Tag: FDA guidelines

Problems with ensuring proper alignment in capsule filling equipment during validation.

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Problems with ensuring proper alignment in capsule filling equipment during validation. Problems with Ensuring Proper Alignment in Capsule Filling Equipment During Validation Introduction: In the pharmaceutical industry, the production of solid oral dosage forms, particularly capsules, demands high precision and accuracy. Ensuring proper alignment in capsule filling equipment is critical during the validation process to…

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

Challenges in assessing the stability of capsules containing biological APIs.

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Challenges in assessing the stability of capsules containing biological APIs. Challenges in assessing the stability of capsules containing biological APIs. Introduction: The pharmaceutical industry is increasingly focusing on the development of capsules containing biological Active Pharmaceutical Ingredients (APIs) due to their potential in treating various complex diseases. However, ensuring the stability of these capsules poses…

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

High rejection rates in visual inspection due to operator dependency.

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High rejection rates in visual inspection due to operator dependency. High Rejection Rates in Visual Inspection Due to Operator Dependency Introduction: The visual inspection of solid oral dosage forms, particularly capsules, plays a pivotal role in ensuring product quality and safety in the pharmaceutical industry. While this process is critical for maintaining high standards, it…

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

Poor reproducibility in cleaning validation results for multi-product facilities.

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Poor reproducibility in cleaning validation results for multi-product facilities. Poor reproducibility in cleaning validation results for multi-product facilities. Introduction: In the pharmaceutical industry, ensuring that equipment is properly cleaned between different product batches is critical to maintaining product quality and patient safety. Multi-product facilities, which manufacture a variety of pharmaceutical products, face unique challenges in…

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

Troubleshooting Uneven Sealing in Double-Layer Strip Packs

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Troubleshooting Uneven Sealing in Double-Layer Strip Packs Troubleshooting Uneven Sealing in Double-Layer Strip Packs Introduction: In the pharmaceutical industry, packaging plays a crucial role in ensuring the quality, safety, and efficacy of solid dosage forms such as tablets. Among the various packaging formats, double-layer strip packs are widely used due to their cost-effectiveness and protective…

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Solid Dosage form, Tablets

Problems with establishing acceptance criteria for cleaning validation studies.

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Problems with establishing acceptance criteria for cleaning validation studies. Problems with Establishing Acceptance Criteria for Cleaning Validation Studies Introduction: In the pharmaceutical industry, maintaining cleanliness and preventing cross-contamination are paramount to ensuring product safety and efficacy. Cleaning validation studies are critical components of Good Manufacturing Practice (GMP) compliance. They confirm that cleaning processes consistently produce…

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

Problems with ensuring consistent lubrication of capsule filling machines.

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Problems with ensuring consistent lubrication of capsule filling machines. Problems with Ensuring Consistent Lubrication of Capsule Filling Machines Introduction: In the realm of pharmaceutical manufacturing, capsule filling machines play a pivotal role in ensuring the accurate and efficient production of both hard and soft gelatin capsules. These machines require regular maintenance and lubrication to function…

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

Inadequate systems for monitoring capsule storage equipment performance.

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Inadequate systems for monitoring capsule storage equipment performance. Inadequate systems for monitoring capsule storage equipment performance. Introduction: In the pharmaceutical industry, maintaining the integrity and efficacy of solid oral dosage forms, such as capsules, is paramount. Proper storage is essential to ensure that these products remain safe and effective until they reach the end-user. However,…

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

Inadequate systems for verifying cleaning effectiveness for gelatin-free formulations.

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Inadequate systems for verifying cleaning effectiveness for gelatin-free formulations. Inadequate systems for verifying cleaning effectiveness for gelatin-free formulations. Introduction: In the pharmaceutical industry, ensuring the cleaning effectiveness of manufacturing equipment is critical, especially when producing gelatin-free formulations. Such formulations represent a growing trend due to dietary preferences, allergies, and religious beliefs. However, the absence of…

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

Challenges in validating nitrogen purity levels for capsule drying processes.

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Challenges in validating nitrogen purity levels for capsule drying processes. Challenges in Validating Nitrogen Purity Levels for Capsule Drying Processes Introduction: In the pharmaceutical industry, maintaining the quality and integrity of solid oral dosage forms, such as capsules, is paramount. The drying process of capsules, whether hard or soft gelatin, is a critical step that…

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

Troubleshooting Heat Sensitivity of Packaging Films During Sealing

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Troubleshooting Heat Sensitivity of Packaging Films During Sealing Troubleshooting Heat Sensitivity of Packaging Films During Sealing Introduction: In the dynamic world of pharmaceutical manufacturing, packaging plays a vital role in ensuring product integrity and efficacy. Among the various facets of packaging, heat sealing of films is critical, especially in maintaining the sterility and stability of…

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Solid Dosage form, Tablets

Difficulty in validating air exchange rates in encapsulation areas.

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Difficulty in validating air exchange rates in encapsulation areas. Difficulty in validating air exchange rates in encapsulation areas. Introduction: In pharmaceutical manufacturing, particularly in the production of solid oral dosage forms like capsules, maintaining optimal air quality is crucial. The encapsulation area, where hard and soft gelatin capsules are manufactured, demands stringent environmental controls to…

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