Tag: regulatory requirements]

Poor reproducibility in assay testing for encapsulated suspensions.

April 18, 2025 Admin

Poor reproducibility in assay testing for encapsulated suspensions. Poor reproducibility in assay testing for encapsulated suspensions. Introduction: In the pharmaceutical industry, ensuring the quality and efficacy of drug products is paramount. Encapsulated suspensions, particularly in the form of hard and soft gelatin capsules, present unique challenges in maintaining consistent assay results. Assay testing is critical…

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

Inadequate validation of capsule performance under freezing conditions.

April 16, 2025 Admin

Inadequate validation of capsule performance under freezing conditions. Inadequate validation of capsule performance under freezing conditions Introduction: In the pharmaceutical industry, solid oral dosage forms like capsules are a popular choice due to their convenience, stability, and patient compliance. However, the performance of capsules under various environmental conditions, especially freezing conditions, can be a significant…

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

Poor oversight of quality assurance systems for third-party manufacturers.

April 12, 2025 Admin

Poor oversight of quality assurance systems for third-party manufacturers. Poor oversight of quality assurance systems for third-party manufacturers. Introduction: In the pharmaceutical industry, maintaining high standards of product quality is paramount. The increasing reliance on third-party manufacturers, also known as Contract Manufacturing Organizations (CMOs), has introduced complexities in quality assurance oversight. These organizations are pivotal…

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

Addressing Granule Segregation During Roller Compaction

March 19, 2025 Admin

Addressing Granule Segregation During Roller Compaction Addressing Granule Segregation During Roller Compaction Introduction: In the realm of pharmaceutical manufacturing, ensuring the uniformity and quality of solid dosage forms such as tablets is crucial. Roller compaction is a dry granulation process commonly used to improve the flow properties and compressibility of powders. However, one of the…

Solid Dosage form, Tablets

Difficulty in maintaining accurate logs for temperature and humidity controls.

March 17, 2025 Admin

Difficulty in maintaining accurate logs for temperature and humidity controls. Difficulty in Maintaining Accurate Logs for Temperature and Humidity Controls Introduction: In the pharmaceutical industry, maintaining precise environmental controls is crucial, especially for solid oral dosage forms like capsules. Both hard and soft gelatin capsules are sensitive to temperature and humidity fluctuations, which can affect…

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

Problems with ensuring compliance with pharmacovigilance requirements.

March 12, 2025 Admin

Problems with ensuring compliance with pharmacovigilance requirements. Problems with ensuring compliance with pharmacovigilance requirements. Introduction: Pharmacovigilance plays a critical role in the pharmaceutical industry, ensuring the safety and efficacy of drugs throughout their lifecycle. Compliance with pharmacovigilance requirements is essential for maintaining drug safety, protecting patient health, and fulfilling regulatory obligations. However, achieving and maintaining…

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

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