Tag: FDA guidelines

Addressing Cross-Contamination Risks in Shared Tablet Manufacturing Equipment

May 5, 2025 Admin

Addressing Cross-Contamination Risks in Shared Tablet Manufacturing Equipment Addressing Cross-Contamination Risks in Shared Tablet Manufacturing Equipment Introduction: In the pharmaceutical industry, ensuring the safety and efficacy of drug products is paramount. With the increasing demand for diverse medications, many manufacturers utilize shared equipment for tablet production to optimize resources. However, shared equipment can pose significant…

Solid Dosage form, Tablets

Ensuring Robustness in QA Monitoring for Immediate Release Tablets

May 5, 2025 Admin

Ensuring Robustness in QA Monitoring for Immediate Release Tablets Ensuring Robustness in QA Monitoring for Immediate Release Tablets Introduction: Quality Assurance (QA) in the pharmaceutical industry is a critical component that ensures the safety, efficacy, and quality of medicinal products. For immediate release tablets, which are designed to disintegrate and release their active pharmaceutical ingredients…

Solid Dosage form, Tablets

Managing Adhesion Failures in Sustained Release Tablet Coating Layers During Validation

May 5, 2025 Admin

Managing Adhesion Failures in Sustained Release Tablet Coating Layers During Validation Managing Adhesion Failures in Sustained Release Tablet Coating Layers During Validation Introduction: Sustained release tablets are a cornerstone in modern pharmaceutical delivery systems, designed to release their active ingredient gradually over time to maintain therapeutic levels in the bloodstream. The coating on these tablets…

Solid Dosage form, Tablets

Ensuring Consistency in Granule Size Distribution During Validation Testing

May 4, 2025 Admin

Ensuring Consistency in Granule Size Distribution During Validation Testing Ensuring Consistency in Granule Size Distribution During Validation Testing Introduction: In the pharmaceutical industry, ensuring consistency in granule size distribution during validation testing is crucial for the production of high-quality solid dosage forms, particularly tablets. Granule size directly influences the flowability, compressibility, and dissolution rates of…

Solid Dosage form, Tablets

Troubleshooting Non-Uniform Layer Adhesion in Coating Machines During Validation

May 4, 2025 Admin

Troubleshooting Non-Uniform Layer Adhesion in Coating Machines During Validation Troubleshooting Non-Uniform Layer Adhesion in Coating Machines During Validation Introduction: In the world of pharmaceutical manufacturing, the coating of tablets is a critical step that ensures the delivery of active pharmaceutical ingredients (APIs) with precision and efficacy. A uniform coating not only enhances the aesthetic appeal…

Solid Dosage form, Tablets

Ensuring Robustness of Coating Adhesion in Multi-API Tablets Over Time

May 4, 2025 Admin

Ensuring Robustness of Coating Adhesion in Multi-API Tablets Over Time Ensuring Robustness of Coating Adhesion in Multi-API Tablets Over Time Introduction: In the dynamic landscape of pharmaceutical manufacturing, ensuring the robustness of coating adhesion in multi-API (Active Pharmaceutical Ingredient) tablets is crucial. The coating plays a pivotal role in protecting the drug, controlling its release,…

Solid Dosage form, Tablets

Managing Surface Erosion in Sugar-Coated Tablets During Stability Studies

May 3, 2025 Admin

Managing Surface Erosion in Sugar-Coated Tablets During Stability Studies Managing Surface Erosion in Sugar-Coated Tablets During Stability Studies Introduction: In the pharmaceutical industry, sugar-coated tablets have been a popular choice for delivering active pharmaceutical ingredients (APIs) due to their aesthetic appeal, ease of swallowing, and ability to mask the taste of certain drugs. However, during…

Solid Dosage form, Tablets

Challenges in achieving uniform capsule transparency during validation.

May 3, 2025 Admin

Challenges in achieving uniform capsule transparency during validation. Challenges in achieving uniform capsule transparency during validation. Introduction: In the pharmaceutical industry, the demand for consistent and high-quality solid oral dosage forms has never been greater. Among these, capsules, particularly hard and soft gelatin capsules, stand out due to their versatility and consumer preference for ease…

Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

Addressing Residual Detergent Issues in Cleaning Validation Studies

May 3, 2025 Admin

Addressing Residual Detergent Issues in Cleaning Validation Studies Addressing Residual Detergent Issues in Cleaning Validation Studies Introduction: In the pharmaceutical industry, cleaning validation is an essential process to ensure that equipment used in the manufacturing of drugs is properly cleaned, preventing cross-contamination and ensuring product safety and efficacy. One of the critical components of cleaning…

Solid Dosage form, Tablets

Inadequate systems for verifying capsule printing ink adhesion.

May 2, 2025 Admin

Inadequate systems for verifying capsule printing ink adhesion. Inadequate systems for verifying capsule printing ink adhesion. Introduction: In the pharmaceutical industry, capsules are a popular solid oral dosage form, offering a convenient and effective delivery system for active ingredients. However, the integrity and identification of these capsules depend heavily on the quality and adherence of…

Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

Difficulty in ensuring proper documentation for quality-related investigations.

May 2, 2025 Admin

Difficulty in ensuring proper documentation for quality-related investigations. Difficulty in ensuring proper documentation for quality-related investigations Introduction: In the pharmaceutical industry, ensuring comprehensive and meticulous documentation for quality-related investigations is not just a regulatory requirement but a cornerstone for maintaining product efficacy and patient safety. Documentation serves as the evidence of compliance with Good Manufacturing…

Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

Preventing Incorrect Barcode Printing on Tablet Packaging Materials

May 2, 2025 Admin

Preventing Incorrect Barcode Printing on Tablet Packaging Materials Preventing Incorrect Barcode Printing on Tablet Packaging Materials Introduction: In the pharmaceutical industry, accurate barcode printing on packaging is crucial for ensuring patient safety, regulatory compliance, and efficient supply chain management. Barcodes facilitate the tracking and tracing of pharmaceutical products, aiding in the prevention of counterfeit drugs…

Solid Dosage form, Tablets