Quality Control/Quality Assurance

The agency sent a warning letter to Resonance Laboratories Pvt. Ltd. after an inspection found possible contamination problems.

FDA issued a warning letter to Cixi Zhixin Bird Clean-Care Product Co., Ltd for violations of cGMP for finished pharmaceuticals.

EDQM outlines the steps it will take to implement the ICH Q3D guideline on elemental impurities.

The company was cited by FDA for violations of sterile processing GMPs.

FDA plans to advance initiatives for ensuring reliable production of drugs and biologics in 2017.

The agency put Baoying County Fukang Medical Appliance Co., Ltd. on import alert after observing violations at the company’s Yangzhou City facility.

The commission concluded its P4Bio pilot phase with the adoption of the monograph for etanercept.

Biopharma must see regulators as partners in their efforts to provide safe and effective therapies.

A consistent approach in assessing risk is an important aspect of successful quality management.

The commission approved future plans, appointed members, and adopted texts during its November 2016 session.

Wockhardt Limited received a warning letter from FDA for CGMP violations.

FDA issued a warning letter to Srikem Laboratories Pvt. Ltd. for data integrity violations

BioPharm International spoke with Selexis CEO and Chairman Igor Fisch, PhD about the latest cell-line development advances.

Are investigations supporting or hindering performance excellence?

Designing systems using the principles of good documentation practice, including validated audit trails, is a key piece of a manufacturing data integrity program.

Experts discuss recent advances in cell viability testing methods in bioreactors.

Laboratoire Sintyl S.A. received an FDA warning letter for CGMP quality violations.

EDQM and the Japanese Pharmacopoeia will improve the sharing of information on therapeutic products that are common in both Europe and Japan.

The Indian facility was cited for a range of quality and data integrity violations.

The agency published a guideline for the implementation of ICH Q3D.

FDA issued a warning letter to Lima & Pergher Industria e Comercio S/A for CGMP violations.

FDA cites two Xinxiang Tuoxin Biochemical facilities with CGMP deviations.

FDA issued a warning letter to the company for quality control violations.

The agency sent a warning letter to Cape Apothecary for adulterated drugs.

FDA issued a warning letter to College Pharmacy for multiple violations.