Chinese manufacturer Zhejiang Ludao Technology received an FDA Warning Letter in February, 2018. During the FDA inspection, the missing Audit Trail Review for the HPLC system was particularly criticised.
Microbiological testing of topical drug products to prove compliance with the specifications prior to release and correct labelling is mandatory for products applied to the skin. Find out, what GMP violations regarding the manufacturing, testing and labelling FDA inspectors found during an inspection.
The USP recently posted the announcement of its intent to cancel and redevelop the drafts of packaging chapters previously published in the Pharmacopeial Forum. Read more about USP´s chapters on glass containers and elastomeric closures.
The guideline VDI 6022 Part 1 underwent substantial revisions and now contains many new obligations for manufacturers, planners, constructors, operators and supervisors of HVAC systems and air conditioners.
The ECA Pharmaceutical Microbiology Working Group completed the first chapter of their guidance on handling of microbiological deviations to support members in dealing with OOS and OOL results.
With the authorities' increasing attention to data governance and data integrity the ECA's Data Integrity Task Force's just released version 2.0 of its Data Integrity Guide provides an ideal tool for implementing data integrity in practice.
In the last weeks there were stories about the UK remaining in the EMA even after Brexit. Would this be possible?
After an FDA inspection with relevant results, the FDA usually expects a response within 15 days. What happens, however, if there is no response to the FDA inspection results?
In the EU database for Non-Compliance Reports of European inspections, there is a new entry for the inspection of a pharmaceutical manufacturer in India from November 2017. Main focus of the findings: cross contamination.
The revised versions of two Ph. Eur. general packaging chapters have been published for comment in Pharmeuropa. Read more about 3.2.8. Sterile single-use plastic syringes and 3.2.6. Sets for the transfusion of blood and blood components.