"Perfection is the Enemy of Good"
By Martin VanTrieste
I made this simple statement during a presentation last year, based on Voltaire’s quote “the perfect is the enemy of good,” to explain the importance of moving swiftly to protect patients, and it has since become a mantra of Rx-360.
But what does it mean exactly? Read more
Thank You for Visiting Us at the PDA Annual Meeting
Rx-360 exhibited at the PDA Annual Meeting in Las Vegas, spreading the word of the organization’s mission and progress.
At the PDA meeting there were many interesting presentations about manufacturing science but there were also a few key take-a-ways about new GMP developments. Read more
Click here to view the presentations
Please note, this link will expire by May 8, 2009
June 3-4 Seminar: Global Supply Chain Integrity and Anticounterfeiting (ISPE)
The integrity of the pharmaceutical supply chain is becoming the focus of increasing concern and scrutiny. The supply chain is becoming more complex, the number of environmentally sensitive products is rising sharply and the sophistication of counterfeiters is alarming.
Consequently, the industry is facing increasing legislative scrutiny and guidance on ensuring the quality of its products throughout their entire lifecycle. The FDA, the European Commission, and WHO have both issued recent guidance documents to address these challenges while regulatory agencies around the world are in the process of reviewing their regulations in an attempt to assure safe, efficacious drug supply from the manufacturer to the final delivery to the patient.
Click here for more information on this seminar
Hogan & Hartson Pharmaceutical and Biotechnology Update:
Current Trends in FDA's Pharmaceutical Good Manufacturing Practice (GMP) Warning Letters
In the past twelve months, the U.S. Food and Drug Administration (FDA) has issued more than 25 Warning Letters to manufacturers of finished pharmaceuticals and active pharmaceutical ingredients (APIs) for violations of the current good manufacturing practice
(GMP) regulations. A detailed review of these Warning Letters provides a number of useful insights into where the FDA is currently focusing its limited GMP enforcement resources, and where the agency may start to place greater emphasis in the future. Read more
Trade versus Trust in the Pharmaceutical Supply Chain
Courtesy of Clarkston Consulting
Life sciences organizations invest a significant percentage of revenue into building brand awareness and company reputation. Like most manufacturing business, they know that losing control of their supply chain threatens the investment in their brand. It only takes one case of contamination, from any source, to cause loss of life and destroy the public’s trust, along with your sales, brand image and shareholder’s confidence. Read more
News - 24 April 2009
Drug and Device Accountability Act of 2009
Drug and Device Accountability Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to deem a drug or device to be misbranded unless certain conditions related to registration of establishments, identification of prior transactions, labeling for country of manufacture, and provision of required information on importation are met. Read more
News - 14 April 2009
FDA Uncovers a Show and Shadow Factory Related to Heparin API Production
Two Warning Letters were issued by the FDA which only highlighted the necessity for Rx-360 to be successful. From reading these FDA issued Warning Letters it appears that the FDA uncovered a “Show Factory” at Shanghai No. 1 Biochemical & Pharmaceutical Co. Ltd, and its “Shadow Factory” at Qingdao Kangyuan or Qingdao Jiulong. Read more
News - 18 April 2009
Spanish Ministry of Health has demanded to recall 14 batches of the injectable product Clindamicina
The Spanish Ministry of Health has demanded to recall 14 batches of the injectable product Clindamicina as the Chinese manufacturer of the API, Zhejiang Tiantai Pharmaceuticals, has failed to comply with GMP. The European Directorate for the Quality of Medicines & HealthCare (EDQM) has also suspended their CEP.
In parallel, Spanish Ministry of Health is requesting the audit reports that support GMP declaration by the QP only for Chinese manufacturers.
We should all be aware of these types of events and increase our diligence when selecting and auditing suppliers.
Join us for Rx-360's Launch Meeting in D.C. on June 5