Compliance

Bio News | cGMP Manufacture | Facilities | Industry News | Inspections

GRAM Completes Successful FDA Inspection

Following eight day inspection, GRAM was found to be in compliance with cGMP, with no Form 483 observations issued

11.09.18

Aseptic Processing | Formulation Development | Information Technology | Logistics | QA/QC

Galentic Pharma

Pranoy Parikh, Business Development 11.08.18

Validation

Pilgrim Quality Solutions, an IQVIA company

Pilgrim Quality Solutions is a leading global provider of enterprise quality management software and services for the Life Sciences and other highly regulated industries. For more than 20 years, Pilgrim has automated thousands of processes that ensur…

Sandy Carson, MarCom & Events Manager 11.08.18

Bio News | Industry News | Inspections

Avance Completes Successful FDA Inspection

Houston facility was successfully inspected by the U.S. FDA on October 1 through October 4, 2018.

10.31.18

Bio News | Industry News | Promotions & Moves | Regulatory Affairs

CROMSOURCE Appoints Regulatory Services Director

David R. Dills has more than 28 years of experience in the medical device and pharmaceutical industry

10.26.18

Breaking News | Industry News | Inspections

Almac Completes HPRA Inspection at its European Campus

Can now support analysis of commercial drug product and provide flexible secondary labelling and packaging solutions

10.26.18

Recipharm Audit Results in Licence Restriction

Five non-critical highly potent products from the Ashton-u-Lyne, UK site suspended due to potential cross contamination risk

10.25.18

Bio News | cGMP Manufacture | Industry News | Inspections | Scale-up/Technology Transfer

SEA Vision Launches HarleNir

Near Infrared Hyperspectral vision system can inspect an entire batch on the manufacturing line in a fully automated fashion

10.22.18

Bio News | cGMP Manufacture | Facilities | Industry News | Inspections

Almac Completes Successful HSA Inspection

Underwent regulatory inspection by the Health Sciences Authority of its facility in Singapore

10.22.18

Regulatory Affairs

Reporting CPPs to FDA

Importance of identifying critical process parameters in original submissions to FDA.

Aloka Srinivasan, Ph.D. Lachman, Consultant Services 10.10.18

Regulatory Affairs | Serialization

Serialization & EU FMD Readiness

Executives from Recipharm and TraceLink provide insight into a recent report from FutureLink Munich 2018

Tim Wright, Editor, Contract Pharma 10.10.18

Breaking News | Industry News | QA/QC

USP Launches Impurities for Development Program

Aims to help manufacturers meet quality standards and regulatory requirements to control impurities

10.10.18

Logistics | Process Validation | QA/QC

Nulogy Launches Quality & Compliance Solution

Capabilities provided to contract packagers are purpose-designed for compliance and GMP compatible and unique to the market

Online Exclusives10.04.18

Samsung BioLogics' Plant 3 Starts Production

World’s largest single bio manufacturing plant is cGMP ready and started production (OOF, out of freezing) after validation

10.01.18

APIs | Breaking News | Facilities | Industry News | Inspections

Asymchem Passes FDA Inspection at API Mfg. Site

Reports successful FDA inspection of Tianjin 2 development and commercial manufacturing facility with no Form 483 issued

09.14.18

Validation

Particle Technology Labs

Premier cGMP laboratory, dedicated to particle size and characterization. Non-biased facility provides the most appropriate instrument and result based upon your sample types and needs. Testing includes Particle Size, BET Surface Area, Pore Volume Di…

Kelli Hubert, Customer Service Manager 09.14.18

Bio News | Collaborations & Alliances | Industry News | Regulatory Affairs