Tag: pharmaceutical regulations

Troubleshooting Failures in Residual Solvent Management for Compressed Air Systems

March 16, 2025 Admin

Troubleshooting Failures in Residual Solvent Management for Compressed Air Systems Troubleshooting Failures in Residual Solvent Management for Compressed Air Systems Introduction: Residual solvents are a crucial concern in pharmaceutical manufacturing, particularly when it comes to ensuring the safety and efficacy of solid dosage forms like tablets. Compressed air systems, often used in the production process,…

Solid Dosage form, Tablets

Troubleshooting Uneven Compression Force in Multi-Layer Tablets

March 16, 2025 Admin

Troubleshooting Uneven Compression Force in Multi-Layer Tablets Troubleshooting Uneven Compression Force in Multi-Layer Tablets Introduction: In the pharmaceutical industry, multi-layer tablets represent a crucial innovation, offering benefits such as multiple drug release profiles and combinations in a single dose. However, the manufacturing of these tablets comes with its own set of challenges. One significant issue…

Solid Dosage form, Tablets

Difficulty in testing for uniformity of multi-particulate capsule formulations.

March 16, 2025 Admin

Difficulty in testing for uniformity of multi-particulate capsule formulations. Difficulty in testing for uniformity of multi-particulate capsule formulations. Introduction: In the pharmaceutical industry, ensuring the uniformity of dosage units is crucial for both efficacy and safety. Multi-particulate capsule formulations are increasingly popular due to their flexibility in delivering a consistent dose of active pharmaceutical ingredients…

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

Poor reproducibility in recovery rates for rinse sampling validation.

March 15, 2025 Admin

Poor reproducibility in recovery rates for rinse sampling validation. Poor reproducibility in recovery rates for rinse sampling validation. Introduction: In the pharmaceutical industry, maintaining rigorous standards for cleanliness and contamination control is paramount. Rinse sampling validation is a critical component of this process, ensuring that manufacturing equipment is adequately cleaned between batches. However, achieving consistent…

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

Poor communication between quality assurance and production teams.

March 14, 2025 Admin

Poor communication between quality assurance and production teams. Poor communication between quality assurance and production teams. Introduction: In pharmaceutical manufacturing, the synergy between quality assurance (QA) and production teams is pivotal for ensuring the safety, efficacy, and quality of products. However, poor communication between these departments can lead to significant challenges, including compliance risks, production…

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

Validating Rinse Sampling Procedures in Cleaning Validation for Film-Coated Tablets

March 14, 2025 Admin

Validating Rinse Sampling Procedures in Cleaning Validation for Film-Coated Tablets Validating Rinse Sampling Procedures in Cleaning Validation for Film-Coated Tablets Introduction: In the pharmaceutical industry, ensuring the cleanliness of manufacturing equipment is crucial, especially when producing film-coated tablets. Cleaning validation, particularly rinse sampling procedures, plays a pivotal role in confirming that any residues from previous…

Solid Dosage form, Tablets

Managing Documentation Errors in Coating Processes

March 14, 2025 Admin

Managing Documentation Errors in Coating Processes Managing Documentation Errors in Coating Processes Introduction: In the pharmaceutical industry, coating processes are critical in ensuring that tablets meet both aesthetic and functional requirements. Proper documentation in these processes is vital, not only for maintaining quality and consistency but also for complying with regulatory standards. This article delves…

Solid Dosage form, Tablets

Troubleshooting Non-Adherence of Coating Materials in Enteric Tablets

March 13, 2025 Admin

Troubleshooting Non-Adherence of Coating Materials in Enteric Tablets Troubleshooting Non-Adherence of Coating Materials in Enteric Tablets Introduction: Enteric tablets are specially designed solid dosage forms that remain intact in the acidic environment of the stomach and dissolve in the more neutral pH of the intestine. This ensures that active pharmaceutical ingredients (APIs) are released at…

Solid Dosage form, Tablets

Poor reproducibility in validation data for semi-automated encapsulation systems.

March 13, 2025 Admin

Poor reproducibility in validation data for semi-automated encapsulation systems. Poor reproducibility in validation data for semi-automated encapsulation systems. Introduction: In the pharmaceutical industry, the precision and consistency of encapsulation systems, particularly semi-automated ones, are paramount. Encapsulation plays a vital role in drug delivery, ensuring each dose contains the correct amount of active pharmaceutical ingredient (API)….

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

Difficulty in validating water quality for multi-product capsule facilities.

March 13, 2025 Admin

Difficulty in validating water quality for multi-product capsule facilities. Difficulty in Validating Water Quality for Multi-Product Capsule Facilities Introduction: In the pharmaceutical industry, water quality is a critical component of manufacturing processes, especially in facilities that produce solid oral dosage forms like capsules. Both hard and soft gelatin capsules require water of a specific quality…

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

High variability in stability data for oil-filled capsules.

March 12, 2025 Admin

High variability in stability data for oil-filled capsules. High variability in stability data for oil-filled capsules. Introduction: In the pharmaceutical industry, maintaining the stability of medicinal products is crucial to ensure their safety, efficacy, and quality over their shelf life. Among various dosage forms, oil-filled capsules—encompassing both hard and soft gelatin variants—present unique challenges in…

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

Managing Failures in Moisture Content Tests for Hygroscopic APIs

March 11, 2025 Admin

Managing Failures in Moisture Content Tests for Hygroscopic APIs Managing Failures in Moisture Content Tests for Hygroscopic APIs Introduction: In the pharmaceutical industry, Active Pharmaceutical Ingredients (APIs) form the backbone of drug manufacturing. Among these, hygroscopic APIs present unique challenges due to their inherent ability to absorb moisture from the environment. Accurate moisture content testing…

Solid Dosage form, Tablets