Tag: FDA Regulations

Validating Equipment for High-Speed Compression of Multi-Layer Tablets

April 6, 2025 Admin

Validating Equipment for High-Speed Compression of Multi-Layer Tablets Validating Equipment for High-Speed Compression of Multi-Layer Tablets Introduction: In the pharmaceutical industry, the demand for multi-layer tablets has been increasing due to their ability to deliver multiple drugs with different release profiles in a single dosage form. This has led to the need for high-speed compression…

Solid Dosage form, Tablets

Challenges in testing capsules with delayed-release profiles.

April 6, 2025 Admin

Challenges in testing capsules with delayed-release profiles. Challenges in testing capsules with delayed-release profiles. Introduction: Delayed-release capsules are a crucial innovation in pharmaceutical science, allowing for the targeted delivery of medications to specific areas of the gastrointestinal tract. By releasing the active ingredient at a predetermined time or location, these capsules enhance the drug’s efficacy…

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

Inadequate systems for verifying capsule sealing machine calibration.

April 6, 2025 Admin

Inadequate systems for verifying capsule sealing machine calibration. Inadequate systems for verifying capsule sealing machine calibration Introduction: In the pharmaceutical industry, ensuring the integrity of capsule products is paramount. This integrity often hinges on the precise calibration of capsule sealing machines. These machines play a critical role in maintaining the quality and efficacy of both…

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

Inadequate systems for reviewing and updating quality-related documents.

April 5, 2025 Admin

Inadequate systems for reviewing and updating quality-related documents. Inadequate Systems for Reviewing and Updating Quality-Related Documents Introduction: In the pharmaceutical industry, maintaining up-to-date and accurate quality-related documents is crucial. These documents ensure compliance with regulatory standards, facilitate efficient operations, and uphold product quality and safety. Despite their significance, many organizations struggle with inadequate systems for…

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

Inadequate monitoring of packaging line cleanliness.

April 4, 2025 Admin

Inadequate monitoring of packaging line cleanliness. Inadequate Monitoring of Packaging Line Cleanliness Introduction: In the pharmaceutical industry, maintaining the cleanliness of packaging lines is critical to ensuring the safety, efficacy, and quality of drug products. Packaging lines are where the final steps of product handling occur, and any lapse in cleanliness can lead to contamination,…

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

Poor enforcement of corrective and preventive action (CAPA) programs.

April 3, 2025 Admin

Poor enforcement of corrective and preventive action (CAPA) programs. Poor enforcement of corrective and preventive action (CAPA) programs. Introduction: Corrective and Preventive Action (CAPA) programs serve as a cornerstone in pharmaceutical quality management systems. Their primary goal is to identify, address, and mitigate quality issues, ensuring that products meet regulatory standards and patient safety requirements….

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

Ensuring Batch Record Accuracy During Tablet Manufacturing

March 27, 2025 Admin

Ensuring Batch Record Accuracy During Tablet Manufacturing Ensuring Batch Record Accuracy During Tablet Manufacturing Introduction: In the pharmaceutical industry, the manufacturing of tablets is a critical process that requires precision, consistency, and adherence to stringent regulatory standards. Ensuring batch record accuracy is pivotal not only for compliance with regulatory requirements but also for ensuring product…

Solid Dosage form, Tablets

Difficulty in ensuring proper calibration of HVAC flow sensors.

March 23, 2025 Admin

Difficulty in ensuring proper calibration of HVAC flow sensors. Difficulty in Ensuring Proper Calibration of HVAC Flow Sensors Introduction: In pharmaceutical manufacturing, maintaining a controlled environment is crucial to ensure product quality and safety. Heating, Ventilation, and Air Conditioning (HVAC) systems play a pivotal role in regulating these environments. Central to the efficacy of an…

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

Ensuring Robustness in Content Uniformity Tests for Multi-Layer Tablets

March 20, 2025 Admin

Ensuring Robustness in Content Uniformity Tests for Multi-Layer Tablets Ensuring Robustness in Content Uniformity Tests for Multi-Layer Tablets Introduction: In the pharmaceutical industry, ensuring the quality and efficacy of solid dosage forms such as multi-layer tablets is of paramount importance. Multi-layer tablets offer the advantage of combining different drugs or release profiles in a single…

Solid Dosage form, Tablets

Poor reproducibility in monitoring capsule disintegration times.

March 16, 2025 Admin

Poor reproducibility in monitoring capsule disintegration times. Poor reproducibility in monitoring capsule disintegration times. Introduction: In the realm of pharmaceutical research and manufacturing, ensuring the quality and efficacy of solid oral dosage forms is paramount. Among these, capsules, both hard and soft gelatin, are widely used due to their convenience and efficacy in drug delivery….

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

Addressing API Variability Issues During Quality Assurance Audits

March 16, 2025 Admin

Addressing API Variability Issues During Quality Assurance Audits Addressing API Variability Issues During Quality Assurance Audits Introduction: In the pharmaceutical industry, ensuring the consistency and reliability of Active Pharmaceutical Ingredients (APIs) is crucial, especially during quality assurance audits. API variability can significantly impact the safety, efficacy, and quality of the final product, making it a…

Solid Dosage form, Tablets

Real-Time Detection of Coating Defects in Sustained Release Tablets

March 15, 2025 Admin

Real-Time Detection of Coating Defects in Sustained Release Tablets Real-Time Detection of Coating Defects in Sustained Release Tablets Introduction: In the pharmaceutical industry, the production of sustained release tablets is a critical process that ensures the controlled release of active ingredients over time, enhancing therapeutic efficacy and patient compliance. The coating of these tablets plays…

Solid Dosage form, Tablets