Tag: pharmaceutical quality assurance]

Inadequate systems for monitoring microbial levels in purified water.

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Inadequate systems for monitoring microbial levels in purified water. Inadequate systems for monitoring microbial levels in purified water. Introduction: In the pharmaceutical industry, maintaining the purity of water used in manufacturing processes is critical. Purified water is an essential component in the production of solid oral dosage forms, such as capsules. However, without proper monitoring…

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

Resolving Sticking Issues in Bottle Filling of Sugar-Coated Tablets

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Resolving Sticking Issues in Bottle Filling of Sugar-Coated Tablets Resolving Sticking Issues in Bottle Filling of Sugar-Coated Tablets Introduction: Sugar-coated tablets are a preferred dosage form due to their palatable taste and aesthetic appeal. However, during the bottle filling process, sticking issues can occur, posing significant challenges to pharmaceutical manufacturers. These issues can lead to…

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Solid Dosage form, Tablets

Managing Vendor Audits for Quality of Excipients in Sugar-Coated Tablets

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Managing Vendor Audits for Quality of Excipients in Sugar-Coated Tablets Managing Vendor Audits for Quality of Excipients in Sugar-Coated Tablets Introduction: In the pharmaceutical industry, the quality of excipients in sugar-coated tablets is of paramount importance. Excipients play a crucial role in ensuring the stability, efficacy, and safety of the final product. The process of…

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Solid Dosage form, Tablets

Poor validation of capsule weight variation for oil-based fills.

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Poor validation of capsule weight variation for oil-based fills. Poor validation of capsule weight variation for oil-based fills Introduction: In the pharmaceutical industry, the production of capsules, especially those containing oil-based fills, presents unique challenges. Capsules are a preferred solid oral dosage form due to their versatility and ability to deliver precise doses of medication….

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

Managing Failure in Moisture Content Tests for Hygroscopic Tablets

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Managing Failure in Moisture Content Tests for Hygroscopic Tablets Managing Failure in Moisture Content Tests for Hygroscopic Tablets Introduction: In the pharmaceutical industry, ensuring the quality and efficacy of medicinal products is paramount. Hygroscopic tablets, which are prone to absorbing moisture from the environment, present unique challenges in this regard. Moisture content tests are critical…

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Solid Dosage form, Tablets

Problems with achieving uniform capsule appearance in transparent packs.

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Problems with achieving uniform capsule appearance in transparent packs. Problems with achieving uniform capsule appearance in transparent packs. Introduction: The pharmaceutical industry continually strives for excellence in manufacturing practices, with capsule appearance being a critical quality attribute. Uniformity in capsule appearance is not only essential for aesthetic appeal but also for ensuring consumer confidence in…

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

Resolving Coating Integrity Issues in Enteric-Coated Tablets

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Resolving Coating Integrity Issues in Enteric-Coated Tablets Resolving Coating Integrity Issues in Enteric-Coated Tablets Introduction: Enteric-coated tablets are a critical component of modern pharmaceutical formulations. These specialized coatings are designed to withstand the acidic environment of the stomach, ensuring that the active pharmaceutical ingredient (API) is released in the more neutral pH of the small…

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Solid Dosage form, Tablets

Reducing Rejection Rates in Automated Coating Processes

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Reducing Rejection Rates in Automated Coating Processes Reducing Rejection Rates in Automated Coating Processes Introduction: The pharmaceutical industry is continuously evolving, with automation playing a pivotal role in enhancing efficiency and consistency in manufacturing processes. One critical aspect of tablet production is the coating process, which not only improves the aesthetic appeal of tablets but…

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Solid Dosage form, Tablets

Detecting Layer Delamination in Multi-Layer Tablets During Production

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Detecting Layer Delamination in Multi-Layer Tablets During Production Detecting Layer Delamination in Multi-Layer Tablets During Production Introduction: In the pharmaceutical industry, multi-layer tablets offer a sophisticated solution to delivering complex drug regimens. These tablets are designed to release active ingredients at different rates or to combine incompatible agents within a single dosage form. However, ensuring…

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Solid Dosage form, Tablets

Ensuring Compliance with Regulatory Standards for Utility Validation Reports

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Ensuring Compliance with Regulatory Standards for Utility Validation Reports Ensuring Compliance with Regulatory Standards for Utility Validation Reports Introduction: In the pharmaceutical industry, utilities such as water systems, HVAC, and compressed gases are integral to manufacturing processes. Ensuring compliance with regulatory standards for utility validation reports is crucial for maintaining product safety, efficacy, and quality….

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Solid Dosage form, Tablets

Difficulty in validating capsule sealing for capsules with multi-layer fills.

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Difficulty in validating capsule sealing for capsules with multi-layer fills. Difficulty in validating capsule sealing for capsules with multi-layer fills Introduction: Capsules have long been a preferred dosage form in the pharmaceutical industry due to their versatility and convenience. The advent of multi-layer fills in capsules has paved the way for innovative drug delivery systems….

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

High rejection rates due to misprinted labels on packaging.

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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…

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