Tag: Regulatory Guidelines

Troubleshooting Folding Issues in Leaflets for Large Packaging Formats

June 4, 2025 Admin

Troubleshooting Folding Issues in Leaflets for Large Packaging Formats Troubleshooting Folding Issues in Leaflets for Large Packaging Formats Introduction: In the pharmaceutical industry, the integrity and precision of packaging are paramount, not just for aesthetics but for compliance and patient safety. Leaflets, often referred to as patient information leaflets (PILs), are crucial components of pharmaceutical…

Solid Dosage form, Tablets

Validating Spray Gun Settings for Even Coating Distribution

June 1, 2025 Admin

Validating Spray Gun Settings for Even Coating Distribution Validating Spray Gun Settings for Even Coating Distribution Introduction: In the pharmaceutical industry, ensuring that tablets have an even coating is crucial not only for aesthetic purposes but also for the functionality of the dosage form. The coating protects the active pharmaceutical ingredient (API), controls release profiles,…

Solid Dosage form, Tablets

Investigating API Potency Retention in Immediate Release Tablets Over Time

May 11, 2025 Admin

Investigating API Potency Retention in Immediate Release Tablets Over Time Investigating API Potency Retention in Immediate Release Tablets Over Time Introduction: In the pharmaceutical industry, ensuring the efficacy and safety of medicinal products is paramount. One critical aspect of this is the potency retention of the Active Pharmaceutical Ingredient (API) in immediate release tablets over…

Solid Dosage form, Tablets

Managing Documentation Errors During QA Audits for Coated Tablets

May 5, 2025 Admin

Managing Documentation Errors During QA Audits for Coated Tablets Managing Documentation Errors During QA Audits for Coated Tablets Introduction: In the pharmaceutical industry, maintaining rigorous quality assurance (QA) standards is critical, particularly during the production of coated tablets. These solid dosage forms are widely used, and their efficacy and safety hinge on meticulous manufacturing processes…

Solid Dosage form, Tablets

Inadequate control over capsule component traceability.

April 26, 2025 Admin

Inadequate control over capsule component traceability. Inadequate control over capsule component traceability. Introduction: In the pharmaceutical industry, ensuring the traceability of capsule components is crucial for maintaining product quality, ensuring patient safety, and complying with regulatory standards. Traceability refers to the ability to track every ingredient and material used in the manufacturing of capsules, from…

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

Difficulty in monitoring gelatin solution temperature during preparation.

April 18, 2025 Admin

Difficulty in monitoring gelatin solution temperature during preparation. Difficulty in Monitoring Gelatin Solution Temperature During Preparation Introduction: In the pharmaceutical industry, the preparation of gelatin solutions is a critical step in the manufacturing of both hard and soft gelatin capsules. Maintaining the appropriate temperature of the gelatin solution is crucial for ensuring the quality and…

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

Difficulty in achieving uniform fill weight for low-dose capsules.

April 18, 2025 Admin

Difficulty in achieving uniform fill weight for low-dose capsules. Difficulty in achieving uniform fill weight for low-dose capsules. Introduction: The pharmaceutical industry is constantly striving to ensure that medications are produced with the utmost precision and accuracy. One of the critical aspects of pharmaceutical manufacturing is achieving uniform fill weight in low-dose capsules. Low-dose medications…

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

Problems with ensuring compliance with regulatory guidelines for capsule packaging.

April 17, 2025 Admin

Problems with ensuring compliance with regulatory guidelines for capsule packaging. Problems with Ensuring Compliance with Regulatory Guidelines for Capsule Packaging Introduction: In the pharmaceutical industry, the packaging of solid oral dosage forms such as capsules plays a critical role in ensuring product safety, efficacy, and quality. Compliance with regulatory guidelines for capsule packaging is essential…

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

Problems with detecting changes in gelatin plasticizer levels during stability testing.

April 16, 2025 Admin

Problems with detecting changes in gelatin plasticizer levels during stability testing. Problems with Detecting Changes in Gelatin Plasticizer Levels During Stability Testing Introduction: In the pharmaceutical industry, solid oral dosage forms, particularly gelatin capsules, are prevalent due to their ease of use and patient compliance. However, maintaining the stability of these dosage forms is critical…

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

Challenges in validating cleaning procedures for encapsulation lines shared across products.

April 14, 2025 Admin

Challenges in validating cleaning procedures for encapsulation lines shared across products. Challenges in Validating Cleaning Procedures for Encapsulation Lines Shared Across Products Introduction: In the pharmaceutical industry, ensuring the cleanliness of encapsulation lines that are shared across different products is critical. This process is not only essential for maintaining product integrity but also for adhering…

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

Problems with testing capsules containing high API load.

April 13, 2025 Admin

Problems with testing capsules containing high API load. Problems with testing capsules containing high API load. Introduction: In the pharmaceutical industry, capsules are a popular solid oral dosage form due to their versatility and ease of administration. As the demand for high-dose medications increases, the challenge of creating capsules with a high Active Pharmaceutical Ingredient…

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