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5S in Pharmaceutical Industry: Steps, GMP Compliance, Benefits & Implementation GMP • Lean • QA 5S in Pharmaceutical Industry – Implementation, Benefits & Guidelines Learn how to apply 5S (Seiri, Seiton, Seiso, Seiketsu, Shitsuke) to boost GMP compliance , strengthen data integrity , and improve productivity in pharma manufacturing and QC labs. 5S Circle for Pharmaceutical Industry A circular diagram showing five equal segments labeled Seiri, Seiton, Seiso, Seiketsu, and Shitsuke. 5S Pharma • GMP • Lean ...

Indian Generic Medicine Market: Global Impact and Role in Poor Countries Indian Generic Medicine Market: Global Impact and Role in Poor Countries The Indian generic medicine market is one of the largest in the world, playing a crucial role in making healthcare affordable and accessible. India is often called the “Pharmacy of the World” because it supplies low-cost yet high-quality generic drugs to more than 200 countries. With a growing global demand for affordable treatments, Indian pharmaceutical companies are bridging the gap between innovation and accessibility. What Are Generic Medicines? Generic medicines are pharmaceutical drugs that are bioequivalent to branded drugs in dosage, strength, quality, and performance. They are launched once the patent of the branded drug expires. These medicines are much cheaper because companies do not need to invest in research, marketing, or heavy branding costs. India’s Role in the Global Generic...

Tooling in Tablet Compression | Types, Handling, Cleaning, and Storage Tooling in Tablet Compression: Types, Procurement, Usage, Handling, Cleaning, and Storage Tooling in tablet compression plays a critical role in pharmaceutical manufacturing. The quality, safety, and consistency of tablets depend directly on the punches and dies used in compression machines. Poorly maintained tooling can lead to problems like capping, lamination, weight variation, tablet sticking, and regulatory non-compliance. Therefore, understanding types of tooling, procurement standards, handling, cleaning, and proper storage is essential for ensuring Good Manufacturing Practices (GMP). 1. Introduction to Tooling in Tablet Compression In pharmaceutical tablet manufacturing, punches and dies are collectively called tooling . They determine the tablet’s size, shape, weight, embossing, and overall quality. Any deviation in tooling specification can affect ...

Data Integrity in Pharmaceutical Industry – Audit Trail, Deviation & Investigation Data Integrity in Pharmaceutical Industry Data integrity in pharmaceutical industry Pharmaceutical data integrity Audit trail in pharma Deviation investigation pharmaceutical ALCOA+ principles pharma CAPA pharma data integrity FDA data integrity guidance EU GMP data integrity Pharma compliance data integrity Introduction Data integrity is a cornerstone of quality assurance in the pharmaceutical industry. Global regulatory agencies—including the US FDA , EMA , WHO , and MHRA —require that data be complete, consistent, and accurate throughout its lifecycle . Any compromise in data integrity can compromise patient safety, trigger regulatory penalties, or damage reputation. This article explores the need, references, detailed procedures, audit trail mechanisms, deviation handling, limitations, and im...

Pharmaceutical Water Systems — Working Principle, Tests, Limits & Validation Pharmaceutical Water Systems — Working Principle, Tests, Limits & Validation A practical guide for production, QA and utilities engineers explaining design, operation, testing and compliance of Purified Water (PW), Highly Purified Water (HPW) and Water for Injection (WFI). This article covers: system overview and unit operations; how PW and WFI are produced and distributed; required routine tests (TOC, conductivity, microbiology, endotoxin); common acceptance limits and how they are applied; sampling & monitoring strategy; qualification/validation essentials; and practical troubleshooting tips. Key authoritative guidance used: WHO Annex 3 (WPU), USP guidance on TOC and conductivity, and the EP revision allowing membrane-produced WFI. 0 1. Water grades used in pharma (short) Purified Water ...

AI in Medicine — Advancements in Gene Therapy, Critical Illness Treatment & Prevention Feature AI & Gene Therapy Updated: Aug 26, 2025 AI in Medicine: Advancements in Gene Therapy, Critical Illness Treatment & Prevention Explore how artificial intelligence accelerates gene therapy, improves outcomes in critical illness, enables targeted prevention — plus pros, cons and real-world challenges. Read Full Post Download The merging of AI and genomics is one of the fastest-moving fronts in modern medicine. From analyzing raw DNA to designing CRISPR edits and predicting therapy outcomes, AI shortens timelines, improves precision, and helps clinicians make life-saving decisions. How AI Accelerates Gene Therapy Data analysis at scale AI rapidly process...