Auditors Due?

GMP and GDP (good manufacturing practices & good distribution practices) are the minimum requirements that food, product or pharmaceutical manufacturers must meet to assure that their products are of high quality and do not pose any risk to the consumer or public.

Medicine and food must be manufactured, stored and distributed within label conditions, yet Terrance Madigan of the MHRA (The Medicines and Healthcare Products Regulatory Agency), identified during a 2011 review of GDP deficiencies, that an astounding 51% of inspections demonstrated deficiencies with temperature control and monitoring (28.5% Critical, 22.5% Other).

Hygiene, cross-contamination prevention, calibration of weighing equipment and trace-ability of supplies, for example, are the most obvious regulations to adhere to in order to meet GMP or GDP guidelines. However, manufacturers and distributors are increasingly incurring non-conformances in their audits, due to not having temperature and humidity equipment tested correctly… despite the fundamental fact that ALL products, medicines & foods are temperature sensitive.

Auditors are stringent in ensuring temperature equipment and humidity equipment are accurate enough to fall within set, legal parameters:

Food standards have a legal requirement for temperature equipment to be calibrated to within an accuracy of ±1.0°C
EU pharma regulations demand a measurement accuracy of ±0.5°C

How would your business be affected if your temperature and humidity equipment was out of calibration by just 3°c (for example)?

Would your food or product be spoiled and unfit for human consumption, if manufactured at an incorrect temperature or humidity?

Can your business afford to be found non-compliant?

Call Temperature Test today on 01282 615645 or email us at [email protected]

Temperature Test is ISO 9001:2105 accredited & is a division of  Weighing Scales Ltd