Tag: pharmaceutical quality

Troubleshooting Failures in Cleaning Validation for Multi-Layer Tablet Equipment

April 12, 2025 Admin

Troubleshooting Failures in Cleaning Validation for Multi-Layer Tablet Equipment Troubleshooting Failures in Cleaning Validation for Multi-Layer Tablet Equipment Introduction: In the pharmaceutical industry, maintaining the cleanliness of equipment is crucial for ensuring product safety and efficacy. Cleaning validation is a critical aspect of Good Manufacturing Practices (GMP) that ensures that equipment used in the production…

Solid Dosage form, Tablets

Difficulty in evaluating the impact of excipient changes on capsule stability.

April 12, 2025 Admin

Difficulty in evaluating the impact of excipient changes on capsule stability. Difficulty in Evaluating the Impact of Excipient Changes on Capsule Stability Introduction: In the pharmaceutical industry, the stability of a drug product is a critical factor that influences its safety, efficacy, and shelf-life. Capsules, both hard and soft gelatin, are popular solid oral dosage…

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

Ensuring Uniform Film Thickness in Blister Pack Lids

April 11, 2025 Admin

Ensuring Uniform Film Thickness in Blister Pack Lids Ensuring Uniform Film Thickness in Blister Pack Lids Introduction: In the pharmaceutical industry, blister packaging is a crucial component for ensuring the integrity, safety, and efficacy of solid dosage forms such as tablets. The uniformity of film thickness in blister pack lids is vital as it directly…

Solid Dosage form, Tablets

Poor validation of capsule disintegration profiles for capsules stored under stressed conditions.

April 11, 2025 Admin

Poor validation of capsule disintegration profiles for capsules stored under stressed conditions. Poor validation of capsule disintegration profiles for capsules stored under stressed conditions. Introduction: In the pharmaceutical industry, ensuring the effective disintegration of capsules is crucial for the drug’s efficacy and safety. Disintegration testing is an essential quality control measure that determines whether capsules…

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

Inadequate systems for verifying capsule alignment in high-speed operations.

April 11, 2025 Admin

Inadequate systems for verifying capsule alignment in high-speed operations. Inadequate Systems for Verifying Capsule Alignment in High-Speed Operations Introduction: In the pharmaceutical manufacturing industry, ensuring the proper alignment of capsules in high-speed operations is crucial for maintaining product quality and compliance with regulatory standards. Misalignment can lead to significant production inefficiencies, increased waste, and potential…

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

Poor enforcement of preventive maintenance schedules for critical equipment.

April 9, 2025 Admin

Poor enforcement of preventive maintenance schedules for critical equipment. Poor enforcement of preventive maintenance schedules for critical equipment. Introduction: Preventive maintenance is a cornerstone of pharmaceutical manufacturing, especially when dealing with critical equipment such as capsule filling machines. These machines are vital in ensuring the production of solid oral dosage forms like hard and soft…

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

Poor reproducibility in monitoring powder flow properties during encapsulation.

April 7, 2025 Admin

Poor reproducibility in monitoring powder flow properties during encapsulation. Poor reproducibility in monitoring powder flow properties during encapsulation. Introduction: In the pharmaceutical industry, encapsulation is a critical process for the manufacturing of solid oral dosage forms. The flow properties of powders are essential, as they determine the efficiency and consistency of the encapsulation process. Poor…

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

Investigating Stability of Coating Polymers Under UV Exposure

April 6, 2025 Admin

Investigating Stability of Coating Polymers Under UV Exposure Investigating Stability of Coating Polymers Under UV Exposure Introduction: The stability of coating polymers under ultraviolet (UV) exposure is a crucial aspect of pharmaceutical development, particularly for solid dosage forms like tablets. Coating polymers serve multiple functions: they protect the active pharmaceutical ingredient (API), control the release…

Solid Dosage form, Tablets

Inadequate systems for verifying capsule sealing machine calibration.

April 6, 2025 Admin

Inadequate systems for verifying capsule sealing machine calibration. Inadequate systems for verifying capsule sealing machine calibration Introduction: In the pharmaceutical industry, ensuring the integrity of capsule products is paramount. This integrity often hinges on the precise calibration of capsule sealing machines. These machines play a critical role in maintaining the quality and efficacy of both…

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

Inadequate systems for reviewing and updating quality-related documents.

April 5, 2025 Admin

Inadequate systems for reviewing and updating quality-related documents. Inadequate Systems for Reviewing and Updating Quality-Related Documents Introduction: In the pharmaceutical industry, maintaining up-to-date and accurate quality-related documents is crucial. These documents ensure compliance with regulatory standards, facilitate efficient operations, and uphold product quality and safety. Despite their significance, many organizations struggle with inadequate systems for…

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

Managing Failures in Adhesion Testing During Film-Coating Validation

April 5, 2025 Admin

Managing Failures in Adhesion Testing During Film-Coating Validation Managing Failures in Adhesion Testing During Film-Coating Validation Introduction: In the pharmaceutical industry, the film-coating process is critical to the production of high-quality tablets. This process not only enhances the appearance of the tablets but also controls the release of the active ingredients, protects the core from…

Solid Dosage form, Tablets

Inadequate protocols for evaluating shell-to-fill interaction effects.

April 5, 2025 Admin

Inadequate protocols for evaluating shell-to-fill interaction effects. Inadequate Protocols for Evaluating Shell-to-Fill Interaction Effects in Capsules Introduction: In the pharmaceutical industry, solid oral dosage forms such as capsules are a staple due to their ease of administration and versatility. Capsules, which can be either hard or soft gelatin, serve as a vehicle to deliver active…

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