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:
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