For organisations in the healthcare and pharmaceutical industry, ensuring good manufacturing practices (GMP) is essential. Testo's Validation service is designed to help businesses with GMP compliance for Therapeutic Goods Administration (TGA) or Food and Drug Administration (FDA) guidelines. Alongside our excellent range of monitoring equipment, Testo's Validation service focuses on two critical areas - temperature mapping and equipment validation.
Any medical testing or pharmaceutical manufacturing facility requires strict control over environmental conditions, in particular temperature. Storage areas and laboratories must be kept within specific levels, ensuring the quality and safety of samples or products.
Temperature mapping involves the expert assessment of storage facilities, refrigerators and cold rooms, identifying where limits are required and installing the equipment to monitor them. This includes our range of temperature and humidity data loggers and monitoring systems, allowing users to observe fluctuations and be alerted when limits are breached.
Ensuring GMP compliance for temperature-sensitive pharmaceuticals must be a priority for any organisation in the industry - temperature mapping through Testo's Validation service makes that job easier. Equipment validation
Having the right equipment is one thing; making sure it meets international regulatory standards and is in accordance with GMPs is another. With Testo's Validation service, experienced consultants will conduct an assessment of existing equipment to verify that it is up to the task.
Equipment validation involves the identification and examination of critical quality attributes (CQAs) and critical process parameters (CPPs) in pharmaceutical equipment, with specialist consultants able to identify risks and calculate the likelihood and impact of equipment failure.
Testo's Validation service provides the confidence and peace of mind that your equipment is safe and reliable enough to pass any auditing process. Testo and PharmOut
Testo and PharmOut
Testo has partnered with PharmOut, a rapidly growing, Australian-based international consultancy firm, to offer Validation to our customers. PharmOut has experience in GMP compliance, qualification and validation, TGA regulatory, engineering and architectural consulting services to the pharmaceutical, blood and tissue, medical device manufacturers, hospitals and pharmacy operations.
We have the product expertise, and we're proud to be teamed up with the temperature mapping and equipment validation experts from PharmOut. Get in touch with us today to ensure that your facilities and equipment meet all the necessary compliance standards.