Tag: FDA guidelines

Challenges in maintaining consistent quality for multi-particulate capsules.

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Challenges in maintaining consistent quality for multi-particulate capsules. Challenges in maintaining consistent quality for multi-particulate capsules. Introduction: In the pharmaceutical industry, maintaining consistent quality in multi-particulate capsules is crucial for ensuring therapeutic efficacy and patient safety. Multi-particulate capsules offer numerous advantages, such as targeted drug delivery, controlled release profiles, and improved bioavailability. However, the complexity…

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

Poor reproducibility in validation data for modified-release capsules.

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Poor reproducibility in validation data for modified-release capsules. Poor reproducibility in validation data for modified-release capsules. Introduction: Modified-release capsules are pivotal in modern therapeutics, offering controlled drug delivery that improves patient compliance and therapeutic outcomes. However, ensuring the reproducibility of validation data for these formulations is crucial in maintaining their efficacy and safety. Inconsistent validation…

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

Lack of automation in sampling procedures for quality testing.

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Lack of automation in sampling procedures for quality testing. Lack of automation in sampling procedures for quality testing. Introduction: In the pharmaceutical industry, quality testing is a critical component of the manufacturing process, particularly for solid oral dosage forms such as capsules. Ensuring these products meet stringent quality standards is vital for patient safety and…

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

Ensuring Adequacy of Spray Gun Calibration in Coating Process Validation

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Ensuring Adequacy of Spray Gun Calibration in Coating Process Validation Ensuring Adequacy of Spray Gun Calibration in Coating Process Validation Introduction: The pharmaceutical industry demands precision and excellence, especially when it comes to manufacturing solid dosage forms like tablets. One crucial aspect of this process is the coating of tablets, which serves not only aesthetic…

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Solid Dosage form, Tablets

Poor reproducibility in rinse sampling data for lipid-based formulations.

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Poor reproducibility in rinse sampling data for lipid-based formulations. Poor reproducibility in rinse sampling data for lipid-based formulations. Introduction: Lipid-based formulations have gained significant attention in the pharmaceutical industry due to their ability to enhance the bioavailability of poorly water-soluble drugs. However, ensuring the cleanliness of manufacturing equipment used for these formulations poses unique challenges,…

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

Challenges in validating cleaning procedures for lipid-based formulations.

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Challenges in validating cleaning procedures for lipid-based formulations. Challenges in Validating Cleaning Procedures for Lipid-Based Formulations Introduction: Lipid-based formulations have gained significant traction in the pharmaceutical industry due to their ability to enhance the bioavailability of poorly water-soluble drugs. However, with these formulations come unique challenges, especially in the context of manufacturing and cleaning. Proper…

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

Problems with ensuring consistent capsule shell thickness across validation batches.

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Problems with ensuring consistent capsule shell thickness across validation batches. Problems with Ensuring Consistent Capsule Shell Thickness Across Validation Batches Introduction: In the pharmaceutical industry, maintaining consistent capsule shell thickness across validation batches is critical for ensuring product quality and efficacy. The capsule shell not only protects the integrity of the encapsulated medication but also…

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

Difficulty in maintaining consistent capsule hardness over the stability period.

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Difficulty in maintaining consistent capsule hardness over the stability period. Difficulty in maintaining consistent capsule hardness over the stability period. Introduction: Capsules, both hard and soft gelatin, are a prevalent form of oral dosage in the pharmaceutical industry due to their versatility and patient compliance. However, maintaining consistent hardness throughout the stability period is a…

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

Inadequate systems for verifying tamper-evident features on packaging.

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Inadequate systems for verifying tamper-evident features on packaging. Inadequate Systems for Verifying Tamper-Evident Features on Packaging Introduction: In the pharmaceutical industry, ensuring the integrity and security of drug packaging is paramount. Tamper-evident features on packaging are critical in safeguarding against unauthorized access and contamination, thereby protecting consumers and maintaining trust in pharmaceutical products. However, inadequate…

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

Troubleshooting Residual Solvent Issues in Film-Coated Tablets During Validation

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Troubleshooting Residual Solvent Issues in Film-Coated Tablets During Validation Troubleshooting Residual Solvent Issues in Film-Coated Tablets During Validation Introduction: The pharmaceutical industry is highly regulated, with stringent guidelines ensuring that products are safe and effective for consumers. Among the numerous challenges faced by manufacturers is the control of residual solvents in film-coated tablets. These solvents,…

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Solid Dosage form, Tablets

Challenges in ensuring consistent capsule coating thickness during validation.

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Challenges in ensuring consistent capsule coating thickness during validation. Challenges in ensuring consistent capsule coating thickness during validation. Introduction: In the pharmaceutical industry, capsules are a prevalent solid oral dosage form due to their ease of administration and ability to deliver precise dosages. Both hard and soft gelatin capsules can be coated for various reasons…

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

Poor alignment of capsule printing during high-speed operations.

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Poor alignment of capsule printing during high-speed operations. Poor alignment of capsule printing during high-speed operations. Introduction: The pharmaceutical industry is heavily reliant on efficient and accurate manufacturing processes, especially when it comes to solid oral dosage forms like capsules. Capsule printing is a critical step, serving as a method of identification, branding, and ensuring…

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