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Harnessing Informatics for Effective Lab Inspections and Audits

By Joe Liscouski

Product safety is one of the driving factors in government oversight, as applied to the consumer. Whether it is concerned with medications, food, transportation, or housing, product safety drives the development of regulations for manufacturing and production across industries. As a result, the consumer is better assured of their purchase or medical treatment, feeling more secure that something terrible isn’t going to happen, at least due to product quality. That assurance is printed on the packages as nutritional labeling, assays for medications, or other means. The intent is to trust the information provided so that when you reach for a pain reliever that lists the strength of the medicine, you can feel confident that it is correct.

What is that confidence based on? It isn’t trusting producers will “do the right thing”; it’s because someone is methodically monitoring the producers’ activities to ensure they are “doing the right thing” and being held accountable. This article will look at the guidelines that apply to laboratory inspections, the common problems that arise (where information exists), and the role that laboratory informatics can play in making compliance easier.

Within laboratories, the point of guidelines is to ensure the validity of laboratory results, i.e. that the accuracy and integrity of the data and information provided are high. One thing you will notice as we list and review the various guidelines is that they are often drawn from documents applied to manufacturing/production facilities. For example:

The concern here is for products that reach the consumer rather than those currently in the research and development (R&D) phase of their operations, although those should apply the guidelines to their work. One exception is the FDA, which conducts lab inspections for labs involved with clinical trials, or studies in organisms when the results of that work will be used in FDA approvals for medical products as they move through the clinical trials/approval process.

Other regulations, standards, and guidelines help ensure the integrity of lab results when analytical data and information is made available to the public, for example, via water quality testing. These include:

Beyond this, the Occupational Safety and Health Administration (OSHA) has standards to protect laboratory workers.

Note: The guidelines we are considering here are for overall lab operations and differ from specific test guidelines/methods produced by the ASTM[1], United States Pharmacopeia (USP)[2], and other standards/regulatory bodies.

When we consider lab inspections, several questions need to be answered: What laboratory activities and functions are being evaluated? What are the guidelines that are being used? What types of problems are being uncovered? We’ll address those questions now.

As noted earlier, the purpose of the inspection process is to ensure the results of laboratory work are on a solid footing and to uncover areas where things need to be improved to ensure the results are reliable. That is the basis for including a requirement for a validation process to produce documented proof that something works as intended and is needed. The areas that need to be addressed fall into the following categories, as shown in Figures 1 and 2.

Figure 1 — Summary of basic categories of lab functions

Figure 2 — Fully expanded lab function diagram. The diagram will be difficult to read, so the individual sections are split out in Figures 3–7.

The point of including this diagram is to show at least some of the interconnections between functions. A complete set of interconnections would be challenging to view, but most should be easily understood.

The list of functions is not intended to be a detailed depiction of the subject but one common to many industries. Some industries may expand or edit points, for example, organism handling.

One thing to note: these are not depictions of informatics systems but of lab functions devoid of software considerations. A given software application may cover multiple areas totally or partially. It is up to you to decide how to partition functions and deal with overlapping service offerings. Some might be specific to one lab, and others, such as inventory control, address the needs of several labs.

Figure 3 — Laboratory procedures management

Figure 4 — Experiments and testing. These are descriptions of activities without considering whether they occur in research or service labs. In an implementation devoid of software, it doesn’t matter, but a distinction would be created if the lab used an electronic lab notebook (ELN) or laboratory information management system (LIMS).

