Pharmaceutical Manufacturing Blog Posts

A decision has been taken by the international cleanroom community to move forward with the work to revise ISO 14698 – Cleanroom Biocontamination Control. The vote was accepted with 13 countries giving ‘Yes’ votes and only the USA ANSI team...

Parenteral products (products that are administered to the body by injection) are designed, formulated and packaged to be sterile and to maintain sterility. One of the most important parts of the packaging of the sterile drug product is the container...

Boston - Following the reports about the contaminated sterile medicines produced by the NEEC pharmacy, the State of Massachusetts has closed three more compounding pharmacies due to concerns over risks to patients. In September 2012 it was re...

Pharmaceutical Regulatory Inspections - a practical guide is a new book edited by Madhu Raju Saghhe. This new book contains a practical advice and insight to help different types of pharmaceutical organisations prepare for ...

Cleanrooms in which biotechnology pharmaceutical processing takes place are subject to environmental monitoring. The frequency at which such monitoring should be performed can be difficult to determine. This paper uses quality risk assessment methods...

In January 2013, an comprehensive new book about cleanrooms in the pharmaceutical and healthcare sectors is to be published: 'Cleanroom Management in Pharmaceuticals and Healthcare'. "Everything you need to know about the operation&nb...

In January 2013, an comprehensive new book about cleanrooms in the pharmaceutical and healthcare sectors is to be published: 'Cleanroom Management in Pharmaceuticals and Healthcare'. "Everything you need to know about the operation&n...

Ten biopharma companies have formed TransCelerate BioPharma Inc, a not-for-profit organisation using money and personnel from each firm, with a mission to speed up the development of new medicines. The firms involved are: Abbott, AstraZeneca, Boeh...

In addition to the fungal meningitis issue relating to the steroids produced by the New England Compounding Center (NECC), the U.S. Food and Drug Administration has reported on further contamination concerns associated with the same pharmacy in relat...

Researchers have discovered a new white blood cell type that could revolutionise the design and discovery process for vaccines. Scientists from Newcastle University (UK) allied with Singapore's Agency for Science, Technology and Research to describe...

Pharmaceutical Online have an interesting article about container closure testing. It is important that all pharmaceutical preparations are tested to show that there is no ingress of contamination. The article does, however, focus on just one technol...

“In the draft guidance document, the FDA qualifies the capabilities of spore log reduction testing. The document reads, in part: “FDA does not recommend the use of spore log reduction testing as a method to determine the effectiveness of the clea...

Interesting podcast about raw materials entering process facilities: Raw materials can bring a pathogen or virus into your manufacturing plant and raw material control is of paramount importance to ensure biological safety perspective and...

How much does the global biopharmaceutical industry spends a year on R&D? How much does it cost to bring a drug to market? What are the odds of success of a lead compound approved for human usage? What are the top performing therapeutic areas? Wh...

The PDA are undertaking a survey to document current industry practice for visual inspection of injectable products. Compare results with previous surveys conducted in 1996 and 2003, as referenced by the A3P. For details, see PDA. Posted by: Dr.

William (JR) Humbert, Validation Manager Cook Pharmica has hosted a Podcast for Pharmaceutical Technology. The description is: “This podcast discusses the 2011 FDA Guidance for the Industry, Process Validation: General Principles and Practices,...

‘The CDC Handbook’, a new ‘Guide to Cleaning & Disinfecting Cleanrooms’ has just been published and is available as a paperback and an e-Book. Edited by Dr Tim Sandle, a pharmaceutical microbiologist, the CDC Handbook has contributions fr...

PharmPro has an article on its website about free-drying (lyophilisation), an important drug preservation technique. Here is an extract: “A great deal of thought, time and money goes into developing and creating quality pharmaceuticals, nutra...

How should consumers get rid of unwanted pharmaceuticals and other drug products? A new report assess the best way in terms of cost and environmental impact and has concluded that those unwanted pills should be simply thrown in the thrash. Co...

Maintaining environmental control in a pharmaceutical manufacturing environment is in large part dependent on the facility’s cleaning and disinfection program. The program requires the selection of the appropriate disinfectants, their pro...