Resources

Events

12 October 2023

No headings were found on this page.

The GMP Insiders Expert Team is a group of seasoned professionals specializing in quality assurance, regulatory compliance, and operational innovation in pharmaceutical and biotech manufacturing. United by a passion for advancing Good Manufacturing Practices, they transform complex compliance challenges into clear, actionable strategies that drive operational excellence.

Author Articles

Subscribe to our Newsletter

Latest GMP Posts

News, Warning Letters

March 13, 2025

FDA Warns Linghai ZhanWang for Unsafe Materials, Stability Failures, and Poor Oversight

FDA issues a warning letter to Linghai ZhanWang for failing raw material testing, stability studies, and quality oversight, placing its products on Import Alert 66-40.

Articles, QC

March 10, 2025

Reference vs Retention Samples: What is the Difference?

Look into the key differences between reference and retention samples in pharma, their roles in GMP, storage rules, and regulatory guidelines for compliance.

News, Warning Letters

March 6, 2025

FDA Warning Letter Analysis: Chem-Tech, Ltd. – Deficiencies in OOS Investigation, Cleaning Validation and More

FDA issues a warning letter to Chem-Tech, Ltd. for improper OOS investigations, unvalidated cleaning procedures, and poor quality oversight. Key findings and corrective actions inside.

News, Regulatory Updates

March 4, 2025

USP–NF Proposed Drafts in PF 51(2): Key Highlights and Industry Impact

Discover the key updates in USP–NF PF 51(2), including revisions to chromatography, analytical instrument qualification, microbial contamination control, solubility measurements, and residual solvent analysis.

News, Warning Letters

March 27, 2025

FDA Issues Warning Letter to Yangzhou Sion Commodity Co., Ltd.

FDA warns Yangzhou Sion for CGMP violations, citing failures in component testing, QC oversight, and data integrity. CAPA plan and timelines included.

News, Warning Letters

March 20, 2025

FDA Warns Aspen SA Sterile Operations for CGMP Violations in Lab Controls, Aseptic Practices, Data Integrity, and Environmental Monitoring

The FDA has issued a warning letter to Aspen SA Sterile Operations for serious CGMP violations, including failures in lab controls, aseptic practices, data integrity, and environmental monitoring.

News, Warning Letters

March 13, 2025

FDA Warns Linghai ZhanWang for Unsafe Materials, Stability Failures, and Poor Oversight

FDA issues a warning letter to Linghai ZhanWang for failing raw material testing, stability studies, and quality oversight, placing its products on Import Alert 66-40.

Articles, QC

March 10, 2025

Reference vs Retention Samples: What is the Difference?

Look into the key differences between reference and retention samples in pharma, their roles in GMP, storage rules, and regulatory guidelines for compliance.

News, Warning Letters

March 6, 2025

FDA Warning Letter Analysis: Chem-Tech, Ltd. – Deficiencies in OOS Investigation, Cleaning Validation and More

FDA issues a warning letter to Chem-Tech, Ltd. for improper OOS investigations, unvalidated cleaning procedures, and poor quality oversight. Key findings and corrective actions inside.

News, Regulatory Updates

March 4, 2025

USP–NF Proposed Drafts in PF 51(2): Key Highlights and Industry Impact

News, Warning Letters

March 27, 2025

FDA Issues Warning Letter to Yangzhou Sion Commodity Co., Ltd.

FDA warns Yangzhou Sion for CGMP violations, citing failures in component testing, QC oversight, and data integrity. CAPA plan and timelines included.

News, Warning Letters

March 20, 2025

FDA Warns Aspen SA Sterile Operations for CGMP Violations in Lab Controls, Aseptic Practices, Data Integrity, and Environmental Monitoring

The FDA has issued a warning letter to Aspen SA Sterile Operations for serious CGMP violations, including failures in lab controls, aseptic practices, data integrity, and environmental monitoring.

News, Warning Letters

March 13, 2025

FDA Warns Linghai ZhanWang for Unsafe Materials, Stability Failures, and Poor Oversight

FDA issues a warning letter to Linghai ZhanWang for failing raw material testing, stability studies, and quality oversight, placing its products on Import Alert 66-40.

Articles, QC

March 10, 2025

Reference vs Retention Samples: What is the Difference?

Look into the key differences between reference and retention samples in pharma, their roles in GMP, storage rules, and regulatory guidelines for compliance.

GMP Insiders - Your trusted source for GMP compliance!

Subscribe

Resources

Home

News

Services

FAQ

Events

Table of Contents

FDA Warns Linghai ZhanWang for Unsafe Materials, Stability Failures, and Poor Oversight

Reference vs Retention Samples: What is the Difference?

FDA Warning Letter Analysis: Chem-Tech, Ltd. – Deficiencies in OOS Investigation, Cleaning Validation and More

USP–NF Proposed Drafts in PF 51(2): Key Highlights and Industry Impact

FDA Issues Warning Letter to Yangzhou Sion Commodity Co., Ltd.

FDA Warns Aspen SA Sterile Operations for CGMP Violations in Lab Controls, Aseptic Practices, Data Integrity, and Environmental Monitoring

FDA Warns Linghai ZhanWang for Unsafe Materials, Stability Failures, and Poor Oversight

Reference vs Retention Samples: What is the Difference?

FDA Warning Letter Analysis: Chem-Tech, Ltd. – Deficiencies in OOS Investigation, Cleaning Validation and More

USP–NF Proposed Drafts in PF 51(2): Key Highlights and Industry Impact

FDA Issues Warning Letter to Yangzhou Sion Commodity Co., Ltd.

FDA Warns Aspen SA Sterile Operations for CGMP Violations in Lab Controls, Aseptic Practices, Data Integrity, and Environmental Monitoring

FDA Warns Linghai ZhanWang for Unsafe Materials, Stability Failures, and Poor Oversight

Reference vs Retention Samples: What is the Difference?

Contact Info