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Risk-Based USFDA Inspections and the Use of AI Tools in Pharmaceutical Audits

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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

Tablet Compression Tooling: Types of Punches and Dies, Components, Inspection and Maintenance

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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

Product Quality Complaint Rate in Pharma

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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

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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

Overview of ACTD (Asean Common Technical Document) and eCTD

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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)

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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 Process in Europe

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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

Drug Registration Process in USA and Canada

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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

Determination of Expiry Date in Pharma Oral Dosage Forms

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Determination of Expiry Date in Pharma Oral Dosage Forms: Stability, ICH Guidelines & Shelf-Life Calculation (2026 Guide) Quick Summary: Expiry date of oral dosage forms (tablets, capsules, syrups) is determined by stability studies per ICH Q1A(R2). Shelf-life is assigned based on real-time long-term data where the drug remains within 90-110% assay, no significant change in … Read more