Visual Inspectors Qualification in Oral Solid Dosage Forms: Complete GMP Guide | PharmaShare Visual Inspectors Qualification in Oral Solid Dosage Forms: Complete GMP Guide Visual inspection is the last line of defence before a tablet or capsule reaches the patient. A single chipped tablet, a black spot, a broken capsule, or a wrong imprint can … Read more
End-to-End Migration of Quality Processes in Pharma: A Complete GMP Playbook | PharmaShare End-to-End Migration of Quality Processes in Pharma: A Complete GMP Playbook Migration of Quality processes is no longer optional. Pharma companies are moving from site-based, paper-driven QA to centralized Global QA Hubs and eQMS like TrackWise, Veeva, or MasterControl. But here is … Read more
Certificate of Conformance (CoC) in Pharma: Complete Guide Certificate of Conformance (CoC) in the Pharmaceutical Industry: A Complete Guide Category: Pharmaceutical Quality Assurance | GMP | Quality Management System 1. Introduction Quality assurance and regulatory compliance are essential elements of pharmaceutical manufacturing. Every pharmaceutical product must be manufactured, tested, packaged, stored and distributed in accordance … Read more
Risk-Based USFDA Inspections and the Use of AI Tools in Pharmaceutical Audits: A Complete Guide for 2026 Last Updated: October 2026 Risk-based inspections and Artificial Intelligence (AI) are important topics in modern pharmaceutical quality management. The USFDA uses risk-based approaches to prioritize inspection activities, while AI-assisted analytics offer opportunities for pharmaceutical companies to identify quality … Read more
Most Recent Trends in USFDA Audits and Inspections (2026): A Complete Guide for Pharmaceutical Quality Professionals Last updated: October 2026 USFDA inspections are evolving as pharmaceutical manufacturing becomes more global, digital, and complex. In 2026, pharmaceutical companies must be prepared for risk-based inspections, increased scrutiny of foreign manufacturing facilities, detailed examination of quality systems, and … Read more
Tablet compression tooling is one of the most important parts of pharmaceutical tablet manufacturing. The quality, shape, size, thickness and appearance of a tablet depend partly on the condition and design of the punches and dies used during compression. Proper tooling selection, inspection, cleaning, maintenance and storage help pharmaceutical manufacturers maintain consistent tablet quality, reduce … Read more
Punches and Dies Used in Pharmaceutical Tablet Compression – Types, Standards & Maintenance | PharmaShare Punches and Dies Used in Pharmaceutical Tablet Compression Operation: A Complete Guide Published by PharmaShare.in | Category: Tablet Manufacturing | 10 Min Read | QA / Production In tablet manufacturing, the compression machine is the heart, but punches and dies … Read more
Types of Sensors Used in Pharmaceutical Packaging | PharmaShare Types of Sensors Used in Pharmaceutical Packaging and Their Functions In pharmaceutical manufacturing, packaging is not just about protection and presentation — it is a critical control point for patient safety, regulatory compliance, and product integrity. A single packaging error can lead to a product recall, … Read more
Lot Acceptance Rate (LAR) in Pharma – Formula, Importance, FDA Quality Metrics LOT ACCEPTANCE RATE (LAR) IN PHARMA What is Lot Acceptance Rate? Lot means Batch. Lot Acceptance Rate is percentage of lots (batches) that are accepted and released for distribution out of total lots manufactured in a given period. It is one of the … Read more
Invalidated OOS Rate (IOOSR) in Pharma – FDA Quality Metrics Explained INVALIDATED OOS RATE (IOOSR) IN PHARMA What is OOS? OOS means Out of Specification. When test result goes outside the approved specification limit, it is called OOS. Example: Assay specification is 95.0% to 105.0%. If result comes 93.2%, it is OOS. OOS can happen … Read more
