Tag: Compliance Audits

Validating Batch Records for Regulatory Compliance in Tablet Manufacturing

May 25, 2025 Admin

Validating Batch Records for Regulatory Compliance in Tablet Manufacturing Validating Batch Records for Regulatory Compliance in Tablet Manufacturing Introduction: In the pharmaceutical industry, ensuring the integrity and accuracy of batch records is paramount, particularly in the manufacturing of tablets. Batch records serve as a critical component in the documentation of each step of the manufacturing…

Solid Dosage form, Tablets

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 maintaining accurate logs for temperature and humidity controls.

March 17, 2025 Admin

Difficulty in maintaining accurate logs for temperature and humidity controls. Difficulty in Maintaining Accurate Logs for Temperature and Humidity Controls Introduction: In the pharmaceutical industry, maintaining precise environmental controls is crucial, especially for solid oral dosage forms like capsules. Both hard and soft gelatin capsules are sensitive to temperature and humidity fluctuations, which can affect…

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

Addressing Non-Conformance in Weight Variation Tests During QA Audits

March 15, 2025 Admin

Addressing Non-Conformance in Weight Variation Tests During QA Audits Addressing Non-Conformance in Weight Variation Tests During QA Audits Introduction: In the realm of pharmaceutical manufacturing, ensuring the quality and consistency of solid dosage forms like tablets is paramount. One critical parameter assessed during quality assurance (QA) audits is the weight variation of tablets. Consistent tablet…

Solid Dosage form, Tablets

Troubleshooting Failures in Residual Solvent Control for Compressed Air Systems

March 7, 2025 Admin

Troubleshooting Failures in Residual Solvent Control for Compressed Air Systems Troubleshooting Failures in Residual Solvent Control for Compressed Air Systems Introduction: In the pharmaceutical industry, maintaining the purity of compressed air systems is critical for ensuring the safety and efficacy of solid dosage forms such as tablets. Residual solvent control plays a vital role in…

Solid Dosage form, Tablets