Article archive

Final QP Declaration Template by EMA

18/06/2014 15:43
More than three years ago, the EMA has published two draft documents for a template for the QP's declaration concerning GMP compliance of the API used as starting material and verification of its supply chain called "The QP declaration template": 1. The draft template for the Qualified Person's...

Guidance on Cleaning Validation in Active Pharmaceutical Ingredients Plants by APIC

18/06/2014 00:45
An APIC multinational working group has compiled a new guidance on cleaning validation with the title "APIC Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredients Plants". Publication date is May 2014 and the document can be downloaded from the APIC website. The...

FDA launches openFDA to provide easy access to valuable FDA public data

15/06/2014 22:40
The U.S. Food and Drug Administration has launched openFDA, a new initiative designed to make it easier for web developers, researchers, and the public to access large, important public health datasets collected by the agency. In alignment with the recent Presidential Executive Order on Open Data...

Seetharam Kandarpa Receives ASQ-Certified Pharmaceutical GMP Professional

14/06/2014 07:48
  Milwaukee, Wis., 06/07/2014 — The Certification Board of ASQ is pleased to announce that Seetharam  Kandarpa has completed the requirements to be named an ASQ-Certified Pharmaceutical GMP  Professional, or ASQ-CPGP.   As such, Seetharam Kandarpa has reached a...

Important Judgement in the GMP World: EU Commission entitled to take far-reaching Decisions when GMP Deviations are found

12/06/2014 21:49
A judgement of the EU Court of Justice (Sixth Chamber) from 10 April 2014 on the suspension of the marketing and the withdrawal of certain medicinal products batches has been published. The judgement highlights the importance of the decisions taken by the EU Commission. Moreover it is pointed out...

Particles continue to cause major compliance problems and recalls

11/06/2014 22:04
Again, a batch of sterile products has been recalled due to detected particles. In this case, the company Hospira has initiated a recall of the medicinal product "Labetalol Hydrochloride". Labetalol Hydrochloride a clear colourless solution for intravenous administration used in cases of severe...

New Procedure for co-ordinating GCP-Inspections by CHMP

10/06/2014 22:06
The GCP Inspectors Working Group of the European Medicines Agency (EMA) has finally published the Procedure for coordinating GCP inspections requested by the CHMP (EMA/INS/GCP/55482/2013). This procedure describes the different steps of the Good Clinical Practice (GCP) inspection process and...

Health & drug to remain under administrative control of two ministries despite streamlining process by Modi govt

30/05/2014 11:40
Though the new government led by Narendra Modi in India has merged different departments and streamlined the ministries for better governance and control while reducing the flab, the control of the health and drugs will remain under two ministries, maintaining the status quo. Sources said though...

Mylan launches atovaquone & proguanil hydrochloride tablets

30/05/2014 11:37
  Mylan Inc., a global pharmaceutical company committed to setting new standards in health care, has launched atovaquone and proguanil hydrochloride tablets, 62.5 mg/25 mg and 250 mg/100 mg, the generic version of GlaxoSmithKline's Malarone tablets.  Mylan received final approval from...

FDA Warns German Drugmaker for Potentially Contaminating Products

28/05/2014 15:42
    German drugmaker Sanum-Kehlbeck has been cited for using the same equipment to produce penicillin and non-penicillin products, a situation that could lead to serious allergenic reactions in some patients. The non-penicillin products could be contaminated with penicillin, the FDA said...
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