In June 2015 ICH issued a Q & AÂ Guidance document that complements the Guidance for Industry Active Pharmaceutical Ingredients, ICH Q7. 2000. Since 2000, experience with implementing the guidance has created a need for clarification of various sections. ICH Q7 should be applied in combination with the principles laid down for development and manufacturing in … [Read more...]
Smoke Study Findings Contribute to Mylan Laboratories Warning Letter (8/06/2015)
The following is the second Blog in an on-going series of Blogs obtained from a Warning Letter about Mylan Laboratories, Bangalore, India as well as other Mylan (Agila Specialties Private Ltd.) facilities in India. This second Blog continues the review of the Mylan facilities which were audited February 6-13, 2015 and are located at Plot No. 284-B (19A) Bommasandra Jigani Link … [Read more...]
BIOBURDEN CONTROL OF NONSTERILE DRUG SUBSTANCES AND PRODUCTS (USP)
A NEW PROPOSED USP GENERAL INFORMATION CHAPTER USP recently released a new DRAFT in a much anticipated area that has gained significant attention over the past half dozen years. The subject, "USP<1115> Bioburden Control of Nonsterile Drug Substances and Products", has generated much controversy as … [Read more...]
