Tag: pharmaceutical best practices

Addressing Non-Compliance in QA Tests for Multi-Layer Tablets

May 16, 2025 Admin

Addressing Non-Compliance in QA Tests for Multi-Layer Tablets Addressing Non-Compliance in QA Tests for Multi-Layer Tablets Introduction: In the pharmaceutical industry, multi-layer tablets have emerged as a preferred solid dosage form due to their ability to deliver multiple active pharmaceutical ingredients (APIs) in a single dose and to provide controlled release of medications. However, ensuring…

Solid Dosage form, Tablets

Validating Rinse Volume Requirements in Cleaning Validation Protocols

May 15, 2025 Admin

Validating Rinse Volume Requirements in Cleaning Validation Protocols Validating Rinse Volume Requirements in Cleaning Validation Protocols Introduction: In the pharmaceutical industry, ensuring that manufacturing equipment is free from contaminants is paramount to product safety and efficacy. Cleaning validation is a critical component of Good Manufacturing Practice (GMP) to confirm that cleaning processes are effective and…

Solid Dosage form, Tablets

Ensuring Robustness in Steam Quality Tests for Coating Equipment

May 13, 2025 Admin

Ensuring Robustness in Steam Quality Tests for Coating Equipment Ensuring Robustness in Steam Quality Tests for Coating Equipment Introduction: In the pharmaceutical industry, maintaining high standards of quality and compliance is critical, especially during the production of solid dosage forms such as tablets. One crucial aspect in the manufacturing process is the coating of tablets,…

Solid Dosage form, Tablets

Investigating Solvent Evaporation Effects on Coated Tablets During Storage

May 13, 2025 Admin

Investigating Solvent Evaporation Effects on Coated Tablets During Storage Investigating Solvent Evaporation Effects on Coated Tablets During Storage Introduction: In the pharmaceutical industry, the stability and integrity of coated tablets during storage are paramount to ensuring their efficacy and safety. Solvent evaporation is a critical factor that can affect the coating’s performance, leading to potential…

Solid Dosage form, Tablets

Ensuring Consistency in Hardness Testing During Validation of Compression Lines

May 11, 2025 Admin

Ensuring Consistency in Hardness Testing During Validation of Compression Lines Ensuring Consistency in Hardness Testing During Validation of Compression Lines Introduction: The pharmaceutical industry places a significant emphasis on the quality and consistency of solid dosage forms, particularly tablets. Tablet hardness is a critical quality attribute that influences not only the tablet’s mechanical strength but…

Solid Dosage form, Tablets

Managing Brittleness in High-Dose Tablets Under Stability Conditions

May 11, 2025 Admin

Managing Brittleness in High-Dose Tablets Under Stability Conditions Managing Brittleness in High-Dose Tablets Under Stability Conditions Introduction: In the pharmaceutical industry, the development of high-dose tablets presents several challenges, particularly concerning their brittleness under stability conditions. Brittleness can compromise the efficacy, safety, and quality of the medication, which is crucial for patient health. Understanding and…

Solid Dosage form, Tablets

Ensuring Consistency in Layer Adhesion for Multi-Layer Tablets During Validation

May 10, 2025 Admin

Ensuring Consistency in Layer Adhesion for Multi-Layer Tablets During Validation Ensuring Consistency in Layer Adhesion for Multi-Layer Tablets During Validation Introduction: In the pharmaceutical industry, multi-layer tablets are gaining prominence due to their ability to deliver multiple drugs or release profiles within a single dosage form. This complexity brings forth challenges, particularly in ensuring consistency…

Solid Dosage form, Tablets

Managing Deviations in Batch Records for Enteric-Coated Tablets

May 9, 2025 Admin

Managing Deviations in Batch Records for Enteric-Coated Tablets Managing Deviations in Batch Records for Enteric-Coated Tablets Introduction: In the pharmaceutical industry, maintaining the integrity of batch records is crucial for ensuring the quality and compliance of drug products. Enteric-coated tablets, designed to withstand the acidic environment of the stomach and dissolve in the more neutral…

Solid Dosage form, Tablets

Ensuring Moisture Protection in Primary Packaging for Enteric-Coated Tablets

May 8, 2025 Admin

Ensuring Moisture Protection in Primary Packaging for Enteric-Coated Tablets Ensuring Moisture Protection in Primary Packaging for Enteric-Coated Tablets Introduction: In the pharmaceutical industry, ensuring the stability and efficacy of enteric-coated tablets is critical. These tablets are specifically designed to pass through the stomach intact and dissolve in the intestine. Moisture exposure can compromise the integrity…

Solid Dosage form, Tablets

Managing Documentation Deviations in Process Validation Protocols

May 7, 2025 Admin

Managing Documentation Deviations in Process Validation Protocols Managing Documentation Deviations in Process Validation Protocols Introduction: In the pharmaceutical industry, process validation is a critical component of ensuring product quality and compliance with regulatory standards. It involves a series of documented procedures and protocols designed to confirm that a manufacturing process consistently produces a product meeting…

Solid Dosage form, Tablets

Troubleshooting Failures in Layer Adhesion During Bilayer Tablet Equipment Validation

May 6, 2025 Admin

Troubleshooting Failures in Layer Adhesion During Bilayer Tablet Equipment Validation Troubleshooting Failures in Layer Adhesion During Bilayer Tablet Equipment Validation Introduction: Bilayer tablets have emerged as a significant advancement in pharmaceutical dosage forms, offering the potential for controlled release, improved patient compliance, and enhanced therapeutic efficacy. However, their manufacturing presents unique challenges, particularly concerning layer…

Solid Dosage form, Tablets

Troubleshooting API Loss in Extended Release Tablets Stored at High Humidity

May 6, 2025 Admin

Troubleshooting API Loss in Extended Release Tablets Stored at High Humidity Troubleshooting API Loss in Extended Release Tablets Stored at High Humidity Introduction: Extended release tablets are a cornerstone of modern pharmaceutical formulations, offering controlled release of active pharmaceutical ingredients (APIs) over time to improve patient compliance and therapeutic efficacy. However, when these tablets are…

Solid Dosage form, Tablets