Analytical quality control refers to all those processes and procedures designed to ensure that the results of laboratory analysis are consistent, comparable, accurate and within specified limits.

QC laboratories perform a critical role in demonstrating pharmaceutical products are consistently manufactured, safe, potent, and pure. At the same time, the number of tests run by QC laboratories is ...

Aseptic processing demands reliable, robust, and validated analytical methods to ensure sterility, safety, and quality, ...

With the publication of ICH Q2(R2) and ICH Q14, the modern Quality by Design (QbD) paradigm introduced by ICH Q8 for manufacturing has now been extended to Quality Control (QC). A life cycle and ...

Sigma metrics constitute a quantitative approach that integrates bias, imprecision and total allowable error to evaluate the performance of clinical laboratory assays ...

Many laboratories are unsure about which QC practices are needed and what criteria to use to assess the acceptability of the performance of analytical materials, to meet not only their requirements, ...

Sherry Gu, Executive Vice President and CTO at WuXi Biologics, explains the critical challenges of developing bispecific ...

Gene therapy is an emerging field and industry is yet to work out how best to manufacture these life-saving products says expert. Interest in gene therapy is growing, says Andrew Powaleny, public ...

If you like working independently and knowing exactly what needs to be done and how to do it, this may be the career for you. You must have a strong sense of ethics and be able to stand your ground ...

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In light of an established need for more efficient analytical procedures, this publication, which documents the findings of an IAEA coordinated research project (CRP) on “Quality Control of Pesticide ...