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In the ever-evolving world of pharmaceuticals, compliance with regulations is essential. Our thermal validation service helps you meet these standards while protecting your product and your reputation.

What is Thermal Validation in the Pharma Industry?

It refers to the process of verifying the performance of equipment used to control temperature-sensitive processes. This includes processes such as storage, transportation, and production of pharmaceutical products. The aim of thermal validation is to ensure that these processes are consistent and that the temperature is kept within specified limits to ensure product quality and efficacy.

The thermal validation process involves data loggers, temperature probes, and other monitoring devices to measure and record the temperature of the equipment and the product being stored or transported.

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In India, the compliances to be followed for thermal validation services in the pharmaceutical industry are regulated by the Central Drugs Standard Control Organization (CDSCO). The following are some of the key compliances to be followed:

– Good Manufacturing Practices (GMP)

– Good Documentation Practices (GDP)

– World Health Organization (WHO) guidelines

– International Organization for Standardization (ISO)

– International Conference on Harmonization (ICH) guidelines

– Food and Drug Administration (FDA) 21 CFR Part 11 Compliance

– International Organization for Standardization (ISO 9001 & ISO 45001)

– Occupational Safety & Health Administration (OSHA)

– EN285 (European Standards)

– Parenteral Drug Association (PDA)

– International Society for Pharmaceutical Engineering (ISPE)

Thermal validation services are essential for a variety of industries that handle temperature-sensitive products or processes

Pharmaceutical industry: Pharmaceutical companies require thermal validation services to ensure the quality, safety, and efficacy of temperature-sensitive products, such as vaccines, biologics, and medications.
Biotech industry: Biotechnology companies require thermal validation services to ensure the preservation and stability of temperature-sensitive products, such as cell lines, biologics, and vaccines.
Food and beverage industry: Food and beverage companies require thermal validation services to ensure the safety, quality, and freshness of temperature-sensitive products, such as dairy products, meat, and produce.
Chemical industry: Chemical companies require thermal validation services to ensure the safety and quality of temperature-sensitive products, such as hazardous materials, flammables, and refrigerants.
Medical device industry: Medical device companies require thermal validation services to ensure the safety and effectiveness of temperature-sensitive products, such as implantable devices, surgical instruments, and diagnostic equipment.
Life sciences industry: Life sciences companies require thermal validation services to ensure the stability and efficacy of temperature-sensitive products, such as lab reagents, samples, and specimens.
Logistics and supply chain industry: Logistics and supply chain companies require thermal validation services to ensure the temperature control and preservation of temperature-sensitive products during storage and transportation.