Tag: USFDA guidelines

Managing Static Charge in Powder Handling Systems During Production

March 7, 2025 Admin

Managing Static Charge in Powder Handling Systems During Production Managing Static Charge in Powder Handling Systems During Production Introduction: In the world of pharmaceutical manufacturing, maintaining the integrity and safety of production processes is paramount. One often overlooked but critical aspect is the management of static charge in powder handling systems. Static electricity can cause…

Solid Dosage form, Tablets

Poor reproducibility in monitoring capsule disintegration profiles.

March 6, 2025 Admin

Poor reproducibility in monitoring capsule disintegration profiles. Poor reproducibility in monitoring capsule disintegration profiles. Introduction: The disintegration profile of capsules is a critical quality attribute that significantly impacts the bioavailability and therapeutic efficacy of the drug product. Ensuring consistent and reproducible disintegration times is essential for achieving regulatory compliance and maintaining product quality. Despite its…

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

Investigating Poor API Distribution in Content Uniformity Tests

March 6, 2025 Admin

Investigating Poor API Distribution in Content Uniformity Tests Investigating Poor API Distribution in Content Uniformity Tests Introduction: The pharmaceutical industry is heavily reliant on the precision and consistency of its products. One critical aspect of ensuring drug efficacy and safety is maintaining uniformity in the active pharmaceutical ingredient (API) distribution within solid dosage forms like…

Solid Dosage form, Tablets

Ensuring Consistency in Compression Force Across Batches During Equipment Validation

March 6, 2025 Admin

Ensuring Consistency in Compression Force Across Batches During Equipment Validation Ensuring Consistency in Compression Force Across Batches During Equipment Validation Introduction: In the pharmaceutical industry, ensuring consistency in the manufacturing process is crucial for producing high-quality medications. One critical aspect of this is maintaining a consistent compression force during the tablet manufacturing process. Compression force…

Solid Dosage form, Tablets

Troubleshooting Failures in Airborne Particle Monitoring for Compression Areas

March 6, 2025 Admin

Troubleshooting Failures in Airborne Particle Monitoring for Compression Areas Troubleshooting Failures in Airborne Particle Monitoring for Compression Areas Introduction: In pharmaceutical manufacturing, particularly in the production of solid dosage forms like tablets, maintaining a controlled environment is crucial for ensuring product quality and safety. One of the critical components of this control is airborne particle…

Solid Dosage form, Tablets

Managing Failures in Adhesion Testing During Enteric-Coating Validation

March 6, 2025 Admin

Managing Failures in Adhesion Testing During Enteric-Coating Validation Managing Failures in Adhesion Testing During Enteric-Coating Validation Introduction: Enteric coating is a critical process in the pharmaceutical industry, designed to protect active ingredients from the acidic environment of the stomach and release them in the more neutral pH of the intestine. This process not only ensures…

Solid Dosage form, Tablets

Inadequate systems for monitoring gelatin solution viscosity during validation.

March 6, 2025 Admin

Inadequate systems for monitoring gelatin solution viscosity during validation. Inadequate systems for monitoring gelatin solution viscosity during validation. Introduction: In the pharmaceutical industry, ensuring the quality and consistency of solid oral dosage forms is crucial. Gelatin capsules, both hard and soft, are popular due to their ease of use and ability to encapsulate a variety…

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

Ensuring Batch-to-Batch Consistency in Hardness Testing for Coated Tablets

March 6, 2025 Admin

Ensuring Batch-to-Batch Consistency in Hardness Testing for Coated Tablets Ensuring Batch-to-Batch Consistency in Hardness Testing for Coated Tablets Introduction: In the pharmaceutical industry, ensuring the quality and efficacy of tablet formulations is paramount. Among various quality parameters, hardness testing plays a crucial role in assessing the mechanical integrity of coated tablets. The consistency of tablet…

Solid Dosage form, Tablets

Troubleshooting Failures in Humidity Control Systems for Compression Rooms

March 5, 2025 Admin

Troubleshooting Failures in Humidity Control Systems for Compression Rooms Troubleshooting Failures in Humidity Control Systems for Compression Rooms Introduction: Maintaining optimal humidity control in compression rooms is a critical component of pharmaceutical manufacturing, particularly in the production of tablets. The environment in which tablets are compressed can significantly affect their quality and stability. Humidity levels…

Solid Dosage form, Tablets

Managing Failures in Humidity Monitoring Systems for Coating Equipment

March 5, 2025 Admin

Managing Failures in Humidity Monitoring Systems for Coating Equipment Managing Failures in Humidity Monitoring Systems for Coating Equipment Introduction: In the pharmaceutical industry, humidity control is a critical factor in the production of tablets, particularly during the coating process. Humidity levels can significantly affect the quality and efficacy of the final product. Coating equipment must…

Solid Dosage form, Tablets

Managing Static Electricity in Packaging Operations for Hygroscopic Tablets

March 5, 2025 Admin

Managing Static Electricity in Packaging Operations for Hygroscopic Tablets Managing Static Electricity in Packaging Operations for Hygroscopic Tablets Introduction: In the pharmaceutical industry, the packaging of hygroscopic tablets presents unique challenges, primarily due to their affinity for moisture. Static electricity can exacerbate these challenges by attracting particles and causing tablets to clump together, leading to…

Solid Dosage form, Tablets

Addressing Non-Compliance in Utility Validation for Hygroscopic Tablet Production

March 5, 2025 Admin

Addressing Non-Compliance in Utility Validation for Hygroscopic Tablet Production Addressing Non-Compliance in Utility Validation for Hygroscopic Tablet Production Introduction: In the pharmaceutical industry, producing high-quality tablets that meet regulatory standards is crucial. Among various tablet forms, hygroscopic tablets present unique challenges due to their moisture sensitivity. Utility validation is a vital part of ensuring that…

Solid Dosage form, Tablets