Last modifications on European GMP, which are taking effect on Mach 15th, (Chapter 3 and especially Chapter 5) are going to impact on existing facilities and equipment, and they are going to force a rethinking of all steps and measures to be taken in order to avoid cross contamination; not just for these products so-called “high potency” but in general for all pharmaceutical products. Every pharmaceutical product must have a risk analysis based on a toxicological assessment. Measures to be taken in order to avoid cross contamination will be determined in accordance with a risk analysis, based on the Quality Risk Management principles and they should be commensurate with the risksRead more
1. Introduction The requirements in the cosmetic sector are defined in the regulation of the CE Nº 1223/2009 of the European Parliament and of the Council about cosmetic products that was published in the Official Journal on December 22, 2009, […]Read more
1.Introduction The EMA has approved on the 20th of November 2014, the new guide “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities”. Once approved, this guide will have to […]Read more
INGELYT, through our partner QUALIA, has attended the last CHINA PHARM 2014
19th edition of CHINA-PHARM, hold in Shenzen the last October, the fair occupied more than 30.000m2 with 431 exhibitors from 22 countries.
In cooperation with QUALIA , INGELYT introduced some of its high specialized products, as the airtight doors with pneumatic seal.
In addition INGELYT introduced the new services of consultancy and advising focused to the Pharmaceutical Industry.
Using a risk assessment methodology to evaluate the potential hazards of disposing human fluids contaminated with Following the current protocols sanitary sewers may be used for the safe disposal of patient waste. Ebola virus through the hospital sewer network, it seems that the use of autonomous WC system inside of the containment patient room provides a safer, reliable and validatable way to manage these kind of waste, in addition these systems don’t require special utilities, personnel or investmentsRead more