Industrial Pharmacy
Conducting BE Studies for NTI Drugs
Here’s a detailed explanation of how bioequivalence (BE) studies are conducted for narrow therapeutic index (NTI) drugs, including regulatory expectations, study design, analytical methods, and statistical analysis: Detailed Overview: Bioequivalence Study for NTI Drugs What are NTI Drugs? NTI (Narrow Therapeutic Index) drugs are those where small differences in dose ... Read More
DCP vs. MRP | Choosing the Right Regulatory Pathway in the EU
Navigating the European regulatory landscape can be complex, especially when seeking approval for medicinal products across multiple countries. Two key procedures streamline this process: Decentralized Procedure (DCP) and Mutual Recognition Procedure (MRP). While both facilitate multi-country approvals, understanding their differences is essential for strategic regulatory planning. Decentralized Procedure (DCP) DCP ... Read More
Handling Conflicting Regulatory Requirements | A Strategic Approach
In global regulatory affairs, one of the most complex challenges we face is resolving conflicting requirements from different regulatory bodies. Each agency has its own set of expectations, shaped by regional regulations, scientific perspectives, and risk tolerance. Navigating these differences requires a strategic, risk-based approach to ensure compliance while maintaining ... Read More
Ways to Extend the Lifespan of C18 Columns & Guard Columns
Use a Guard Column Filter and Degas Mobile Phase Use Proper pH and Buffer Conditions Regular Column Flushing Avoid Prolonged Exposure to Aqueous Buffers Inject Clean Samples Optimize Flow Rate and Pressure General Precautions Before Cleaning Initial Rinse (Removing Buffer and Salts) Purpose: To remove any buffer salts that may ... Read More
Seamless Technology Transfer in Topical Products
Technology transfer (TT) is crucial for ensuring product consistency, compliance, and scalability in topical formulations (creams, gels, ointments). A structured TT minimizes risks in scale-up, process validation, and site transfers. R&D to Manufacturing Transfer Site-to-Site Transfer Successful TT requires QbD-driven process control, cross-functional collaboration, and regulatory alignment to ensure smooth ... Read More
Clean-in-Place in pharmaceutical Industry
CIP, or Clean-in-Place, is a critical process in the pharmaceutical industry, ensuring that equipment and systems are effectively cleaned without disassembly. Importance of CIP in Pharmaceuticals Key Components of CIP Systems Steps in a CIP Process Read also: Resource Person: Omar Salah
Nonviable Particle in Sterile Manufacturing
In sterile environments, non-viable particles are non-living particulate matter like dust, skin cells, or fibers that can act as a carrier for viable particles and pose a risk to product sterility, necessitating monitoring and control. Nature of Non-Viable Particles Non-viable particles include: Sources of Contamination Non-viable particles can enter sterile ... Read More
Common QC Lab Errors in Pharma
Q: What are the major root causes of QC lab errors? Q: What is a common error in HPLC sample preparation? A: Improper sample dissolution leading to inaccurate quantification, peak area variability, and inconsistent retention times. Q: What are the root causes of this issue and How it resolved? A: ... Read More
Pharmaceutical Disintegrants and It’s Mechanism of Action
Croscarmellose Sodium(CCS) Crospovidone Sodium Starch Glycolate Microcrystalline Cellulose(MCC) Pre-Gelatinized Starch Low-Substituted Hydroxypropyl Cellulose (L-HPC) Ion Exchange Resins (e.g., Polacrilin Potassium) Read also:
Sink Factor in Dissolution Testing
Dissolution testing is a cornerstone of pharmaceutical development, providing invaluable insights into how drugs behave in the body. One critical aspect often overlooked is the sink factor and its pivotal role in ensuring the accuracy and relevance of dissolution results. What is Sink Factor? Sink factor refers to the ratio ... Read More