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

Most Recent Trends in USFDA Audits and Inspections (2026)

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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: 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

Punches and dies in Tablet Compression

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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

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"Learn about 12 types of sensors used in pharmaceutical packaging - vision, temperature, leak detection, serialization, checkweighers and their functions for FDA compliance."

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

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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

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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

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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