Tag: Validation protocol

Addressing Non-Compliance in Process Validation for Hygroscopic Tablets

June 4, 2025 Admin

Addressing Non-Compliance in Process Validation for Hygroscopic Tablets Addressing Non-Compliance in Process Validation for Hygroscopic Tablets Introduction: In the pharmaceutical industry, the process validation of hygroscopic tablets presents unique challenges. Hygroscopic tablets are those that have a tendency to absorb moisture from their surroundings, which can lead to significant issues in their stability, efficacy, and…

Solid Dosage form, Tablets

Validating Water for Injection (WFI) Systems in Multi-Product Facilities

May 26, 2025 Admin

Validating Water for Injection (WFI) Systems in Multi-Product Facilities Validating Water for Injection (WFI) Systems in Multi-Product Facilities Introduction: Water for Injection (WFI) is a critical component in pharmaceutical manufacturing, particularly in multi-product facilities where diverse formulations are produced. WFI is used for dissolving or diluting substances or preparations during production, ensuring sterility and non-pyrogenicity….

Solid Dosage form, Tablets

Poor reproducibility in swab recovery studies during cleaning validation.

April 22, 2025 Admin

Poor reproducibility in swab recovery studies during cleaning validation. Poor reproducibility in swab recovery studies during cleaning validation. Introduction: Cleaning validation is a critical component of Good Manufacturing Practices (GMP) in the pharmaceutical industry. It ensures that any equipment used in the production of drug products is adequately cleaned to prevent contamination of subsequent batches….

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

Challenges in validating cleaning procedures for encapsulation lines shared across products.

April 14, 2025 Admin

Challenges in validating cleaning procedures for encapsulation lines shared across products. Challenges in Validating Cleaning Procedures for Encapsulation Lines Shared Across Products Introduction: In the pharmaceutical industry, ensuring the cleanliness of encapsulation lines that are shared across different products is critical. This process is not only essential for maintaining product integrity but also for adhering…

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

Problems with ensuring consistent gelatin plasticizer levels during validation.

April 2, 2025 Admin

Problems with ensuring consistent gelatin plasticizer levels during validation. Problems with Ensuring Consistent Gelatin Plasticizer Levels During Validation Introduction: The pharmaceutical industry faces numerous challenges when it comes to the formulation and validation of solid oral dosage forms, particularly capsules. Among these challenges, ensuring consistent gelatin plasticizer levels is critical in maintaining the quality and…

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

Troubleshooting Residual Binder Issues in Granulation Equipment During Validation

March 14, 2025 Admin

Troubleshooting Residual Binder Issues in Granulation Equipment During Validation Troubleshooting Residual Binder Issues in Granulation Equipment During Validation Introduction: In the pharmaceutical industry, ensuring the quality and efficacy of solid dosage forms like tablets is paramount. Granulation is a critical process in tablet manufacturing, where powders are agglomerated to form granules, enhancing flowability and compressibility…

Solid Dosage form, Tablets

Validating Rinse Sampling Procedures in Cleaning Validation for Film-Coated Tablets

March 14, 2025 Admin

Validating Rinse Sampling Procedures in Cleaning Validation for Film-Coated Tablets Validating Rinse Sampling Procedures in Cleaning Validation for Film-Coated Tablets Introduction: In the pharmaceutical industry, ensuring the cleanliness of manufacturing equipment is crucial, especially when producing film-coated tablets. Cleaning validation, particularly rinse sampling procedures, plays a pivotal role in confirming that any residues from previous…

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

Ensuring Robustness in Utility Validation for High-Speed Compression Equipment

March 2, 2025 Admin

Ensuring Robustness in Utility Validation for High-Speed Compression Equipment Ensuring Robustness in Utility Validation for High-Speed Compression Equipment Introduction: In the pharmaceutical industry, the production of solid dosage forms, particularly tablets, is a critical process that demands precision, efficiency, and compliance with stringent regulatory standards. High-speed compression equipment plays a pivotal role in this process,…

Solid Dosage form, Tablets