The FDA has recently issued a Warning Letter to criticize, among other things, the lack of revalidation at a pharmaceutical manufacturer. At first sight, this seems surprising, as it replaces stage 3 of the process validation lifecycle, the Continued Process Verification, the periodic re-validation that was common in the past (exceptions are made in the sterile area). What are the reasons for FDA's request?
Deficiencies in aseptic production have led to a Warning Letter for the Japanese company Takeda Pharmaceutical Company Limited. Part 1 of the News deals with inadequate cleanroom performance and inadequate controls of materials used in aseptic production. What were the reasons for this Warning Letter?
In the current Pharmacopeial Forum revised drafts of the two previously published USP Chapters <665> and <1665> on plastic materials used in pharmaceutical manufacturing have been published for comment.
The unpopular deficiency letters of the FDA contain numerous standard formulations and follow a fixed scheme in their structure. Read more here about the structure of the Warning Letters and why their reading can be very useful in preparing for an FDA inspection.
Deficiencies in microbiological environmental monitoring have led to a Warning Letter for the Korean company Samchundang Pharm Co. What deficiencies were found at the inspected company and what measures were required to remedy them?
In June you could already read about a WHO draft guideline on the topic of limit values in cleaning validation. This draft has now been significantly revised and re-issued with a new title "Point to consider when including Health-Based Exposure Limits (HBELs) in cleaning validation". What changes have been made?
Since at least the end of the 80s, equipment qualification has been an official expected standard. In the meantime, electronic documentation systems have been widely used. Nevertheless, pharmaceutical companies often still work with paper, especially in the field of equipment qualification. Would it not be possible to use more qualification documents electronically? This is something we wanted to find out from you. 14 questions were asked to give an overview of this topic.
A manufacturer of homeopathic drugs and hormone preparations in the USA has received a Warning Letter from the FDA due to several GMP violations. Among other things, highly active drugs were produced on the same equipment as the other products.
The webinar on semi-automated visual inspection of parenteralia on June 16, 2020 met with great interest. In addition to many basic questions regarding visual inspection, specific questions about semi-automated inspection were asked and answered during the webinar. Here you can find a short selection.
In July 2018, the ECA Analytical Quality Control Group published version one of its guideline on Analytical Procedure Lifecycle Management (APLM) in support of the development of USP <1220> and the ICH revision of Q2(R2) and the newly proposed Q14.
In the last newsletter you could already read about a new Aide-Memoire of the PIC/S for the inspection of health-based exposure limits (HBEL). At the same time, the PIC/S has published a Q&A document on HBEL and cross-contamination. What is behind this Q&A paper?
The "Good Distribution Practice for Active Substances Guidance on interpretation and implementation" has been published recently as a joint publication of the ECA Foundation's GDP Association and the Pharmaceutical Quality Group of the Chartered Quality Institute. An interactive PDF of the document is now accessible free of charge in the member's area of the European GDP Association.
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a firm that manufactures and distributes OTC products. The Warning Letter summarizes significant violations of current Good Manufacturing Practice (CGMP). The company failed, amongst others, to have the proper controls in place to prevent the unauthorized manipulation of laboratory raw electronic data. Furthermore, the laboratory management could not provide an adequate explanation for several unofficial HPLC injections.
Data integrity issues remain at the focus of FDA inspections. Insufficient or missing controls to ensure the integrity of electronic test data were one of the reasons for the Warning Letter issued to the American company Stason Pharmaceuticals.
The WHO published the revised draft of its guideline "Good Manufacturing Practices: water for pharmaceutical use" already end of July. The first revised draft of the guideline was published in May 2020. The new, second version contains further changes.