Tag: GMP

Detecting Core Erosion in Sugar-Coated Tablets During Coating Processes

March 8, 2025 Admin

Detecting Core Erosion in Sugar-Coated Tablets During Coating Processes Detecting Core Erosion in Sugar-Coated Tablets During Coating Processes Introduction: The pharmaceutical industry relies heavily on the integrity and efficacy of solid dosage forms like tablets. Among these, sugar-coated tablets have been traditionally used for their aesthetic appeal and ability to mask unpleasant tastes. However, the…

Solid Dosage form, Tablets

Common Pitfalls in Weight Uniformity Testing for Immediate Release Tablets

March 8, 2025 Admin

Common Pitfalls in Weight Uniformity Testing for Immediate Release Tablets Common Pitfalls in Weight Uniformity Testing for Immediate Release Tablets Introduction: Weight uniformity testing is a critical quality control measure in the pharmaceutical industry, particularly for immediate release tablets. Ensuring consistency in tablet weight is essential not only for compliance with regulatory standards but also…

Solid Dosage form, Tablets

Difficulty in validating cleaning methods for enteric-coated formulations.

March 7, 2025 Admin

Difficulty in validating cleaning methods for enteric-coated formulations. Difficulty in Validating Cleaning Methods for Enteric-Coated Formulations Introduction: In the pharmaceutical industry, maintaining stringent cleanliness standards is crucial to ensure product safety and efficacy. One area that presents significant challenges is the cleaning validation for enteric-coated formulations. These formulations are designed to resist the acidic environment…

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

Addressing Cross-Contamination Risks in Utility Systems for Hygroscopic Tablets

March 7, 2025 Admin

Addressing Cross-Contamination Risks in Utility Systems for Hygroscopic Tablets Addressing Cross-Contamination Risks in Utility Systems for Hygroscopic Tablets Introduction: In the pharmaceutical industry, ensuring the integrity and safety of drug products is paramount. Hygroscopic tablets, which readily absorb moisture from the environment, pose unique challenges during manufacturing. Cross-contamination in utility systems can compromise the quality…

Solid Dosage form, Tablets

Ensuring Compliance with Clean Steam Standards in Multi-Product Facilities

March 7, 2025 Admin

Ensuring Compliance with Clean Steam Standards in Multi-Product Facilities Ensuring Compliance with Clean Steam Standards in Multi-Product Facilities Introduction: In the dynamic landscape of pharmaceutical manufacturing, ensuring compliance with clean steam standards is critical, particularly in multi-product facilities. Clean steam is crucial for maintaining the sterility and quality of pharmaceutical products. It is used in…

Solid Dosage form, Tablets

Troubleshooting Non-Uniform Disintegration in Coated Tablets During Testing

March 7, 2025 Admin

Troubleshooting Non-Uniform Disintegration in Coated Tablets During Testing Troubleshooting Non-Uniform Disintegration in Coated Tablets During Testing Introduction: Coated tablets are a prevalent form of medication delivery in the pharmaceutical industry, designed to improve the stability, appearance, and release characteristics of the active pharmaceutical ingredient (API). The disintegration of these tablets is a critical quality attribute…

Solid Dosage form, Tablets

Validating Cleanroom HVAC Systems for Enteric-Coated Tablet Manufacturing

March 6, 2025 Admin

Validating Cleanroom HVAC Systems for Enteric-Coated Tablet Manufacturing Validating Cleanroom HVAC Systems for Enteric-Coated Tablet Manufacturing Introduction: In the pharmaceutical industry, the manufacturing of enteric-coated tablets requires stringent environmental controls to ensure product integrity and patient safety. The role of Heating, Ventilation, and Air Conditioning (HVAC) systems in maintaining cleanroom conditions is critical. These systems…

Solid Dosage form, Tablets

Validating Rinse Sampling Protocols for Cleaning Validation in Multi-Product Facilities

March 5, 2025 Admin

Validating Rinse Sampling Protocols for Cleaning Validation in Multi-Product Facilities Validating Rinse Sampling Protocols for Cleaning Validation in Multi-Product Facilities Introduction: In the dynamic field of pharmaceutical manufacturing, maintaining stringent hygiene and safety standards is paramount. Multi-product facilities, which handle the production of various drugs using shared equipment, face unique challenges in preventing cross-contamination. A…

Solid Dosage form, Tablets

Challenges in ensuring consistent capsule integrity under stressed conditions.

March 4, 2025 Admin

Challenges in ensuring consistent capsule integrity under stressed conditions. Challenges in ensuring consistent capsule integrity under stressed conditions. Introduction: Capsules, both hard and soft gelatin, are among the most popular solid oral dosage forms in the pharmaceutical industry due to their ease of administration and ability to encapsulate a wide range of medicinal compounds. However,…

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

Troubleshooting Failures in Residual Moisture Control for Purified Water Systems

March 4, 2025 Admin

Troubleshooting Failures in Residual Moisture Control for Purified Water Systems Troubleshooting Failures in Residual Moisture Control for Purified Water Systems Introduction: In the pharmaceutical industry, maintaining the quality and safety of products is paramount. One critical aspect of ensuring product integrity is the control of residual moisture in purified water systems. Residual moisture can affect…

Solid Dosage form, Tablets

Validating Steam Quality for Fluid Bed Granulators in Multi-Product Facilities

March 4, 2025 Admin

Validating Steam Quality for Fluid Bed Granulators in Multi-Product Facilities Validating Steam Quality for Fluid Bed Granulators in Multi-Product Facilities Introduction: In the complex landscape of pharmaceutical manufacturing, ensuring the highest quality of products is paramount. One critical aspect of this process is the validation of steam quality, particularly in multi-product facilities where fluid bed…

Solid Dosage form, Tablets

Ensuring Robustness in Purified Water Flow Rates for Cleaning Validation

March 4, 2025 Admin

Ensuring Robustness in Purified Water Flow Rates for Cleaning Validation Ensuring Robustness in Purified Water Flow Rates for Cleaning Validation Introduction: In the pharmaceutical industry, maintaining high standards of cleanliness and sanitation is paramount. One critical component of this process is the use of purified water for cleaning validation. The flow rate of purified water…

Solid Dosage form, Tablets