Tag: quality management systems

Developing Validation Protocols for Tablet Compression Processes

May 10, 2025 Admin

Developing Validation Protocols for Tablet Compression Processes Developing Validation Protocols for Tablet Compression Processes Introduction: The pharmaceutical industry is tasked with ensuring that medications are both safe and effective for consumer use. Part of this responsibility involves the validation of various processes, including the tablet compression process—a critical step in the manufacturing of solid dosage…

Solid Dosage form, Tablets

Addressing Cross-Contamination Risks in Shared Tablet Manufacturing Equipment

May 5, 2025 Admin

Addressing Cross-Contamination Risks in Shared Tablet Manufacturing Equipment Addressing Cross-Contamination Risks in Shared Tablet Manufacturing Equipment Introduction: In the pharmaceutical industry, ensuring the safety and efficacy of drug products is paramount. With the increasing demand for diverse medications, many manufacturers utilize shared equipment for tablet production to optimize resources. However, shared equipment can pose significant…

Solid Dosage form, Tablets

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

Ensuring Robustness in Weight Variation Control During Compression Validation

May 1, 2025 Admin

Ensuring Robustness in Weight Variation Control During Compression Validation Ensuring Robustness in Weight Variation Control During Compression Validation Introduction: In the pharmaceutical industry, ensuring the uniformity and consistency of tablet production is crucial. Weight variation in tablets can lead to significant quality issues, impacting both efficacy and safety. This makes weight variation control a critical…

Solid Dosage form, Tablets

Inadequate systems for monitoring cross-linking in gelatin shells.

April 23, 2025 Admin

Inadequate systems for monitoring cross-linking in gelatin shells. Inadequate Systems for Monitoring Cross-Linking in Gelatin Shells Introduction: In the pharmaceutical industry, gelatin capsules are a popular choice for encapsulating a wide range of medications due to their ease of use, consumer preference, and bioavailability. However, one of the critical quality concerns associated with gelatin capsules,…

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

Inadequate systems for validating capsule hardness testing equipment.

April 21, 2025 Admin

Inadequate systems for validating capsule hardness testing equipment. Inadequate systems for validating capsule hardness testing equipment. Introduction: The pharmaceutical industry demands rigorous quality control measures to ensure the safety and efficacy of its products. Among these measures, validating equipment used for testing the hardness of capsules is crucial. Capsule hardness is an essential parameter that…

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

Inadequate systems for monitoring capsule release profiles.

April 17, 2025 Admin

Inadequate systems for monitoring capsule release profiles. Inadequate systems for monitoring capsule release profiles. Introduction: The pharmaceutical industry is a cornerstone of modern healthcare, where ensuring the efficacy and safety of medications is paramount. Solid oral dosage forms, particularly capsules, play a significant role due to their convenience and patient compliance. However, the inadequacy of…

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

Ensuring Robustness in Quality Management Systems for Multi-Layer Tablets

March 31, 2025 Admin

Ensuring Robustness in Quality Management Systems for Multi-Layer Tablets Ensuring Robustness in Quality Management Systems for Multi-Layer Tablets Introduction: In the pharmaceutical industry, multi-layer tablets represent a significant advancement in drug delivery systems. They offer distinct advantages such as controlled release profiles, improved patient compliance, and the ability to combine incompatible drugs into a single…

Solid Dosage form, Tablets

Troubleshooting Failures in In-Process Monitoring for Film-Coated Tablets

March 22, 2025 Admin

Troubleshooting Failures in In-Process Monitoring for Film-Coated Tablets Troubleshooting Failures in In-Process Monitoring for Film-Coated Tablets Introduction: In the pharmaceutical industry, film-coated tablets represent a significant portion of solid dosage forms due to their enhanced stability, ease of swallowing, and aesthetic attributes. The coating process is critical, as it affects the tablet’s performance and patient…

Solid Dosage form, Tablets

Inadequate systems for monitoring capsule defect trends over time.

March 16, 2025 Admin

Inadequate systems for monitoring capsule defect trends over time. Inadequate systems for monitoring capsule defect trends over time. Introduction: The pharmaceutical industry is under constant pressure to maintain high standards of quality and safety, particularly when it comes to solid oral dosage forms such as capsules. Capsules, which can be either hard or soft gelatin,…

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

Inadequate systems for monitoring capsule integrity during validation.

March 9, 2025 Admin

Inadequate systems for monitoring capsule integrity during validation. Inadequate Systems for Monitoring Capsule Integrity During Validation Introduction: In the pharmaceutical industry, the integrity of capsules, whether hard or soft gelatin, is crucial for ensuring the efficacy and safety of the medication contained within. Monitoring capsule integrity during validation is an essential part of the manufacturing…

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