Are Active Pharmaceutical Ingredient Manufacturers Compliant With New FDA GMP Guidance?

By Deb Bartel, 12th October 2016

In September, the FDA published Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients to provide API manufacturers with recommendations intended to ensure compliance with regulations. What is in the new FDA Guidance: This guidance document, originally published by ICH in 2000, includes recommended best practices for computer systems, such as: Validation System documentation Security Record protection and retention Audit trails  … Read more

Are you ready for the FDA guidance on Data Integrity and Compliance?

By Deb Bartel, 1st May 2016

The FDA just published a new, draft guidance document on good manufacturing practices (cGMP) for drugs. This document is intended to address the frequent data integrity issues found during FDA inspection of pharmaceutical and API manufacturing sites. What’s new in this draft FDA guidance document: Clarifications & Definitions of Terms This draft guidance contains clarifications and definitions for the terms  … Read more

Are you complying with the European Commission’s new version of Annex 16?

By Deb Bartel, 23rd November 2015

In October, a new version of Annex 16 was published due to significant changes in the globalization of pharmaceutical supply chains and the introduction of new quality control strategies. Annex 16 was last published in 2001, so this version has significant improvements. The deadline for compliance with this version of Annex 16 is 15-APR-2016. What’s in this new version: This version  … Read more

Are you prepared for WHO draft guidance on Good Data and Record Management Practices?

By Deb Bartel, 5th October 2015

In September 2015, the World Health Organization (WHO) published a draft guidance document focused solely on data integrity. This is due to recent increases in the number of inspection observations related to data management practices. These WHO recommendations are intended to ensure the integrity of both paper and electronic data and records. Share this with your team, so you can  … Read more

Are your procedures aligned with the FDA Guidance for Analytical Procedures and Methods Validation?

By Deb Bartel, 7th August 2015

Last month, the FDA published this document for drug and biological license applicants submitting analytical procedures and methods validation data to document the identity, strength, quality, purity, and potency of drug substances and products. This guidance is intended to complement the International Conference on Harmonisation (ICH) guidance Q2(R1) Validation of Analytical Procedures: Text and Methodology for developing and validating analytical methods. Computer and software related  … Read more