Tag: Regulatory Guidelines

Poor validation of capsule disintegration profiles for capsules stored under stressed conditions.

April 11, 2025 Admin

Poor validation of capsule disintegration profiles for capsules stored under stressed conditions. Poor validation of capsule disintegration profiles for capsules stored under stressed conditions. Introduction: In the pharmaceutical industry, ensuring the effective disintegration of capsules is crucial for the drug’s efficacy and safety. Disintegration testing is an essential quality control measure that determines whether capsules…

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

Difficulty in ensuring proper folding of carton inserts.

April 10, 2025 Admin

Difficulty in ensuring proper folding of carton inserts. Difficulty in ensuring proper folding of carton inserts. Introduction: In the pharmaceutical industry, carton inserts play a crucial role in delivering essential information about the medication, such as dosage instructions, contraindications, and storage guidelines. Ensuring that these inserts are folded correctly is vital for both compliance with…

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

Poor enforcement of preventive maintenance schedules for critical equipment.

April 9, 2025 Admin

Poor enforcement of preventive maintenance schedules for critical equipment. Poor enforcement of preventive maintenance schedules for critical equipment. Introduction: Preventive maintenance is a cornerstone of pharmaceutical manufacturing, especially when dealing with critical equipment such as capsule filling machines. These machines are vital in ensuring the production of solid oral dosage forms like hard and soft…

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 ensuring consistent water pressure in distribution systems.

April 6, 2025 Admin

Problems with ensuring consistent water pressure in distribution systems. Problems with Ensuring Consistent Water Pressure in Distribution Systems Introduction: In the pharmaceutical industry, maintaining consistent water pressure in distribution systems is critical for the production of solid oral dosage forms, including hard and soft gelatin capsules. Water is a fundamental component in many pharmaceutical processes,…

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

Problems with achieving consistent quality in aluminum foil printing.

April 3, 2025 Admin

Problems with achieving consistent quality in aluminum foil printing. Problems with achieving consistent quality in aluminum foil printing. Introduction: In the pharmaceutical industry, packaging plays a crucial role in protecting products and ensuring their efficacy and safety. Aluminum foil is extensively used in packaging for solid oral dosage forms, particularly capsules, due to its excellent…

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

Troubleshooting Failures in Cleaning Validation for Coating Equipment

March 20, 2025 Admin

Troubleshooting Failures in Cleaning Validation for Coating Equipment Troubleshooting Failures in Cleaning Validation for Coating Equipment Introduction: In the pharmaceutical industry, maintaining the integrity of cleaning validation processes is crucial, especially for coating equipment in the production of tablets. Cleaning validation ensures that the equipment is free from contaminants and residues that could affect product…

Solid Dosage form, Tablets

Ensuring Consistency in Coating Thickness During Stress Testing

March 19, 2025 Admin

Ensuring Consistency in Coating Thickness During Stress Testing Ensuring Consistency in Coating Thickness During Stress Testing Introduction: In the pharmaceutical industry, the coating of tablets is a critical process that ensures not only the aesthetic appeal but also the functional performance of the dosage form. A consistent coating thickness is vital for maintaining the integrity…

Solid Dosage form, Tablets

Addressing Poor Adhesion in Enteric Coating Processes

March 18, 2025 Admin

Addressing Poor Adhesion in Enteric Coating Processes Addressing Poor Adhesion in Enteric Coating Processes Introduction: Enteric coating is a crucial process in the pharmaceutical industry, designed to ensure that tablets withstand the acidic environment of the stomach and release their active ingredients in the more neutral pH of the intestine. However, poor adhesion during the…

Solid Dosage form, Tablets

Managing Excessive Binder Use in Wet Granulation Processes

March 15, 2025 Admin

Managing Excessive Binder Use in Wet Granulation Processes Managing Excessive Binder Use in Wet Granulation Processes Introduction: In the pharmaceutical industry, wet granulation is a crucial process used to improve the flowability and compressibility of powder blends, ultimately ensuring the production of high-quality tablets. Binders play an essential role in wet granulation, providing the necessary…

Solid Dosage form, Tablets

Troubleshooting Non-Adherence of Coating Materials in Enteric Tablets

March 13, 2025 Admin

Troubleshooting Non-Adherence of Coating Materials in Enteric Tablets Troubleshooting Non-Adherence of Coating Materials in Enteric Tablets Introduction: Enteric tablets are specially designed solid dosage forms that remain intact in the acidic environment of the stomach and dissolve in the more neutral pH of the intestine. This ensures that active pharmaceutical ingredients (APIs) are released at…

Solid Dosage form, Tablets

Inadequate systems for monitoring cleaning agent residues in rinse water.

March 11, 2025 Admin

Inadequate systems for monitoring cleaning agent residues in rinse water. Inadequate Systems for Monitoring Cleaning Agent Residues in Rinse Water Introduction: Ensuring the cleanliness of pharmaceutical manufacturing equipment is critical to maintaining product safety and efficacy. In the production of solid oral dosage forms, such as capsules, the presence of cleaning agent residues in rinse…

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