02

May

2001

ICH GMP Guidance for APIs Software References

0

The International Conference on Harmonization (www.ich.org) issued “GOOD MANUFACTURING PRACTICE GUIDE FORACTIVE PHARMACEUTICAL INGREDIENTS” November 10.2000.

FDA participates actively in the ICH. Section 5.4 of this guideline is a specific section with some basic requirements for computerized system. Section 5.42 actually mentions COTS (commerical software) and retrospective validation specifically and states:
“Commercially available software that has been qualified does not require the
same level of testing. If an existing system was not validated at time of installation, a retrospective validation could be conducted if appropriate documentation is available.”

Section 12 of the guideline is on Validation in general. Sub-section 12.42,12.43, 12.44 recognize and discuss prospective, concurrent, and retrospective valdation.
Section 12.6 discusses revalidation and states conditions under which periodic revalidation is not necessary.

Although this guidleline is for APIs it is likely the concepts are valid for qualification and validation represent current thinking in other applications as well.

The full guideline is at the link provided.

SoftwareCPR keywords: Drug, OTSS, process validation

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