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Pharmaceutical Microbiology · 23h ago

Computer Systems Validation

The MHRA are continuing their series on data integrity and computer systems validation. The latest blog post has some useful information (this time from Balall Naeem), such as:If you are abl...
Pharmaceutical Microbiology · 1d ago

Microbiological monitoring of pharmaceutical water systems

Water is widely used in pharmaceutical manufacturing; either as a raw material, as an ingredient, or as a final product. Water is also used for rinsing equipment or for the preparation of di...
Pharmaceutical Microbiology · 2d ago

MHRA GMP Inspection Deficiency Data Trend 2016

The GMDP Inspectorate has improved the way of gathering the inspection deficiency data for 2016. The new data trending can allow industries to identify:The severities and frequencies by the ...
Pharmaceutical Microbiology · 3d ago

Silver Bullet Against MRSA: Silver Ion-coated Devices

Methicillin-resistant Staphylococcus aureus (MRSA) infections are caused by a type of staph bacteria that has become resistant to the antibiotics used to treat ordinary staph infections. The...
Pharmaceutical Microbiology · 4d ago

Chemical purity regulatory findings

New Applications for Certificates of Suitability (CEP) for chemical purity (Top 10 deficiencies)The EDQM has issued a document that summarises the ten most frequent questions raised after th...
Pharmaceutical Microbiology · 6d ago

Guidance on quality of water for pharmaceutical use

Concept paper on the need for revision of note for guidance on quality of water for pharmaceutical useUp to now, the production of Water for Injections (WFI) had been limited to distillation...
Pharmaceutical Microbiology · 6d ago

Why we get diarrhea

Does diarrhea serve a purpose? Does it actually help clear the bacteria causing a gastrointestinal infection, or is it merely a symptom of disease that should be prevented as much as possibl...
Pharmaceutical Microbiology · 1w ago

Test for Abnormal Toxicity

The scientific validity and rationale of the test for abnormal toxicity has been the subject of debate for some time in Europe. The test was originally developed for detecting external conta...
Pharmaceutical Microbiology · 1w ago

FDA - Burkholderia cepacia complex poses a contamination risk

FDA warned drug manufacturers on May 22, 2017 about a series of product recalls involving Burkholderia cepacia complex (BCC) contamination. BCC is a water-borne pathogen that can be found in...
Pharmaceutical Microbiology · 1W ago

Risk assessment and pharmaceutical processing hazards

Pharmaceutical medicines are expected to be efficacious and to perform according to the product licence or as directed by the medical practitioner. Medicines are also expected to be safe, an...