Tag: Regulatory compliance

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

Challenges in validating nitrogen purity for capsule storage conditions.

April 29, 2025 Admin

Challenges in validating nitrogen purity for capsule storage conditions. Challenges in validating nitrogen purity for capsule storage conditions. Introduction: In the pharmaceutical industry, maintaining the integrity and stability of solid oral dosage forms such as capsules is paramount. The use of nitrogen as an inert gas in storage environments plays a crucial role in preserving…

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

Difficulty in monitoring capsule moisture content during accelerated stability studies.

April 28, 2025 Admin

Difficulty in monitoring capsule moisture content during accelerated stability studies. Difficulty in monitoring capsule moisture content during accelerated stability studies. Introduction: Monitoring the moisture content in capsules during accelerated stability studies is a critical component in the pharmaceutical industry. These studies are essential for predicting the shelf life and ensuring the quality, safety, and efficacy…

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

Managing Non-Homogeneity in Dissolution Profiles for Coated Tablets

April 28, 2025 Admin

Managing Non-Homogeneity in Dissolution Profiles for Coated Tablets Managing Non-Homogeneity in Dissolution Profiles for Coated Tablets Introduction: Coated tablets are a widely used solid dosage form in the pharmaceutical industry, offering benefits such as improved taste masking, controlled drug release, and enhanced stability. However, achieving consistent dissolution profiles is critical as it directly impacts the…

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

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

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

April 26, 2025 Admin

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…

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

Challenges in validating nitrogen systems used for capsule storage.

April 26, 2025 Admin

Challenges in validating nitrogen systems used for capsule storage. Challenges in validating nitrogen systems used for capsule storage. Introduction: In the pharmaceutical industry, the storage of solid oral dosage forms such as capsules necessitates meticulous environmental control to maintain product stability and efficacy. Nitrogen systems are frequently employed to create an inert atmosphere, thereby preventing…

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

Problems with establishing acceptance criteria for cleaning validation studies.

April 26, 2025 Admin

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…

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

Difficulty in ensuring proper calibration of flow meters in water distribution systems.

April 26, 2025 Admin

Difficulty in ensuring proper calibration of flow meters in water distribution systems. Difficulty in ensuring proper calibration of flow meters in water distribution systems. Introduction: Flow meters play a critical role in water distribution systems, especially within pharmaceutical manufacturing, where precision and accuracy are paramount. Ensuring the proper calibration of these devices is vital to…

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

Difficulty in preventing dust contamination during the packing process.

April 25, 2025 Admin

Difficulty in preventing dust contamination during the packing process. Difficulty in Preventing Dust Contamination During the Packing Process Introduction: In the realm of pharmaceutical manufacturing, ensuring the integrity and safety of products is paramount. This is especially true in the case of solid oral dosage forms such as capsules. Among the numerous challenges faced in…

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