Tag: pharmaceutical compliance

Ensuring Adequacy of Spray Gun Calibration in Coating Process Validation

April 17, 2025 Admin

Ensuring Adequacy of Spray Gun Calibration in Coating Process Validation Ensuring Adequacy of Spray Gun Calibration in Coating Process Validation Introduction: The pharmaceutical industry demands precision and excellence, especially when it comes to manufacturing solid dosage forms like tablets. One crucial aspect of this process is the coating of tablets, which serves not only aesthetic…

Solid Dosage form, Tablets

Challenges in ensuring proper serialization for track-and-trace requirements.

April 16, 2025 Admin

Challenges in ensuring proper serialization for track-and-trace requirements. Challenges in ensuring proper serialization for track-and-trace requirements. Introduction: Serialization in the pharmaceutical industry is a crucial process that involves assigning a unique identifier to each saleable unit of a drug, ensuring traceability throughout the supply chain. This process is essential for preventing counterfeit drugs, enhancing patient…

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

Inadequate systems for verifying tamper-evident features on packaging.

April 16, 2025 Admin

Inadequate systems for verifying tamper-evident features on packaging. Inadequate Systems for Verifying Tamper-Evident Features on Packaging Introduction: In the pharmaceutical industry, ensuring the integrity and security of drug packaging is paramount. Tamper-evident features on packaging are critical in safeguarding against unauthorized access and contamination, thereby protecting consumers and maintaining trust in pharmaceutical products. However, inadequate…

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

Ensuring Consistent Strip Sealing Quality for Multi-API Tablets

April 15, 2025 Admin

Ensuring Consistent Strip Sealing Quality for Multi-API Tablets Ensuring Consistent Strip Sealing Quality for Multi-API Tablets Introduction: In the pharmaceutical industry, ensuring the integrity and quality of tablet packaging is paramount, especially for multi-active pharmaceutical ingredient (multi-API) tablets. These complex formulations require precise handling and packaging to maintain efficacy and safety. Strip sealing is a…

Solid Dosage form, Tablets

Problems with validating capsule drying trays for uniform heat distribution.

April 15, 2025 Admin

Problems with validating capsule drying trays for uniform heat distribution. Problems with validating capsule drying trays for uniform heat distribution. Introduction: In the pharmaceutical industry, the drying process of capsules is a critical step that directly affects the quality and stability of the final product. Proper drying ensures that moisture content is reduced to a…

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

Difficulty in achieving reproducibility in capsule shell thickness measurements.

April 13, 2025 Admin

Difficulty in achieving reproducibility in capsule shell thickness measurements. Difficulty in Achieving Reproducibility in Capsule Shell Thickness Measurements Introduction: In the pharmaceutical industry, ensuring the consistency and quality of solid oral dosage forms such as capsules is imperative. Capsule shell thickness is a critical quality attribute that affects the integrity, dissolution, and overall performance of…

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

Inadequate validation of capsule disintegration profiles for multi-particulate capsules.

April 13, 2025 Admin

Inadequate validation of capsule disintegration profiles for multi-particulate capsules. Inadequate validation of capsule disintegration profiles for multi-particulate capsules. Introduction: In the pharmaceutical industry, the validation of capsule disintegration profiles is a critical aspect of ensuring drug efficacy and patient safety. This is particularly important for multi-particulate capsules, which can offer benefits such as improved bioavailability…

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

Preventing Seal Weakness in Double-Layer Blister Packs

April 11, 2025 Admin

Preventing Seal Weakness in Double-Layer Blister Packs Preventing Seal Weakness in Double-Layer Blister Packs Introduction: In the pharmaceutical industry, the integrity of packaging is paramount to ensure the safety and efficacy of medications. Double-layer blister packs are widely used for their durability and protective properties, safeguarding tablets from environmental factors like moisture and light. However,…

Solid Dosage form, Tablets

High rejection rates due to improperly filled capsule packs.

April 11, 2025 Admin

High rejection rates due to improperly filled capsule packs. High Rejection Rates Due to Improperly Filled Capsule Packs Introduction: In the pharmaceutical industry, solid oral dosage forms such as capsules are a cornerstone due to their convenience and efficacy in delivering medication. However, the integrity of capsule packs is paramount to ensure patient safety and…

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

Addressing Impact of Oxidative Stress on Sugar-Coated Tablets

April 11, 2025 Admin

Addressing Impact of Oxidative Stress on Sugar-Coated Tablets Addressing Impact of Oxidative Stress on Sugar-Coated Tablets Introduction: In the pharmaceutical industry, the stability of drug formulations is paramount to ensuring efficacy and safety. Among the various solid dosage forms, sugar-coated tablets offer unique benefits such as taste masking and protection of active ingredients. However, these…

Solid Dosage form, Tablets

Difficulty in implementing real-time quality monitoring systems.

April 10, 2025 Admin

Difficulty in implementing real-time quality monitoring systems. Difficulty in Implementing Real-Time Quality Monitoring Systems Introduction: In the pharmaceutical industry, maintaining high standards of product quality is of paramount importance. The advent of real-time quality monitoring systems presents an opportunity to enhance product consistency and ensure compliance with stringent regulatory requirements. These systems allow for continuous…

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

Challenges in detecting improper sealing of capsule containers.

April 10, 2025 Admin

Challenges in detecting improper sealing of capsule containers. Challenges in detecting improper sealing of capsule containers. Introduction: In the pharmaceutical industry, ensuring the integrity of packaging is paramount, especially for solid oral dosage forms like capsules. Proper sealing of capsule containers is crucial not only for maintaining the efficacy and shelf-life of the product but…

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