Figure 5 — Inventory control, as noted earlier, may be within one lab or span the needs of a multi-lab facility. Some functions, such as sample locations, could be duplicated in an ELN or LIMS

Figure 6 — Laboratory safety functions. Lab personnel should be aware of what these items are, how they are to be used, and how to test if they are functional (this may be a facilities management responsibility)

Figure 7 — Lab Management functions

The inspection guidelines will vary by industry. For example, pharmaceutical and biotech industries are thoroughly covered by the FDA, an organization that has the authority to bring research and production operations to a halt if serious issues are encountered. Stopping the production of a pharmaceutical plant is a significant occurrence. Once the problem has been corrected, the plant may require cleanup to bring it back to normal operating conditions. Other industries, such as independent testing labs in the environmental sector, may be affected by regulations, standards, and guidelines from the EPA and ISO, with inspections performed by the A2LA. While listing organizations and their guidelines, a given industry or lab may be affected by requirements from multiple groups. The policies cover the same materials for many issues, but you should be aware that unique needs can exist. The following table will show the responsible agency and reference documents for guidelines. Note that some documents focus on the audit/inspection process rather than the requirements of the full guideline.

The analysis of problems uncovered during inspections comes largely from industries covered by the FDA and its guidelines in Form 483 letters[4] sent to organizations. These can cover all aspects of a company’s operations, though as noted earlier, enforcement is usually confined to production operations and potential products being considered for clinical trials. A recent (2022) American Pharmaceutical Review article[5] asks: “Why are the top 10 FDA Form 483 issues mostly the same for the past twenty-three years? What is/are the cause(s)?” Among the problems this article uncovered for lab operations are:

Beyond that, the article notes that many of these failures are the result of the inadequate application of technologies. The author notes “many small firms are still paper-based and do not have the necessary money and technology to analyze process and analytical data in such a way that allows for proactive responses to trends.”

A second article entitled “Data Integrity: 2020 FDA Data Integrity Observations in Review”[6] discussed failures of data integrity, an important topic over the last few years. Among the concerns it covers are:

While the points above we specifically addressed within the pharma/biotech industries, there is no reason to assume that they are limited to those fields. The same problems can likely be found in any industry. Analysis of Form 483s is often done because of the importance of the information they contain, and their availability through the Freedom of Information Act with some redactions.

Within the realm of guidelines covered in this piece, the dominant activity within the lab is testing and activities that support service laboratory operations. The service lab is common in most industries. The details of sample types and testing will vary, but the operational behavior will be the same and will work like this:

LIMS are designed to carry out this work and have facilities to solve many of the issues noted as failures in the previous section. For example, if you look at the elements discussed under the topic of data integrity, the top four bullets shouldn’t occur. LIMS do not let you delete data although data can be edited. If it is edited, a reason must be given for the change, who made the change must be documented, and when the new data is entered it shouldn’t overwrite the old data but be maintained as part of an audit trail. If questions arise about changes to data, the history is preserved within the LIMS. Many of these problems can still occur with spreadsheet implementations of sample tracking, but a LIMS installation will avoid any of these issues.

LIMS often have built-in document management facilities, so documentation loss is prevented, and the material is easily searched. Documentation of tests and exception reporting is also a feature of LIMS. A specific program to support stability testing, one of the failure points noted, can be incorporated as part of the software.

The introduction of laboratory informatics can streamline lab operations by providing a single point of access to look up documentation, procedures, schedules, test requirement, test results, trends in data, flagged out-of-spec samples, and so on. It can end the paper chase in lab operations.

[1] https://ASTM.org/

[2] https://usp.org/

[3] https://wwepa.gov/sites/default/files/2013-09/documents/glpstudyrejection.pdf

[4] Form FDA 483, “Inspectional Observations,” is a form used by the FDA to document and communicate concerns discovered during these inspections

[5] Lynn, J., “A Discourse on Pharmaceutical cGMP FDA Form 483 Trends: Why are We Re-Living the Same Issues Over the Last 23 Years?”, American Pharmaceutical Review, Volume 24 Issue 4, May/June 2022, pgs 72- 78

[6] https://wwamericanpharmaceuticalreview.com/Featured-Articles/565600-Data-Integrity-2020-FDA-Data- Integrity-Observations-in-Review/

How to Explain blackpool removals to Your Grandparents

Harnessing Informatics for Effective Lab Inspections and Audits

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