This Manual, created by the ISPE Germany/Austria/Switzerland (D/A/CH) Affiliate was created outside the normal process for ISPE Guidance Documents and did not go through a rigorous review to ensure alignment with other ISPE Guidance Documents and accuracy of content. However, ISPE believes the content has value to the industry and is, therefore, making the Manual available to its members and customers, translated into English but unchanged from the original German content.