

  1. Pre-validation
  2. Process validation
  3. Post validation maintenance

Generally, there are 4 types of equipment validation and are cover under pre-validation and process validation phases.

The 4 types of equipment validation are:

  1. Design Qualification (DQ)
  2. Installation Qualification (IQ)
  3. Operational Qualification (OQ)
  4. Performance Qualification (PQ)

1. Pre-validation of equipment:

The pre-validation is the first phase of equipment validation. Pre-validation includes Design Qualification (DQ) and Installation Qualification (IQ).

Design Qualification consists of; User Requirement Specification (URS), Functional Specification, Operational Specification, Vendor qualification, Factory Acceptance Test (FAT), and Installation consists of Site Acceptance Test (SAT), Installation of hardware and software.

2. Process validation of Equipment:

The next phase of validation is Process validation. Process validation includes Operational Qualification (OQ), Performance Qualification (PQ), and Revalidation.

Operational Qualification consists of; Functional Tests, Security tests, Performance validation consist of the ongoing performance of the equipment, and specified application testing. Change in material, changes in equipment, change in packing material, change in the manufacturing process are part of revalidation.

These all are types of validation in pharmaceutical industry.

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Validation in Pharmaceutical Industry