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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...

Importance of Airlocks in Pharmaceutical Industry | WHO GMP Guide 🔹 Importance of Airlocks in Pharmaceutical Industry: WHO GMP Guidelines In the pharmaceutical industry , maintaining product quality and patient safety is non-negotiable. One of the critical engineering controls that helps achieve this is the airlock system . Airlocks play a vital role in cleanroom design, contamination control, and GMP compliance . Whether it is a material airlock or personnel airlock , the primary objective is to prevent cross-contamination and ensure classified areas remain protected. 🔹 What is an Airlock in Pharmaceutical Industry? An airlock is a small, enclosed space with two or more doors that connects areas of different cleanliness levels in a pharmaceutical facility. It allows controlled passage of materials or personnel from one cleanroom grade to another without directly exposing the critical area. The pri...

Differential Pressure in Pharmaceutical Industry | WHO GMP Guidelines Differential Pressure in Pharmaceutical Industry: Principle, Usage & WHO GMP Requirements In the pharmaceutical industry , maintaining proper differential pressure between cleanrooms and controlled areas is a cornerstone of GMP (Good Manufacturing Practice) compliance. This principle ensures the protection of products, personnel, and environment from cross-contamination. Regulatory bodies such as WHO, USFDA, EMA and PIC/S emphasize stringent requirements for air pressure control in manufacturing facilities. This article provides a detailed guide on principle, usage, requirements, pressure cascade, WHO GMP guidelines, and best practices for differential pressure in pharmaceutical cleanrooms and HVAC systems. With over 3000 words of detailed analysis , it serves as a reference for regulatory affairs professionals, QA/QC experts, HVAC e...

How to Prepare Module 3 (CMC) in CTD Dossier | USFDA WHO GMP Guide 📘 How to Prepare Module 3 (CMC) in CTD Dossier: Detailed USFDA & WHO GMP Guide The Common Technical Document (CTD) is the globally accepted format for regulatory submissions in USFDA, EMA, Japan, and ROW markets . Among its modules, Module 3: CMC (Chemistry, Manufacturing, and Controls) is the backbone that ensures quality, safety, efficacy, and GMP compliance of pharmaceutical products. 🔹 Structure of Module 3 (CMC) Module 3 is divided into two key parts — Drug Substance (API) and Drug Product (FDF) . Below is a breakdown: 1. Drug Substance (3.2.S) S.1 General Information – Nomenclature, structure, properties. S.2 Manufacture – Manufacturer details, GMP compliance, process flow. S.3 Characterisation – Impurities, polymorphism, structure confirmation. S.4 Control of Drug Substance – Specifications, analytical me...

ANDA in ROW Market: How Generic Drug Approval Works Outside the US ANDA (Abbreviated New Drug Application) is the USFDA pathway for generic drug approval. In the ROW (Rest of the World) markets — countries outside highly regulated blocs such as US, EU, Japan, Canada, and Australia — generic approval follows similar scientific principles (quality, safety, bioequivalence) but uses local/regional submission routes and WHO-GMP alignment. This post explains regulatory pathways, dossier formats (CTD/ACTD), BE expectations, WHO-GMP intersection, market opportunities, and practical best practices for pharma companies targeting ROW regions. Contents Overview: ANDA vs ROW Generic Approval ROW Regions & Local Regulators Dossier Formats: eCTD / CTD / ACTD Bioequivalence Requirements in ROW WHO-GMP Alignment & Inspection Expectations Market Opportunities & Commercial Drivers ...