Saturday, 1 February 2014

Ranbaxys Toansa plant products banned by USFDA due to data integrity issues

Ranbaxys Toansa plant products banned by USFDA due to data integrity issues

Ranbaxy Laboratories had entered into a $500-million settlement in May last year after allegations of fake test results and selling of adulterated products. Now, the USFDA has banned products from Toansa plant of Ranbaxy Laboratories which has affected Ranbaxy with regards to selling products in the US market. Data integrity violations have been cited by the US regulator leading to ban at read more

Admissions notification for various Quality Council of India (QCI), Government of India Approved and Certified and Industry Endorsed Programmes in 1) Pharma Good Manufacturing Practices 2) QA & QC 3) Regulatory Affairs and also in 4) Clinical Research 5) Good Laboratory Practice & 6) IPR(E cum distance learning) VIEW NOW

FDA notes flies in sample storage room at Toansa plant

The US Food and Drug Administration (FDA) has presented a final guidance aiming to clarify the need for information given in the Dear Doctor or ‘Dear Healthcare Provider’ (DHCP) letters. These letters are bulk mailers and are usually sent out to inform about an adverse reaction or a problem with the usage of a drug or medicinal product.Such letters are read more

EU, UK and Aussie regulators focus on Ranbaxys Toansa plant

Fourth warning letter in the last 9 months has been issued to NVN Therapeutics, a manufacturer of a medical food, by the US Food and Drug Administration (FDA). As given by the FDA guidelines, medical foods are not intended to be a part of general diet like consuming vegetables and fruits to reduce the risk of obesity or read more

Indian drug regulator too watches for Ranbaxys Toansa plant

With a host of activities occurring around Ranbaxys Toansa plant at Punjab, the Indian drug regulator, Drug Controller General of India (DCGI), also felt the need to take active involvement. The drug regulator has ordered the company to provide with complete details and explanation regarding the violation of good manufacturing practice (GMP) standards at 

USFDA issues warning letters for GMP violations

There has been a general increase in warning letters issued by USFDA, for violations of good manufacturing practice (GMP) standards. Recently, USFDA conducted inspections at some food and drug manufacturing sites and issued warning letters to the companies. One warning letter was issued to Gadre Marine Export read more

Quinapril tablets recalled by Lupin Pharmaceuticals from the US market

After failing the impurity specification test for multiple lots of quinapril tablets, the US subsidiary of Lupin Pharmaceuticals has voluntarily recalled quinapril tablets from the US market under class-II. As given by USFDA, in class-II recall, the use of a violative product during manufacturing can cause temporary or adverse health consequences that are reversible and