Tag: pharmaceutical regulatory guidelines

Inadequate systems for monitoring HVAC system alarms during validation.

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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…

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

Difficulty in detecting microscopic defects in capsule shells.

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Difficulty in detecting microscopic defects in capsule shells. Difficulty in Detecting Microscopic Defects in Capsule Shells Introduction: Capsules are one of the most popular solid oral dosage forms in the pharmaceutical industry, offering a convenient and effective means of drug delivery. However, maintaining the integrity and quality of capsule shells is crucial, as defects can…

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

Poor reproducibility in steam quality validation for sterilization processes.

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Poor reproducibility in steam quality validation for sterilization processes. Poor reproducibility in steam quality validation for sterilization processes. Introduction: In the pharmaceutical industry, sterilization processes are vital for ensuring the safety and efficacy of products, particularly those that are administered in sterile form, such as injectables and certain types of capsules. Steam sterilization, one of…

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

Resolving Non-Uniform API Distribution in Extended Release Tablets Over Time

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Resolving Non-Uniform API Distribution in Extended Release Tablets Over Time Resolving Non-Uniform API Distribution in Extended Release Tablets Over Time Introduction: The pharmaceutical industry is constantly evolving, with a significant focus on developing efficient drug delivery systems. Extended release tablets are a crucial component of this landscape, designed to release active pharmaceutical ingredients (APIs) over…

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Solid Dosage form, Tablets