Your drug from development to GDP-compliant distribution. Supported at every stage.

The 2022 version of the EU GMP Guide Annex 1 requires a documented contamination control strategy that brings together all contamination-relevant elements of a site: facility and cleanroom design, personnel and material flow, environmental monitoring, barrier and isolator technology, and the underlying quality risk management per ICH Q9(R1). What matters is the evidence that the individual measures work as a coherent concept.

FDA inspections assess against 21 CFR Part 210/211; where deficiencies are found, they end with Form 483 observations, and with a Warning Letter if the case escalates. EU inspections are carried out by the competent authorities of the Member States, and the EMA coordinates them for centrally authorized medicinal products. They assess against the EU GMP Guide (EudraLex Volume 4); where deficiencies are found, they lead to an inspection report, and to a Statement of Non-Compliance with consequences for the GMP certificate if the case escalates. The two overlap heavily in substance; preparation, however, must understand the respective procedure, documentation language, and escalation logic.

A risk-based validation per GAMP 5 is the foundation, but it only covers 21 CFR Part 11 and the EU GMP Guide Annex 11 once audit trail configuration, access controls, and electronic signatures are explicitly tested and regularly reviewed during ongoing operations. Data integrity per ALCOA remains a continuous process, beyond the validation record.

The clean handover of process knowledge. The EU GMP Guide Annex 15 requires qualification and validation of the new facility; the process performance qualification (PPQ, FDA Process Validation Guidance 2011) demonstrates with commercial batches reproducible manufacturing at the target scale. When a transfer fails, it is usually because the rationale for critical process parameters from development per ICH Q8 to Q10 was not documented in a traceable way at the new scale.

The EU GDP Guidelines 2013/C 343/01 require that the declared storage conditions are maintained across the entire supply chain and substantiated through temperature mapping and calibrated temperature monitoring, including at the handover between the parties involved. The basis is a documented quality system with a designated responsible person per § 52a AMG. For biologics and vaccines, the qualified cold chain thereby becomes a critical part of product quality.