A Guest Post from Oliver Yu, CTO, FDAzilla
A core belief of drug manufacturing is that the drug alone is not the product of the pharmaceutical company. The drug and the documentation proving that the drug was made properly is the output of the pharmaceutical company. This belief is at the core of data integrity. If you think about it, in no other industry is the integrity of the data held to such a high standard.
When you first start out at a drug company, it’s often said, “If you didn’t document it, it didn’t happen.” So you can do the work, but if you didn’t complete of a set of paper forms (i.e. the Manufacturing Formula)… or you didn’t execute the electronic records, then you might as well toss all the work that you did.
Every single batch of drugs has a paper/audit trail that can prove:
- What operation was performed
- When the operation was performed
- Who performed it
- How it was performed (per pre-approved procedures)
So this whole data integrity thing, why it’s a big deal is simply because we’re talking about injecting a substance into the patient’s body, bypassing nature’s safeguards.
We had better be certain and have precautions in assuring that we did it right. That’s why this whole data integrity thing is even being talked about.
Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483s, Inspector Profiles, Enforcement Analytics, and GMP Regulatory Intelligence. Contact us if you ever have questions at [email protected].