Tag: USFDA guidelines

Difficulty in validating temperature control systems for capsule storage areas.

April 20, 2025 Admin

Difficulty in validating temperature control systems for capsule storage areas. Difficulty in Validating Temperature Control Systems for Capsule Storage Areas Introduction: Temperature control is a critical factor in the pharmaceutical industry, particularly for the storage of solid oral dosage forms like capsules. Both hard and soft gelatin capsules are susceptible to environmental conditions, which can…

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

Poor standardization of in-process quality control procedures.

April 20, 2025 Admin

Poor standardization of in-process quality control procedures. Poor standardization of in-process quality control procedures. Introduction: In the pharmaceutical industry, maintaining the highest quality standards is paramount. This is especially true for solid oral dosage forms, such as hard and soft gelatin capsules, where the absence of rigorous in-process quality control (IPQC) can lead to significant…

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

Poor validation of capsule tamper-evident packaging systems.

April 20, 2025 Admin

Poor validation of capsule tamper-evident packaging systems. Poor validation of capsule tamper-evident packaging systems. Introduction: In the pharmaceutical industry, ensuring the integrity and safety of drug products is paramount. Capsule tamper-evident packaging systems are essential in safeguarding these products from tampering and contamination, which can have dire consequences for both patient safety and company reputation….

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

Problems with ensuring consistent compressed air quality for capsule production.

April 19, 2025 Admin

Problems with ensuring consistent compressed air quality for capsule production. Problems with ensuring consistent compressed air quality for capsule production Introduction: In the pharmaceutical industry, the production of capsules, both hard and soft gelatin, requires strict adherence to quality standards, especially concerning the compressed air systems used in manufacturing processes. Compressed air is a critical…

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

Poor reproducibility in capsule shell thickness validation data.

April 19, 2025 Admin

Poor reproducibility in capsule shell thickness validation data. Poor reproducibility in capsule shell thickness validation data. Introduction: In the pharmaceutical industry, ensuring the quality and consistency of solid oral dosage forms is paramount. Capsules, particularly hard and soft gelatin variants, are widely used due to their ability to deliver precise doses and protect sensitive ingredients….

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

High variability in sealing strength for capsule containers.

April 19, 2025 Admin

High variability in sealing strength for capsule containers. High variability in sealing strength for capsule containers. Introduction: In the pharmaceutical industry, ensuring the quality and integrity of solid oral dosage forms is paramount. Capsule containers, especially hard and soft gelatin capsules, are widely used due to their convenience and efficiency in drug delivery. However, one…

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

Challenges in validating encapsulation equipment for multi-drug formulations.

April 19, 2025 Admin

Challenges in validating encapsulation equipment for multi-drug formulations. Challenges in validating encapsulation equipment for multi-drug formulations. Introduction: In the ever-evolving landscape of pharmaceutical manufacturing, the encapsulation of multi-drug formulations has emerged as a strategic approach to enhance therapeutic outcomes and patient compliance. However, the validation of encapsulation equipment for such complex formulations presents unique challenges….

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

Challenges in ensuring proper filtration levels in HVAC return air ducts.

April 19, 2025 Admin

Challenges in ensuring proper filtration levels in HVAC return air ducts. Challenges in Ensuring Proper Filtration Levels in HVAC Return Air Ducts Introduction: In the pharmaceutical industry, maintaining optimal air quality is crucial for ensuring product safety and compliance with stringent regulatory standards. Heating, Ventilation, and Air Conditioning (HVAC) systems play a pivotal role in…

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

Difficulty in calibrating capsule weight variation detection systems.

April 19, 2025 Admin

Difficulty in calibrating capsule weight variation detection systems. Difficulty in Calibrating Capsule Weight Variation Detection Systems Introduction: In the pharmaceutical industry, ensuring the consistent quality and weight of capsules is critical to efficacy and safety. Capsule weight variation is a significant concern, as it can impact dosage accuracy and patient outcomes. The calibration of capsule…

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

Challenges in assessing stability of capsules with non-aqueous fills.

April 18, 2025 Admin

Challenges in assessing stability of capsules with non-aqueous fills. Challenges in assessing stability of capsules with non-aqueous fills. Introduction: In the pharmaceutical industry, ensuring the stability of drug products is crucial for maintaining efficacy and safety. Capsules, both hard and soft gelatin, are popular solid oral dosage forms. However, when these capsules are filled with…

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

Challenges in maintaining consistent capsule weight variation during validation.

April 17, 2025 Admin

Challenges in maintaining consistent capsule weight variation during validation. Challenges in Maintaining Consistent Capsule Weight Variation During Validation Introduction: In the pharmaceutical industry, maintaining consistent capsule weight variation is critical during the validation phase of capsule production. This process ensures that each capsule contains the correct amount of active pharmaceutical ingredient (API), providing efficacy and…

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

Addressing Root Cause Analysis for Failures in Weight Variation Tests

April 17, 2025 Admin

Addressing Root Cause Analysis for Failures in Weight Variation Tests Addressing Root Cause Analysis for Failures in Weight Variation Tests Introduction: In the pharmaceutical industry, ensuring the consistency and quality of solid dosage forms like tablets is paramount. One critical quality control measure is the weight variation test, which evaluates the uniformity of tablet weights…

Solid Dosage form, Tablets