Tag: Risk management

Addressing Non-Compliance in Process Validation for Hygroscopic Tablets

June 4, 2025 Admin

Addressing Non-Compliance in Process Validation for Hygroscopic Tablets Addressing Non-Compliance in Process Validation for Hygroscopic Tablets Introduction: In the pharmaceutical industry, the process validation of hygroscopic tablets presents unique challenges. Hygroscopic tablets are those that have a tendency to absorb moisture from their surroundings, which can lead to significant issues in their stability, efficacy, and…

Solid Dosage form, Tablets

Addressing Residual Solvent Build-Up in Sugar-Coating Pans During Validation

May 25, 2025 Admin

Addressing Residual Solvent Build-Up in Sugar-Coating Pans During Validation Addressing Residual Solvent Build-Up in Sugar-Coating Pans During Validation Introduction: The sugar-coating process in pharmaceutical manufacturing plays a crucial role in enhancing the aesthetic appeal, taste masking, and stability of tablets. However, managing residual solvent build-up during this process, particularly in the coating pans, is a…

Solid Dosage form, Tablets

Managing Cross-Contamination Risks in Coating Machines Used for Extended Release Tablets

May 23, 2025 Admin

Managing Cross-Contamination Risks in Coating Machines Used for Extended Release Tablets Managing Cross-Contamination Risks in Coating Machines Used for Extended Release Tablets Introduction: In the pharmaceutical industry, ensuring product safety and efficacy is paramount, and one critical aspect of this is managing cross-contamination risks. This is especially crucial in the production of extended-release tablets, where…

Solid Dosage form, Tablets

Addressing Cross-Contamination Risks in Blending Equipment During Cleaning Validation

May 19, 2025 Admin

Addressing Cross-Contamination Risks in Blending Equipment During Cleaning Validation Addressing Cross-Contamination Risks in Blending Equipment During Cleaning Validation Introduction: The pharmaceutical industry is committed to ensuring the safety and efficacy of its products. One critical component of this commitment is the prevention of cross-contamination, particularly in the manufacturing of solid dosage forms like tablets. Blending…

Solid Dosage form, Tablets

Managing Failures in Cleaning Validation for High-Speed Coating Lines

May 14, 2025 Admin

Managing Failures in Cleaning Validation for High-Speed Coating Lines Managing Failures in Cleaning Validation for High-Speed Coating Lines Introduction: In the pharmaceutical industry, maintaining stringent hygiene and cleanliness standards is paramount, especially in the production of solid dosage forms like tablets. High-speed coating lines, which apply protective or functional coatings to tablets, play a critical…

Solid Dosage form, Tablets

Managing Deviations in Batch Records for Enteric-Coated Tablets

May 9, 2025 Admin

Managing Deviations in Batch Records for Enteric-Coated Tablets Managing Deviations in Batch Records for Enteric-Coated Tablets Introduction: In the pharmaceutical industry, maintaining the integrity of batch records is crucial for ensuring the quality and compliance of drug products. Enteric-coated tablets, designed to withstand the acidic environment of the stomach and dissolve in the more neutral…

Solid Dosage form, Tablets

Managing Documentation Deviations in Process Validation Protocols

May 7, 2025 Admin

Managing Documentation Deviations in Process Validation Protocols Managing Documentation Deviations in Process Validation Protocols Introduction: In the pharmaceutical industry, process validation is a critical component of ensuring product quality and compliance with regulatory standards. It involves a series of documented procedures and protocols designed to confirm that a manufacturing process consistently produces a product meeting…

Solid Dosage form, Tablets

Poor reproducibility in cleaning validation results for multi-product facilities.

April 26, 2025 Admin

Poor reproducibility in cleaning validation results for multi-product facilities. Poor reproducibility in cleaning validation results for multi-product facilities. Introduction: In the pharmaceutical industry, ensuring that equipment is properly cleaned between different product batches is critical to maintaining product quality and patient safety. Multi-product facilities, which manufacture a variety of pharmaceutical products, face unique challenges in…

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

Difficulty in detecting residual APIs on capsule filling equipment.

April 22, 2025 Admin

Difficulty in detecting residual APIs on capsule filling equipment. Difficulty in Detecting Residual APIs on Capsule Filling Equipment Introduction: The pharmaceutical industry is committed to ensuring the highest standards of quality and safety. One critical aspect of this is the effective cleaning of capsule filling equipment to prevent cross-contamination and ensure product purity. Residual Active…

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

Challenges in implementing robust quality audits for capsule production.

April 20, 2025 Admin

Challenges in implementing robust quality audits for capsule production. Challenges in implementing robust quality audits for capsule production. Introduction: In the ever-evolving pharmaceutical industry, maintaining stringent quality standards is paramount, especially when it comes to the production of capsules. Capsules, whether hard or soft gelatin, are among the most widely used solid oral dosage forms,…

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

Difficulty in validating temperature control systems for capsule storage areas.

April 20, 2025 Admin

Difficulty in validating temperature control systems for capsule storage areas. Difficulty in Validating Temperature Control Systems for Capsule Storage Areas Introduction: Temperature control is a critical factor in the pharmaceutical industry, particularly for the storage of solid oral dosage forms like capsules. Both hard and soft gelatin capsules are susceptible to environmental conditions, which can…

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

Inadequate control over changes in raw material suppliers.

April 19, 2025 Admin

Inadequate control over changes in raw material suppliers. Inadequate control over changes in raw material suppliers Introduction: In the pharmaceutical industry, maintaining consistent quality and efficacy of products is paramount. One critical aspect that can significantly impact these factors is the control over raw material suppliers. Changes in suppliers can lead to variations in product…

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