The technology is designed to enable connection to any source data system, enabling connectivity in identifying, monitoring, and managing trial risks.
Kyowa Kirin reorganizes to create quality division that reports directly to CEO Masashi Miyamoto.
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.
Continuous manufacturing gives agility to the supply chain that the industry did not previously have, according to a principal scientist Janssen.
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.
SGS North America completed a four day-audit of Envigo’s laboratory animal diet facility.
Spanish regulators have criticised operations at a facility operated by vaccine firm Euro Far Alergi S.L.
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.
Failure to discuss impurities and unacceptable starting materials topped the list of deficiencies in CEP applications in 2011 according to the EDQM.
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.
The US Pharmacopeial Convention (USP) and the FDA are calling for stricter quality standards for the production and supply of heparin.
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.
Excipient makers could save up to 200 man hours with a new industry-driven, third-party audit certification scheme set to launch next week.
April saw the publication of the second draft of Excipact, a set of certification standards for third-party auditors of excipient manufacturers.
PRA choose MetricStream for help with compliance management
PRA International will use MetricStream’s GRC software solution in an attempt to strengthen its compliance and quality management programs.
Ricerca’s Lyon facility ISO certified
CRO Ricerca Biosciences has gained ISO 9001:2008 Certification for quality management systems at its facility in Lyon, France.
World Courier network meets GxP requirements
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 lab gains drug quality accreditation
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.
Artel's QA/QC services driving expansion
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.
Fluorotechnics buys into electrophoresis market
Australian proteomics fluorescence expert Fluorotechnics has
acquired ETC Elektrophorese-Technik to gain access to the company's
electrophoresis expertise and product lines.
Dr Reddy's beefs up quality image
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.
Manufacturers to get insider tips from big guns
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
New toolkit to assist drug quality assurance
Best Practices Research and Consulting have put together a toolkit
to help pharma companies improve manufacturing quality assurance
ARTEL and Caliper deal enhances lab data integrity
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 plant falls foul of FDA rules
Roche's Burgdorf plant making insulin pumps has serious regulatory
compliance problems, said the FDA, which could block import of the
products unless resolved.
Trained staff key to manufacturing QC
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.