Tag: pharmaceutical compliance

Inadequate systems for monitoring cross-linking in gelatin shells.

April 23, 2025 Admin

Inadequate systems for monitoring cross-linking in gelatin shells. Inadequate Systems for Monitoring Cross-Linking in Gelatin Shells Introduction: In the pharmaceutical industry, gelatin capsules are a popular choice for encapsulating a wide range of medications due to their ease of use, consumer preference, and bioavailability. However, one of the critical quality concerns associated with gelatin capsules,…

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

Inadequate systems for monitoring capsule weight loss due to evaporation.

April 23, 2025 Admin

Inadequate systems for monitoring capsule weight loss due to evaporation. Inadequate Systems for Monitoring Capsule Weight Loss Due to Evaporation Introduction: Capsules, both hard and soft gelatin, are among the most popular solid oral dosage forms in the pharmaceutical industry, renowned for their ease of administration and ability to encapsulate a wide range of formulations….

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

Problems with ensuring consistent cleaning of capsule printing heads.

April 23, 2025 Admin

Problems with ensuring consistent cleaning of capsule printing heads. Problems with Ensuring Consistent Cleaning of Capsule Printing Heads Introduction: In the pharmaceutical industry, capsule printing is a critical process that involves imprinting information, such as dosage details or branding, onto the surface of capsules. Maintaining the cleanliness of capsule printing heads is crucial to ensure…

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

High rejection rates due to improper foil alignment in blister packs.

April 21, 2025 Admin

High rejection rates due to improper foil alignment in blister packs. High Rejection Rates Due to Improper Foil Alignment in Blister Packs Introduction: In the pharmaceutical industry, blister packaging remains one of the most critical elements in ensuring product safety, efficacy, and patient compliance. As a preferred choice for packaging solid oral dosage forms like…

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

Poor correlation between laboratory and field stability data for capsules.

April 20, 2025 Admin

Poor correlation between laboratory and field stability data for capsules. Poor correlation between laboratory and field stability data for capsules. Introduction: In the pharmaceutical industry, stability testing is a critical component that ensures the safety, efficacy, and quality of drug products throughout their shelf life. Capsules, both hard and soft gelatin, are popular solid oral…

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

Difficulty in ensuring compliance with packaging material standards for capsules.

April 20, 2025 Admin

Difficulty in ensuring compliance with packaging material standards for capsules. Difficulty in ensuring compliance with packaging material standards for capsules Introduction: In the pharmaceutical industry, ensuring compliance with packaging material standards for capsules is crucial for maintaining product integrity, efficacy, and safety. Capsules, whether hard or soft gelatin, are sensitive to environmental factors like humidity,…

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

High variability in sealing strength for capsule containers.

April 19, 2025 Admin

High variability in sealing strength for capsule containers. High variability in sealing strength for capsule containers. Introduction: In the pharmaceutical industry, ensuring the quality and integrity of solid oral dosage forms is paramount. Capsule containers, especially hard and soft gelatin capsules, are widely used due to their convenience and efficiency in drug delivery. However, one…

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

Problems with validating capsule release testing equipment.

April 19, 2025 Admin

Problems with validating capsule release testing equipment. Problems with Validating Capsule Release Testing Equipment Introduction: In the pharmaceutical industry, ensuring the consistent and reliable release of active pharmaceutical ingredients (APIs) from capsules is crucial for therapeutic efficacy. Capsule release testing, also known as dissolution testing, is a critical quality control process used to evaluate the…

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

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

Poor reproducibility in assay testing for encapsulated suspensions.

April 18, 2025 Admin

Poor reproducibility in assay testing for encapsulated suspensions. Poor reproducibility in assay testing for encapsulated suspensions. Introduction: In the pharmaceutical industry, ensuring the quality and efficacy of drug products is paramount. Encapsulated suspensions, particularly in the form of hard and soft gelatin capsules, present unique challenges in maintaining consistent assay results. Assay testing is critical…

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

Poor reproducibility in validation data for capsule storage equipment.

April 18, 2025 Admin

Poor reproducibility in validation data for capsule storage equipment. Poor reproducibility in validation data for capsule storage equipment. Introduction: The pharmaceutical industry relies heavily on precise and reliable data to ensure the safety and efficacy of its products. One critical area where data integrity is paramount is in the storage of capsules, both hard and…

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

Inadequate monitoring systems for capsule shell flexibility.

April 18, 2025 Admin

Inadequate monitoring systems for capsule shell flexibility. Inadequate Monitoring Systems for Capsule Shell Flexibility Introduction: In the pharmaceutical industry, capsules, especially gelatin-based ones, are a prevalent dosage form due to their ease of use and ability to encapsulate both solid and liquid formulations. However, ensuring the flexibility and integrity of these capsule shells is crucial…

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