The formation or flakes of glass particles on the inside of glass containers is referred to as delamination. These glass fragments, created by the interaction of the solution with the container walls, can pose a risk, especially when it comes to parenterals.
When an inspection unearths severe GMP violations, the FDA sometimes issues a ban on imports for the concerned products of a company. Read here what conflicts can arise when such an import alert concerns APIs of a Chinese manufacturer which were classified as prequalified in an inspection by the WHO beforehand.
The European Medicines Agency (EMA) recently posted on its website that the new EU Clinical Trial Regulation will come into application during 2019 instead of in October 2018, as previously announced. Read more about the new time schedule for application of the Clinical Trial Regulation EU No. 536/2014.
A new USP general Chapter that describes the basic principles and practices used in the characterization of tablet compression has been approved and published. Read more about the new USP chapter <1062> Tablet Compression Characterization.
In the pharmaceutical industry, HEPA filters are used as terminal filters for the processing or filtration of air in production spaces. They are mandatory in sterile production, although they are somtimes also used in the manufacture of solid or semisolid dosage forms. Amongst the HEPA or high-efficiency particulate filters are Filter Classes H13 to H14 (DIN 1822), the latter with a retention rate of 99.995%. But how often do HEPA filters need to be changed?
FDA recently published a draft document on the use of electronic records and signatures in clinical trials. Read more about FDA´s draft document Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers.
Members of the ECA Visual Inspection Board have finished their work on a position paper regarding Container-/Closure-Integrity testing. The new document is now available in the download section of the ECA Visual Inspection website.
EMA's document on the implementation of ICH Q3D for already marketed products contains essential recommendations for marketing authorisation holders. Learn why risk assessments with regard to elemental impurities for existing marketed products are so important and how to decide about the necessity of a variation procedure.
The current edition of the Swissmedic Journal 05/2017 and the Technical Interpretation I-SMI.TI.17 specify the requirements with regard to the independence and the obligation of presence of the Swiss QP.
To maintain the qualified state of a pharmaceutical water system, a reliable maintenance plan is necessary. This is an official requirement, though it does also make sense from an operational viewpoint. Maintenance intervals based on the criticality of individual components are usually defined during qualification. But what is the rule here?
The Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) updated the Guidance for Industry "Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)".
In March 2017, the FDA published another Warning Letter to an Indian pharmaceutical manufacturer due to GMP violations. The letter describes findings with regard to complaint handling, leaking of sterile products and the corresponding CAPA processing as well as on the non-compliance with quality agreements.
Incorrect sampling has led to an FDA Warning Letter for an API manufacturer in China. The FDA inspectors criticised that around 10% of the API batches manufactured exceeded the impurity limit set. Read more about this FDA Warning Letter.