Tag: USFDA regulations

Inadequate control over capsule component traceability.

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Inadequate control over capsule component traceability. Inadequate control over capsule component traceability. Introduction: In the pharmaceutical industry, ensuring the traceability of capsule components is crucial for maintaining product quality, ensuring patient safety, and complying with regulatory standards. Traceability refers to the ability to track every ingredient and material used in the manufacturing of capsules, from…

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

Addressing Air Entrapment in Strip Packaging Machines

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Addressing Air Entrapment in Strip Packaging Machines Addressing Air Entrapment in Strip Packaging Machines Introduction: In the pharmaceutical industry, strip packaging machines play a critical role in ensuring the protection and integrity of solid dosage forms like tablets. However, air entrapment during the packaging process can compromise product quality and shelf life. Understanding how to…

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Solid Dosage form, Tablets

Inadequate monitoring systems for capsule shell flexibility.

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Inadequate monitoring systems for capsule shell flexibility. Inadequate Monitoring Systems for Capsule Shell Flexibility Introduction: In the pharmaceutical industry, capsules, especially gelatin-based ones, are a prevalent dosage form due to their ease of use and ability to encapsulate both solid and liquid formulations. However, ensuring the flexibility and integrity of these capsule shells is crucial…

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

Problems with ensuring consistent cleaning of drying trays.

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Problems with ensuring consistent cleaning of drying trays. Problems with ensuring consistent cleaning of drying trays. Introduction: In the pharmaceutical industry, maintaining cleanliness in production equipment is paramount to ensure product safety and efficacy. Drying trays, utilized extensively in the manufacturing of solid oral dosage forms like capsules, play a crucial role in the drying…

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

Lack of validated protocols for testing highly hydrophobic APIs.

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Lack of validated protocols for testing highly hydrophobic APIs. Lack of validated protocols for testing highly hydrophobic APIs. Introduction: In the pharmaceutical industry, the development and testing of Active Pharmaceutical Ingredients (APIs) are crucial for ensuring drug efficacy and safety. However, one significant challenge that researchers and formulators face is dealing with highly hydrophobic APIs,…

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

Ensuring Robustness in Quality Management Systems for Multi-Layer Tablets

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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…

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Solid Dosage form, Tablets

Ensuring Consistency in API Release Profiles for Controlled Release Tablets

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Ensuring Consistency in API Release Profiles for Controlled Release Tablets Ensuring Consistency in API Release Profiles for Controlled Release Tablets Introduction: In the world of pharmaceuticals, controlled release tablets play a pivotal role in ensuring the therapeutic efficacy of drugs. These formulations are designed to release active pharmaceutical ingredients (APIs) at a predetermined rate, maintaining…

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Solid Dosage form, Tablets

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

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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…

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

Challenges in validating backup utility systems for capsule manufacturing.

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Challenges in validating backup utility systems for capsule manufacturing. Challenges in validating backup utility systems for capsule manufacturing. Introduction: In the intricate field of pharmaceutical manufacturing, ensuring the uninterrupted operation of utility systems is crucial, particularly in the production of solid oral dosage forms like capsules. The reliability of backup utility systems, including power, HVAC,…

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

Addressing Non-Conformance in Weight Variation Tests During QA Audits

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Addressing Non-Conformance in Weight Variation Tests During QA Audits Addressing Non-Conformance in Weight Variation Tests During QA Audits Introduction: In the realm of pharmaceutical manufacturing, ensuring the quality and consistency of solid dosage forms like tablets is paramount. One critical parameter assessed during quality assurance (QA) audits is the weight variation of tablets. Consistent tablet…

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Solid Dosage form, Tablets

Addressing Non-Uniform Thickness in Enteric-Coated Tablet Layers

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Addressing Non-Uniform Thickness in Enteric-Coated Tablet Layers Addressing Non-Uniform Thickness in Enteric-Coated Tablet Layers Introduction: In the pharmaceutical industry, ensuring the quality and efficacy of medicinal products is paramount. Enteric-coated tablets are designed to release their active ingredients in the intestine rather than the stomach, which is crucial for drugs that are sensitive to stomach…

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Solid Dosage form, Tablets

Ensuring Adequacy of Humidity Control for Immediate Release Tablet Compression Rooms

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Ensuring Adequacy of Humidity Control for Immediate Release Tablet Compression Rooms Ensuring Adequacy of Humidity Control for Immediate Release Tablet Compression Rooms Introduction: In the pharmaceutical industry, the production of immediate-release tablets requires stringent control of environmental conditions, particularly humidity, to ensure product quality and efficacy. Humidity levels can significantly impact the physical and chemical…

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Solid Dosage form, Tablets