Tag: Data Integrity

If you don’t find what you are looking for, try using a different term or contact us.

Software Validation in GMP featured image with digital binary code and compliance theme.

Software Validation in GMP: Continuous, Risk-Based Control Across the Lifecycle

Explore risk-based software validation in GMP, from CSV to continuous assurance, ensuring compliance, data integrity, and efficiency....
fda-warning-letter-analysis

FDA Warning Letter to Somerset Therapeutics Pvt. Ltd. (India) Issued September 2025

FDA issues Warning Letter to Somerset Therapeutics citing major cGMP failures in aseptic practices, investigations, and reporting....
ALCOA++ in GMP: Practical Data Integrity for Labs and Manufacturing - Featured Image

ALCOA++ in GMP: Practical Data Integrity for Labs and Manufacturing

Explore ALCOA++ in GMP: practical data integrity principles that keep records accurate, traceable, and inspection-ready....
CSV in pharmaceutical manufacturing - featured image

Computer System Validation (CSV) in the Pharmaceutical Industry

Practical guide to CSV in pharma: lifecycle validation, Annex 11 updates, GAMP 5 methods, CSA approach, and real-world compliance practices....
USP Releases New Draft Proposals in Pharmacopeial Forum 51(4) - Featured Image

USP–NF PF 51(4) Draft Published

USP–NF PF 51(4) introduces draft chapters on data integrity, suspensions, disinfectants, chemometrics, and analytical lifecycle, impacting GMP pharma operations....
FDA Inspection Readiness Guideline: How to prepare for unannounced global audits

FDA Inspection Readiness: How to Prepare for Unannounced Global Audits

Discover global strategies for FDA Inspection Readiness, real-time GMP compliance, and regulatory confidence....
fda-warning-letter-analysis

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...
fda-warning-letter-analysis

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...
fda-warning-letter-analysis

FDA Highlights Systemic Issues at Mylan Laboratories in Recent Warning

FDA warns Mylan Laboratories for critical cGMP violations in quality control, data integrity, and governance, urging urgent corrective actions to...
Good Chromatography Practices – Meeting Industry Standards

Good Chromatography Practices – Meeting Industry Standards

Learn how Good Chromatography Practices enhance data integrity, ensure compliance, and boost efficiency in pharmaceutical labs for reliable, safe product...

BECOME A GMP INSIDER

Stay in touch and be the first to get the latest GMP News!