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.
The UK MHRA saw an increase in sterility issues at drug plants in 2016 although quality system problems remained the most common deficiency seen during inspections.
Several FDA officials are currently visiting India and meeting with manufacturer CEOs and government officials to discuss the way the agency’s inspections are expected to change over time.
Deficiencies related to manufacturers’ quality systems are by far the most prevalent issue cited from inspections by the UK’s MHRA (Medicines and Healthcare Products Regulatory Agency), the agency said in a report on 2013 inspections.
UK pharmaceutical test media supplier Cherwell Laboratories says its receipt of BSI ISO 9001:2008 accreditation demonstrates its commitment to quality.
The US Food and Drug Administration (FDA) has released a draft
guideline document outlining a model for implementing the
International Conference on Harmonization's (ICH) Q10.
Drug manufacturers can better understand how they can achieve
regulatory compliance and avoid production stoppages and recalls by
following new guidance issued by the US Food and Drug
Administration (FDA).
UK packaging giant Rexam, a major producer of pharmaceutical
closures and one of the world's top five consumer packaging groups,
has introduced a range of LDPE and foil laminate bags and drum
liners manufactured in a cGMP compliant...