All health products registered with the Health Ministry must have a valid MAL registration number or hologram security label.
The filter integrity test market benefits from rising demand in food & beverage and biopharmaceutical sectors driven by ...
In the pharmaceutical industry, cleanrooms are categorized based on the level of airborne particle concentration necessary to meet the cleanliness standards required for the specific manufacturing ...
Both the USA cGMP 1 and EU GMP 2 dictate that cleanroom classification must be carried out according to ISO 14644-1. The version of this ISO standard released in 1999 4 was rewritten by a group of ...
~ All you need to know on what has changed in Health Canada’s latest update and how to plan ahead ~ Health Canada has published Version 4.0 of the Good Manufacturing Practices (GMP) Guide for Natural ...
Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in each country or region and cover areas such as facility design and sanitation, product testing, product ...
Manufacturers of combination products were offered a list on Tuesday of flexible mechanisms that can be used to comply with the US Food and Drug Administration’s (FDA) requirements for good ...
In August 2022, the European Commission published a revision to Annex 1 “Manufacture of Sterile Medicinal Products” in EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines that will ...
The regulatory group known as the Pharmaceutical Inspection Co-operation Scheme (PIC/S) said in a letter released this week that it is “unanimously concerned” about the public health and safety impact ...