Tag: Pharma regulations

Validating Real-Time Monitoring Systems for Blending Equipment

May 18, 2025 Admin

Validating Real-Time Monitoring Systems for Blending Equipment Validating Real-Time Monitoring Systems for Blending Equipment Introduction: In the pharmaceutical industry, ensuring the consistent quality of solid dosage forms is paramount. One critical step in the manufacturing process is blending, where different ingredients are combined to ensure uniformity. With the advent of real-time monitoring systems, pharmaceutical companies…

Solid Dosage form, Tablets

Difficulty in ensuring proper documentation for quality-related investigations.

May 2, 2025 Admin

Difficulty in ensuring proper documentation for quality-related investigations. Difficulty in ensuring proper documentation for quality-related investigations Introduction: In the pharmaceutical industry, ensuring comprehensive and meticulous documentation for quality-related investigations is not just a regulatory requirement but a cornerstone for maintaining product efficacy and patient safety. Documentation serves as the evidence of compliance with Good Manufacturing…

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

Challenges in maintaining proper records for batch-specific quality deviations.

April 21, 2025 Admin

Challenges in maintaining proper records for batch-specific quality deviations. Challenges in maintaining proper records for batch-specific quality deviations Introduction: In the pharmaceutical industry, maintaining precise and thorough records of batch-specific quality deviations is vital for ensuring product safety and regulatory compliance. These records are essential for tracking the history of a product, identifying the root…

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

Inadequate systems for verifying capsule coating equipment calibration.

March 30, 2025 Admin

Inadequate systems for verifying capsule coating equipment calibration. Inadequate systems for verifying capsule coating equipment calibration. Introduction: In the pharmaceutical industry, the precision of capsule coating processes is critical for ensuring product quality and compliance with regulatory standards. Capsules, whether hard or soft gelatin, require exact coating specifications to achieve the desired therapeutic effect, stability,…

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