Tag: GMP compliance

High rejection rates due to improper alignment of capsule compartments.

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High rejection rates due to improper alignment of capsule compartments. High Rejection Rates Due to Improper Alignment of Capsule Compartments Introduction: In the pharmaceutical industry, the production of solid oral dosage forms, particularly capsules, is a critical process that requires precision and accuracy. Capsules, whether hard or soft gelatin, are a popular choice for delivering…

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

Difficulty in establishing validated cleaning procedures for semi-solid formulations.

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Difficulty in establishing validated cleaning procedures for semi-solid formulations. Difficulty in Establishing Validated Cleaning Procedures for Semi-Solid Formulations Introduction: In the pharmaceutical industry, maintaining cleanliness and avoiding cross-contamination are paramount, particularly when dealing with semi-solid formulations. These formulations, which include creams, ointments, gels, and pastes, present unique challenges in terms of cleaning validation due to…

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

Validating Calibration Procedures for Coating Spray Guns

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Validating Calibration Procedures for Coating Spray Guns Validating Calibration Procedures for Coating Spray Guns Introduction: The pharmaceutical industry places a significant emphasis on the precision and reliability of manufacturing processes, particularly in the realm of solid dosage forms like tablets. One critical aspect of this is the coating process, which requires meticulous attention to detail…

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Solid Dosage form, Tablets

Addressing Seal Integrity Failures in Sachet Packaging for Immediate Release Tablets

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Addressing Seal Integrity Failures in Sachet Packaging for Immediate Release Tablets Addressing Seal Integrity Failures in Sachet Packaging for Immediate Release Tablets Introduction: In the pharmaceutical industry, the packaging of immediate release tablets is crucial for ensuring their efficacy and shelf life. Sachet packaging, a popular choice for its convenience and cost-effectiveness, must maintain seal…

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Solid Dosage form, Tablets

Challenges in validating equipment for multi-dose capsule filling operations.

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Challenges in validating equipment for multi-dose capsule filling operations. Challenges in validating equipment for multi-dose capsule filling operations Introduction: In the pharmaceutical industry, ensuring the accuracy and reliability of capsule filling operations is critical to the production of safe and effective medications. Multi-dose capsule filling operations present unique challenges due to the complex nature of…

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

Addressing Deviations in Stability Studies for Bilayer Tablets

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Addressing Deviations in Stability Studies for Bilayer Tablets Addressing Deviations in Stability Studies for Bilayer Tablets Introduction: Bilayer tablets have emerged as a versatile drug delivery system, offering the advantage of combining two different drugs or formulations with varied release profiles in a single dosage form. This innovation not only improves patient compliance but also…

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Solid Dosage form, Tablets

Inadequate systems for verifying capsule tamper-resistance features.

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Inadequate systems for verifying capsule tamper-resistance features. Inadequate Systems for Verifying Capsule Tamper-Resistance Features Introduction: Ensuring the integrity and safety of pharmaceuticals is paramount in the healthcare industry. Capsules, as one of the most prevalent solid oral dosage forms, require robust tamper-resistance features to protect against contamination, counterfeiting, and unauthorized access. However, inadequate systems for…

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

Managing Layer Separation in Sugar-Coated Tablets Under Accelerated Conditions

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Managing Layer Separation in Sugar-Coated Tablets Under Accelerated Conditions Managing Layer Separation in Sugar-Coated Tablets Under Accelerated Conditions Introduction: Sugar-coated tablets have long been a staple in pharmaceutical formulations, offering benefits such as masking unpleasant tastes, improving tablet appearance, and protecting active pharmaceutical ingredients (APIs) from environmental factors. However, they also present unique challenges, particularly…

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Solid Dosage form, Tablets

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

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

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