Tag: USFDA guidelines

Identifying Root Causes of Capping in Compression Stages

March 10, 2025 Admin

Identifying Root Causes of Capping in Compression Stages Identifying Root Causes of Capping in Compression Stages Introduction: In the pharmaceutical industry, the compression stage of tablet manufacturing is crucial. It is during this stage that granulated material is transformed into tablets of uniform size and dosage. However, this process is not without its challenges. One…

Solid Dosage form, Tablets

Managing Punch Adhesion Issues in Tablet Press Machines During Validation

March 10, 2025 Admin

Managing Punch Adhesion Issues in Tablet Press Machines During Validation Managing Punch Adhesion Issues in Tablet Press Machines During Validation Introduction: In the pharmaceutical industry, the production of high-quality tablets is crucial for ensuring patient safety and therapeutic efficacy. One of the persistent challenges faced during tablet manufacturing is punch adhesion, commonly referred to as…

Solid Dosage form, Tablets

Managing Failure in Moisture Content Tests for Hygroscopic Tablets

March 10, 2025 Admin

Managing Failure in Moisture Content Tests for Hygroscopic Tablets Managing Failure in Moisture Content Tests for Hygroscopic Tablets Introduction: In the pharmaceutical industry, ensuring the quality and efficacy of medicinal products is paramount. Hygroscopic tablets, which are prone to absorbing moisture from the environment, present unique challenges in this regard. Moisture content tests are critical…

Solid Dosage form, Tablets

Difficulty in ensuring proper cleaning of vacuum transfer systems.

March 10, 2025 Admin

Difficulty in ensuring proper cleaning of vacuum transfer systems. Difficulty in Ensuring Proper Cleaning of Vacuum Transfer Systems Introduction: In the pharmaceutical industry, maintaining impeccable hygiene and cleanliness standards is pivotal, particularly in the manufacturing processes of solid oral dosage forms like capsules. Vacuum transfer systems, essential in these processes, pose unique cleaning challenges. These…

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

Validating Adequacy of Binder Distribution in Compression Processes

March 9, 2025 Admin

Validating Adequacy of Binder Distribution in Compression Processes Validating Adequacy of Binder Distribution in Compression Processes Introduction: In the pharmaceutical industry, ensuring the quality and efficacy of solid dosage forms such as tablets is paramount. A critical aspect of this is the distribution of binders during the compression process. Binders play a key role in…

Solid Dosage form, Tablets

Inadequate methods for monitoring oil leakage in soft gelatin capsules.

March 9, 2025 Admin

Inadequate methods for monitoring oil leakage in soft gelatin capsules. Inadequate methods for monitoring oil leakage in soft gelatin capsules. Introduction: Soft gelatin capsules, commonly known as softgels, are a popular dosage form in the pharmaceutical industry due to their ability to encapsulate oils and active ingredients that are sensitive to light or oxidation. However,…

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

Problems with ensuring consistent pressure balancing in multi-room facilities.

March 9, 2025 Admin

Problems with ensuring consistent pressure balancing in multi-room facilities. Problems with ensuring consistent pressure balancing in multi-room facilities. Introduction: In pharmaceutical manufacturing, maintaining a controlled environment is critical to ensuring product quality and compliance with regulatory standards. One of the vital aspects of environmental control is pressure balancing in multi-room facilities, particularly in cleanrooms where…

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

Preventing Core Breakage in Multi-Layer Tablets During Compression

March 8, 2025 Admin

Preventing Core Breakage in Multi-Layer Tablets During Compression Preventing Core Breakage in Multi-Layer Tablets During Compression Introduction: In the pharmaceutical industry, the development of multi-layer tablets offers a strategic approach to deliver multiple active pharmaceutical ingredients (APIs) or to control the release profiles of medications. However, the manufacturing of these complex dosage forms presents unique…

Solid Dosage form, Tablets

High variability in results of content uniformity testing for low-dose drugs.

March 8, 2025 Admin

High variability in results of content uniformity testing for low-dose drugs. High Variability in Results of Content Uniformity Testing for Low-Dose Drugs Introduction: The pharmaceutical industry is tasked with the critical role of ensuring that every dose of medication administered to patients is safe, effective, and of high quality. One of the major quality control…

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

Optimizing Batch Coding Placement on Tablet Packaging Materials

March 8, 2025 Admin

Optimizing Batch Coding Placement on Tablet Packaging Materials Optimizing Batch Coding Placement on Tablet Packaging Materials Introduction: The pharmaceutical industry is highly regulated, with stringent requirements for product safety, traceability, and compliance. One critical aspect of pharmaceutical packaging is the placement of batch coding on tablet packaging materials. Batch codes are essential for traceability, allowing…

Solid Dosage form, Tablets

Addressing Coating Peel-Off During Stability Studies

March 8, 2025 Admin

Addressing Coating Peel-Off During Stability Studies Addressing Coating Peel-Off During Stability Studies Introduction: In the realm of pharmaceutical manufacturing, ensuring the stability and integrity of tablet coatings is paramount. Coatings play a crucial role in protecting the active pharmaceutical ingredient (API), controlling release profiles, improving patient compliance, and enhancing the aesthetic appeal of the product….

Solid Dosage form, Tablets

Preventing Non-Uniform API Distribution in Multi-API Tablets

March 8, 2025 Admin

Preventing Non-Uniform API Distribution in Multi-API Tablets Preventing Non-Uniform API Distribution in Multi-API Tablets Introduction: In the intricate world of pharmaceutical manufacturing, ensuring the uniform distribution of Active Pharmaceutical Ingredients (APIs) within multi-API tablets is crucial. These tablets are essential for delivering multiple therapeutic effects simultaneously, often improving patient compliance. However, achieving uniform API distribution…

Solid Dosage form, Tablets