Non-GxP

The company that operates a system decides how it is classified; we do not classify our customers' systems. The PIC/S guidance PIC/S PIC/S, the Pharmaceutical Inspection Co-operation Scheme, describes itself as a non-binding, informal co-operative arrangement between regulatory authorities in the field of GMP for medicines. Read in the glossary → document PI 041-1 expects these regulated users, as it calls them, to keep an inventory of all computerised systems in use, with an assessment of the function and criticality of each system and its data. It gives three example levels: direct GMP/GDP GMP Good manufacturing practice (GMP) is the part of quality assurance ensuring that medicinal products are consistently produced, imported and controlled to standards appropriate to their intended use. Read in the glossary → impact, indirect impact and no impact. For manufacturing, Annex 11 of the EU GMP Guide says an up-to-date listing of all relevant systems and their GMP functionality should be available.

The term appears, undefined, in PI 011-3. It says retrospective validation Validation In the EU GMP and GDP glossaries, validation is the action of proving that any procedure, process, equipment, material, activity or system actually leads to the expected results. Read in the glossary → might be justified if a non-GxP system GxP GxP is an umbrella term for the good practice guides and requirements of the regulated pharmaceutical sector, such as good manufacturing practice (GMP) and good distribution practice (GDP). Read in the glossary → is newly classified as a GxP system, so a classification is not fixed. It also says the reasoning behind critical or non-critical classifications should be documented, and that any risk potentially affecting GxP compliance should be clearly identified.

Our business applications Business application In general terms, a business application is software used to perform or support business functions. Read in the glossary → for the pharma sector are intended for settings the operator classifies as non-GxP. We do not offer computer system validation for them: we produce no IQ/OQ/PQ documentation (see Validation) and do not follow a GAMP 5 GAMP GAMP, short for Good Automated Manufacturing Practice, is guidance published by ISPE on a risk-based approach to computerised systems in GxP environments. Read in the glossary → approach (see GAMP). In one tender, a pharma company's own user requirements specification classified the portal it wanted built as non-GxP. That classification did not mean the portal had no requirements.