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Spectrometers have to be fit for their intended use; however, regulators separate analytical instrument qualification from computerized system validation. We critically review the qualification and validation approaches in the World Health Organization Technical Report Series (WHO TRS) 1019 Annex 3 and its applicability to spectrometer systems., In December 2023, the Indian Good Manufacturing Practices (GMP) and Requirements of Premises, Plant and Equipment for Pharmaceutical Products regulations (Schedule M) were revised, with Section 12 stating: The guidelines [...]

INTRODUCTION It is widely accepted that health-related social needs (HRSN), such as food, housing, and transportation, play a critical role in overall health and wellbeing. (1,2) The COVID-19 pandemic amplified [...], PURPOSE Efforts during the COVID-19 pandemic to address the health-related social needs (HRSN) of Medicare and Medicaid beneficiaries, such as food and housing, were insufficient. We examined HRSN data from the Accountable Health Communities study collected in Oregon to understand changes in these needs at the onset and during the first 2 years of the pandemic. METHODS We conducted an interrupted time series analysis with data from 21,522 Medicare and Medicaid beneficiaries screened for overall HRSN between May 13, 2019 and December 24, 2021. Secondary interrupted time series analyses were conducted for each type of HRSN assessed with the Accountable Health Communities screening tool: food, housing, transportation, utilities, and interpersonal safety. RESULTS The interrupted time series analysis indicated an abrupt 17.7-percentage point increase in overall HRSN around March 23, 2020, which did not significantly decline during the subsequent 2 years. Food, housing, and interpersonal safety needs increased by 16.5, 15.9, and 4.4 percentage points, respectively, with no significant decline thereafter. Transportation and utility needs increased by 7.2 and 7.5 percentage points, respectively, but decreased significantly after the start of the pandemic (decreasing by 0.2 and 0.1 percentage points each week, respectively). CONCLUSIONS The jump in HRSN following the start of the pandemic and the persistence of need, particularly in food and housing, highlight the importance of research to better understand which public health and health care interventions, investments, and policies effectively address HRSN.

Data process mapping is an effective way to identify data integrity vulnerabilities and remediate them. A modified example published by the Active Pharmaceutical Ingredients Committee (APIC) is reviewed critically. Can [...]

The updated version of United States Pharmacopoeia (USP) general chapter Chromatography has changes that impact chromatography parameters. In this column, we look at the current version and the update of USP on high performance liquid chromatography (HPLC) that becomes effective 1st May 2025. Do you fully understand the changes and how they will impact your laboratory?, CHROMATOGRAPHIC ANALYSIS IN regulated Good Manufacturing Practice (GMP) laboratories is under the control of pharmacopoeial general chapters. These should define the qualification parameters for instrumentation and System Suitability Test (SST) [...]

The United States Food and Drug Administration (FDA) is using Remote Interactive Evaluations (RIE) to assess regulatory compliance, review submission material, or determine the timing of future inspections. Here, we look at some of the impacts of RIE on GxP laboratories. Although RIE is voluntary, is this an offer that you cannot refuse?, Since the pandemic, changes have occurred in the regulatory oversight of GxP laboratories because of travel restrictions or country access. Instead of an inspection (physical entry to a facility) via [...]

Tired of life as your analytical results are always out of specification (OOS)? Fed up with yet another laboratory investigation? Get those rotten chromatograms to generate passing results by learning ways to manipulate peak integration from the experts... and now I have your undivided attention... and how reviewers, quality assurance (QA), and inspectors can detect them!, HOW A CHROMATOGRAPHY data system (CDS) can be involved in data falsification in regulated good practice (GXP) environments is public knowledge since the 2005 Able Laboratories fraud case (1). Chromatograms [...]

Computerized System Validation (CSV) is usually associated with great mountains of paper (GMP). Why should this be the case? Ask yourself, am I lazy? Why write multiple documents if only one is required to validate a spectrometer with a simple intended use? Interested? Read on..., Today's the day you have been waiting for! Your brand-new UV-visible (UV-vis) or infrared (IR) spectrometer and controlling software is due to arrive in your regulated laboratory. The instrument's location [...]

In her review of Thomas Clerc's study of the 18th arrondissement (December 20 and 27), Marie Darrieussecq identifies an immediate precedent for his work as that of Georges Perec, who, [...]

A new revision to the U.S. Food and Drug Administration (FDA)'s Compliance Program Guide for Pre-Approval Inspections (PAIs) has added a fourth objective: Commitment to Quality in Pharmaceutical Development. PAIs are going to be very interesting now....., Spectroscopists usually consider chromatography as sample cleanup for their analysis. However, all spectroscopists working in regulated laboratories are living with the fallout of the 2005 fraud perpetrated by the chromatographers [...]

