Tag: FDA Regulations

Ensuring Adequacy of Process Controls for Granulation Stages

June 5, 2025 Admin

Ensuring Adequacy of Process Controls for Granulation Stages Ensuring Adequacy of Process Controls for Granulation Stages Introduction: Granulation is a critical process in the pharmaceutical industry, playing a pivotal role in the production of solid dosage forms such as tablets. It involves the aggregation of powder particles to form larger granules, which enhance the flow…

Solid Dosage form, Tablets

Evaluating Effect of Packaging Interactions on Stability of Sustained Release Tablets

May 30, 2025 Admin

Evaluating Effect of Packaging Interactions on Stability of Sustained Release Tablets Evaluating Effect of Packaging Interactions on Stability of Sustained Release Tablets Introduction: In the pharmaceutical industry, ensuring the stability of sustained release tablets is paramount to maintaining efficacy and safety. These tablets are designed to release active ingredients over an extended period, offering advantages…

Solid Dosage form, Tablets

Validating Batch Records for Regulatory Compliance in Tablet Manufacturing

May 25, 2025 Admin

Validating Batch Records for Regulatory Compliance in Tablet Manufacturing Validating Batch Records for Regulatory Compliance in Tablet Manufacturing Introduction: In the pharmaceutical industry, ensuring the integrity and accuracy of batch records is paramount, particularly in the manufacturing of tablets. Batch records serve as a critical component in the documentation of each step of the manufacturing…

Solid Dosage form, Tablets

Ensuring Robustness in Disintegration Time During Validation Testing

May 24, 2025 Admin

Ensuring Robustness in Disintegration Time During Validation Testing Ensuring Robustness in Disintegration Time During Validation Testing Introduction: In the pharmaceutical industry, the disintegration time of tablets is a critical quality attribute that directly impacts drug release and bioavailability. Ensuring robustness in disintegration time during validation testing is essential to maintain consistency in therapeutic efficacy and…

Solid Dosage form, Tablets

Ensuring Packaging Compatibility for Tablets with Extended Stability Requirements

May 4, 2025 Admin

Ensuring Packaging Compatibility for Tablets with Extended Stability Requirements Ensuring Packaging Compatibility for Tablets with Extended Stability Requirements Introduction: In the pharmaceutical industry, ensuring the stability and efficacy of tablets throughout their shelf life is paramount. This is particularly critical for tablets with extended stability requirements. The compatibility between the packaging and the tablet formulation…

Solid Dosage form, Tablets

Inadequate systems for validating capsule appearance inspection processes.

April 24, 2025 Admin

Inadequate systems for validating capsule appearance inspection processes. Inadequate systems for validating capsule appearance inspection processes. Introduction: The pharmaceutical industry is marked by stringent quality requirements, particularly when it comes to solid oral dosage forms like capsules. A critical aspect of manufacturing is ensuring the appearance of capsules meets predefined standards, as this directly impacts…

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

Preventing Dust Accumulation in Sealing Areas for Hygroscopic Tablets

April 20, 2025 Admin

Preventing Dust Accumulation in Sealing Areas for Hygroscopic Tablets Preventing Dust Accumulation in Sealing Areas for Hygroscopic Tablets Introduction: In the pharmaceutical industry, maintaining the integrity and efficacy of hygroscopic tablets is a critical concern. These tablets are highly sensitive to moisture and can be compromised if exposed to environmental conditions that allow for dust…

Solid Dosage form, Tablets

Difficulty in monitoring powder compaction during filling.

April 19, 2025 Admin

Difficulty in monitoring powder compaction during filling. Difficulty in Monitoring Powder Compaction During Filling Introduction: In the pharmaceutical industry, the precision of powder compaction during the filling process is crucial to ensure the quality and efficacy of solid oral dosage forms, such as hard and soft gelatin capsules. Monitoring powder compaction is a complex task,…

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

Ensuring API Stability in Freeze-Thaw Cycles for Temperature-Sensitive Tablets

April 19, 2025 Admin

Ensuring API Stability in Freeze-Thaw Cycles for Temperature-Sensitive Tablets Ensuring API Stability in Freeze-Thaw Cycles for Temperature-Sensitive Tablets Introduction: Active Pharmaceutical Ingredients (APIs) are the heart of any medication, providing the therapeutic effect intended for the patient. In the realm of solid dosage forms, particularly tablets, preserving the stability of APIs is crucial. Temperature-sensitive tablets,…

Solid Dosage form, Tablets

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

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