Discover the top 10 audit-ready practices for QA and QC professionals in the pharmaceutical industry. Learn how ALCOA+, CAPA, change control, and document management ensure GMP compliance and inspection readiness.
Read MoreHuman error in pharmaceutical analysis refers to personnel mistakes that can compromise product quality, patient safety, and regulatory compliance. These errors usually arise from systemic factors—such as unclear procedures, poor communication, insufficient training, or equipment issues—rather than individual fault alone. Human Error Case Study: Real-Life Incident from a Pharmaceutical Laboratory Background Early in my career, […]
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Quality Control (QC) is a product-focused and reactive approach that involves inspecting, testing, and measuring finished products to identify and correct defects after production. In contrast, Quality Assurance (QA) is a process-focused and proactive approach that aims to prevent defects by developing and implementing quality standards throughout the entire product lifecycle. In essence, QA builds […]
Read MoreThe MACO calculation, or the Maximum Allowable Carryover calculation in pharmaceutical manufacturing, determines the maximum residue from a previous product that can remain on shared equipment without risking contamination or harm to the next product or patient. It is essential for cleaning validation to ensure effective cleaning and prevent cross-contamination. FAQs on MACO Calculation […]
Read MoreControl Samples Or Retention Samples or Reference Samples are reference materials with known properties used to verify the accuracy and reliability of tests, serving as benchmarks to ensure consistent, acceptable results. These samples play a critical role in post-market surveillance, regulatory compliance, and the investigation of complaints. In this article, I will discuss the definition, […]
Read More9+ Top Pharma Quality Control (QC) Interview Questions and Answers
Read MoreLearn DQ, IQ, OQ, And PQ: Concept with applications, case studies and FAQs
Read MoreLearn the key difference between validation and qualification in pharmaceutical manufacturing and why both are essential for GMP compliance and product quality.
Read MoreLearn what Is limit test and why It Is important in pharmaceutical analysis with FAQs
Read MoreLearn about monographs and standard testing procedures (STP), key differences, writing process, and benefits with FAQs.
Read MoreLearn about Pharmaceuticals Certificate of Analysis its content, preparation and approval with FAQS
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HPLC (High-Performance Liquid Chromatography) is a chromatographic technique that employs a solid stationary phase and a liquid mobile phase to efficiently separate, identify, and quantify components within a sample or complex mixture The term “chromatography” refers to the general process of separation, while a “chromatograph” is the instrument used, and a “chromatogram” is the visual […]
Read MoreSulphated Ash Test In Pharmaceutical Analysis: Why, How, And At What level , procedure, calculation, case studies and FAqs
Read MoreLearn about Loss on Drying test, purpose, procedure, acceptable limits , case studies and FAQs
Read MoreLearn how Headspace Gas Chromatography improves pharmaceutical quality by managing OVIs. Includes GC-HS principles, method development, applications, advantages, and FAQs
Read Moreppm, mcg and percentage are the units of measurement and play a crucial role in pharmaceutical development. In both synthetic and analytical chemistry, precise measurements are key to accurate sample preparation and analysis. Among the most frequently used units in this process are ppm, mcg/µg, and % – terms that, while common, often lead to […]
Read MoreLearn the essentials of peak integration in chromatographic analysis, including integration types, common errors, influencing factors, and practical tips to avoid mistakes.
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Learn the importance of assay in pharmaceutical development. Discover how assays ensure drug quality, safety, and efficacy, and explore the steps and precautions involved in performing them
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Learn CSV (computer system validation) with our 12-step ultimate guide to enhance efficiency in pharmaceutical data management.
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Explore Karl Fischer coulometric titration for precise water measurement at a very low level in drug development processes. Essential for pharma success.
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