Pharma Digest
Drug-Device Combination Products | Innovations and Compliance
In the ever-evolving landscape of medical technologies, drug-device combination products represent a cutting-edge integration of drugs, medical devices, and biologics. These products offer innovative solutions for disease management, but they also demand a robust understanding of regulatory frameworks and compliance to ensure safety, efficacy, and quality. What Are Combination Products? ... Read More
QMS in Pharmaceutical Industry
A Quality Management System (QMS) is a formalized framework that outlines the structure, responsibilities, and processes for achieving quality objectives in an organization. The QMS ensures that products or services meet customer and regulatory requirements. Content of a QMS: A typical QMS consists of the following elements: Quality Policy: A ... Read More
Navigating Bioequivalence Study Guidelines Across Global Regulatory Bodies
When conducting bioequivalence (BE) or bioavailability (BA) studies for regulatory approval, guidelines from different regulatory bodies must be adhered to. Here’s a summary of the key considerations and variations across major regulatory agencies Regulatory Guidelines Comparison USFDA Special Cases: Study Design: EMA Acceptance Range: Study Design: WHO Study Design: MHRA ... Read More
Comprehensive List of Pharmaceutical Guidelines
Self Inspection & Batch Review Risk Management Deviation Handling Change Control Out of Specification (OOS) Corrective and Preventive Action (CAPA) Process Validation Cleaning Validation Data Integrity Stability Studies GMP Pharmaceutical Quality System Pharmaceutical Development Good Storage and Distribution Practices (GSDP) Electronic documents and records Read also:
Impurity Specification Across Different Regulatory Bodies
Impurities in pharmaceutical products play a critical role in ensuring drug quality, safety, and efficacy. Regulatory bodies such as the USFDA, EMA, PMDA, and others have specific guidelines for identifying, quantifying, and controlling impurities. Types of Impurities Key Guidelines for Impurity Control USFDA EMA PMDA (Japan) WHO Indian Pharmacopeia Differences ... Read More
Justification for Control of Elemental Impurities in Formulation
Introduction Definition: Elemental impurities are trace levels of metals that can be introduced into drug products from raw materials, manufacturing processes, or container closure systems. Regulatory requirement: ICH Q3D and relevant pharmacopeial guidelines (USP <232>, <233>) specify acceptable limits for elemental impurities to ensure patient safety. Identification of Potential Sources ... Read More
Trend Analysis for Elemental Impurities
Trend analysis for elemental impurities is not explicitly required by guidelines like ICH Q3D . However, certain aspects of stability trends and variability need to be considered to ensure compliance and accurate reporting. Stability Trends for Elemental Impurities In most cases, if no such risk is identified, monitoring for trends ... Read More
Effect of pH in Analytical Method
As a chromatographer not many of us are aware of how critical pH is in your method development, sometimes it is even considered as an inconsequential factor, which could have a negligible effect on our analysis. However, in truth pH can make or break your analysis, choosing the correct or ... Read More
Media and Buffers in Dissolution Method Development
Sink Conditions: Volume of medium should be at least 3 times that needed to form a saturated solution (USP definition). pH Range: Typical range is 1.1 to 6.8, but can be adjusted up to pH 8.0 for solubility. Common Buffers: Surfactants: Medium Deaeration: Ensure medium is deaerated to prevent bubbles, ... Read More
Powder Shape and Their Effect on Tablet Properties
The pharmaceutical industry relies heavily on powders for the formulation of solid dosage forms, particularly tablets. Powder properties, including particle size and shape, directly affect the manufacturing process and the performance of the final product. While particle size has been extensively studied, the influence of particle shape has garnered increasing ... Read More
Does an F2 Similarity Value of 50 Mean the Two Dissolution Profiles are Only 50% Similar?
No, the similarity factor (F2) is a mathematical representation of the quadratic mean difference between two dissolution profiles across all considered time points. An F2 value of 50 indicates that the two profiles differ by a small margin, with a mean difference of approximately 10%. The similarity factor is not ... Read More