In-house Packaging

If services in the field of in-house packaging are required we organise, coordinate and supervise the manufacturing processes (labelling, packaging and distribution) of clinical study medication used in international clinical studies with due consideration for the relevant regulations and guidelines. In addition, we provide qualified assistance for all compliance issues. Individual tasks are as follows:

• Ensuring GMP compliant manufacturing and recommendation for approval of manufacturing instructions (in Germany in accordance with § 13 AMWHV)
• Initiating the release of clinical study medication (in Germany in accordance with § 13 AMWHV) including the provision of required documents for statutory archiving
• Coordination and supervision of timelines in respect of on-time delivery of all clinical trials
• Consultation with regards to regeneration and optimization of existing workflows and IT projects
• Creation and revision of SOPs including incorporation and implementation of new guidelines in existing SOP-System
• Preparation and supervision of audits, qualification and validation as well as coordination of corrective measures
• Compilation and evaluation of deviations and organisation of subsequent corrective measures (Deviation Handling)