Pharma Digest
Pharmaceutical QA for Packaging and Labeling Controls
Introduction Packaging and labeling play critical roles in pharmaceutical product integrity, safety, and compliance. Quality assurance (QA) measures must ensure accurate labeling, secure packaging, and compliance with regulatory requirements. In this blog, we’ll explore pharmaceutical QA controls for packaging and labeling. Key QA Considerations Regulatory Requirements Packaging QA Controls Labeling ... Read More
Importance of API Flow Properties in Formulation Development
Flow properties of an Active Pharmaceutical Ingredient (API) play a significant role in formulation development, especially for solid dosage forms like tablets and capsules. Poor flowability can lead to production issues and affect the quality of the final product. Here’s a breakdown of why flow properties are important and how ... Read More
Process Simulation through Media Fill in Pharmaceutical Manufacturing
In the backroom of the pharmaceutical industry the need to ensure quality and safety is an uncompromising goal. Media filling simulation is one of the essential tools to achieve this stringent goal. In this article we will delve deeper into this concept exploring its importance the methods it follows and ... Read More
Difference Between Industry 1.0, 2.0, 3.0 and 4.0
The main differences between the four industrial revolutions are the technologies used and the resulting impacts on manufacturing, the economy, and society: Industry 1.0The first industrial revolution began in the 1760s in England and used water and steam power to mechanize production. This led to more affordable and accessible goods. ... Read More
Formulation Development Strategy for BCS Class III Molecules
For BCS Class 3 drugs, which are characterized by high solubility but low permeability, the primary formulation approach focuses on enhancing their permeability to improve bioavailability. Here are strategies tailored to different dosage forms: Oral Solid Dosage Forms Permeation Enhancers: Adding permeation enhancers like surfactants, bile salts, or certain excipients ... Read More
Solubility Enhancement Techniques for BCS Class II Molecules
For BCS Class II drugs, which have low solubility but high permeability, formulation efforts center on enhancing solubility to improve bioavailability. Here’s how we turn API properties into actionable formulation strategies: Solubility Improvement With BCS Class II drugs’ low solubility, enhancing solubility is key for bioavailability. Techniques include: Particle Size ... Read More
Formulation Development Strategy for BCS Class I Molecules
For BCS Class I drugs, with high solubility and high permeability, formulation strategies across various dosage forms are generally more straightforward than for other BCS classes. These drugs can dissolve and permeate easily, meaning that the focus is typically on optimizing stability, dosage form design, and patient compliance rather than ... Read More
Importance of Understanding the Biopharmaceutics Classification System
Guides Formulation Strategy: The BCS class helps in identifying the solubility and permeability characteristics of the drug. Drugs in different classes require distinct formulation approaches. For example, a poorly soluble drug (BCS Class II or IV) may need solubility enhancement techniques like solid dispersions or nano-formulations. Predicts Drug Absorption and ... Read More
Role of Standard Operating Procedures (SOPs) in Pharmaceutical QA
Introduction In the pharmaceutical industry, Standard Operating Procedures (SOPs) play a vital role in ensuring quality assurance (QA). SOPs provide a systematic approach to performing tasks, minimizing errors, and ensuring compliance with regulatory requirements. In this blog, we’ll explore the importance, benefits, and best practices of SOPs in pharmaceutical QA. ... Read More
Cluster Development Program (CDP) & Data Governance
In the pharmaceutical industry, data governance is crucial for ensuring the quality, integrity, and compliance of data. The Cluster Development Program (CDP) is a framework that enables companies to implement data governance effectively. In this blog, we’ll explore why CDP and data governance are mandatory in the pharmaceutical industry and ... Read More
Re-Validation in Computerized System Validation (CSV)
In Computerized System Validation (CSV), revalidation refers to the process of re-assessing and re-qualifying a system after significant changes or events that may impact its validated state. It ensures that the system continues to operate as intended and in compliance with regulatory requirements. Revalidation is often required in the following ... Read More