Quality + Regulatory

The number and complexity of temperature monitoring regulations are increasing for temperature sensitive drugs and medical products at both the global and local levels. Data is mounting to show the expense and customer dissatisfaction with medications and medical products that have questionable temperature histories. This is especially true with increasingly expensive specialty drugs.

Balancing the needs of regulators who require comprehensive operating procedures with the needs of your customers such as HCPs and patients who want something simple and easy to understand is challenging. Temptime temperature indicators, for the full manufacturer-to-patient journey or to cover the higher-risk last mile, provide the right balance of simplicity-of-use and interpretation with reliable, medical device quality assurance.

Additionally, adding visual temperature monitoring as an adjunct to packaging for those unpredictable supply chain glitches, has saved many of our customers a significant amount of expense in both packaging and shipping of returns and reships.

Temptime® Quality Systems Regulations and GMPs

At Temptime, we have developed an integrated quality system based on the requirements of the ISO 9001 Quality System Standard, ISO 13485 Medical Devices, and the FDA’s Quality System Regulation to meet Good Manufacturing Practices (GMP).

Temptime Quality Policy

The intent of the Quality Policy is to communicate Temptime Corporation’s commitment to customer satisfaction and the promotion of global health by continually improving the effectiveness of our quality management system and by efficient execution of plans to meet quality objectives.

Temptime Corporation’s quality policy is:

  • We operate efficiently
  • We consistently meet customer expectations and regulatory requirements
  • We continually improve.

Temptime ISO Certification

Temptime earned certification to the ISO 9001 Quality System Standard in March of 2001. In April of 2008, the company obtained the additional certification to the ISO 13485 Medical Devices – Quality Management Systems – Requirements for regulatory purposes. The company is assessed annually for conformance to these two standards.

Temptime ISO 9001-2015 Certificate July 2022
ISO Certificate for Time-Temperature Indicators
Temptime ISO 13485-2016 Certificate July 2022
ISO Certificate for Blood Temperature Indicators

Temptime Audits

Temptime is routinely audited by many major global vaccine suppliers and by some of the largest pharmaceutical and medical device companies in the world. We welcome and encourage you to visit us on-site so you can assess our operation. Please contact us to schedule a customer audit.

Temptime Implementation and Support

Temptime works closely with your internal team to develop a uniquely customized logistical implementation plan, which includes;

  • Packaging procedure review to support an optimal launch of the product
  • Process evaluation to integrate the application of the indicator
  • Work flow recommendations
  • Support in the design of user communication tools
  • Training of your sales and operations employees

Additionally, patient and healthcare provider (HCP) education are critical. At Temptime, we anticipate and appreciate any questions that the receiver of a temperature monitored specialty pharmacy product might have, and continue to develop educational resources for patients and HCPs.