Author: masuuglobal
GxP GAP Assessment Audits: Strengthening Compliance Across the Entire Quality Spectrum
GxP GAP Assessment Audits: Strengthening Compliance Across the Entire Quality Spectrum The Pharmaceutical, Biotechnology, and Life Sciences industries have experienced a rapid acceleration in their evolving regulatory expectations. Organizations within these sectors have a duty to remain compliant with Good Manufacturing Practices (GMP) as well as the complete range of GxPs: from Good Laboratory Practice… Continue reading GxP GAP Assessment Audits: Strengthening Compliance Across the Entire Quality Spectrum
Regulatory Submissions Management: Driving Compliance and Speed in Global Markets
Regulatory Submissions Management: Driving Compliance and Speed in Global Markets These days, rules around the world keep getting stricter. If you’re trying to launch a new drug, medical device, or even a cosmetic, you can’t afford to mess up your regulatory submissions management process. Getting these submissions right quickly and by the book makes all… Continue reading Regulatory Submissions Management: Driving Compliance and Speed in Global Markets
Good Clinical Practice (GCP) Audits: Ensuring Quality and Integrity in Clinical Research
Good Clinical Practice (GCP) Audits: Ensuring Quality and Integrity in Clinical Research Clinical research never slows down, and the stakes are high. You can’t cut corners on quality, safety, or ethics—not even for a second. That’s why Good Clinical Practice, or GCP, exists.
The Role of GMP Internal Audits in Ensuring Quality Excellence
The Role of GMP Internal Audits in Ensuring Quality Excellence Staying compliant with Good Manufacturing Practice (GMP) standards is essential for pharmaceutical and life-science organizations to ensure product quality, protect patient safety, and follow regulations.
GMP Vendor Audits: Strengthening Supply Chain Quality and Compliance
GMP Vendor Audits: Strengthening Supply Chain Quality and Compliance In the pharmaceutical and life sciences sector, the quality of your end product is closely tied to the reliability of your suppliers. As global supply chains grow more intricate, regulatory bodies like the FDA, EMA, MHRA, and WHO are raising their expectations for companies to show… Continue reading GMP Vendor Audits: Strengthening Supply Chain Quality and Compliance
GMP Virtual Audits: Enhancing Compliance Through Remote Oversight
GMP Virtual Audits: Enhancing Compliance Through Remote Oversight In the modern fast-paced pharmaceutical and life-sciences workplace, keeping operations efficient and at the same time ensuring compliance with the regulations has never been more important. Conventional on-site Good Manufacturing Practice (GMP) audits are time-consuming, expensive and logistically difficult, particularly in situations involving international suppliers or separate… Continue reading GMP Virtual Audits: Enhancing Compliance Through Remote Oversight
GMP Pre-Assessment: A Proactive Approach to Quality Compliance
GMP Pre-Assessment: A Proactive Approach to Quality Compliance Good Manufacturing Practice (GMP) compliance in the modern world of relative pharmaceutical and life-science regulation is not only a necessity but also a central pillar in product quality, patient safety and business survival.
EDQM GUIDELINE ON REQUIREMENTS FOR REVISION/RENEWAL OF CERTIFICATES OF SUITABILITY TO THE EUROPEAN PHARMACOPOEIA MONOGRAPHS
EDQM GUIDELINE ON REQUIREMENTS FOR REVISION/RENEWAL OF CERTIFICATES OF SUITABILITY TO THE EUROPEAN PHARMACOPOEIA MONOGRAPHS EDQM Guideline Revision: The European Directorate for the Quality of Medicines & HealthCare (EDQM) has revised the “Guideline on requirements for revision and renewal of certificates of suitability to the European Pharmacopoeia monographs” (PA/PH/CEP (04) 02) to align it with… Continue reading EDQM GUIDELINE ON REQUIREMENTS FOR REVISION/RENEWAL OF CERTIFICATES OF SUITABILITY TO THE EUROPEAN PHARMACOPOEIA MONOGRAPHS
What is a Common Technical Document (CTD)?
What is a Common Technical Document (CTD)? Pharmaceutical companies seeking global market approval must navigate complex regulatory requirements. To simplify submissions and harmonize standards, the International Council for Harmonisation (ICH) introduced the Common Technical Document (CTD). This format has become the backbone of regulatory filings worldwide, ensuring consistency, efficiency, and transparency in drug approval processes.
What is GMP Certification?
What is GMP Certification? In the pharmaceutical industry, patient safety and product quality are non‑negotiable. To ensure medicines are consistently produced and controlled according to quality standards, companies must comply with Good Manufacturing Practices (GMP). Achieving GMP Certification demonstrates that a manufacturer adheres to globally recognized guidelines, reinforcing trust among regulators, healthcare providers, and patients.