Validering og dokumentation
Vi kan levere præcis den type dokumentation du har behov for til din validerings process
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LSS tilbyder tilpasser validerings dokumentation iht. cGMP og GAMP 5 regulativer
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Dokumentationen certificere at udstyret er designet, fremstillet og fungerer i henhold til dine URS krav.
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Validaeringspakkerne er sammensat af DS, DQ, IQ/OQ and FMEA risiko analyse
1.Design Specification
a) Design specification
b) Design Review with customer
2.Basic Documentation package
a) Quality Activity Plan
b) Design Specification incl. design review
c) URS – DS cross reference list
d) FAT & SAT Test Protocol & Report
3.Extended Documentation package
a) Quality Activity Plan
b) Design Specification incl. design review
c) URS – DS cross reference list
d) FAT & SAT Test Protocol & Report
e) IQ Protocol, based on customers specification in the URS (Q or C indication)
f) OQ Protocol, based on customers specification in the URS (Q or C indication)
4.Validation Documentation package
a) Quality Activity Plan
b) Design Specification incl. design review
c) URS – DS cross reference list
d) FAT & SAT Test Protocol & Report
e) Validation Plan
f) Risk Management Plan
g) FMEA risk analysis performed according to the Machine Design Specification and the product criticality (determined by the customer).
h) IQ Protocol prepared according to the FMEA
i) OQ Protocol prepared according to the FMEA
j) Validation Summary Report
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