Product Development – API & Formulations
Overview - The terms used in drug formulations and active medicinal ingredients are widespread in the pharmaceutical business. It is a constant challenge for pharmaceutical corporations to develop new patent…
Computer System Validation in Pharma
In the fast-paced and highly regulated world of pharmaceuticals, computerized systems are integral to various processes, from research and development to manufacturing and distribution. Ensuring the efficacy, safety, and quality…
A Comprehensive Guide to Design Qualification in Pharma and Biotech Facilities
INTRODUCTION - Design Qualification includes all facets of facility and equipment design and acquisition. It is meant to have everything that could happen during the design, development, and checkout phases,…
Key Qualities for Regulatory and Quality Consultants
Regulatory consultants and medical device consultancies are groups of highly skilled healthcare industry experts. The medical device sector is developing ever-more-advanced equipment with the swift advancement of medical knowledge. However,…
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…
