Breaking News on Pharmaceutical Technology

Product news > QA/QC & validation

Latest news headlines

Products

Suppliers

Group offers "pharma leadership on demand”

20-Oct-2008 - A UK company has been launched with the aim of providing high level management expertise to pharmaceutical companies on an “on-demand” basis.

News in brief

InfraServ Knapsack gets bigger in GMP analyses

19-Oct-2008 - German contract services firm InfraServ Knapsack has added three new capabilities in its analytical division aimed at servicing Good Manufacturing Practice (GMP) production.

Applied Biosystems' rapid Mycoplasma detection kit

14-Oct-2008 - The MicroSEQ detection platform, developed by Applied Biosystems, looks set to revolutionise the detection of bacterial Mycoplasma in industrial scale biopharmaceutical manufacturing.

Exclusive interview

Artel's QA/QC services driving expansion

14-Oct-2008 - With big pharma and biopharma looking to cut costs and increase efficiency, liquid handling experts Artel have found that their services are in greater need than ever before.

Certification at top of agenda for IPEC Europe

09-Oct-2008 - The International Pharmaceutical Excipients Council (IPEC) of Europe has outlined the actions it is taking as it continues to develop awareness of the need for safe excipients.

BioVigilant files rapid detection tech DMFs with FDA

08-Oct-2008 - BioVigilant says that two type V DMFs for its IMD-A rapid microbial detection system, which it has filed with the US FDA, can now be referenced by clients hoping to use it in drug manufacture, potentially reducing review times.

Sanal salt granted GMP certification

06-Oct-2008 - AkzoNobel has been awarded a good manufacturing practice (GMP) certificate for Sanal (sodium chloride) salt manufactured at its plant in Mariager, Denmark.

Pfizer narrows research focus again

02-Oct-2008 - Pfizer is shifting its research focus to those diseases where its sees the potential for the biggest treatment improvements and profits, while dropping eight disease areas including cholesterol.

Marketing deal for Prosonix’s SonoLab

30-Sep-2008 - Syrris has become the primary marketer for Prosonix’s new SonoLab laboratory scale sonocrystallisation and sonoprocessing equipment.

Handheld device for validating raw materials

29-Sep-2008 - Ahura Scientific has launched an updated version of its TruScan handheld instrument, which allows for raw materials to be quickly verified.

Sandoz’ SA plant gets WHO NoC letter

23-Sep-2008 - The WHO has issued Sandoz with a Notice of Concern (NoC) after an inspection of the firm’s Kempton Park facility in South Africa identified 41 deviations from GMP standards.

Capsugel targets toxics sector with vibration-free hood

18-Sep-2008 - Oral dose filling specialist Capsugel hopes that its new Xcelohood containment system will improve industrial weighing operations during the preparation of high-potency drugs.

Exclusive interview with IPEC China chairman Nevin Cheng

IPEC China’s chairman sets out next steps

18-Sep-2008 - IPEC China must become a “harmonisation bridge between China and other countries,” according to Colorcon’s Nevin Cheng who was recently elected chairman of the new organisation.

FDA blocks imports from two Ranbaxy plants

17-Sep-2008 - The FDA has issued generics giant Ranbaxy Laboratories with two warning letters, detailing “extensive deviations from US cGMP requirements” at the firm’s manufacturing plants in Dewas and Paonta Sahib, India.

Manufacturing facilities: News in brief

16-Sep-2008 - in-PharmaTechnologist.com's latest round-up of developments in pharmaceutical manufacturing features news of the world’s “biggest pharmaceutical allergen production unit”, Lentigen’s relocation and a cytotoxic robot.

New EC GMP regulations for radiopharma

15-Sep-2008 - Revised good manufacturing practice (GMP) requirements for the production of radiopharmaceuticals have been published by the European Commission (EC).

Residual solvents guidelines cause ANDA “uncertainty”

11-Sep-2008 - Companies have failed to provide the information needed under the USP’s new chapter regarding residual solvents, causing them to incorrectly file ANDAs, according to the Office of Generic Drugs (OGD).

Pharma manufacturing products: News in brief

10-Sep-2008 - in-PharmaTechnologist.com’s latest round up of products launched in the pharmaceutical manufacturing sector includes new offerings from Genevac, Lock and AdvantaPure.

FDA publishes final rule on cGMP amendments

09-Sep-2008 - The US Food and Drug Administration (FDA) has published its latest amendments to current good manufacturing practice (cGMP) regulations.

FDA lists drugs with potential safety issues

09-Sep-2008 - A list of drugs currently being evaluated for potential safety issues by the US Food and Drug Administration (FDA) has been posted on its website.

FDA seizes drugs worth $74,000

25-Aug-2008 - The US Food and Drug Administration (FDA) has ordered the seizure of $74,000 worth of Xiadafil VIP tablets after SEI Pharmaceuticals refused to withdraw them from the market.

FDA clears APP’s Barceloneta plant

20-Aug-2008 - APP Pharmaceuticals, currently the sole supplier of therapeutic heparin vials to the US market, has received FDA approval to manufacture three new formulations of the blood-thinner at its plant in Barceloneta, Puerto Rico.

Counterfeits take chunk out of TCM sales

19-Aug-2008 - The impact counterfeit pharmaceuticals can have on a company’s sales has been highlighted by Tongjitang Chinese Medicines’ (TCM) second quarter results.

USP opens its first site in Brazil

19-Aug-2008 - The US Pharmacopeia (USP) has continued to expand its global reach by opening a site in São Paulo, Brazil; its first in Latin America.

Manufacturing facility news in brief

18-Aug-2008 - in-PharmaTechnologist.com's round-up of developments in pharmaceutical manufacturing features news of SAFC’s new highly potent API plant, ISPE’s Facility of the Year Awards and Israel’s proposed entry into PIC/S.

Sign up for your free newsletter