How can a continuous process be kept in a controlled state and how is it validated? How should deviations in a continuous process be handled? The conference "Continuous Manufacturing", in Berlin from 4-5 December 2019 will answer those questions and cover OSD and Biotech manufacturing.
With news, trainings and conferences, a comprehensive guidelines database, publications and more the ECA is the leading European training and information services provider in the GMP and GDP environment.
FDA's Warning Letters provide a valuable source of detailed information and can be helpful in preparing for an inspection, making a more detailed analysis worthwhile. Read more here about what FDA inspectors have discovered in recent months regarding frequent weaknesses at GMP-liable pharmaceutical manufacturers.
The data integrity topic raises a number of questions. Current questions are addressed in a loose sequence of News. Question 6: How can I handle analysis devices that are connected to a LIMS via a middleware? The manufacturer does not allow access to the original data in the automated analyser though.
Cannabidiol (CBD) is currently marketed in a variety of product types, such as oil drops, infused pouches, capsules, syrups, teas and topical lotions and creams. Therefore, the FDA is working on the evaluation of regulatory policies related to cannabis and cannabis-derived ingredients.
The main material used in plant engineering is stainless steel. The variant 316L is regarded as standard; material incompatibilities of steel with the product play almost no role. This is different for plastics. Beside the leach-out, ageing and surface finishing, other quality features are often specified. Now, what are the general requirements for plastics in pharmaceutical plant engineering?