Velkommen til IFF QA erfa møde d. 15. marts Erfaringer med miljømonitorering og tolkning af nyt anneks 1.

Transkript

1 Velkommen til IFF QA erfa møde d. 15. marts 2018 Erfaringer med miljømonitorering og tolkning af nyt anneks 1. 1

2 Fast agenda kl Nyt fra kurser, seminarer, myndighedsinspektioner, audit som I vil dele med andre 2. Fagligt oplæg/emne/workshop: Eksterne foredragsholdere hvor muligt og kombineret med medlemmers oplæg 3. Faglige cases og eller bestemte problematikker der kan deles med andre. Oplæg til dialog og med mulig slot-tid. 4. Emner til de kommende arrangementer og mulige kontaktpersoner 5. Evt. IFF kommentering af Anneks 1 6. Dialog / learning points 2

3 Kurser, seminarer, myndighedsinspektioner, audit? 3

4 Fagligt emne nr. 1 Novo Nordisk - tolkning af nye krav i Eudralex anneks 1 ved Jette Christensen fra Novo Nordisk. Dialog 4

5 Fagligt oplæg nr. 2 NB aflyst pga. sygdom Xellia s erfaringer med miljømonitorering, ved Frederik Brix Skautrup og Marianne Skovgaard-Nielsen Dialog 5

6 Cases og/eller problematikker til dialog Faglige cases og/eller problematikker, der kan deles med andre? 6

7 IFF kommentarer til anneks 1- draft We very much appreciate the effort to update Annex 1 but we find the degree of details very profound and this does not allow the use of a risk based approach which is already widely used in the industry. We find it unclear that the Scope states The manufacture of sterile medicinal products and at the same time states that..may be used to support the manufacture of other products that are not intended to be sterile line It is not correct language to use the word prevented : In the text for example in line The aim is to reduce the risk of microbial, particulate and pyrogen contamination in the final product. 7

8 IFF kommentarer til anneks 1 - draft We find that the current document is contradictory to other chapters of EUDRALEX volume 4. Further many details regarding pharmaceutical quality systems, personnel, training, risk assessment, deviation handling are described instead of referring to existing chapters. This can be misunderstood as the Annex 1 is the only valid stand-alone guideline. We would propose that for general requirements reference to the existing chapter are made. Furthermore, the new requirements are not in accordance with the ISO series of standards, used and accepted over many years in the pharmaceutical industry and adopted as acceptable by the Health Authorities. We find that the current document contradicts the requirements of the current water EU monographs used in the aseptic/sterile productions (PW/WFI). 8

9 IFF kommentarer til anneks 1 - draft We find that the current document introduces several additional terms not used previously and not defined in the glossary. We propose to use the same terms as used previously in other documents to ensure compliance (e.g. Line 201 (APS) test new abbreviation not defined in glossary meaning Aseptic Process Simulation test, previously named Media Fills. Another example: Line 2076 Clean Non Classified (CNC) area instead of Controlled Non Classified (CNC) area, which is usually used). Line 1251 states that If a liquid product cannot be terminally sterilized by a microbiocidal process, it should be sterilized by filtration through a sterile, sterilizing grade filter How to be complying? A lot of already approved and marketed products cannot be terminally sterilized or sterile filtered. 9

10 IFF kommentarer til anneks 1- draft Line 1580 states Viable and non-viable. This should be changed to Total particles as stated in the current Annex 1. It is not possible in advance to know if the particles are viable or not. Line 1778 mention Process simulation test using a sterile nutrient media and/or placebo. What does placebo mean in this context and it is not defined in the glossary nor explained in the text. 10

11 Emne til de næste QA erfa møder i 2018 Erfa møde d. 15. august kl E-leaning Pharmakon vil gerne fortælle om deres erfaringer Andre? Fælles Erfa møde d. 15. november kl (QA + RA) Tolkning af ny ICH Q12 Oplæg fra lægemiddelstyrelsen og efterfølgende dialog 11

12 Dialog / learning points Anette Frost Jensen fra Leo Parma anbefalede et 1 dags EM kursus på Pharmakon, med mange praktiske eksempler.. Vi skal være opmærksomme på de øgede krav i nyt anneks 1, som er planlagt til at træde i kraft ultimo IFF, flere større virksomheder og forskellige organisationer er ved at kommentere det opdaterede anneks 1 Tak for i dag 12