Industrial Pharmacy
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
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
Formulation Development Strategy for BCS Class IV Molecules
For a Class IV drug (low solubility and low permeability) in the Biopharmaceutics Classification System (BCS), formulation development needs a strategic approach to address these limitations. Here’s how this information can be leveraged: Enhancing Solubility: Solubility-Enhancing Techniques: Use solubilizers, surfactants, or co-solvents in the formulation to improve the drug’s solubility. ... 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