Tag: FDA Compliance

Validating Spray Gun Settings for Even Coating Distribution

June 1, 2025 Admin

Validating Spray Gun Settings for Even Coating Distribution Validating Spray Gun Settings for Even Coating Distribution Introduction: In the pharmaceutical industry, ensuring that tablets have an even coating is crucial not only for aesthetic purposes but also for the functionality of the dosage form. The coating protects the active pharmaceutical ingredient (API), controls release profiles,…

Solid Dosage form, Tablets

Investigating API Potency Retention in Immediate Release Tablets Over Time

May 11, 2025 Admin

Investigating API Potency Retention in Immediate Release Tablets Over Time Investigating API Potency Retention in Immediate Release Tablets Over Time Introduction: In the pharmaceutical industry, ensuring the efficacy and safety of medicinal products is paramount. One critical aspect of this is the potency retention of the Active Pharmaceutical Ingredient (API) in immediate release tablets over…

Solid Dosage form, Tablets

Troubleshooting Residual Detergent Issues in Cleaning Validation for Rotary Coating Pans

May 9, 2025 Admin

Troubleshooting Residual Detergent Issues in Cleaning Validation for Rotary Coating Pans Troubleshooting Residual Detergent Issues in Cleaning Validation for Rotary Coating Pans Introduction: In the pharmaceutical industry, ensuring the cleanliness of manufacturing equipment is paramount to maintaining product quality and patient safety. Rotary coating pans, essential in the production of coated tablets, must be meticulously…

Solid Dosage form, Tablets

Challenges in maintaining proper records for batch-specific quality deviations.

April 21, 2025 Admin

Challenges in maintaining proper records for batch-specific quality deviations. Challenges in maintaining proper records for batch-specific quality deviations Introduction: In the pharmaceutical industry, maintaining precise and thorough records of batch-specific quality deviations is vital for ensuring product safety and regulatory compliance. These records are essential for tracking the history of a product, identifying the root…

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

Poor reproducibility in assay testing for encapsulated suspensions.

April 18, 2025 Admin

Poor reproducibility in assay testing for encapsulated suspensions. Poor reproducibility in assay testing for encapsulated suspensions. Introduction: In the pharmaceutical industry, ensuring the quality and efficacy of drug products is paramount. Encapsulated suspensions, particularly in the form of hard and soft gelatin capsules, present unique challenges in maintaining consistent assay results. Assay testing is critical…

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

Poor reproducibility in disintegration testing for coated capsules.

April 15, 2025 Admin

Poor reproducibility in disintegration testing for coated capsules. Poor reproducibility in disintegration testing for coated capsules Introduction: In the pharmaceutical industry, disintegration testing is a critical quality control measure that ensures that oral dosage forms, such as capsules, break down within a specified time to release their active ingredients. This is particularly important for coated…

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

Inadequate oversight of capsule manufacturing data integrity.

April 13, 2025 Admin

Inadequate oversight of capsule manufacturing data integrity. Inadequate Oversight of Capsule Manufacturing Data Integrity Introduction: In the pharmaceutical industry, maintaining data integrity is paramount to ensuring the quality and safety of products. This is especially critical in the manufacturing of solid oral dosage forms, such as capsules, where precise data management is integral to the…

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

Problems with testing capsules containing high API load.

April 13, 2025 Admin

Problems with testing capsules containing high API load. Problems with testing capsules containing high API load. Introduction: In the pharmaceutical industry, capsules are a popular solid oral dosage form due to their versatility and ease of administration. As the demand for high-dose medications increases, the challenge of creating capsules with a high Active Pharmaceutical Ingredient…

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

Poor reproducibility in weight variation measurements over extended storage.

April 13, 2025 Admin

Poor reproducibility in weight variation measurements over extended storage. Poor reproducibility in weight variation measurements over extended storage. Introduction: In the pharmaceutical industry, ensuring the consistency and quality of solid oral dosage forms is paramount. Capsules, both hard and soft gelatin, are popular due to their ease of administration and versatility. However, maintaining their weight…

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

Difficulty in validating emergency power systems for utility backups.

April 7, 2025 Admin

Difficulty in validating emergency power systems for utility backups. Difficulty in Validating Emergency Power Systems for Utility Backups Introduction: In the pharmaceutical industry, the reliability of utility systems is paramount. Ensuring that emergency power systems are validated effectively is critical to maintaining the integrity and continuity of manufacturing processes, especially in the event of power…

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

Problems with validating sterilization processes for gelatin solutions.

April 7, 2025 Admin

Problems with validating sterilization processes for gelatin solutions. Problems with validating sterilization processes for gelatin solutions. Introduction: Sterilization is a critical process in the pharmaceutical industry, especially for solid oral dosage forms like capsules. Gelatin solutions, used in both hard and soft gelatin capsules, require meticulous sterilization to ensure product safety and efficacy. However, validating…

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

Poor validation of emergency backup systems for utility operations.

April 5, 2025 Admin

Poor validation of emergency backup systems for utility operations. Poor validation of emergency backup systems for utility operations. Introduction: In the pharmaceutical industry, maintaining continuous and reliable utility operations is crucial for ensuring product quality and adhering to regulatory standards. Emergency backup systems are vital for sustaining these operations during power failures or other utility…

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