Problems with the Current USP
As a starting point, let’s look at my critique of the current version of USP <1058> based on the “Focus on Quality” column that I wrote in November 2010 (8). Summarizing my concern with the current version of USP <1058>, the following issues are noted:
Problem 1: Users Are Responsible for DQ
The current version of the general chapter says mainly that the manufacturer is responsible for DQ. Rubbish! The user is responsible for the system as he selects and uses the instrument or system to generate regulated data.
Problem 2: The True Role of the Manufacturer Is Missing
The manufacturer or supplier is involved throughout the integrated AIQ-CSV process. This starts with the design of the instrument or system, through training to use the item, qualification services, calibration and requalification, and updates of software. This is the elephant in the room. The role of the manufacturer needs to be integrated into the process more.
Problem 3: Poor Software Validation Guidance
The implicit validation of software in Group B instruments is a good approach and was consistent with the approach advocated in Good Automated Manufacturing Practice (GAMP) versions 1–4 (19). However, consistency disappeared with the dropping of GAMP software category 2 in the current version of the GAMP guide (20). Schuessler and colleagues (21) have mapped the current GAMP software categories against the USP groups including the subcategories advocated by Burgess and McDowall (16,17). Furthermore, the Food and Drug Administration (FDA) validation reference (22) quoted in USP <1058> is intended for medical device software and not configurable software often seen in analytical laboratories.
Problem 4: Groups Can Be Misleading
There is a list of devices that are placed in the three groups; however, this can be misleading. For example, in the current version of <1058> a dissolution bath is placed in Group C. In reality, a standalone dissolution bath is a Group B instrument that only undergoes calibration and any firmware is implicitly validated through the qualification process. However, if the dissolution bath is controlled by a separate computer system, then it will be classified as a Group C item. This approach has the potential to lead to confusion by placing an instrument in either too high a group and doing too much work or in a lower group and generating a compliance gap.
What Has Changed in the Proposed <1058>?
The best way to summarize the changes in the proposed version of USP <1058> is by comparing the two versions. This is done in Table I, which shows the topics in the current version of <1058> (mainly) with one or two additions from the new version of the general chapter. The center and right-hand columns summarize the content and many changes in the new and proposed versions, respectively. I should sound a note of caution here: This is a summary of changes and does not go into depth. For more detail you should read both the current and proposed versions of <1058> to glean this detailed information.
Is the Proposed USP <1058> Better?
Not all improvements to regulations and regulatory guidance may be good or even required. Therefore, we must ask the question about the proposed USP <1058>: Is it any better? To answer this question, let’s return to the four problems with the current version that I outlined earlier in this column and see.