Tag: FDA guidelines

Difficulty in monitoring capsule quality during transport.

April 20, 2025 Admin

Difficulty in monitoring capsule quality during transport. Difficulty in Monitoring Capsule Quality During Transport Introduction: The pharmaceutical industry increasingly relies on complex supply chains to distribute medications worldwide, including solid oral dosage forms like capsules. Ensuring the quality of these capsules during transport is crucial for maintaining their efficacy and safety. Capsules, whether hard or…

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

Optimizing Cartoning Processes for Irregularly Shaped Tablets

April 20, 2025 Admin

Optimizing Cartoning Processes for Irregularly Shaped Tablets Optimizing Cartoning Processes for Irregularly Shaped Tablets Introduction: The pharmaceutical industry is continuously evolving, with innovations in drug formulations and delivery systems. Among these, irregularly shaped tablets have emerged as a vital frontier, offering enhanced efficacy and patient compliance. However, these uniquely designed tablets pose significant challenges in…

Solid Dosage form, Tablets

Problems with validating capsule release testing equipment.

April 19, 2025 Admin

Problems with validating capsule release testing equipment. Problems with Validating Capsule Release Testing Equipment Introduction: In the pharmaceutical industry, ensuring the consistent and reliable release of active pharmaceutical ingredients (APIs) from capsules is crucial for therapeutic efficacy. Capsule release testing, also known as dissolution testing, is a critical quality control process used to evaluate the…

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

Poor reproducibility in capsule drying validation results for multi-layer formulations.

April 19, 2025 Admin

Poor reproducibility in capsule drying validation results for multi-layer formulations. Poor reproducibility in capsule drying validation results for multi-layer formulations. Introduction: The pharmaceutical industry continuously strives to enhance the quality and efficacy of solid oral dosage forms, including capsules. Among these, multi-layer formulations have gained popularity due to their ability to deliver complex dosing regimens…

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

Problems with ensuring proper cleaning of high-shear mixers used in formulation.

April 19, 2025 Admin

Problems with ensuring proper cleaning of high-shear mixers used in formulation. Problems with ensuring proper cleaning of high-shear mixers used in formulation. Introduction: In the pharmaceutical industry, maintaining the cleanliness of high-shear mixers is vital for ensuring product quality and patient safety. These mixers are essential in the formulation of solid oral dosage forms, particularly…

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

Ensuring Adequacy of Binder Distribution in Sustained Release Tablet Validation

April 19, 2025 Admin

Ensuring Adequacy of Binder Distribution in Sustained Release Tablet Validation Ensuring Adequacy of Binder Distribution in Sustained Release Tablet Validation Introduction: In the complex world of pharmaceutical manufacturing, sustained release tablets represent a crucial advancement in medication delivery systems. These tablets offer numerous benefits, including improved patient compliance and enhanced bioavailability. However, the validation of…

Solid Dosage form, Tablets

Inadequate control over changes in raw material suppliers.

April 19, 2025 Admin

Inadequate control over changes in raw material suppliers. Inadequate control over changes in raw material suppliers Introduction: In the pharmaceutical industry, maintaining consistent quality and efficacy of products is paramount. One critical aspect that can significantly impact these factors is the control over raw material suppliers. Changes in suppliers can lead to variations in product…

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

Poor reproducibility in validation data for capsule storage equipment.

April 18, 2025 Admin

Poor reproducibility in validation data for capsule storage equipment. Poor reproducibility in validation data for capsule storage equipment. Introduction: The pharmaceutical industry relies heavily on precise and reliable data to ensure the safety and efficacy of its products. One critical area where data integrity is paramount is in the storage of capsules, both hard and…

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

Poor oversight of third-party vendors supplying capsule shells.

April 18, 2025 Admin

Poor oversight of third-party vendors supplying capsule shells. Poor Oversight of Third-Party Vendors Supplying Capsule Shells Introduction: In the pharmaceutical industry, ensuring the quality and safety of solid oral dosage forms, such as capsules, is paramount. Capsules, whether hard or soft gelatin, serve as vital delivery vehicles for medications. However, the integrity of these capsules…

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

Ensuring Robustness in Compression Force Settings During Validation Processes

April 18, 2025 Admin

Ensuring Robustness in Compression Force Settings During Validation Processes Ensuring Robustness in Compression Force Settings During Validation Processes Introduction: In the pharmaceutical industry, ensuring the robustness of compression force settings during the validation of tablet production is crucial. Compression force is a critical parameter that affects the mechanical strength, dissolution, and overall quality of the…

Solid Dosage form, Tablets

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

Poor validation of analytical methods for capsule testing.

April 18, 2025 Admin

Poor validation of analytical methods for capsule testing. Poor validation of analytical methods for capsule testing. Introduction: The validation of analytical methods is a critical component of pharmaceutical development and manufacturing, especially for solid oral dosage forms like capsules. Both hard and soft gelatin capsules require precise and reliable analytical methods to ensure their safety,…

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