GxP for Investigational Medicinal Products

GxP requirements from R & D to Investigational Medicinal Products

Prior to the introduction of medicinal products to the market, the regulations of Good Practice (GxP) have to be followed during production and development.

These include in particular, Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Distribution Practice (GDP).

During the product life cycle of a medicinal product, quality requirements increase continuously from research and development through the different clinical phases to market maturity. Already in the course of development and formulation, the first compliance measures for Good Manufacturing Practice (GMP) have to be implemented. These basically include all GMP relevant topics which are to be applied on a risk-based approach according to the respective development stage.1

In case medicinal products shall be manufactured for a clinical trial, a manufacturing authorisation and a corresponding GMP certificate are already required for this purpose.2

Upon request, the respective regulatory authority will conduct an on-site inspection to verify compliance with national law and EU GMP requirements. Prior to this, an appropriate quality management system must have been established, which demonstrates suitable measures to ensure the proper quality and safety of the medicinal products according to EU standards. In Particular, the following aspects must be documented and ensured: description of the internal processes, the suitability of all premises and facilities, the conformity of materials used, the qualification of the personnel and the quality of external services.

We offer full services along the entire product life cycle:

GMP in R & D

  • Development of GMP-compliant processes and methods (including CPP and CQA)
  • Definition, description, adaptation and verification of QC test methods
  • Validation: production, analytic, cleaning & transfer
  • Special services for ATMPs

GMP for manufacturing of investigational medicinal products, including the relevant application to obtain or extend your authorisation/ GMP certificate (according to § 13 or § 72 AMG):

  • Generation of the Site Master File
  • Preparation of Standard Operating Procedures (SOPs) and related forms
  • Qualification of premises, facilities and equipment as well as the preparation of the corresponding documentation
  • Validation of processes, methods, systems and transport management procedures
  • Creation of hygiene concept
  • Scientific Advice
  • Support in the selection of key personnel
  • Training of employees
  • Identification, selection and qualification of external service providers
  • Audits and contractual agreements for external services (e.g. suppliers, analysis, transport)
  • Audits to prepare the QP Declaration for the import of products into the EU
  • Investigational product specific requirements: Labelling, provision through just-in-time processes, return shipments and destruction
  • Mock inspection: in preparation for the inspection
  • Support during the audit
  • Consulting scale up/scale out and automation processes
  • Special GMP services for ATMPs

GDP for investigational medicinal products:

  • Logistics for clinical supplies: storage & distribution
  • Support in procurement of comparator medication
  • Supply chain optimisation

With the support of our experienced professionals, you will accelerate your entry into the pharmaceutical/biotech market!

1 ICH Guideline on Pharmaceutical Development Q8(R2); in development: ICH Q14 Analytical Procedure Development and Revision of Q2 (R1) Analytical Validation; WHO Working Document QAS/20.865 (Nov. 2020) Good Practices for Research and Development Facilities;

2 for the manufacturing authorisation: according to § 13 (1) of the German Medicines Act; for the import authorisation: according to § 72 of the German Medicines Act; format according to: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/basicformat_manufacturersauthorisation_en.pdf

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