TABLE OF CONTENTS A large number of the companies involved in preparative HPLC will be using the technique for purification of drugs to cGMP. This chapter will summarize some of the documentation required including equipment qualifications, standard operating procedures, process instructions and process records. It will give some suggested layouts for process documentation with real examples for guidance.
Regulatory guidelines and nomenclature will differ from one country to the next but the general principle remains the same. The Federal Drug Agency (FDA), which is undoubtedly the most discerning authority, presides in the United States. The Orange Guide published by the MHRA [6.1] is useful text and to some extent shows a level of harmonization of the guidelines with the FDA.
The principle for the documentation trail and qualification process surrounding the purchase installation of equipment is a matter of common sense. The following terms are by no means universal but the principle and elements of these are essential to meeting cGMP.
User Requirement Specification (URS) is a basic description of the equipment covering the purpose for which it is required. This is sent to equipment suppliers during the stage of assessing various manufacturers and obtaining cost estimates.
Design Qualification (DQ) is a much more detailed document describing the requirements in full. The DQ may contain engineering drawings and performance specifications such as permitted variance on gradient or flow rate. This document will specify precise requirements such as the grade of stainless steel for construction and the...
