Common Technical Document (CTD)

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Common Technical Document (CTD) In the pharmaceutical world, the Common Technical Document (CTD) is a cornerstone of regulatory submissions. Whether it's for new drug approval, generic drug application, or other pharmaceutical licensing activities, the CTD…

Batch Manufacturing Records

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Batch Manufacturing Records Introduction to Batch Manufacturing Records (BMR) Batch Manufacturing Records (BMR) are the backbone of pharmaceutical manufacturing. These documents capture every detail of the production process, ensuring consistency, traceability, and compliance with regulatory…

ICH Guideline

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Q1/Q5C EWG Targeted Revisions of the ICH Stability Guideline SeriesQ10 Pharmaceutical Quality SystemQ11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)Q11 Q&As Questions & Answers: Selection and Justification of Starting Materials for…

The CTD Unveiled: Your Guide to Quality Standards

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Welcome to our guide on the Common Technical Document (CTD) quality standards, where we make sense of the rules for pharmaceutical submissions. If you've ever felt lost in the maze of regulations, fear not! We're…

Operation of Micrometer Screw Gauge SOP

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1.0 OBJECTIVE : To provide a procedure for Operation of Micrometer Screw Gauge. 2.0 SCOPE : This procedure is applicable to Micrometer Screw Gauge. 3.0 RESPONSIBILITY : Quality control Chemist and above 4.0 ACCOUNTABILITY: Quality…