Tag: pharmaceutical quality assurance]

Poor reproducibility in HVAC validation data for cleanroom environments.

April 16, 2025 Admin

Poor reproducibility in HVAC validation data for cleanroom environments. Poor reproducibility in HVAC validation data for cleanroom environments. Introduction: In the pharmaceutical industry, maintaining the integrity of cleanroom environments is critical to ensuring the quality and safety of products. Heating, Ventilation, and Air Conditioning (HVAC) systems play a pivotal role in controlling the cleanroom environment…

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

Inadequate systems for monitoring the alignment of capsule parts during validation.

April 15, 2025 Admin

Inadequate systems for monitoring the alignment of capsule parts during validation. Inadequate systems for monitoring the alignment of capsule parts during validation. Introduction: In the pharmaceutical industry, the integrity of solid oral dosage forms, such as capsules, is paramount to ensuring the efficacy and safety of medications. Among the critical steps in capsule manufacturing is…

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

High rejection rates due to shell deformation during drying.

April 12, 2025 Admin

High rejection rates due to shell deformation during drying. High rejection rates due to shell deformation during drying. Introduction: Within the realm of pharmaceutical manufacturing, solid oral dosage forms such as capsules remain a staple due to their convenience and efficacy in drug delivery. However, one of the recurring challenges in the production of both…

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

Inadequate systems for monitoring HVAC system alarms during validation.

April 12, 2025 Admin

Inadequate systems for monitoring HVAC system alarms during validation. Inadequate systems for monitoring HVAC system alarms during validation. Introduction: In the pharmaceutical industry, the Heating, Ventilation, and Air Conditioning (HVAC) system plays a critical role in maintaining the controlled environment necessary for the production of high-quality products. A well-functioning HVAC system ensures that the manufacturing…

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

Poor reproducibility in capsule drying validation for high-oil formulations.

April 12, 2025 Admin

Poor reproducibility in capsule drying validation for high-oil formulations. Poor reproducibility in capsule drying validation for high-oil formulations. Introduction: In the pharmaceutical industry, ensuring the quality and consistency of solid oral dosage forms, such as capsules, is paramount. Among the various challenges faced during capsule production, drying validation in high-oil formulations stands out due to…

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

Poor reproducibility in nitrogen validation results for encapsulation processes.

April 11, 2025 Admin

Poor reproducibility in nitrogen validation results for encapsulation processes. Poor reproducibility in nitrogen validation results for encapsulation processes. Introduction: In the pharmaceutical sector, the encapsulation process is pivotal for manufacturing solid oral dosage forms like capsules. Ensuring the reproducibility and reliability of this process is crucial for maintaining product quality and compliance with regulatory standards….

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

Inadequate systems for validating air filtration systems for cleanroom environments.

April 11, 2025 Admin

Inadequate systems for validating air filtration systems for cleanroom environments. Inadequate systems for validating air filtration systems for cleanroom environments. Introduction: In the pharmaceutical industry, maintaining a sterile and contaminant-free environment is crucial to the production of safe and effective products. Cleanrooms, equipped with advanced air filtration systems, play a pivotal role in ensuring product…

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

Preventing Seal Weakness in Double-Layer Blister Packs

April 11, 2025 Admin

Preventing Seal Weakness in Double-Layer Blister Packs Preventing Seal Weakness in Double-Layer Blister Packs Introduction: In the pharmaceutical industry, the integrity of packaging is paramount to ensure the safety and efficacy of medications. Double-layer blister packs are widely used for their durability and protective properties, safeguarding tablets from environmental factors like moisture and light. However,…

Solid Dosage form, Tablets

High rejection rates due to improperly filled capsule packs.

April 11, 2025 Admin

High rejection rates due to improperly filled capsule packs. High Rejection Rates Due to Improperly Filled Capsule Packs Introduction: In the pharmaceutical industry, solid oral dosage forms such as capsules are a cornerstone due to their convenience and efficacy in delivering medication. However, the integrity of capsule packs is paramount to ensure patient safety and…

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

Problems with validating capsule drying processes for low-humidity environments.

April 11, 2025 Admin

Problems with validating capsule drying processes for low-humidity environments. Problems with validating capsule drying processes for low-humidity environments. Introduction: In the realm of pharmaceutical manufacturing, capsules serve as one of the most popular solid oral dosage forms due to their versatility and patient compliance. However, the process of drying capsules, particularly in low-humidity environments, presents…

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

Difficulty in ensuring proper calibration of water temperature control systems.

April 10, 2025 Admin

Difficulty in ensuring proper calibration of water temperature control systems. Difficulty in ensuring proper calibration of water temperature control systems. Introduction: Water temperature control systems are integral to the pharmaceutical manufacturing process, particularly in the production of solid oral dosage forms such as hard and soft gelatin capsules. Proper calibration of these systems is crucial…

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