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IPA questions FAERS data interpretation in the Ohio State University study

Express Pharma

The organisation stated, PV (pharmacovigilance) events are generally a reflection of the properties of the active drug substance and the drug product, irrespective of where it is manufactured. Thus, it cannot be conclusively linked with the manufacturing site or manufacturers.

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WuXi STA breaks ground on new Delaware manufacturing facility

European Pharmaceutical Review

Contract research, development and manufacturing organisation (CRDMO) WuXi STA has broken ground on its new 190-acre pharmaceutical manufacturing campus in Middletown, Delaware, US. The biopharmaceutical industry is part of Delaware’s DNA,” stated Delaware Governor John Carney.

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Tracking the Drug Trail

Pharmaceutical Technology

TABLET FORMATS One of the problems with track and trace for pharmaceuticals across the world is the way drugs are dealt with on an item level in Europe and the US. In the US solid dosage forms are distributed as containers of tablets and these can only be coded on the container and not on a per-item basis.

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Pharmaceutical sampling procedures for non-sterile products

GMPSOP

Table of Contents Importance of sampling in pharmaceutical industry Pharmaceutical sampling procedures are carried out during and at each major processing step during the manufacturing to ensure the highest quality is attained. Pharmaceutical sampling procedures ensure all of the above. as their visual aids.

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Overview of pharmaceutical quality control steps and implementations

GMPSOP

Proper labeling and traceability are essential when it comes to reagents. All reagents, whether bought from suppliers or made in the lab, must have legible labels with their name, lot or batch number, and vendor information. Labels that identify divisions in reagents should enable us to locate the original source.

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What are the elements of quality control process in pharmaceuticals

GMPSOP

Typical flow of samples in a quality control laboratory The quality control laboratory receives samples that are collected randomly at the beginning, middle, and end of manufacturing processes. Quality is everyone’s responsibility, and it should pervade every aspect of pharmaceutical manufacture and packaging.

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04 Steps to Investigate Out of Specification (OOS) Result

GMPSOP

Each tablet has the label claim of 100mg (w/w). Pharmaceutical manufacturers must have written procedures on the steps to take when any result does not meet specifications. Access to exclusive content for an affordable fee. It is improbable that all 20 results will be 100 mg exactly. The original single result is invalidated.