Tag: FDA guidelines

Poor reproducibility in dissolution profiles for lipid-based capsules.

April 24, 2025 Admin

Poor reproducibility in dissolution profiles for lipid-based capsules. Poor reproducibility in dissolution profiles for lipid-based capsules. Introduction: Lipid-based capsules, encompassing both hard and soft gelatin varieties, are critical in the delivery of poorly water-soluble drugs. These formulations improve bioavailability, allowing for efficient drug release and absorption. However, achieving consistent dissolution profiles in lipid-based capsules poses…

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

Difficulty in ensuring compliance with capsule-specific pharmacopeial standards.

April 24, 2025 Admin

Difficulty in ensuring compliance with capsule-specific pharmacopeial standards. Difficulty in ensuring compliance with capsule-specific pharmacopeial standards. Introduction: In the pharmaceutical industry, ensuring compliance with pharmacopeial standards is crucial for the safety and efficacy of drug products. Capsules, both hard and soft gelatin varieties, are a popular dosage form due to their convenience and ability to…

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

Addressing Over-Drying Issues in Granulation During Validation Runs

April 24, 2025 Admin

Addressing Over-Drying Issues in Granulation During Validation Runs Addressing Over-Drying Issues in Granulation During Validation Runs Introduction: In the pharmaceutical industry, granulation is a critical step in the production of solid dosage forms such as tablets. It involves the agglomeration of powder particles to form granules, which enhance the flowability and compressibility of the powder,…

Solid Dosage form, Tablets

Poor correlation between in vitro dissolution and stability data.

April 24, 2025 Admin

Poor correlation between in vitro dissolution and stability data. Poor correlation between in vitro dissolution and stability data. Introduction: In the pharmaceutical industry, the correlation between in vitro dissolution and stability data is pivotal for ensuring the efficacy and safety of solid oral dosage forms, particularly capsules. Dissolution testing is a key quality control measure…

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

Challenges in validating sealing equipment for oil-filled capsules.

April 23, 2025 Admin

Challenges in validating sealing equipment for oil-filled capsules. Challenges in validating sealing equipment for oil-filled capsules Introduction: In the pharmaceutical industry, the encapsulation process is critical, particularly when it involves oil-filled capsules. These capsules are essential for delivering hydrophobic compounds and essential oils that do not mix well with water. Ensuring the integrity of these…

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

Preventing Seal Integrity Failures in Multi-Layer Blister Packs

April 23, 2025 Admin

Preventing Seal Integrity Failures in Multi-Layer Blister Packs Preventing Seal Integrity Failures in Multi-Layer Blister Packs Introduction: In the pharmaceutical industry, ensuring the integrity of packaging is paramount to safeguarding the efficacy and safety of medicinal products. Multi-layer blister packs are a popular choice due to their ability to protect sensitive pharmaceuticals from environmental factors…

Solid Dosage form, Tablets

Inadequate systems for monitoring cross-linking in gelatin shells.

April 23, 2025 Admin

Inadequate systems for monitoring cross-linking in gelatin shells. Inadequate Systems for Monitoring Cross-Linking in Gelatin Shells Introduction: In the pharmaceutical industry, gelatin capsules are a popular choice for encapsulating a wide range of medications due to their ease of use, consumer preference, and bioavailability. However, one of the critical quality concerns associated with gelatin capsules,…

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

Challenges in validating capsule inspection machines for transparent capsules.

April 23, 2025 Admin

Challenges in validating capsule inspection machines for transparent capsules. Challenges in Validating Capsule Inspection Machines for Transparent Capsules Introduction: In the pharmaceutical industry, solid oral dosage forms like capsules are crucial due to their ease of use and precise dosing capabilities. Among these, transparent capsules have gained popularity because they allow consumers and healthcare professionals…

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

Problems with ensuring consistent cleaning of capsule printing heads.

April 23, 2025 Admin

Problems with ensuring consistent cleaning of capsule printing heads. Problems with Ensuring Consistent Cleaning of Capsule Printing Heads Introduction: In the pharmaceutical industry, capsule printing is a critical process that involves imprinting information, such as dosage details or branding, onto the surface of capsules. Maintaining the cleanliness of capsule printing heads is crucial to ensure…

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

Poor validation of temperature sensors in capsule drying ovens.

April 22, 2025 Admin

Poor validation of temperature sensors in capsule drying ovens. Poor validation of temperature sensors in capsule drying ovens. Introduction: Temperature control is a critical aspect of pharmaceutical manufacturing, especially in the drying of capsules. Accurate temperature monitoring ensures the quality and efficacy of both hard and soft gelatin capsules. However, poor validation of temperature sensors…

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

Inadequate systems for verifying cleaning agent effectiveness for lipid residues.

April 22, 2025 Admin

Inadequate systems for verifying cleaning agent effectiveness for lipid residues. Inadequate systems for verifying cleaning agent effectiveness for lipid residues. Introduction: In the pharmaceutical industry, the effectiveness of cleaning agents in removing lipid residues is crucial, particularly in the production of solid oral dosage forms like capsules. Inadequate cleaning can lead to cross-contamination, affecting product…

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

Poor reproducibility in swab recovery studies during cleaning validation.

April 22, 2025 Admin

Poor reproducibility in swab recovery studies during cleaning validation. Poor reproducibility in swab recovery studies during cleaning validation. Introduction: Cleaning validation is a critical component of Good Manufacturing Practices (GMP) in the pharmaceutical industry. It ensures that any equipment used in the production of drug products is adequately cleaned to prevent contamination of subsequent batches….

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