FDA in St. Vulbas
Everything began with an email from the US agency on April 11, 2018, indicating that the FDA would inspect our site from June 25–29, 2018. The news came on the evening at the end of an important customer audit, when the pressure was decreasing, but this feeling did not finally last long…
We received the information with excitement, but also with a certain tension and the intuition that a lot of work would be required to prepare the inspection at the best.
Preparatory meetings with the site management enabled us to define the priority topics to work on and the resources to be allocated.
A corporate audit was also planned beginning of June and was used as a mock inspection. Data integrity and control of forms were the main points of focus and highlighted the need to rapidly implement an improved system. Rehearsals of site presentation as well as some process presentations were performed. The Quality Assurance team, accompanied by the other departments of the site (Production, Scale-Up, Quality Control, Purchasing) made important efforts to be ready for D-day. Some investments were also necessary for revamping rooms and painting equipment.
Inspector Yumi Hiramine, an experienced US FDA inspector, was responsible for conducting the inspection – a GMP routine inspection – during the week. Wolfgang Hacker, Agata Ochocinska and Emeline Beaucart were present in the inspection room. The back room was composed of Peter Kiechle, the QA team (Laure Bourasseau, Mélissa Bouzidi, Alexia Hocine and Francine Wartak), Delphine Winkelmann (former and future QA) and Frantz Schmutz from the Evionnaz Quality System team. The organization end efficiency of the back room was remarkable: the flow of documents and their review as well as following up the status of requests were totally under control!
The inspector was not focused on a specific product or system, except the purified water production. In particular, she requested to assist in the sampling of the purified water loop as well as the microbiological testing. A big “well done“ to Philippe Dubois, who succeeded in all these activities despite the high pressure!
After five days of inspection, only one 483 observation was raised by the inspector regarding wet product stability data. This observation, however, as it does not question the quality of the products synthesized in St. Vulbas, keeps us confident in our quality system and the respect of regulations.
This audit also showed us that a united team can accomplish big things… A big THANK YOU to the Saint-Vulbas, Evionnaz and Zofingen colleagues for all their help, efforts and involvement during this intense period.
Authority Inspections in Hameln
This year, inspectorates from Brazil (ANVISA), USA (FDA), Korea (KFDA) and Russia (Ministry of Industry and Trade) visited Siegfried Hameln. The visit by the agency from Libya is scheduled for December.The general GMP understanding of the agency inspections at the Hameln site this year were very much in alignment with our understanding of compliance. Nevertheless, each inspection seemed to have its own character mainly owing to specific local GMP regulations and the way the inspections were carried out. The most important topic that came up in each of the inspections was the separation of responsibilities and conformance of the site’s master documentation with regulatory filing. Let’s see how the Libyan agency will run the upcoming inspection in December.
FDA Inspection in Pennsville
On April 2, 2018, Ms. Nancy Espinal, investigator for the US Food and Drug Administration (FDA), arrived unannounced for a routine GMP surveillance inspection of Siegfried, USA LLC. Ms. Espinal indicated that it would be an abbreviated inspection covering two systems: Quality and Materials. After a brief introduction and orientation to Pennsville Ms. Espinal selected six products for deeper review. The inspection was hosted by Thomas Minich, Director of Compliance, with close support from Janet Nixon, Sr. QA Manager. The “back room” was managed by Jamie Osborne, Quality Systems manager, and Barb Vergara, DEA manager. During this six day inspection twenty employees were interviewed and over 200 documents were reviewed. The investigator was thorough and expected rapid response to requests for documents and information. Due to the demonstrated knowledge and capability of the Pennsville team we were able to address all concerns raised and our inspection concluded with No Actions Indicated! This result is consistent with a long track record of excellent inspection performance by the Pennsville team and a big congratulations is in order to all Pennsville employees who work daily to insure we remain “inspection ready” at all times.
Successfull Pre-Approval Inspection at our Malta Site by the US FDA
On 20 December 2017, an exclusive customer filed the full set of registration documents for their Drug product at the US-Authority Food and Drug Administration (FDA). This filing was the trigger for an FDA inspection sometime in 2018.
The drug product is indicated for adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) and will improve the wakefulness of these patients.
This project was the first customer-specific project where we developed the API and the drug product at Siegfried. With this concept we offered our customer a unique “one-stop-shop” service with Siegfried as their single point of contact.
In March 2018 we got it information that the inspection by the US FDA will take place from 28 May to 1 June 2018 at our Malta site. We set up a core team with 8 people to prepare the inspection. Several rehearsals and training activities were performed to prepare the inspection. In addition to the investments in our personnel (mainly internal and external training) different investments in our infrastructure were made (e.g. new flooring of the warehouse).
The inspector Yvesna Blaise was hosted by Nadia Spiteri, Wolfgang Hacker, Remo Borer, Carmen Doran and Peter Kiechle during the 5 days. The “war” room was supported by a very competent and efficient back office, which was challenged by many document requests. Beside the review and preparation of the requested documents, thousands of pages of raw data had to be copied and pdfs had to be prepared.
After 5 very demanding days the inspector confirmed that she will propose the approval of the registration dossier at the FDA. She also confirmed that she will not issue a form 483, which means that we passed the inspection without any formal observation.
Malta is proud to have passed this very important inspection without any observation. It confirms the success of our preparations and improvements in the last 7 to 8 months.
In addition, it is a perfect example of the great collaboration between the different stakeholders involved in that “project”: our staff at Malta, subject matter experts and Corporate Compliance in Zofingen and finally our customer.
A big thanks to all our colleagues at Malta and Zofingen who facilitated and contributed to this success.