GMP News - Pharmaceutical Technology


New WHO Guideline on "Cold Production of WFI"

In February 2019, the WHO published a new Guideline for comment on the production of WFI using non-distillation methods. Read more about the draft entitled "Production of Water for Injection by Means other than Distillation".



News from the ICH on Continuous Manufacturing

In June 2018 already, the International Council for Harmonisation (ICH) announced the coming issuance of a new ICH Guideline on continuous manufacturing. Now, the ICH has released further news about the planned content of the new guideline ICH Q13.



New VDI Guidelines for Clean Room Technology

The Association of German Engineers (VDI ="Verein Deutscher Ingenieure") has recently released two new draft guidelines from the area of clean room technology: one regarding central air handling systems, and the other one regarding air filter systems.



Revision of EMA's Guideline on the Use of Pharmaceutical Water

In the course of the revision of the European Pharmacopoeia which allows the production of WFI with other methods than distillation, the revision of EMA's "Guideline on the quality of water for pharmaceutical use" has become necessary.



Non-Compliance at Italian Sterile Manufacturer

In the course of an inspection conducted in October 2018, the Italian health authority discovered several GMP deviations in the areas of sterile manufacturing, packaging and QC testing at an Italian manufacturer. Read more details about the Non-Compliance Report which can now be found in EMA's inspection database.



USP article on pharmaceutical continuous manufacturing

In the latest edition of the Pharmacopoeial Forum 44(6), the US pharmacopoeia USP has published a so-called Stimuli Article on pharmaceutical continuous manufacturing. Apart from important definitions, the document contains further information on material properties and characteristics as well as risk management approaches for continuous manufacturing.



ISO standard for packaging machines

A new international technical committee ISO/TC 313 Packaging Machinery has been founded, which will be responsible for establishing international standards for packaging equipment and systems.



European Pharmacopoeia: New Chapter on Visual Inspection for Visible Particles

The European Pharmacopoeia has published a new chapter on testing of parenterals for visible, particulate matter in Pharmeuropa 30.4.



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.



Non-Compliance Report for Indian API manufacturer

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.



New: ICH Q13 supports continuous manufacturing

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.


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