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
Overview of Various National Filing Terminologies: Regulated vs Emerging Markets – US, EU, Japan, Brazil, Tanzania, Russia, Hong Kong Quick Summary: Pharmaceutical industry is one of the most highly regulated industries to protect health of masses. While world regulations are harmonizing, they can be divided into 4 major categories – North America (US, Canada), Europe … Read more
Regulatory Filing in Pharma: How to Develop One Drug for Global Markets – US, EU, and ROW Quick Summary: Regulatory requirements of various countries vary. It is challenging to develop a single drug which can be simultaneously submitted in all countries. So regulatory strategy must be fixed BEFORE development starts, otherwise you will get major … Read more
