GMP Inspectors Zero In On Contaminants, “Goodness” Of Basic Tests
This article was originally published in The Tan Sheet
Good manufacturing practice inspectors are looking for contamination from chloramphenicol, solvents, micro-bacterial treatments and elements such as lead and arsenic, FDA’s Fabricant says. He also says inspectors are testing the validity of specification and identity tests firms use to meet basic GMP requirements.
You may also be interested in...
In Brief: NAD trims BPI claims, formula price-fixing in China, FDA warns Formulife and identifies spiked supplements, NBTY’s consumer redress
BPI discontinues claims at NAD’s behest; China levies fines for infant formula price-fixing; Public Citizen pans OTC Oxytrol; FDA advises ProNatural supplements cannot be topical; FDA warns Formulife on DMAA; FDA uncovers more spiked supplements; NBTY pays back consumers over omega-3 claims; Algean reminded about re-inspection fee.
J&J reports worldwide consumer sales dipped 0.6% to $3.6 billion despite retailers buying more upper respiratory and analgesic products to prepare for the cough and cold season. But in key OTC categories the firm is regaining market share it lost when its iconic brands were temporarily not available.
GlaxoSmithKline restructures its management to ensure adequate focus on its three core areas, pharmaceutical, vaccine and consumer. Consumer product sales fell 3% to $1.72 billion in the third quarter due to continuing supply interruptions and generally weaker markets.