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Manufacturing

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How To Find And Remedy Data Integrity Lapses In Microbiology Labs

Analytical chemistry labs may get all the attention when it comes to the search for data integrity failures, but FDA and industry experts say not to overlook the possibility of such failures in microbiology labs. Just keep in mind that the highly manual operations in these labs calls for a different approach to auditing.

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Biocon, Dr Reddy’s Might Be Out Of The Woods On GMP Issue

Two Indian firms – Biocon and Dr Reddy’s – have received crucial establishment inspection reports (EIRs) from the US FDA amid improved compliance levels at their manufacturing sites.

Manufacturing Compliance

FDA’s Delay Issuing DSCSA Grandfathering Guidance Creating Problems For Manufacturers

US agency's delay in issuing guidance for how it intends to handle un-serialized 'grandfathered' drug products is creating headaches for manufacturers and other parties in the pharmaceutical distribution chain.

Manufacturing Quality

European Commission Finally Delivers On GMP Standards For ATMPs

Following protracted consultations with stakeholders on how best to specify good manufacturing practice standards for advanced therapies, the European Commission has at last published the long-awaited guideline. The industry is now keen to work with EU inspectors and competent authorities to develop a common understanding of the risk-based principles outlined in the final document.

Manufacturing Europe

Medicines In The Environment: EU Moots Action On ‘Green’ Manufacturing, Pack Sizes, Discharges

Stakeholders in the EU are being asked to give their views on ways of addressing the problem of pharmaceuticals posing public health risks when they enter the environment via their manufacture, use and disposal. “Green” manufacturing and design, closer monitoring of discharges and more appropriate pack sizes are among proposals put forward.

Compliance Europe

Lawsuit, Warning Letter Mark Return Of B. Cepacia As GMP Issue

Lawsuit over infant's death and warning letter over recurring contamination underscore the importance of screening for Burkholderia cepacia and when found, removing the microorganism from pharmaceutical manufacturing processes.

Quality Compliance

Risk Assessments Of New Drug Elemental Impurities Get Mixed Reviews From Regulators

ICH Q3D went into effect in June 2016 for new drugs, but so far doesn't seem to have completely resolved worries about the presence of elemental impurities in drug products.

Manufacturing Quality
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