GMP Basics of Good Documentation Practices (GDocP)
Good documentation practices (GDocP) are key components of GMP compliance. Good record-keeping not only helps you during regulatory inspections (GMP audits), it is mandatory to ensure your documentation …
The time has come for us to talk about the Data Integrity elephant in the GMP room. Despite Data Integrity being a hot topic in industry for the past 5 years, it continues to …
Yes, we are still talking about the very old issue of Good Manufacturing Practice Pens or GMP pens and the most suitable colour of ink for pharmaceutical manufacturing pens and other issues. The various …
Since the MHRA released their data integrity guide back in March 2015, there has been a constant drip-feed of articles, blogs, commentary, and more worryingly, more guidance on the topic of Data Integrity. Lets …
In July 2016, the MHRA released a draft document for consultation entitled MHRA GxP Data Integrity Definitions and Guidance for Industry. As the name suggests, it is a glossary of DI terms where the …
Within the last 30 days, the US FDA released two new Warning Letters and yes-you guessed it, all contain data integrity violations. Lets look them below:
Falsifying test data from a stability batch
The latest Warning Letter is …
Data Integrity Violations
Source: Washington Post, Sept 26, 2015 – Thanks to Volkswagen
Data Integrity violations or data errors can happen in 3 ways: fat finger errors (an accidental lapse by an operator), falsification (a …
The review of data is the basis of everything that we do in the industry. It is the foundation of regulatory filings, controls in manufacturing, the checks in laboratory analysis, assurance of product release …
Pharmaceutical Cloud Computing
As we evaluate pharmaceutical cloud computing as an option we see pharma companies are slow to adopt cloud computing services, mainly because of the perceived data security / data integrity risk and …
The acronym ALCOA has been around since the 1990’s, is used by regulated industries as a framework for ensuring data integrity, and is key to Good Documentation Practice (GDP). ALCOA relates to data, whether …
