Tag: Analytical methods

Resolving Issues in Stability Testing for Immediate Release Tablets

March 11, 2025 Admin

Resolving Issues in Stability Testing for Immediate Release Tablets Resolving Issues in Stability Testing for Immediate Release Tablets Introduction: Stability testing is a critical component in the development and lifecycle management of pharmaceutical products. For immediate release tablets, which are designed to disintegrate and release their active ingredients promptly upon administration, ensuring stability is paramount….

Solid Dosage form, Tablets

Poor recovery of residues in rinse sampling during validation.

March 9, 2025 Admin

Poor recovery of residues in rinse sampling during validation. Poor recovery of residues in rinse sampling during validation. Introduction: In the pharmaceutical industry, ensuring the cleanliness of manufacturing equipment is paramount. One of the critical aspects of cleaning validation is rinse sampling, which helps ensure that no residue from previous manufacturing processes remains on the…

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

Difficulty in validating cleaning procedures for equipment exposed to hygroscopic powders.

March 8, 2025 Admin

Difficulty in validating cleaning procedures for equipment exposed to hygroscopic powders. Difficulty in validating cleaning procedures for equipment exposed to hygroscopic powders. Introduction: In the pharmaceutical industry, ensuring the cleanliness of manufacturing equipment is paramount to maintaining product quality and safety. This task becomes particularly challenging when dealing with hygroscopic powders, which are prone to…

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

Difficulty in validating cleaning methods for enteric-coated formulations.

March 7, 2025 Admin

Difficulty in validating cleaning methods for enteric-coated formulations. Difficulty in Validating Cleaning Methods for Enteric-Coated Formulations Introduction: In the pharmaceutical industry, maintaining stringent cleanliness standards is crucial to ensure product safety and efficacy. One area that presents significant challenges is the cleaning validation for enteric-coated formulations. These formulations are designed to resist the acidic environment…

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

Poor reproducibility in monitoring capsule disintegration profiles.

March 6, 2025 Admin

Poor reproducibility in monitoring capsule disintegration profiles. Poor reproducibility in monitoring capsule disintegration profiles. Introduction: The disintegration profile of capsules is a critical quality attribute that significantly impacts the bioavailability and therapeutic efficacy of the drug product. Ensuring consistent and reproducible disintegration times is essential for achieving regulatory compliance and maintaining product quality. Despite its…

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

Validating Rinse Sampling Protocols for Cleaning Validation in Multi-Product Facilities

March 5, 2025 Admin

Validating Rinse Sampling Protocols for Cleaning Validation in Multi-Product Facilities Validating Rinse Sampling Protocols for Cleaning Validation in Multi-Product Facilities Introduction: In the dynamic field of pharmaceutical manufacturing, maintaining stringent hygiene and safety standards is paramount. Multi-product facilities, which handle the production of various drugs using shared equipment, face unique challenges in preventing cross-contamination. A…

Solid Dosage form, Tablets

Ensuring Consistency in Swab Recovery During Cleaning Validation for Coated Tablets

March 4, 2025 Admin

Ensuring Consistency in Swab Recovery During Cleaning Validation for Coated Tablets Ensuring Consistency in Swab Recovery During Cleaning Validation for Coated Tablets Introduction: In the pharmaceutical industry, maintaining a high standard of cleanliness is crucial, especially during the manufacturing of coated tablets. Cleaning validation ensures that the cleaning methods employed are effective in removing residues,…

Solid Dosage form, Tablets

Ensuring Robustness in Thickness Testing for Extended Release Tablets

March 4, 2025 Admin

Ensuring Robustness in Thickness Testing for Extended Release Tablets Ensuring Robustness in Thickness Testing for Extended Release Tablets Introduction: In the pharmaceutical industry, maintaining the robustness and consistency of extended release tablets is paramount for both efficacy and safety. Thickness testing of these tablets plays a crucial role in ensuring their quality and performance. Variability…

Solid Dosage form, Tablets

Ensuring Robustness in Cleaning Validation for Granulators Used with Low-Dose APIs

March 4, 2025 Admin

Ensuring Robustness in Cleaning Validation for Granulators Used with Low-Dose APIs Ensuring Robustness in Cleaning Validation for Granulators Used with Low-Dose APIs Introduction: In the pharmaceutical industry, ensuring the cleanliness and safety of manufacturing equipment is crucial, especially when dealing with low-dose Active Pharmaceutical Ingredients (APIs). Granulators, essential in the tablet production process, must undergo…

Solid Dosage form, Tablets

Validating Residual Solvent Control Measures in Coated Tablets

March 2, 2025 Admin

Validating Residual Solvent Control Measures in Coated Tablets Validating Residual Solvent Control Measures in Coated Tablets Introduction: Residual solvents are volatile chemicals used or produced in the manufacture of pharmaceutical substances, excipients, or in the preparation of drug products. Their presence in pharmaceuticals is a critical quality and safety concern, especially in coated tablets where…

Solid Dosage form, Tablets

Managing Cleaning Validation Failures for Immediate Release Tablet Equipment

March 2, 2025 Admin

Managing Cleaning Validation Failures for Immediate Release Tablet Equipment Managing Cleaning Validation Failures for Immediate Release Tablet Equipment Introduction: In the pharmaceutical industry, ensuring the cleanliness of manufacturing equipment is critical to product quality and safety. Particularly for immediate release tablets, stringent cleaning protocols prevent cross-contamination and guarantee that residue levels remain within acceptable limits….

Solid Dosage form, Tablets

What are the key principles and objectives of GLP?

July 28, 2023July 28, 2023 Admin

Key Principles and Objectives of GLP Key Principles of GLP Good Laboratory Practice (GLP) is founded on several key principles that guide the conduct of nonclinical laboratory studies: 1. Data Integrity: Ensuring that all data generated during the study is accurate, reliable, and traceable to the original records. Data should be complete, transparent, and free…

GLP Guidelines