Audits In Pharmaceuticals
Introduction - In any industry, quality audits are essential for guaranteeing adherence to legal standards. Comparably, quality audits are carried out in the pharmaceutical sector to ensure that the intricate…
Troubleshooting Tips for Common Equipment Challenges in Solid Oral Manufacturing
Gummies, effervescence, soft gels, tablets, capsules, small molecules, and pills. These are known as oral solid dosage (OSD) forms, which are final drug product therapies that are swallowed, dissolved in…
Facility Management And Its Validation For Pharmaceuticals
The pharmaceutical sector has been subject to intense competition over the past few decades, and this pressure has not decreased. New, more effective, and scalable operational models are becoming more…
Transition from MDD to MDR: Key Changes and Implications
What is the MDR (Medical Device Regulation) in Europe? For medical device firms that want to sell their products in the European market, compliance with the European Medical Device Regulation…
Annual Product Quality Review (APQR) /PQR in Pharma
Introduction: The Annual Product Quality Review (APQR)/PQR stands as a pivotal regulatory requirement for pharmaceutical companies, mandated by the FDA and governed by cGMP guidelines. This annual review is imperative…
A Deep Dive into ISO 13485:2016
Background: Although numerous nations have their own set of laws, ISO 13485 is the primary Quality Management System (QMS) standard for medical devices. The QMS's scope can be customized for…
Principles and Compliance Requirements of GMP/GLP for Quality Control and Contract Laboratories
Introduction: Quality control and contract laboratories play a pivotal role in ensuring the safety, efficacy, and quality of pharmaceutical products. To uphold the highest standards, these laboratories must adhere to…
The Evolution of cGMP QbD Risk-Based Process Validation With Insights From FDA, EudraLex, And EMA Guidelines
Introduction: A product can be systematically manufactured using a specific process that meets its predetermined specifications and quality attributes. This is known as validation. Established document evidence or proof offers…
Exploring Electronic Common Technical Document (eCTD) v4.0 for Drug Product Registration
Introduction: In the ever-evolving landscape of pharmaceuticals, the pursuit of more efficient and streamlined processes in drug product registration has led to significant advancements. At the forefront of this transformation…
A Comprehensive Guide to Securing Approval for Medical Devices
Introduction: The journey to bring a medical device to market in the United States is a complex and highly regulated process that necessitates meticulous planning, thorough documentation, and adherence to…
