Tag: Pharmaceutical Industry Challenges

Ensuring Adequate Process Controls for Hygroscopic Tablet Production

May 14, 2025 Admin

Ensuring Adequate Process Controls for Hygroscopic Tablet Production Ensuring Adequate Process Controls for Hygroscopic Tablet Production Introduction: Hygroscopic tablets, known for their ability to absorb moisture from the environment, pose unique challenges in pharmaceutical manufacturing. Ensuring adequate process controls during their production is crucial for maintaining product stability, efficacy, and quality. This comprehensive guide delves…

Solid Dosage form, Tablets

Difficulty in validating cleaning procedures for aqueous-based soft gelatin formulations.

April 22, 2025 Admin

Difficulty in validating cleaning procedures for aqueous-based soft gelatin formulations. Difficulty in validating cleaning procedures for aqueous-based soft gelatin formulations. Introduction: In the pharmaceutical industry, maintaining strict hygiene and cleanliness standards is crucial, especially in the production of solid oral dosage forms such as capsules. Among these, aqueous-based soft gelatin formulations present unique challenges in…

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

Poor reproducibility in swab recovery rates for potent APIs.

April 15, 2025 Admin

Poor reproducibility in swab recovery rates for potent APIs. Poor reproducibility in swab recovery rates for potent APIs. Introduction: In the pharmaceutical industry, ensuring the cleanliness of manufacturing equipment is critical, especially when dealing with potent active pharmaceutical ingredients (APIs). Swab recovery studies are essential for validating the cleaning processes that remove residues from surfaces….

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

Poor enforcement of corrective and preventive action (CAPA) programs.

April 3, 2025 Admin

Poor enforcement of corrective and preventive action (CAPA) programs. Poor enforcement of corrective and preventive action (CAPA) programs. Introduction: Corrective and Preventive Action (CAPA) programs serve as a cornerstone in pharmaceutical quality management systems. Their primary goal is to identify, address, and mitigate quality issues, ensuring that products meet regulatory standards and patient safety requirements….

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

Poor reproducibility in vacuum sealing of capsule containers.

April 1, 2025 Admin

Poor reproducibility in vacuum sealing of capsule containers. Poor Reproducibility in Vacuum Sealing of Capsule Containers Introduction: In the pharmaceutical industry, ensuring the integrity and stability of capsule packaging is crucial. Capsules, whether hard or soft gelatin, are sensitive to environmental factors such as moisture and oxygen, which can compromise their efficacy and shelf life….

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

High rejection rates due to misprinted labels on packaging.

March 7, 2025 Admin

High rejection rates due to misprinted labels on packaging. High Rejection Rates Due to Misprinted Labels on Packaging Introduction: In the pharmaceutical industry, packaging plays a crucial role in ensuring the safety, efficacy, and integrity of products. Accurate labeling is not just a regulatory requirement but also a critical component for patient safety. However, misprinted…

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

Difficulty in validating cleaning processes for high-viscosity formulations.

March 2, 2025 Admin

Difficulty in validating cleaning processes for high-viscosity formulations. Difficulty in Validating Cleaning Processes for High-Viscosity Formulations Introduction: In the pharmaceutical industry, maintaining the integrity and quality of solid oral dosage forms, such as capsules, is of paramount importance. Among these, high-viscosity formulations present unique challenges in the cleaning process validation. This blog delves into the…

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