Today, we will talk about a warning letter GMP Training to Avoid Mistakes in Contract Manufacturing | FDA Warning Letter, received by the company for E.g. XYZ Laboratories.
The warning letter describes the company’s misconduct in using contract manufacturing organizations.
In short- CMOs. Xyz Laboratories is located in the USA.
According to their website, their product line comprises difficult-to-source tablet and capsule products.
I have no idea what it means, as they don’t list their product line on their website.
However, FDA has mentioned two of them in the warning letter.
The first one was Phenazopyridine, which treats urinary symptoms such as pain or burning.
The second was Salsalate – a non-steroidal anti-inflammatory drug for treating fever, pain, and inflammation.
The company claims to have over 100 years of combined experience within the pharmaceutical industry.
I hope they don’t employ more than 100 people.
Now let’s get to the warning letter.
The company received the notice in May 2019.
FDA has stated the company’s quality unit has failed to institute adequate oversight and controls of their CMOs.
This led to the use of many sub-standard contractors not to mention the companies own violations.
Let us take a look at some of those now in GMP Training to Avoid Mistakes in Contract Manufacturing | FDA Warning Letter
When you use CMOs, the quality unit must qualify them and oversee their activities.
It is crucial, as the responsibility for the final product release lies on the contracted.
This must ensure that the product is safe and meets the specifications for identity, strength, quality, and purity.
The FDA has established, that Laboratories brought the final products to the market, without reviewing the certificates of analysis, which they got from the CMOs.
By doing so, it failed to determine the suitability of the product for the market.
The FDA auditor has reviewed the quality agreement the company had in place with the CMOs.
He was less than happy to find out that the company had put all the responsibilities on the CMOs.
They were responsible for manufacturing, packaging, labelling, stability, and product testing.
The quality agreement also indicated that Laboratories had no responsibility for drug product release.
I will remind you again that a product owner cannot delegate finished product release decisions to its contractors.
Here I’m starting to get a bit suspicious and wonder what the 100 years old experienced employees do in this company.
All that is left for them to do is count the cash.
Now move on to the next deviation, You might be pleased to hear that Nationwide Laboratories had at least written procedures of how to qualify and approve contract warehouses.
It included requirements for
They didn’t follow their procedures.
No audit nor qualification of the contract warehouse that they used to store and distribute finished drug products.
I don’t know what’s worse.
Having no procedures or having them in place, but not following them.
I’m leaning toward having them, but consciously ignoring them!
What do you think?
Which one is worse?
Leave your thoughts in the comment section.
Because of all those violations, the company then said that they are committed to hiring a true quality unit.
The FDA was not impressed, because in 2016 they promised, that they were committed to hiring an appropriate quality unit.
Next time they will get the Avengers to help them, I guess. I think when they hire a true quality unit, their company will have a combined experience of 1,000 years.
Now that will be impressive!
Now, moving to the next deviation.
This one concerns drug product complaints.
21 CFR section 211.198 requires product owners to have procedures for handling all written and oral complaints about a drug product. The company had such complaint procedures in place.
It specified that consumers could complain, ask questions, and report adverse effects via a telephone number.
But the telephone number in the written procedure was not the same as on the company’s website.
Let’s call them on the listed number and see what happens, OK, it’s ringing.
The mailbox is full.
I cannot accept any messages at this time. Goodbye! Interesting- They told the FDA auditor, that they had not got any complaints since the last FDA audit, in 2016.
I guess we know now why. To get out of the hole, the company must now show the FDA a plan to address potentially unreported complaints.
Good luck with that.
I hope you enjoyed today’s article “GMP Training to Avoid Mistakes in Contract Manufacturing | FDA Warning Letter” of letters to avoid.