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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.
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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.
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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.
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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.
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.
This involves the qualification of the manufacturing process, equipment, and facilities to ensure that they meet the required standards for quality, safety, and efficacy.
This ensures that the equipment used in manufacturing is thoroughly cleaned to prevent any cross-contamination of products or any residual impurities.
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 validation process typically involves the following steps:
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.
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.
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.
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.
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.
It helps to ensure compliance with regulatory requirements, which is essential for gaining approval for marketing and selling pharmaceutical products.
We maintain strict compliance with regulations and guidelines from organizations such as
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