Tag: pharmaceutical quality systems

Inadequate systems for verifying capsule tamper-resistance features.

April 27, 2025 Admin

Inadequate systems for verifying capsule tamper-resistance features. Inadequate Systems for Verifying Capsule Tamper-Resistance Features Introduction: Ensuring the integrity and safety of pharmaceuticals is paramount in the healthcare industry. Capsules, as one of the most prevalent solid oral dosage forms, require robust tamper-resistance features to protect against contamination, counterfeiting, and unauthorized access. However, inadequate systems for…

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

Managing Non-Adherence to GMP Standards in QA Processes

April 18, 2025 Admin

Managing Non-Adherence to GMP Standards in QA Processes Managing Non-Adherence to GMP Standards in QA Processes Introduction: In the pharmaceutical industry, maintaining strict adherence to Good Manufacturing Practice (GMP) standards is critical to ensuring the safety, efficacy, and quality of drug products. GMP standards, established by regulatory bodies such as the US FDA, provide a…

Solid Dosage form, Tablets

Poor oversight of quality assurance systems for third-party manufacturers.

April 12, 2025 Admin

Poor oversight of quality assurance systems for third-party manufacturers. Poor oversight of quality assurance systems for third-party manufacturers. Introduction: In the pharmaceutical industry, maintaining high standards of product quality is paramount. The increasing reliance on third-party manufacturers, also known as Contract Manufacturing Organizations (CMOs), has introduced complexities in quality assurance oversight. These organizations are pivotal…

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

Inadequate monitoring of packaging line cleanliness.

April 4, 2025 Admin

Inadequate monitoring of packaging line cleanliness. Inadequate Monitoring of Packaging Line Cleanliness Introduction: In the pharmaceutical industry, maintaining the cleanliness of packaging lines is critical to ensuring the safety, efficacy, and quality of drug products. Packaging lines are where the final steps of product handling occur, and any lapse in cleanliness can lead to contamination,…

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

Challenges in maintaining proper documentation for vendor qualification.

March 20, 2025 Admin

Challenges in maintaining proper documentation for vendor qualification. Challenges in maintaining proper documentation for vendor qualification Introduction: In the pharmaceutical industry, vendor qualification is a critical component of ensuring product quality and safety. Proper documentation is not just a regulatory requirement but also a fundamental practice to maintain a reliable and efficient supply chain. Vendor…

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

Real-Time Monitoring of Tablet Thickness During Compression

March 18, 2025 Admin

Real-Time Monitoring of Tablet Thickness During Compression Real-Time Monitoring of Tablet Thickness During Compression Introduction: In the pharmaceutical industry, ensuring the consistent quality of tablets is paramount. Tablet thickness, a critical quality attribute, affects not only the tablet’s appearance but also its dissolution rate and overall efficacy. Real-time monitoring of tablet thickness during compression is…

Solid Dosage form, Tablets

Validating Real-Time Process Monitoring Systems for Coating Applications

March 4, 2025 Admin

Validating Real-Time Process Monitoring Systems for Coating Applications Validating Real-Time Process Monitoring Systems for Coating Applications Introduction: The pharmaceutical industry is continually evolving, with advanced technologies enhancing precision, safety, and efficiency in drug manufacturing. One such advancement is the implementation of real-time process monitoring systems for coating applications in tablet production. These systems play a…

Solid Dosage form, Tablets

Validating Cleanroom Air Change Rates for Hygroscopic Tablet Areas

March 2, 2025 Admin

Validating Cleanroom Air Change Rates for Hygroscopic Tablet Areas Validating Cleanroom Air Change Rates for Hygroscopic Tablet Areas Introduction: In the pharmaceutical industry, maintaining the integrity of tablet production environments is crucial, especially when dealing with hygroscopic materials. Hygroscopic tablets, known for their tendency to absorb moisture from the air, require precisely controlled environments to…

Solid Dosage form, Tablets