The time has come for Canadians to re-envision Sir John, not by grandly reinstalling him atop a plinth but by placing him on the scales of our national history and [...]

Prehistory comprises millions of years and encompasses a diverse range of social, cultural, economic and technological practices. Despite its widespread public popularity, understanding of the chronology and developments of this vast expanse of human history is frequently anachronistic. Here, the author uses the results of museum visitor questionnaires and tracking surveys to assess public preconceptions of prehistory and engagements with museum displays. In addition, the article documents and explores 173 prehistory displays in museums in England, identifying trends in representation. The results point to some significant representational disparities affecting the display of prehistory and highlights some opportunities for reimagining museum prehistory displays. Keywords: prehistory, museums, representation, evaluation, display, visitor engagement, Introduction The temporally extensive and distant nature of prehistory reduces its relatability and accessibility for the general public. In this context, museums are highly influential in shaping how the public [...]

Computerized system validation (CSV) in good practice (GxP)-regulated laboratories is alleged to take ages and generate piles of paper to keep inspectors and auditors quiet. To the rescue is the [...]

Nick MacKinnon (Letters, November 8) offered an example of an inter-racial alien 'abduction'. More broadly, UFO hysteria has tended to be treated as a primarily US-based phenomenon. But Europe had [...]

After the shocking economic collapse of 1929, John Maynard Keynes caustically observed that world leaders had 'no cat in the bag, no rabbits in the hat, no brains in the [...]

Good analytical science and ensuring data integrity requires that analytical procedures should be validated for their intended use (1,2). In addition, the applicable US Federal Drug Administration (FDA) Good Manufacturing [...]

Confused from Quality Control (QC) writes, 'Doctor, Doctor, give me the news! Originally, it was just ALCOA criteria for data integrity, then a plus was added, but now its ALCOA++. What should I do? Help me please!', Well, Confused, the good news is that the doctor is in and can help you unravel the delights and joys of ALCOA and its two offspring. We will trace the [...]

The US was not alone in casting poor posture as an undesirable sign of inferior breeding. At my boarding school in the 1960s, slouching in the dining room occasioned a [...]

The new PIC/S data guidance document PI-041 was published in July 2021. This column is the second part of a review looking at the expectations for computerized systems, outsourcing, regulatory [...]

On 12 December 2019, a novel coronavirus was detected in Wuhan, China. In the following weeks the disease later called COVID?19 rapidly spread through the community and around the world. [...], : Objective: To analyse the implicit discourses within the COVID?19 policy response for Aboriginal and Torres Strait Islander remote communities. Method: This paper uses Bacchi's ?What is the Problem Represented to Be? framework to analyse the Emergency Requirements for Remote Communities Determination under Subsection 477(1) of the Biosecurity Act 2015 (Cth). Results: Despite the leadership of community?controlled health services and regional councils, and the actions of Aboriginal and Torres Strait Islander communities, the policy response constructs Aboriginal and Torres Strait Islander people as vulnerable and mobility as a problem that needs a law and order response. Conclusions: The policy response perpetuates an ongoing paternalistic discourse where Aboriginal and Torres Strait Islander people must be controlled for the sake of their health, informed by notions of Indigeneity as deficient. This stands in contrast with the work of community?controlled health organisations, advocacy by Aboriginal and Torres Strait Islander people for and against restrictions, and examples of communities protecting themselves. Implications for public health: Unilateral government intervention creates limiting discourses of Aboriginal and Torres Strait Islander people. In contrast, ongoing COVID?19 responses can build on the strengths of and work done by Aboriginal and Torres Strait Islander families, leaders, and communities.

The new PIC/S data guidance document was published in July 2021. The guidance will be reviewed in two parts, starting with the scope, data governance, and paper records. Blue whales [...]

The U.S. Food and Drug Administration (FDA) has a new approach to computerized system validation (CSV) called computer system assurance (CSA). Without a draft guidance issued, are we entering an [...]

'SneakerNet,' or the manual transfer of data using a disk or USB stick from one computer system to another, should be long dead, but this noncompliant transfer process still survives. In this edition of 'Focus on Quality,' we discuss why SneakerNet should be consigned to the graveyard of technology., Walk through any laboratory and you'll see a variety of spectrometers with their own data systems to control the instrument, to acquire and process data, and then report the results. [...]

