Interview P4 - GMP Advise & Relations

Question 1

How is knowledge cGMP? What type of GMP-advise have you given?

Answer 1

“A: Know where to find Eudralex Vol.4,CH.5
S: last month advise for QSIP repack.rework (Michiel D.)
T: QM10 R&R input
A: advice reconcilliation - MSD autom.detection.pharmacode.
R: No large process change is needed”

Question 2

“How is your interaction (from QR) with the IPT? “

Answer 2

I started with several structural meetings, but that resulted in just meetings and not a better process. I know where to find the coaches and they know how to find me when needed. Together we get things done. E.g. Joost (PS GL) was looking for the list of 67 impacted CS630 batches as Arno was away, he contacted me, I knew Stefke also had the last version and within 15 min he got the right document.

Question 3

“Bottlenecks examples QR-IPT process? Does everything run smoothly?
Deviation Management - current view / opinion?”

Answer 3

Of course there is room for improvement in the collaboration with the IPT’s. I notice the new QROlv2 and QPs have barely seen the packaging process and that limits the capacity to think with the IPT and ask the right question for IA. It would be great if they could sit several hours on the IPT to see the process and have contact with the IPT staff. At IPT VC we initiated structural Gemba walks to improve collaboration. For BRRs a contact-moment per day can limit the current slow paper-flow.

Question 4

ROT - current view / opinion?

Answer 4

Focus on the MBTR helps to get a result driven mindset. However it does not help that every team has his own metrics (PP4, MBTR, market demand) that result in different priorities for the IPT (volume), QR (Release timing), SCM (no OoS, on time Launces/tenders). Surprising last minute high urgent releases for batches on day 12 disrupt one metric (MBTR) to save another (for a tender). Structured a timely communication would help our site.

Question 5

Collaboration - current view /opinion?

Answer 5

”* ROT & Q-support

* Bottlenecks”

Question 6

Organon - current view / opinion?

Answer 6

“Organon is the most important client for IPT. Almost half of the BL packaging lines are reserved for Organon products. We need to keep good contact with them and show they can trust us in Quality (PIR, low CPM, ROT).
* ROT & Q-support”

Question 7

What type of contact with vendors/suppliers/sites?

Answer 7

Suppliers: Recent JHS diluent samples send up front and label adress to lab, Site: Janumet Singapore coating issues , Client: Akrikhin