Tag: FDA guidelines

Addressing Residual Binder Accumulation in Granulation Equipment During Cleaning Validation

May 1, 2025 Admin

Addressing Residual Binder Accumulation in Granulation Equipment During Cleaning Validation Addressing Residual Binder Accumulation in Granulation Equipment During Cleaning Validation Introduction: In pharmaceutical manufacturing, especially in the production of solid dosage forms like tablets, the granulation process is a critical step. However, residual binder accumulation in granulation equipment poses a significant challenge during cleaning validation….

Solid Dosage form, Tablets

Investigating Non-Uniform Dissolution in Enteric-Coated Tablets During Testing

April 30, 2025 Admin

Investigating Non-Uniform Dissolution in Enteric-Coated Tablets During Testing Investigating Non-Uniform Dissolution in Enteric-Coated Tablets During Testing Introduction: The pharmaceutical industry constantly strives to develop effective drug delivery mechanisms, with enteric-coated tablets serving as a crucial form of solid dosage. These tablets are designed to resist the acidic environment of the stomach, releasing their active ingredients…

Solid Dosage form, Tablets

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

April 30, 2025 Admin

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…

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

Troubleshooting Surface Roughness in Sugar-Coated Tablets During Storage

April 30, 2025 Admin

Troubleshooting Surface Roughness in Sugar-Coated Tablets During Storage Troubleshooting Surface Roughness in Sugar-Coated Tablets During Storage Introduction: Sugar-coated tablets are a prevalent form of oral pharmaceutical dosage due to their aesthetic appeal, taste masking abilities, and protective properties. However, during storage, these tablets can sometimes develop surface roughness, which can compromise their appearance, consumer acceptance,…

Solid Dosage form, Tablets

Lack of validated methods for testing capsule coatings.

April 29, 2025 Admin

Lack of validated methods for testing capsule coatings. Lack of validated methods for testing capsule coatings. Introduction: The pharmaceutical industry relies heavily on solid oral dosage forms, particularly capsules, for drug delivery. Capsules, whether hard or soft gelatin, often require coatings to enhance stability, control release, or mask taste. However, a critical gap persists in…

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

Validating Calibration Procedures for Coating Spray Guns

April 28, 2025 Admin

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…

Solid Dosage form, Tablets

Addressing Seal Integrity Failures in Sachet Packaging for Immediate Release Tablets

April 28, 2025 Admin

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…

Solid Dosage form, Tablets

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

April 27, 2025 Admin

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…

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

Addressing Deviations in Stability Studies for Bilayer Tablets

April 27, 2025 Admin

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…

Solid Dosage form, Tablets

Inadequate systems for verifying capsule tamper-resistance features.

April 27, 2025 Admin

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…

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

Managing Layer Separation in Sugar-Coated Tablets Under Accelerated Conditions

April 27, 2025 Admin

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…

Solid Dosage form, Tablets

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

April 27, 2025 Admin

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…

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