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
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.
In pharmaceutical manufacturing plants there is always the doubt related to when it is necessary to have a dedicated facility or when it is possible to manufacture in a same area different products specially when some of them are steroids, sexual hormones, corticoids, cytostatics, high potency, prostaglandins, …
FDA and EU required dedicated facilities for betalactamics antibiotics and when manipulating pathogenic alive organisms. For the rest of products the segregation and dedicated facilities should be required when the physical and procedural controls cannot demonstrate the capacity to keep under acceptable control limits the risk of cross contamination