GMP auditors need a professional qualification similar to QP status according to a group whose new training scheme is designed to create a competency benchmark.
The US Food and Drug Administration (FDA) has drafted social media guidelines for pharmaceutical companies, regulating the Facebook and Twitter posts of employees who mention drug products.
Whether McKesson will relaunch its bid to acquire German logistics firm Celsio has been questioned by analysts after the proposed $8.3bn (€6.1bn) takeover bid fell through.
AMEC has announced its plan to buy US firm Foster Wheeler AG for $3.2bn (€2.3bn) in a deal that includes the latter’s pharmaceutical plant design services business.
Aurobindo has denied reports of a boiler blast at an Andhra Pradesh, India facility whilst Amgen is investigating an incident at its San Francisco R&D site.
Marine bacteria may yield the next generation of MRSA fighting drugs according to a team that used a peptide from a Pacific Ocean bug to render the hospital superbug less lethal.
Reporting rules designed to prevent drug shortages are likely to be similar in Europe and the US according to the industry group that represents European generic drugmakers.
New GMP rules mean Kangtai Biological Products cannot restart production of a Hepatitis B vaccine wrongly linked to deaths even though authorities now deem it to be safe.
A Hospira plant in India that was issued with a US FDA warning letter last summer has been criticised by the agency again following an inspection last month.
The EMA and US FDA will conduct joint site inspections and share the results of assessments of bioequivalence data for generic drugs under an accord announced last night.
If the Coca-Cola truck can battle the snow each Christmas so too can drug logistics firms using technology, contingency plans and sometimes a good old-fashioned shovel, distributors say.
At this time of year science may play second fiddle to opening presents and drinking mulled wine, but in-Pharmatechnologist.com has leveled the field with its interactive nativity card.
Dissolved API maker Archimica Chemicals has received fines of £120,000 ($196,000) after workers exposed to hazardous chemicals were hospitalized at a plant in Wales, UK.
Contract sales and marketing people who want to work for GSK should think about adopting the new target-free remuneration policy the UK pharmaceutical firm outlined earlier this week.
Firms selling drugs in Brazil have three years to implement track and trace systems capable of monitoring drugs from the factory floor to the pharmacy under a new plan approved by Anvisa.
Novartis has recalled 37 batches of over-the-counter (OTC) cough syrup after its contract manufacturer, BCM, detected a fault on a packaging line at its UK plant.
The US FDA has cited failure to assure an adequate cleaning system at Jubilant Life Science Spokane, Washington State facility, in a recent Warning Letter issued to the firm.
ANVISA has set out what it expects of contractors that provide manufacturing, quality control services and drug storage in the Federal Official Gazette of Brazil (DoU) and invited stakeholders to comment.
Drugmakers seeking ANDAs for certain solid dose, extended-release drugs will need to test what impact alcohol has on their products under new draft guidance on bioequivalence issued by the US FDA.
Medical imaging software firm Median Technologies has signed a three-year contract with US Phase I clinical trial CRO South Texas Accelerated Research Therapeutics (START).
Packaging Coordinators Inc (PCI) has begun construction on a US clinical storage and global distribution facility with demand from international clients being a key driver.
Asking qualified persons (QP) to certify that drug batches comply with manufacturing quality rules in destination EEA markets is unrealistic say groups commenting on proposed revisions to Annex 16 of the EU GMP guidelines.
Almac says it is in a unique position to offer Carbon-14 ADME radiolabeling for the growing antibody-drug conjugate (ADC) market and has already performed the service on a Pfizer candidate.
The US FDA has started work on a national track and trace system for pharmaceuticals after President Barack Obama signed the Drug Quality and Safety Act into law last night.
Smartphones are changing the role of the patient in clinical trials and can be used for industry success, Pfizer and technology provider firm Exco InTouch said at PCT 2013.
The high cost of energy in the UK is having a negative impact on drug and chemical firms' ability to compete according to manufacturers quizzed by the Chemical Industries Association (CIA).
CRA Assessments says its standardised simulation approach to clinical trial monitors is a novel way for CROs and pharma firms to save costs and ensure quality.
US authorities will soon have a new system capable of tracking drugs from the factory floor to the pharmacy shelf after the Senate passed the “Drug Quality and Security Bill” last night.
US Senators will debate pharmaceutical track and trace legislation later today in a session that could have a dramatic impact on how drug supply chains in the country are monitored.
Roche could restart its antibiotic development activities if a superbug busting drug candidate being developed by new partner Polyphor fulfils its early clinical promise.
Remediation at troubled Rocky Mount facility will continue into 2014 Hopira says as it awaits an inspection by the US Food and Drug Administration (FDA).
The US FDA told us that China has “taken longer than FDA had hoped” in approving the visas of new FDA inspectors that would more than double the agency's presence in China.
In one of the largest healthcare fraud settlements in US history, Johnson & Johnson has pleaded guilty to introducing a misbranded drug and must pay approximately $2.2bn (€1.6bn) to resolve criminal and civil liability.
Payers should keep pharmaceutical firms’ quality records in mind when making purchasing decisions to help prevent drug shortages and stimulate manufacturing innovation according to the US FDA.
After almost two years of lagging early phase clinical research work, it seems some CROs are now seeing an uptick in specialized trials that require more scientific expertise.
