Published in 2008 and updated in 2020, the European Union's Good Manufacturing Practice standards (or EU GMP) Annex 1 mentions essential elements of monitoring such as particles, microbiological count, temperature, and relative humidity. In addition, its detailed guidance covers formal risk analysis, alerts, and action limits.
GMP lists various production methodologies, including blow, fill, and seal. In addition, it compares terminally sterilized and aseptic preparation techniques. Other topics covered include pharmaceutical quality systems (PQS) and quality control (QC) requirements.
As well as advocating a contamination control strategy (CCS) for each facility, the guide promotes a holistic approach to detect seemingly independent events, consider common causes, and implement appropriate corrective and preventive actions (CAPA) as necessary.
EU Annex 11 includes detailed guidelines for computerized systems and their requirements for validation and qualification.