Beispiel: Checkliste DD für Biological Product

Wir berücksichtigen und verweisen dazu auf spezifische Referenzen: verschiedene Richtlinien der Gesundheitsbehörden, wie zum Beispiel:

www.ema.europa.eu/en/documents/scientific-guideline/guideline-requirements-quality-documentation-concerning-biological-investigational-medicinal_en-0.pdf

www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-process-validation-revision-1_en.pdf

www.ema.europa.eu/en/documents/report/final-guideline-active-substance-master-file-procedure-revision-4_en.pdf

www.ema.europa.eu/en/documents/scientific-guideline/guideline-plasma-derived-medicinal-products_en.pdf

www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-requirements-chemical-pharmaceutical-quality-documentation-concerning_en.pdf

www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-strategies-identify-mitigate-risks-first-human-early-clinical_en.pdf

www.ema.europa.eu/en/documents/scientific-guideline/guideline-virus-safety-evaluation-biotechnological-investigational-medicinal-products_en.pdf

www.ema.europa.eu/en/documents/presentation/presentation-european-directorate-quality-medicines-healthcare-edqm-european-pharmacopoeia_en.pdf

www.ema.europa.eu/en/documents/scientific-guideline/guideline-requirements-quality-documentation-concerning-biological-investigational-medicinal_en-0.pdf

Beispiel, wie wir die Parameter einer solchen Richtlinie in unseren DD-Prozessen anwenden:

"Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials (September 2018 EMA/CHMP/BWP/534898/2008 rev. 1 corrigendum, Committee for Medicinal Products for Human Use (CHMP) Keywords: Biological product, investigational medicinal product (IMP), clinical trial, quality (Note: The revision of this Guideline was prepared by the CHMP Biologics Working Party with a mandate from the European Commission, to facilitate the implementation of Regulation (EU) No. 536/2014)2

Dementsprechend gelten folgende DD-KRITERIEN mit besonderem Fokus auf ein biologisches Produkt:

Introduction (background)

1.1. Objectives of the guideline

1.2. Scope

1.3. General points concerning all IMPs

1.4. Submission of data

Information on the biological, chemical and pharmaceutical quality concerning biological investigational medicinal products in clinical trials

S Active substance

S.1. General information

S.2. Manufacture

S.3. Characterisation

S.4. Control of the active substance

S.5. Reference standards or materials

S.6. Container closure system

S.7.Stability

P Investigational medicinal product under test

P.1. Description and composition of the investigational medicinal  product

P.2. Pharmaceutical development

P.3. Manufacture

P.4. Control of excipients

P.5. Control of the investigational medicinal product

P.6. Reference  standards  or  materials

P.7. Container closure system

P.8. Stability

"Appendices

A.1. Facilities and equipment

A.2. Adventitious agents safety evaluation

A.3. Excipients

A.4. Solvents for reconstitution and diluents

Information on the quality of authorised, non-modified biological test and comparator products in clinical trials

Information on the quality of modified authorised biological comparator products in clinical trials

Information on the chemical and pharmaceutical quality concerning placebo products in clinical trials

Changes to the investigational medicinal product and auxiliary medicinal product with a need to request a substantial modification to the IMPD.