Tag: USFDA guidelines

Challenges in validating sealing equipment for tamper-evident capsules.

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Challenges in validating sealing equipment for tamper-evident capsules. Challenges in validating sealing equipment for tamper-evident capsules. Introduction: In the ever-evolving pharmaceutical industry, ensuring the safety and integrity of solid oral dosage forms, like capsules, is paramount. Tamper-evident capsules offer an additional layer of security, safeguarding consumers against potential product tampering. However, the process of validating…

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

Difficulty in validating capsule orientation devices for automated filling lines.

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Difficulty in validating capsule orientation devices for automated filling lines. Difficulty in Validating Capsule Orientation Devices for Automated Filling Lines Introduction: In the pharmaceutical industry, the production of solid oral dosage forms such as capsules plays a crucial role. Capsules, whether hard or soft gelatin, are highly favored due to their ease of administration and…

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

Troubleshooting Failures in Humidity Control for Compression Equipment Areas

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Troubleshooting Failures in Humidity Control for Compression Equipment Areas Troubleshooting Failures in Humidity Control for Compression Equipment Areas Introduction: In the pharmaceutical industry, maintaining precise environmental control in manufacturing areas is crucial, especially in compression equipment zones used for tablet production. Humidity control is a significant aspect of this environment, as fluctuations can lead to…

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Solid Dosage form, Tablets

Validating Cleanroom Classification for Multi-API Tablet Production

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Validating Cleanroom Classification for Multi-API Tablet Production Validating Cleanroom Classification for Multi-API Tablet Production Introduction: In the pharmaceutical industry, maintaining a contamination-free environment is crucial, especially when producing multi-active pharmaceutical ingredient (API) tablets. Cleanrooms play a pivotal role in ensuring product quality and safety by controlling environmental factors like particulates and microbial contamination. The validation…

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Solid Dosage form, Tablets

Common Pitfalls in Weight Uniformity Testing for Immediate Release Tablets

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Common Pitfalls in Weight Uniformity Testing for Immediate Release Tablets Common Pitfalls in Weight Uniformity Testing for Immediate Release Tablets Introduction: Weight uniformity testing is a critical quality control measure in the pharmaceutical industry, particularly for immediate release tablets. Ensuring consistency in tablet weight is essential not only for compliance with regulatory standards but also…

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Solid Dosage form, Tablets

Difficulty in validating capsule filling for lipid-based formulations.

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Difficulty in validating capsule filling for lipid-based formulations. Difficulty in Validating Capsule Filling for Lipid-Based Formulations Introduction: Lipid-based formulations have gained significant attention in the pharmaceutical industry due to their potential to improve the bioavailability of poorly soluble drugs. As a result, encapsulating these formulations, particularly in hard or soft gelatin capsules, has become increasingly…

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

Challenges in maintaining proper environmental conditions in production areas.

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Challenges in maintaining proper environmental conditions in production areas. Challenges in maintaining proper environmental conditions in production areas. Introduction: The pharmaceutical industry is highly regulated, with stringent requirements for maintaining optimal environmental conditions in production areas. This is particularly critical for the manufacturing of capsules, both hard and soft gelatin, where environmental control can significantly…

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

Troubleshooting Moisture Loss in Coated Tablets Stored at Low Humidity

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Troubleshooting Moisture Loss in Coated Tablets Stored at Low Humidity Troubleshooting Moisture Loss in Coated Tablets Stored at Low Humidity Introduction: In the pharmaceutical industry, maintaining the stability and efficacy of drug products is paramount. Coated tablets, a common solid dosage form, are often designed with specific moisture content to ensure their integrity and therapeutic…

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Solid Dosage form, Tablets

Addressing Residual Moisture Issues in Purified Water Systems

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Addressing Residual Moisture Issues in Purified Water Systems Addressing Residual Moisture Issues in Purified Water Systems Introduction: Purified water systems play a critical role in pharmaceutical manufacturing, ensuring that the water used in production meets stringent quality and safety standards. However, residual moisture is a common challenge that can compromise the integrity of pharmaceutical products….

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Solid Dosage form, Tablets

Difficulty in validating cleaning methods for enteric-coated formulations.

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Difficulty in validating cleaning methods for enteric-coated formulations. Difficulty in Validating Cleaning Methods for Enteric-Coated Formulations Introduction: In the pharmaceutical industry, maintaining stringent cleanliness standards is crucial to ensure product safety and efficacy. One area that presents significant challenges is the cleaning validation for enteric-coated formulations. These formulations are designed to resist the acidic environment…

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

Managing Granule Attrition in Large-Scale Granulation Operations

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Managing Granule Attrition in Large-Scale Granulation Operations Managing Granule Attrition in Large-Scale Granulation Operations Introduction: In the pharmaceutical industry, granulation is a critical process in the production of solid dosage forms, particularly tablets. During large-scale granulation operations, granule attrition presents significant challenges that can affect product quality, consistency, and efficiency. Managing granule attrition is essential…

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Solid Dosage form, Tablets

Validating Water Circulation Systems for Extended Release Tablet Equipment

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Validating Water Circulation Systems for Extended Release Tablet Equipment Validating Water Circulation Systems for Extended Release Tablet Equipment Introduction: In the pharmaceutical industry, ensuring the quality and safety of extended release tablets is paramount. A critical aspect of this process is the validation of water circulation systems used in tablet manufacturing equipment. Water is a…

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Solid Dosage form, Tablets