Seres Therapeutics draws distinction between its quality practices and those of the fecal microbiota for transplantation (FMT) operations that triggered FDA alert.
API recalls have sparked discussion on the development of impurities during manufacturing and the ways in which risks can be mitigated, according to an industry expert.
There is a common and often unchallenged perception that manufacturing quality standards in pharmerging countries are worrisome, but Lee Newton of Lonza argues this is not the reality.
BioIVT will use its new internal cloud-based Quality Management System to manage clinical trial data at all of its locations, following the acquisition of five companies since 2017.
Jinan Jinda Pharmaceutical Chemi has not fixed GMP deficiencies at its Shandong plant say Spanish regulators calling for ban on nitrofurantoin shipments to the EU.
The Active Pharmaceutical Ingredients Committee (APIC) has unveiled a new guidance document for API distributors that seeks to provide step-by-step instructions on how to meet WHO and European Union guidelines on the distribution of APIs.
Cherwell Laboratories has more than doubled the size of its Bicester, UK, plant that manufactures prepared media for microbial production after a boom in demand for its goods.
Ensuring outsourced clinical research is of a high standard is critical to the viability of the pharma sector and requires cross industry collaboration according to leaders gathered at the Avoca Group’s Quality Summit.
World Courier has GxP compliant status for its whole distribution network, covering more than 140 offices in 50 countries, which it believes no other business in the sector has achieved on such a large scale.
Peru’s National Center for Quality Control (CNCC) has attained ISO/IEC 17025:2005 accreditation, furthering its safety efforts and becoming one of the few Latin American countries to achieve this.
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.
Australian proteomics fluorescence expert Fluorotechnics has
acquired ETC Elektrophorese-Technik to gain access to the company's
electrophoresis expertise and product lines.
India's Dr Reddy's Laboratories has become the first company in the
world to receive a new verification mark for two of its products,
it was announced last week at the CPhI trade show in Milan.
Several top pharmaceutical companies have had their business
practices scrutinized by a benchmarking company to help provide
executives with ways to stay out of trouble with regulatory
authorities.
A technology partnership between ARTEL and Caliper Life Sciences
aims to enhance automated liquid delivery standards improving
laboratory data integrity. The collaboration aims to manufacture
technology to a level that is outlined...
Roche's Burgdorf plant making insulin pumps has serious regulatory
compliance problems, said the FDA, which could block import of the
products unless resolved.
As regulators increase their scrutiny of manufacturing and quality
control, the key to avoiding non-compliance notices lies in
well-trained, knowledgeable personnel, says new report.
