PHARMA KING ACE

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...