Contaminated equipment, OOS results in microbiological testing, and failures in control of incoming goods led to a Warning Letter from the FDA to a U.S. OTC manufacturer.
EMA issues Concept Paper on modern Manufacturing Techniques used for HMPs
The Committee on Herbal Medicinal Products (HMPC) adopted the Concept paper on the development of a Reflection Paper on modern manufacturing techniques used for herbal preparations. The proposed reflection paper should support the industry in the development and application of modern manufacturing methods regarding herbal preparations.
The possible Impact of Artificial Intelligence on the Role of the Qualified Person
Artificial intelligence (AI) is revolutionising industry, and the pharmaceutical sector is no exception. One might think AI reaches its limits when it comes to GMP. But there are promising possibilities.
Packaging of Solid Dosage Forms: Warning Letter in the USA
Due to numerous GMP deficiencies, a US company in the field of solid dosage form packaging received a Warning Letter from the FDA. The inspection had already taken place in November 2022. Since the FDA found the company's response to the Form 483 as insufficient, the Warning Letter now followed.
New VDI Guideline 6022, Blatt 1.1 published as Draft
In June, the VDI published the new guideline 6022 Blatt 1.1 as a draft for comment. The new document is intended to expand on the existing Guideline 6022 Blatt 1, which describes the overall hygiene assessment of ventilation and air-conditioning systems.
Clean-up Phase and Recovery Time - is there a Difference?
When planning cleanrooms and their HVAC systems, questions often arise regarding "recovery time" and "clean-up phase". Are these different requirements, or are they the same? Do these only apply to sterile or also to non-sterile products? And do they have to be measured in operation or at rest?
In a Warning Letter, the FDA describes the inadequate cleaning of product-contact surfaces and the associated risk of cross-contamination at an Egyptian pharmaceutical manufacturer.
FDA Paper on Artificial Intelligence in the Manufacture of Medicines
The US FDA recently published a discussion paper addressing artificial intelligence in the manufacturing of medicinal products. The FDA is considering the extent to which its risk-based regulation is applicable to AI technologies in the manufacturing of medicinal products.
Dead Leg in Pharmaceutical Water System leads to Warning Letter
Due to deficiencies found in an FDA inspection, a US pharmaceutical manufacturer has now received a Warning Letter. Among other things, a dead leg in the pharmaceutical water system is listed as a deficiency.
Do pharmaceutical Water Systems need a sterile Ventilating Filter?
Pharmaceutical water systems (PW and WFI) require a ventilating filter on the storage tank. It prevents dirty ambient air from being sucked into the system when water is withdrawn from the tank. This is often referred to as a sterile filter. However, there are numerous requirements for "real" sterile filtration according to the current EU GMP Annex 1. But is sterile filtration even necessary for this application?
Which Test Sets are used in the 100% Visual Inspection?
In the 100% visual inspection of parenterals required by the pharmacopoeias, so-called test sets with different tasks and properties are used. Find out what these are and what needs to be taken into account.
Is it possible to monitor for Biofilm Infestation using online TOC Measurement?
In pharmaceutical water systems, the TOC value (Total Organic Carbon) is usually determined online. Since bacteria consist mainly of hydrocarbons, the question arises whether TOC monitoring can also provide information about the microbial status of the water system.
Fundamental GMP Deficiencies at Disinfectant Manufacturer
Due to numerous and fundamental GMP deficiencies, the FDA has issued a Warning Letter to a manufacturer of over-the-counter antibacterial hand soap, antiseptics and hand sanitizer in Puerto Rico.
In May 2022, the US FDA inspected an Indian sterile manufacturer, revealing numerous deficiencies that have now led to a Warning Letter. Among other things, deficiencies in media fill, plant and cleanroom design, and environmental monitoring were cited.