Tag: FDA Compliance

Poor validation of analytical methods for multi-drug capsule formulations.

April 3, 2025 Admin

Poor validation of analytical methods for multi-drug capsule formulations. Poor validation of analytical methods for multi-drug capsule formulations. Introduction: In the pharmaceutical industry, the development of multi-drug capsule formulations is a sophisticated process that requires precision and accuracy. The validation of analytical methods for these formulations is crucial as it ensures the quality, efficacy, and…

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

Difficulty in validating capsule drying processes for thermosensitive APIs.

April 1, 2025 Admin

Difficulty in validating capsule drying processes for thermosensitive APIs. Difficulty in validating capsule drying processes for thermosensitive APIs Introduction: In the realm of pharmaceutical manufacturing, ensuring the stability and efficacy of Active Pharmaceutical Ingredients (APIs) is paramount. Thermosensitive APIs, which are prone to degradation at elevated temperatures, pose unique challenges. As capsules, especially hard and…

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

Investigating Root Causes of Hardness Variability in Coated Tablets

March 31, 2025 Admin

Investigating Root Causes of Hardness Variability in Coated Tablets Investigating Root Causes of Hardness Variability in Coated Tablets Introduction: The pharmaceutical industry is committed to ensuring the quality, efficacy, and safety of its products. Among the various dosage forms, coated tablets are one of the most commonly used due to their convenience, stability, and ease…

Solid Dosage form, Tablets

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

Addressing Over-Lubrication in Powder Mixtures for Blending

March 21, 2025 Admin

Addressing Over-Lubrication in Powder Mixtures for Blending Addressing Over-Lubrication in Powder Mixtures for Blending Introduction: In the pharmaceutical industry, the formulation of solid dosage forms like tablets is a finely tuned process that requires precision and careful consideration of multiple variables. Among these, the use of lubricants in powder mixtures for blending is crucial to…

Solid Dosage form, Tablets

Troubleshooting Failures in Content Uniformity Tests for Film-Coated Tablets

March 20, 2025 Admin

Troubleshooting Failures in Content Uniformity Tests for Film-Coated Tablets Troubleshooting Failures in Content Uniformity Tests for Film-Coated Tablets Introduction: Content uniformity is a critical quality attribute in the manufacturing of film-coated tablets. Ensuring that each tablet contains the appropriate amount of active pharmaceutical ingredient (API) is essential for efficacy, safety, and regulatory compliance. Content uniformity…

Solid Dosage form, Tablets

Validating Clean Steam Distribution Systems for Compression Equipment

March 19, 2025 Admin

Validating Clean Steam Distribution Systems for Compression Equipment Validating Clean Steam Distribution Systems for Compression Equipment Introduction: In the pharmaceutical industry, maintaining the integrity and quality of the production environment is paramount. Clean steam is a critical utility in the manufacturing of solid dosage forms, especially tablets, where it is used for sterilization and equipment…

Solid Dosage form, Tablets

Achieving Uniform Blend Distribution in Blending Machines

March 17, 2025 Admin

Achieving Uniform Blend Distribution in Blending Machines Achieving Uniform Blend Distribution in Blending Machines Introduction: In the pharmaceutical industry, ensuring the uniform distribution of active pharmaceutical ingredients (APIs) and excipients in solid dosage forms is critical for product efficacy, safety, and quality. Blending is a key process in tablet manufacturing, where achieving uniform blend distribution…

Solid Dosage form, Tablets

Lack of automation in monitoring capsule defects during production.

March 17, 2025 Admin

Lack of automation in monitoring capsule defects during production. Lack of automation in monitoring capsule defects during production. Introduction: In the pharmaceutical industry, the production of solid oral dosage forms, such as capsules, is a critical segment that demands precision and accuracy. Hard and soft gelatin capsules are widely used due to their convenience and…

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

Resolving Over-Lubrication Issues in Immediate Release Tablets

March 14, 2025 Admin

Resolving Over-Lubrication Issues in Immediate Release Tablets Resolving Over-Lubrication Issues in Immediate Release Tablets Introduction: Immediate release tablets are a mainstay in the pharmaceutical industry, offering quick onset of action and ease of administration. However, the formulation and manufacturing of these tablets present unique challenges, particularly with lubrication. Over-lubrication can compromise tablet quality, affecting disintegration…

Solid Dosage form, Tablets

Ensuring Compliance with Regulatory Guidelines for Extended Release Tablets

March 14, 2025 Admin

Ensuring Compliance with Regulatory Guidelines for Extended Release Tablets Ensuring Compliance with Regulatory Guidelines for Extended Release Tablets Introduction: Extended release tablets are a crucial innovation in pharmaceutical dosage forms, designed to release active pharmaceutical ingredients (APIs) over an extended period. This delivery system improves patient adherence, optimizes therapeutic outcomes, and reduces dosing frequency. However,…

Solid Dosage form, Tablets