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Validation Services - INCEPBio

Accelerate Your Time-to-Market with Expert Pharmaceutical Validation Services and Streamlined Regulatory Compliance.

Our Core Validation Services

Validation Service

Thermal Validation

Thermal validation is a process of testing and validating the heating, cooling, and temperature control systems of equipment and facilities used in pharmaceutical manufacturing, storage, and distribution. Thermal validation is important because temperature control is critical to ensuring the stability, efficacy, and safety of pharmaceutical products.
Learn more about Thermal Validation services.

Validation Services

Cleanroom Validation

Cleanroom validation is a process of testing and validating the performance of a cleanroom, which is a controlled environment that is designed to minimize the levels of airborne particles and contaminants in order to protect products, processes, and personnel. Cleanroom validation is important because it ensures that the cleanroom is operating correctly and is capable of maintaining the required level of cleanliness.
Learn more about our Cleanroom Validation services.

Validation Services

Computer System Validation

Computer system validation (CSV) is a process of ensuring that computer systems used in pharmaceutical manufacturing, testing, and control meet the intended requirements and operate consistently and reliably.
Learn more about our Computer System Validation services .

Pharma Validation is an essential aspect of pharmaceutical manufacturing, as it ensures that a product is consistently manufactured to meet the required quality standards. Here are some of the types of validation services that are offered by companies in the pharmaceutical industry:

Equipment Validation Services

Equipment Validation

Pharmaceutical equipment validation is a process of ensuring that the equipment used in the manufacture, storage, and distribution of pharmaceutical products is qualified, calibrated, and functioning properly. The validation process involves establishing documented evidence that the equipment consistently performs as intended and meets the regulatory requirements and the user's requirements.

Process validation

This involves the qualification of the manufacturing process, equipment, and facilities to ensure that they meet the required standards for quality, safety, and efficacy.

Cleaning validation

This ensures that the equipment used in manufacturing is thoroughly cleaned to prevent any cross-contamination of products or any residual impurities.

Facility and utility validation

This ensures that the facilities and utilities used in manufacturing, such as HVAC systems, water systems, and electrical systems, meet the required standards for quality, safety, and efficacy.

Our Pharmaceutical Validation Process

Our validation process typically involves the following steps:

Design Qualification (DQ)

The design qualification stage is the first step in the validation process. It involves ensuring that the proposed design for the manufacturing process, equipment, and facilities is suitable for its intended use. This includes the selection of appropriate materials, the consideration of regulatory requirements, and the identification of potential risks.

Installation Qualification (IQ)

The installation qualification stage involves verifying that the equipment, facilities, and utilities are installed and functioning correctly. This involves ensuring that the equipment is installed according to the manufacturer's specifications and that it is functioning as intended.

Operational Qualification (OQ)

The operational qualification stage involves verifying that the equipment is capable of performing the required operations consistently and within the specified parameters. This includes testing the equipment under different conditions to ensure that it operates as intended.

Performance Qualification (PQ)

The performance qualification stage involves demonstrating that the manufacturing process, equipment, and facilities can consistently produce a product that meets the required quality standards. This includes testing the product under different conditions and verifying that it meets the required specifications.

Continued Process Verification (CPV)

The continued process verification stage involves ongoing monitoring and verification of the manufacturing process to ensure that it continues to meet the required quality standards. This involves monitoring critical process parameters, such as temperature, pressure, and flow rate, to ensure that they are within the specified range.

Importance of Validation Services

It helps to ensure compliance with regulatory requirements, which is essential for gaining approval for marketing and selling pharmaceutical products.


Compliance with regulatory requirements


Mitigation of risks

Improved data integrity and accuracy

Building confidence in product quality


Improved efficiency

Ensuring Regulatory Compliance

We maintain strict compliance with regulations and guidelines from organizations such as


Our Track Record

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Our validation services can help you meet the highest quality and safety standards, giving you
peace of mind and helping you meet your business goals.