Tag: manufacturing processes

Investigating Coating Adhesion Failures in Enteric-Coated Tablets During Testing

May 10, 2025 Admin

Investigating Coating Adhesion Failures in Enteric-Coated Tablets During Testing Investigating Coating Adhesion Failures in Enteric-Coated Tablets During Testing Introduction: Enteric-coated tablets are designed to withstand the acidic environment of the stomach and dissolve in the more neutral environment of the intestines. This targeted drug delivery system is crucial for drugs that are sensitive to stomach…

Solid Dosage form, Tablets

Problems with establishing acceptance criteria for cleaning validation studies.

April 26, 2025 Admin

Problems with establishing acceptance criteria for cleaning validation studies. Problems with Establishing Acceptance Criteria for Cleaning Validation Studies Introduction: In the pharmaceutical industry, maintaining cleanliness and preventing cross-contamination are paramount to ensuring product safety and efficacy. Cleaning validation studies are critical components of Good Manufacturing Practice (GMP) compliance. They confirm that cleaning processes consistently produce…

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

Inadequate systems for validating capsule hardness testing equipment.

April 21, 2025 Admin

Inadequate systems for validating capsule hardness testing equipment. Inadequate systems for validating capsule hardness testing equipment. Introduction: The pharmaceutical industry demands rigorous quality control measures to ensure the safety and efficacy of its products. Among these measures, validating equipment used for testing the hardness of capsules is crucial. Capsule hardness is an essential parameter that…

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

Managing Non-Adherence to GMP Standards in QA Processes

April 18, 2025 Admin

Managing Non-Adherence to GMP Standards in QA Processes Managing Non-Adherence to GMP Standards in QA Processes Introduction: In the pharmaceutical industry, maintaining strict adherence to Good Manufacturing Practice (GMP) standards is critical to ensuring the safety, efficacy, and quality of drug products. GMP standards, established by regulatory bodies such as the US FDA, provide a…

Solid Dosage form, Tablets

Problems with ensuring consistent capsule shell thickness across validation batches.

April 17, 2025 Admin

Problems with ensuring consistent capsule shell thickness across validation batches. Problems with Ensuring Consistent Capsule Shell Thickness Across Validation Batches Introduction: In the pharmaceutical industry, maintaining consistent capsule shell thickness across validation batches is critical for ensuring product quality and efficacy. The capsule shell not only protects the integrity of the encapsulated medication but also…

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

Inadequate systems for monitoring cleaning validation data across multiple equipment.

April 14, 2025 Admin

Inadequate systems for monitoring cleaning validation data across multiple equipment. Inadequate Systems for Monitoring Cleaning Validation Data Across Multiple Equipment Introduction: In the pharmaceutical industry, maintaining impeccable hygiene and cleanliness is paramount, especially when dealing with solid oral dosage forms like capsules. The efficacy of drugs and patient safety hinge on the ability to prevent…

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

Inadequate systems for monitoring capsule transparency changes over time.

April 8, 2025 Admin

Inadequate systems for monitoring capsule transparency changes over time. Inadequate systems for monitoring capsule transparency changes over time. Introduction: In the realm of pharmaceuticals, maintaining the quality and integrity of solid oral dosage forms such as capsules is paramount. Capsules, both hard and soft gelatin, are popular due to their ease of administration and ability…

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

Problems with validating capsule sealing for oil-based fills.

April 5, 2025 Admin

Problems with validating capsule sealing for oil-based fills. Problems with Validating Capsule Sealing for Oil-Based Fills Introduction: In the pharmaceutical industry, capsules serve as an essential dosage form, particularly for delivering oil-based formulations. The encapsulation of oils presents unique challenges, especially in ensuring the integrity and stability of the seal. Validating capsule sealing for oil-based…

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

Root Cause Analysis for Failures in Coating Layer Adhesion Tests

March 21, 2025 Admin

Root Cause Analysis for Failures in Coating Layer Adhesion Tests Root Cause Analysis for Failures in Coating Layer Adhesion Tests Introduction: The pharmaceutical industry continually strives to optimize the quality and efficiency of its products. Among the various solid dosage forms, tablets are particularly popular due to their stability, ease of administration, and manufacturing efficiency….

Solid Dosage form, Tablets

Difficulty in validating capsule filling equipment for lipid-based suspensions.

March 20, 2025 Admin

Difficulty in validating capsule filling equipment for lipid-based suspensions. Difficulty in validating capsule filling equipment for lipid-based suspensions. Introduction: In the pharmaceutical industry, the encapsulation of lipid-based suspensions presents unique challenges that require meticulous validation of capsule filling equipment. Lipid-based formulations are gaining popularity due to their ability to enhance the bioavailability of poorly water-soluble…

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

Ensuring Compliance with Residual Limits in Cleaning Validation Studies

March 19, 2025 Admin

Ensuring Compliance with Residual Limits in Cleaning Validation Studies Ensuring Compliance with Residual Limits in Cleaning Validation Studies Introduction: In the pharmaceutical industry, maintaining stringent hygiene and cleanliness standards is crucial for ensuring product safety and efficacy. Cleaning validation is an essential component of Good Manufacturing Practices (GMP), particularly in solid dosage forms such as…

Solid Dosage form, Tablets

Troubleshooting Layer Delamination in Sugar-Coated Tablets During Validation

March 18, 2025 Admin

Troubleshooting Layer Delamination in Sugar-Coated Tablets During Validation Troubleshooting Layer Delamination in Sugar-Coated Tablets During Validation Introduction: In the pharmaceutical industry, sugar-coated tablets are a popular dosage form due to their aesthetic appeal and taste-masking properties. However, during the critical phase of validation, one of the most common issues encountered is layer delamination. This problem…

Solid Dosage form, Tablets