Tag: EU GMP

Ensuring Robustness in Steam Quality Tests for Coating Equipment

May 13, 2025 Admin

Ensuring Robustness in Steam Quality Tests for Coating Equipment Ensuring Robustness in Steam Quality Tests for Coating Equipment Introduction: In the pharmaceutical industry, maintaining high standards of quality and compliance is critical, especially during the production of solid dosage forms such as tablets. One crucial aspect in the manufacturing process is the coating of tablets,…

Solid Dosage form, Tablets

Challenges in implementing robust quality audits for capsule production.

April 20, 2025 Admin

Challenges in implementing robust quality audits for capsule production. Challenges in implementing robust quality audits for capsule production. Introduction: In the ever-evolving pharmaceutical industry, maintaining stringent quality standards is paramount, especially when it comes to the production of capsules. Capsules, whether hard or soft gelatin, are among the most widely used solid oral dosage forms,…

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

Problems with ensuring proper calibration of HVAC sensors during validation.

April 13, 2025 Admin

Problems with ensuring proper calibration of HVAC sensors during validation. Problems with Ensuring Proper Calibration of HVAC Sensors During Validation Introduction: In the pharmaceutical industry, maintaining optimal environmental conditions is critical for the production of safe and effective drugs. Heating, Ventilation, and Air Conditioning (HVAC) systems play a pivotal role in controlling these conditions. Accurate…

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

Challenges in validating equipment for encapsulating semi-solid formulations.

April 8, 2025 Admin

Challenges in validating equipment for encapsulating semi-solid formulations. Challenges in validating equipment for encapsulating semi-solid formulations. Introduction: In the pharmaceutical industry, the encapsulation of semi-solid formulations presents unique challenges that require precise validation to ensure product efficacy and safety. Semi-solid formulations, often used for their controlled release properties and enhanced bioavailability, demand stringent equipment validation…

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

Ensuring GMP Compliance in Documentation for Cleaning Validation

March 25, 2025 Admin

Ensuring GMP Compliance in Documentation for Cleaning Validation Ensuring GMP Compliance in Documentation for Cleaning Validation Introduction: In the pharmaceutical industry, Good Manufacturing Practice (GMP) compliance is crucial to ensure the safety and efficacy of medicinal products. One critical aspect of GMP is the validation of cleaning processes to prevent cross-contamination and ensure product purity….

Solid Dosage form, Tablets

Challenges in maintaining proper documentation for vendor qualification.

March 20, 2025 Admin

Challenges in maintaining proper documentation for vendor qualification. Challenges in maintaining proper documentation for vendor qualification Introduction: In the pharmaceutical industry, vendor qualification is a critical component of ensuring product quality and safety. Proper documentation is not just a regulatory requirement but also a fundamental practice to maintain a reliable and efficient supply chain. Vendor…

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

Inadequate methods for validating air flow patterns in manufacturing areas.

March 18, 2025 Admin

Inadequate methods for validating air flow patterns in manufacturing areas. Inadequate Methods for Validating Air Flow Patterns in Manufacturing Areas Introduction: In the pharmaceutical industry, ensuring the proper validation of air flow patterns in manufacturing areas is crucial. These environments, often referred to as cleanrooms, are critical for maintaining product integrity and safety. Air flow…

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

Troubleshooting Failures in Cleanroom Classification for Sugar-Coated Tablet Production

March 2, 2025 Admin

Troubleshooting Failures in Cleanroom Classification for Sugar-Coated Tablet Production Troubleshooting Failures in Cleanroom Classification for Sugar-Coated Tablet Production Introduction: In the pharmaceutical industry, the production of sugar-coated tablets necessitates strict adherence to cleanroom classifications to ensure product quality and patient safety. Cleanrooms are controlled environments where parameters like airborne particles, temperature, and humidity are meticulously…

Solid Dosage form, Tablets