Tag: GMP compliance

Addressing Residual Moisture Issues in Purified Water Systems

March 7, 2025 Admin

Addressing Residual Moisture Issues in Purified Water Systems Addressing Residual Moisture Issues in Purified Water Systems Introduction: Purified water systems play a critical role in pharmaceutical manufacturing, ensuring that the water used in production meets stringent quality and safety standards. However, residual moisture is a common challenge that can compromise the integrity of pharmaceutical products….

Solid Dosage form, Tablets

Difficulty in testing for capsule tamper resistance.

March 7, 2025 Admin

Difficulty in testing for capsule tamper resistance. Difficulty in Testing for Capsule Tamper Resistance Introduction: In the pharmaceutical industry, ensuring the integrity and safety of drug products is paramount. Capsules, both hard and soft gelatin, are popular solid oral dosage forms due to their convenience and efficiency in delivering medication. However, they are vulnerable to…

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

Validating Utility Systems for Immediate Release Tablet Manufacturing Processes

March 7, 2025 Admin

Validating Utility Systems for Immediate Release Tablet Manufacturing Processes Validating Utility Systems for Immediate Release Tablet Manufacturing Processes Introduction: In the pharmaceutical industry, utility systems are vital components in the manufacturing of immediate release tablets. These systems, which include water, HVAC, and compressed air, must be properly validated to ensure they meet stringent quality and…

Solid Dosage form, Tablets

Troubleshooting Failures in Residual Solvent Control for Compressed Air Systems

March 7, 2025 Admin

Troubleshooting Failures in Residual Solvent Control for Compressed Air Systems Troubleshooting Failures in Residual Solvent Control for Compressed Air Systems Introduction: In the pharmaceutical industry, maintaining the purity of compressed air systems is critical for ensuring the safety and efficacy of solid dosage forms such as tablets. Residual solvent control plays a vital role in…

Solid Dosage form, Tablets

Managing Inconsistent Particle Counts During Cleanroom Validation Tests

March 7, 2025 Admin

Managing Inconsistent Particle Counts During Cleanroom Validation Tests Managing Inconsistent Particle Counts During Cleanroom Validation Tests Introduction: In the realm of pharmaceutical manufacturing, cleanrooms play a critical role in ensuring the quality and safety of the products. These controlled environments are essential for maintaining low levels of airborne particles, which can compromise the integrity of…

Solid Dosage form, Tablets

Problems with ensuring consistent air velocity in encapsulation areas.

March 7, 2025 Admin

Problems with ensuring consistent air velocity in encapsulation areas. Problems with ensuring consistent air velocity in encapsulation areas. Introduction: In the pharmaceutical industry, maintaining a controlled environment in encapsulation areas is crucial for product quality and compliance. Consistent air velocity is a key parameter in these controlled environments, ensuring that the air is properly filtered…

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

Addressing Non-Homogeneity in Powder Blends for Multi-API Tablets

March 7, 2025 Admin

Addressing Non-Homogeneity in Powder Blends for Multi-API Tablets Addressing Non-Homogeneity in Powder Blends for Multi-API Tablets Introduction: In the pharmaceutical industry, the production of multi-API (Active Pharmaceutical Ingredient) tablets requires precise formulation and meticulous blending to ensure each tablet meets stringent quality standards. Achieving homogeneity in powder blends is crucial for ensuring that every tablet…

Solid Dosage form, Tablets

Addressing Calibration Failures in Temperature Mapping for Fluid Bed Dryers

March 7, 2025 Admin

Addressing Calibration Failures in Temperature Mapping for Fluid Bed Dryers Addressing Calibration Failures in Temperature Mapping for Fluid Bed Dryers Introduction: Temperature mapping is a critical component in ensuring the consistent and effective operation of fluid bed dryers used in pharmaceutical manufacturing. These dryers are essential for the production of solid dosage forms, particularly tablets,…

Solid Dosage form, Tablets

Validating Water Circulation Systems for Extended Release Tablet Equipment

March 7, 2025 Admin

Validating Water Circulation Systems for Extended Release Tablet Equipment Validating Water Circulation Systems for Extended Release Tablet Equipment Introduction: In the pharmaceutical industry, ensuring the quality and safety of extended release tablets is paramount. A critical aspect of this process is the validation of water circulation systems used in tablet manufacturing equipment. Water is a…

Solid Dosage form, Tablets

Troubleshooting Failures in Compressed Air Distribution Validation

March 7, 2025 Admin

Troubleshooting Failures in Compressed Air Distribution Validation Troubleshooting Failures in Compressed Air Distribution Validation Introduction: In the realm of pharmaceutical manufacturing, ensuring the quality and integrity of all input materials and processes is crucial. Among these, compressed air systems play a vital role in maintaining the sterility and safety of pharmaceutical products. Compressed air is…

Solid Dosage form, Tablets

Managing Static Charge in Powder Handling Systems During Production

March 7, 2025 Admin

Managing Static Charge in Powder Handling Systems During Production Managing Static Charge in Powder Handling Systems During Production Introduction: In the world of pharmaceutical manufacturing, maintaining the integrity and safety of production processes is paramount. One often overlooked but critical aspect is the management of static charge in powder handling systems. Static electricity can cause…

Solid Dosage form, Tablets

Managing Challenges in Validating Spray Guns for Enteric-Coating Applications

March 6, 2025 Admin

Managing Challenges in Validating Spray Guns for Enteric-Coating Applications Managing Challenges in Validating Spray Guns for Enteric-Coating Applications Introduction: In the pharmaceutical industry, enteric coating is a critical process used to ensure that the active pharmaceutical ingredient (API) of a tablet survives the acidic environment of the stomach and is released in the intestine, where…

Solid Dosage form, Tablets