Tag: compliance issues

Poor validation of capsule tamper-evident packaging systems.

April 20, 2025 Admin

Poor validation of capsule tamper-evident packaging systems. Poor validation of capsule tamper-evident packaging systems. Introduction: In the pharmaceutical industry, ensuring the integrity and safety of drug products is paramount. Capsule tamper-evident packaging systems are essential in safeguarding these products from tampering and contamination, which can have dire consequences for both patient safety and company reputation….

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

Poor enforcement of corrective and preventive action (CAPA) programs.

April 3, 2025 Admin

Poor enforcement of corrective and preventive action (CAPA) programs. Poor enforcement of corrective and preventive action (CAPA) programs. Introduction: Corrective and Preventive Action (CAPA) programs serve as a cornerstone in pharmaceutical quality management systems. Their primary goal is to identify, address, and mitigate quality issues, ensuring that products meet regulatory standards and patient safety requirements….

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