Cold Chain Management in the Pharmaceutical Industry
Discover the essentials of cold chain management in pharma to ensure the safety and efficacy of temperature-sensitive products like vaccines and biologics.
Airflow Visualization Smoke Studies (AVS) in Cleanrooms
Airflow Visualization Smoke Studies (AVS) ensure cleanroom compliance by visualizing airflow patterns to detect turbulence and verify unidirectional flow, critical for aseptic environments.
Supplier Qualification in GMP – What Do You Need to Consider?
Learn the essential steps for supplier qualification, ensuring that suppliers meet GMP standards, mitigates risks, and maintains quality in the pharmaceutical industry.
The Role of Batch Manufacturing Records (BMR) in GMP
Learn more about Batch Manufacturing Records (BMR), essential for consistent, safe pharmaceutical production and compliance with regulatory standards.
Worst Case Selection in Cleaning Validation
Optimize cleaning validation in pharmaceutical manufacturing with key strategies for selecting worst-case scenarios, ensuring product safety and efficacy.
Temperature Mapping in GxP Environment
Explore essential strategies for mitigating risks in temperature-controlled environments, ensuring product stability and safety in pharmaceutical storage.
Pharmacovigilance – Ensuring the Safety of Medications
Explore the crucial role of pharmacovigilance in ensuring medication safety, from detecting adverse effects to proactive risk management.
Design Review and Design Qualification in the Pharmaceutical Industry
Explore the crucial roles of Design Review and Design Qualification in the pharmaceutical industry, ensuring equipment meets user needs and complies with rigorous standards.
Best Practices for Environmental Monitoring in the Pharmaceutical Industry
Explore best practices in environmental monitoring for pharmaceutical cleanrooms, ensuring sterility and safety with comprehensive guidelines and tips.
Quality Risk Management in the Pharmaceutical Industry
Explore the essentials of Quality Risk Management in Pharma: Principles, tools, guidelines, and implementation strategies for enhanced safety.
User Requirement Specification: How to Create URS for Successful Equipment Procurement
Explore the essentials of User Requirement Specification (URS) for successful project execution. Learn to craft effective URS documents.
Impurities in Pharmaceuticals: Types, Regulations and Strategies
Discover the essential information about impurities in pharmaceuticals, their types, and how they impact drug quality. Learn about regulatory requirements, testing strategies, and the importance of analytical methods in ensuring…
Good Documentation Practice: Ensuring Data Integrity and Compliance in the Pharmaceutical Industry
Explore effective strategies for maintaining clear and comprehensive records with our guide on good documentation practices, ensuring accuracy and reliability.
GMP Cleanroom Classifications: Understand Class A, B, C and D
Learn GMP cleanroom classes A, B, C, D for contamination control in pharmaceuticals. Understand air cleanliness & particle counts for compliance.
Electronic Quality Management Systems – eQMS
Optimize compliance and quality control in the pharmaceutical industry with eQMS (Electronic Quality Management System). Streamline documentation, enhance regulatory adherence, and elevate overall product quality.
Understanding GxP Regulations in The Pharmaceutical Industry
Navigate success in the pharmaceutical industry with GxP compliance. Explore GMP, GLP, GDP, and GCP for quality, safety, and regulatory excellence
How to Write a Compliant SOP in the Pharma Industry?
Learn how to write SOPs in the pharmaceutical industry. A step-by-step guide on structure, best practices, and ensuring GMP compliance for operational efficiency.
FDA Transitional Enforcement Guidance for Ethylene Oxide Sterilization Facility Changes for Class III Devices
FDA announces a new policy on ethylene oxide sterilization site changes for Class III devices, ensuring supply chain stability and patient safety.
Stability Storage Conditions in Pharma Industry
Learn about stability storage conditions in pharma, including long-term, intermediate, and accelerated studies, climatic zones, regulatory guidelines, and strategies for preserving drug quality, safety, and efficacy across diverse environments.
ICH E6(R3) Annex 2: Draft Version for Good Clinical Practice in Modern Clinical Trials
Draft ICH E6(R3) Annex 2 provides updated GCP guidelines for modern clinical trials, focusing on decentralized designs, data privacy, and participant safety.
What Is Good Manufacturing Practices (GMP)?
Good Manufacturing Practice (GMP) ensures pharmaceuticals are produced consistently with high standards for quality, safety, and efficacy, protecting patient health.
USP Introduces Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents for Early Adoption
The United States Pharmacopeia (USP) has released Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents for early adoption, outlining using non-animal-derived reagents in bacterial endotoxin testing. The guidelines are part…
Good Chromatography Practices – Meeting Industry Standards
Learn how Good Chromatography Practices enhance data integrity, ensure compliance, and boost efficiency in pharmaceutical labs for reliable, safe product outcomes.
FDA Warning Letter: MedOffice Saglik Endustri Anonim Sirketi
he FDA inspection at MedOffice Saglik Endustri Anonim Sirketi revealed significant CGMP violations that could jeopardize product quality and consumer safety. Issues ranged from inadequate testing of drug products to…
10 Tips on How to Prepare for a GMP Inspection
Prepare for GMP inspections with these 10 tips, including audits, updated documentation, staff training, mock inspections, and setting up a war room.
Powders, Granules, and Tablets: What is the Difference
Explore the key differences between powders, granules, and tablets in pharmaceuticals, including their advantages, disadvantages, and manufacturing approaches.