New VDI Guidelines for Barrier Systems, Medical Devices and HVAC systems
In August, the Association of German Engineers (VDI ="Verein Deutscher Ingenieure") released three interesting VDI guidelines. The topics addressed are tightness of containment systems, identification of critical impurities in the manufacturing process of medical devices as well as requirements on the planning and implementation of central HVAC systems. Find out more about the new VDI guidelines.
Serious GMP Deficiencies at Italian Sterile Manufacturer
On the basis of a GMP inspection performed at an Italian sterile manufacturer, the Italian authority (AIFA) recommended the recall of batches and issued a GMP non-compliance report. Read more about the GMP deficiencies observed.
FDA Warning Letter to Indian manufacturer due to an insufficient OOS procedure
In July 2018 the US FDA issued a Warning Letter to an Indian sterile manufacturer. The content of the letter primarily affects the inadequate procedure with OOS results. Besides, further deviations like in the visual inspection and the facility maintenance have been criticized.
During an inspection in March 2018, the French competent authority discovered various GMP violations at the site of an Indian manufacturer. Learn more about the Non-Compliance Report issued on behalf of the EMA.
Warning letter to Indian drug manufacturer due to various deficiencies
Because of the GMP deficiencies found during an inspection and the company's response, which was deemed unsatisfactory by the FDA, the agency has now issued a warning letter. The main complaints: incoming goods testing, release, equipment design and the HVAC system.
Highly Purified Water (HPW) Monograph to be suppressed
The EDQM has announced the suppression of the Highly Purified Water (HPW) Monograph (1927) in 2019. This was justified with the revision of the European Pharmacopoeia which now allows non-distillation methods for the production of water for injection (WFI). As a consequence, the monograph became redundant.
On 22 June, it became official: the International Council for Harmonisation (ICH) announced in a press release that with the new Guideline ICH Q13, they would support the introduction of continuous manufacturing processes into the pharmaceutical industry.
Air technology for laboratories: new VDI guidance published
In April 2018, the new VDI guidance 2051 "Air-conditioning - Laboratories" was published. It covers protection objectives for persons, environment and products in different types of laboratories, such as biological, chemical or radionuclide labs. Read more about the new laboratory guideline.
EMA publishes final Q&A Document on the use of PDE (HBEL) Values
In April 2018, the EMA published the final version of the Q&A document on the use of Health-Based Exposure Limits (HBELs) without special notice. The draft version had become necessary in 2016 because the EMA had generated widespread uncertainty within the pharmaceutical industry with their guideline on setting these limits (PDE values as well). Find out more about the EMA HBEL Document.
Insufficient water system design: warning letter in Mexico
Due to severe GMP violations, the US FDA has issued a warning letter after inspecting a Mexican pharmaceutical manufacturer. Major deficiencies have been found in the pharmaceutical water system as well as in microbial laboratory testing.
New Ph. Eur. Developments in the Visual Inspection of Injectables
Ph. Eur. chapter 2.9.20 on the visual control of parenterals is currently being revised. There are no major changes expected. What is much more interesting is the announcement of a new advising chapter. Read more about the new chapter 5.17.2 on visual inspection.
In the current EU GMP Annex 1, the monitoring of 0.5 and 5 µm particles in clean rooms is a requirement. It refers to technical document ISO 14644, Part 1 for measurement. However, the limit for 5 µm for class ISO 5 (ISO 4.8) has been removed from this document. That is why there had been great expectations for the revised Annex 1 draft.