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
Product Quality Complaint Rate in Pharma – Formula, FDA Expectation, Investigation PRODUCT QUALITY COMPLAINT RATE (PQCR) IN PHARMA What is Product Quality Complaint? Product Quality Complaint is any communication received from customer, patient, doctor, distributor about deficiency related to identity, quality, durability, reliability, safety, effectiveness or performance of a drug product after it is distributed … Read more
Quality Metrics in Pharma – Overview, FDA Guidance, Importance QUALITY METRICS IN PHARMA What are Quality Metrics? Quality Metrics are the numbers or data that are used to measure the quality of product and quality system. It is used to monitor quality and to improve quality of manufacturing and processes. According to FDA, Quality Metrics … Read more
ACTD and eCTD Overview – PharmaShare.in OVERVIEW OF ACTD AND eCTD 1. ACTD – ASEAN COMMON TECHNICAL DOCUMENT ACTD is the common format for submission of dossier in ASEAN countries. ASEAN means Association of South East Asian Nations – 10 countries: Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam. ICH CTD is for … Read more
Overview of Common Technical Document (CTD) – PharmaShare.in OVERVIEW OF COMMON TECHNICAL DOCUMENT (CTD) The Common Technical Document The agreement to assemble all the Quality, Safety and Efficacy information in a common format (called CTD – Common Technical Document) has revolutionized the regulatory review processes, led to harmonized electronic submission that, in turn, enabled implementation … Read more
Drug Registration in Europe: EMA Centralized vs DCP vs MRP vs National Procedure Drug Registration in Europe: Complete Guide to EMA Approval – Centralized, Decentralized, MRP & National Procedure Last Updated: September 2026 | By PharmaShare.in – Regulatory Affairs Simplified Quick Summary: Europe is the 2nd largest pharma market but the most complex. A medicinal … Read more
US vs Canada: Complete Guide to Drug Registration Process – NDA, ANDA, 505(b)(2) vs NDS, ANDS US vs Canada: Complete Guide to Drug Registration Process – NDA, ANDA, 505(b)(2) vs NDS, ANDS Last Updated: September 2026 | By PharmaShare.in – Regulatory Affairs Simplified Quick Summary: The US and Canada are the most lucrative pharma markets … Read more
