Tag: GMP guidelines

Problems with ensuring proper calibration of HVAC sensors during validation.

April 13, 2025 Admin

Problems with ensuring proper calibration of HVAC sensors during validation. Problems with Ensuring Proper Calibration of HVAC Sensors During Validation Introduction: In the pharmaceutical industry, maintaining optimal environmental conditions is critical for the production of safe and effective drugs. Heating, Ventilation, and Air Conditioning (HVAC) systems play a pivotal role in controlling these conditions. Accurate…

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

Problems with validating capsule drying equipment for uniform performance.

April 12, 2025 Admin

Problems with validating capsule drying equipment for uniform performance. Problems with validating capsule drying equipment for uniform performance. Introduction: In the pharmaceutical industry, ensuring the quality and uniformity of solid oral dosage forms like capsules is critical. Capsule drying is a key step in the production process, impacting the final product’s quality, stability, and efficacy….

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

High rejection rates due to shell deformation during drying.

April 12, 2025 Admin

High rejection rates due to shell deformation during drying. High rejection rates due to shell deformation during drying. Introduction: Within the realm of pharmaceutical manufacturing, solid oral dosage forms such as capsules remain a staple due to their convenience and efficacy in drug delivery. However, one of the recurring challenges in the production of both…

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

Problems with ensuring consistent cleaning of drying trays.

April 10, 2025 Admin

Problems with ensuring consistent cleaning of drying trays. Problems with ensuring consistent cleaning of drying trays. Introduction: In the pharmaceutical industry, maintaining cleanliness in production equipment is paramount to ensure product safety and efficacy. Drying trays, utilized extensively in the manufacturing of solid oral dosage forms like capsules, play a crucial role in the drying…

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

Difficulty in ensuring uniform capsule arrangement in multi-dose packs.

April 7, 2025 Admin

Difficulty in ensuring uniform capsule arrangement in multi-dose packs. Difficulty in ensuring uniform capsule arrangement in multi-dose packs. Introduction: In the pharmaceutical industry, the uniform arrangement of capsules in multi-dose packs is critical for ensuring dosage accuracy, patient safety, and compliance with regulatory standards. With the increasing complexity of drug formulations and the demand for…

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

Inadequate validation of capsule storage and handling procedures.

April 7, 2025 Admin

Inadequate validation of capsule storage and handling procedures. Inadequate Validation of Capsule Storage and Handling Procedures Introduction: In the pharmaceutical industry, the storage and handling of capsules are critical to ensuring their efficacy and safety. Capsules, whether hard or soft gelatin, are delicate and require specific environmental conditions to maintain their integrity and therapeutic value….

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

Difficulty in detecting powder buildup in filling equipment.

April 2, 2025 Admin

Difficulty in detecting powder buildup in filling equipment. Difficulty in detecting powder buildup in filling equipment. Introduction: The pharmaceutical industry heavily relies on precision and efficiency, particularly in the production of solid oral dosage forms like capsules. Filling equipment plays a crucial role in ensuring that each capsule meets stringent quality standards. However, one persistent…

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

Difficulty in validating capsule drying processes for thermosensitive APIs.

April 1, 2025 Admin

Difficulty in validating capsule drying processes for thermosensitive APIs. Difficulty in validating capsule drying processes for thermosensitive APIs Introduction: In the realm of pharmaceutical manufacturing, ensuring the stability and efficacy of Active Pharmaceutical Ingredients (APIs) is paramount. Thermosensitive APIs, which are prone to degradation at elevated temperatures, pose unique challenges. As capsules, especially hard and…

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

Preventing Over-Drying of Granules During Fluid Bed Processing

April 1, 2025 Admin

Preventing Over-Drying of Granules During Fluid Bed Processing Preventing Over-Drying of Granules During Fluid Bed Processing Introduction: Fluid bed processing is a cornerstone of pharmaceutical manufacturing, especially in the production of solid dosage forms such as tablets. The process involves suspending particles in a flowing gas stream, typically air, which facilitates the drying of granules…

Solid Dosage form, Tablets

Investigating Root Causes of Hardness Variability in Coated Tablets

March 31, 2025 Admin

Investigating Root Causes of Hardness Variability in Coated Tablets Investigating Root Causes of Hardness Variability in Coated Tablets Introduction: The pharmaceutical industry is committed to ensuring the quality, efficacy, and safety of its products. Among the various dosage forms, coated tablets are one of the most commonly used due to their convenience, stability, and ease…

Solid Dosage form, Tablets

Ensuring Batch Record Accuracy During Tablet Manufacturing

March 27, 2025 Admin

Ensuring Batch Record Accuracy During Tablet Manufacturing Ensuring Batch Record Accuracy During Tablet Manufacturing Introduction: In the pharmaceutical industry, the manufacturing of tablets is a critical process that requires precision, consistency, and adherence to stringent regulatory standards. Ensuring batch record accuracy is pivotal not only for compliance with regulatory requirements but also for ensuring product…

Solid Dosage form, Tablets

Identifying Root Causes of Non-Uniform Coating Thickness in Tablets

March 25, 2025 Admin

Identifying Root Causes of Non-Uniform Coating Thickness in Tablets Identifying Root Causes of Non-Uniform Coating Thickness in Tablets Introduction: In the pharmaceutical industry, the coating of tablets is a critical process that ensures not only the aesthetic appeal and patient compliance but also the protection of the active pharmaceutical ingredient (API) from environmental factors. Non-uniform…

Solid Dosage form, Tablets