The primary goal of the guide is to offer best practice and guidance when establishing excipient stability programs.

Billev Pharma East experts can offer gap analysis of Quality Management Systems, providing a comprehensive report citing the sections of GMP that the site is deficient in and offering suggestions for appropriate CAPA.

Pure TiO2 has at least two key functions in medicinal products: coloring agent and opacifying agent.

Shortages of medicines can result from supply chain disruptions and vulnerabilities affecting the supply of key ingredients and components.

MHRA announced the resumption of international on-site GMP inspections.

According to the Article 87 of the Medicinal Products Act (Off. Gazette of the Republic of Slovenia, No. 17/2014 and 66/2019; hereinafter: ZZdr-2), medicinal products which are placed on the market on the basis of paragraphs one or two of Article 20 of the ZZdr-2, and for medicinal products from indents two, three or four of paragraphs three of Article 20 of the ZZdr-2 which are intended to be issued in pharmacies or specialised stores, must be labelled in the Slovene language on the outer packaging, or immediate packaging if outer packaging is not present.

The introduction of the future UK Medical Device Regulation will be delayed by twelve months.

Listed holders of authorisation should notify the JAZMP about the actual date of launch of the medicinal product in the Republic of Slovenia on the date of launch at the latest and no later than two months before the expected date of cessation or shortage in the case of the temporary or permanent cessation of the medicinal product marketing or shortage, except in cases of force majeure.