Tag: quality improvement

Difficulty in ensuring proper documentation for quality-related investigations.

May 2, 2025 Admin

Difficulty in ensuring proper documentation for quality-related investigations. Difficulty in ensuring proper documentation for quality-related investigations Introduction: In the pharmaceutical industry, ensuring comprehensive and meticulous documentation for quality-related investigations is not just a regulatory requirement but a cornerstone for maintaining product efficacy and patient safety. Documentation serves as the evidence of compliance with Good Manufacturing…

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

Poor standardization of in-process quality control procedures.

April 20, 2025 Admin

Poor standardization of in-process quality control procedures. Poor standardization of in-process quality control procedures. Introduction: In the pharmaceutical industry, maintaining the highest quality standards is paramount. This is especially true for solid oral dosage forms, such as hard and soft gelatin capsules, where the absence of rigorous in-process quality control (IPQC) can lead to significant…

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

High variability in the thickness of blister foil materials.

April 14, 2025 Admin

High variability in the thickness of blister foil materials. High Variability in the Thickness of Blister Foil Materials Introduction: Blister packaging is a critical component in the pharmaceutical industry, offering protection and extended shelf life for solid oral dosage forms like capsules and tablets. However, variability in the thickness of blister foil materials can pose…

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

High rejection rates due to non-compliance with quality standards.

March 26, 2025 Admin

High rejection rates due to non-compliance with quality standards. High Rejection Rates Due to Non-Compliance with Quality Standards Introduction: In the pharmaceutical industry, maintaining high-quality standards in manufacturing processes is imperative. Solid oral dosage forms, particularly capsules, are prevalent due to their convenience and efficiency. However, the rejection rates of these products can often spike…

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