Pharma Digest
Oral Vs Parenteral Dosage Form | Formulation Challenges
Oral dosage form formulation challenges A) Poor Bioavailability Many drugs face challenges in being absorbed through the gastrointestinal (GI) tract due to poor solubility, gastrointestinal pH, or presence of enzymes that degrade the drug before it can be absorbed into the bloodstream. B) Solubility and Stability 1) solubility: Drugs with ... Read More
Effective Artwork Management in Pharmaceutical Industry
In this post, we’ll shift our focus from formulation to a crucial topic: Artwork Management in Pharma. In the pharmaceutical industry, managing artwork for product packaging is essential to ensure compliance, accuracy, and maintaining the brand’s standards. Here’s a detailed look at the process: Initiating the Artwork Request The process ... Read More
Role of QA in New Drug Development and Approval
Introduction The development and approval of new drugs involve a complex process, requiring rigorous quality assurance (QA) measures. QA plays a vital role in ensuring the safety, efficacy, and compliance of new drugs. In this blog, we’ll explore the critical role of QA in new drug development and approval. Why ... Read More
Optimizing Particle Size Distribution (PSD) for Tablet Formulations
Particle Size Distribution (PSD) is a key factor that influences tablet performance, especially when it comes to “disintegration” and “dissolution rates”. Here’s how PSD optimization can benefit different types of formulations: Immediate-Release Tablets Controlled-Release Tablets Poorly Soluble Drugs Direct Compression Tablets Effervescent Tablets Optimizing PSD is essential for tailoring the ... Read More
Handling Customer Complaints in Pharmaceutical Industry
Introduction Customer complaints are critical events in the pharmaceutical industry, requiring prompt attention and resolution. Effective complaint handling ensures patient safety, maintains regulatory compliance, and upholds company reputation. In this blog, we’ll explore best practices for handling customer complaints in pharmaceutical QA. Key Principles Regulatory Requirements Complaint Handling Process Best ... Read More
Validation of ERP System
Enterprise Resource Planning (ERP) system validation is essential in regulated industries, particularly pharmaceuticals, biotechnology, and medical devices, where ERP systems manage key operations like inventory, production, quality control, and distribution. Requirements Gathering User Requirements Specification (URS): Document what the users need from the ERP system, including both functional (what the ... Read More
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