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…
ND Global Attains ISO 9001:2015 Certification for Exceptional Quality Standards
ND Global proudly announces its ISO 9001:2015 certification, a testament to its commitment to delivering top-tier products and services through a robust quality management system. This achievement highlights ND Global's…
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…
ND Global and Aura biosciences Forge Strategic Partnership in Advancing Oncology Therapies
ND Global, a leading provider of Clinical Trial Associate services, is proud to announce its groundbreaking partnership with Aurabiosciences, a trailblazer in the development of innovative oncology targeted therapies. This…
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…