Presenters Anne King, MBA, Zoe Major-McDowall, Zoe Rothberg, Cullen Conway, MPH, Lisa [...], Context Over three years, 50 Oregon clinical practices and a staff of researchers screened 24,828 patients for social needs as part of the Accountable Health Communities Model supported by the Centers for Medicare and Medicaid Services of the U.S. Department of Health and Human Services. Screening took place within clinics, by telephone, and by text. Objective To compare the rate of screening completion using three administration methodologies: in-person in clinical settings, by telephone, and by text. Study Design and Analysis This observational study aimed to understand the effectiveness of the three approaches to screening. Clinical sites selected their administration methodology, and data were collected on the number of surveys offered and completed by patients. Analysis was conducted using the statistics software package R. Sites 50 clinical sites across the State of Oregon Population Studied Medicaid and Medicare members Setting For clinic-based screening, subjects were screened onsite in a clinical setting. Telephone and text screening were conducted using the patients' cellular phone numbers. Intervention/Instrument The data collection tool is the Accountable Health Communities Health- Related Social Needs Screening Tool which includes questions on living situation, food, transportation, utilities, interpersonal safety, income, sex, race, ethnicity, and educational attainment. Outcome Measures The proportion of patients completing the screening via each of the 3 methodologies. Results Of the 15,657 patients offered a screening in a clinic 70% completed the screening. Of the 17,970 patients offered screening over the telephone 47% completed the screening, however only 24% of telephone calls were answered. Finally, of the 9,182 patients who viewed the offer of screening in a text 68% completed the screening, however only 7% of texts were opened. In person and telephone screening administration took similar amounts of time. Texting took the least amount of time to administer at only seconds a text. Conclusions Screening in the clinical setting offered the highest response rate, however, clinics found it challenging to fit screening into their workflows. Telephone and text screening, while less effective, might be considered as part of a multi-modal approach to screening for social needs.

The need to calibrate and qualify analytical instruments and systems is well recognized in laboratories. However, calibrating and qualifying analytical instruments and systems are seen as discrete tasks. There is an increasing regulatory expectation that a risk-based life cycle approach is necessary to ensure 'fitness for purpose' as part of an analytical procedure. The calibration and qualification lifecycle of analytical instruments and systems is a journey and not a sequence of disconnected events., This article describes the principal stages of the lifecycle in both GXP or ISO/IEC 17025 laboratories that ensure that any analytical instrument and system is 'fit for its intended use' [...]

Two recent warning letters show that the US FDA is substantially increasing the amount of remediation work it requires for companies to correct data integrity noncompliance. Understanding the large cost to fix noncompliance is vital to convince laboratories and executive management to be compliant rather than to wait for an inspector to find problems., English is hopeless as there is no word for it. Spanish? Nope. French? Forget it. Chinese? Not a clue. In contrast, German has the word for it. What is it? [...]

Universally available on desktop computers, easy to use, and universally loved by analytical chemists, spreadsheets are used to collate lists of instruments and perform a multitude of calculations in many regulated laboratories. But spreadsheets also present an auditing and inspecting opportunity to find abundant instances of noncompliance and can lead to problems and unnecessary risk. Why is the use of spreadsheets heavily discouraged in a regulated laboratory?, If you turn on any workstation in your laboratory, you will probably find a shortcut to a spreadsheet program. When presented with this icon of temptation and seduction, a willing [...]

Life moves on, and this is reflected in the shifting focus of data integrity issues during regulatory inspections. Much of the original focus during inspections was on shared-user identities, conflicts [...]

Chromatography Data Systems (CDS) have been at the center of multiple FDA 483 citations and warning letters since the Able Laboratories fraud case in 2005 (1). Between 2005 and 2015, [...]

Over the past three months, as coronavirus or COVID-19 has spread from China around the world, many counties have engaged in various forms of lockdown, social distancing, or travel restrictions [...]

Performance qualification (PQ) tests are a vital component of the steps regulated laboratories do to maintain compliance. Therefore, it is essential to understand and apply meaningful PQ tests. However, what does PQ mean in practice for infrared (IR) instruments? The answer may surprise, or even horrify, you., In last September's 'Focus on Quality' column, we presented an analysis of FDA 483 observations and warning letters for infrared instruments and analysis (1). In this article, we are returning [...]

Accurate analytical analysis requires robust and validated analytical procedures. Change is underway in the approach to developing, validating, and using analytical procedures. Are you ready for the changes coming your [...]

I was most interested in John Fuller's 'Theme and variations on the opening sentence of Pride and Prejudice' (December 22/29). Might I add one more? Susan Ferrier's novel The Inheritance [...]

Edward N. Luttwak's assault on UNRWA (Letters, January 12) seems driven equally by animus and ignorance. The settlement of the Palestinian refugees should obviously have been in the homes from [...]

Audit trail review is a key component of the second person review of chromatographic analysis for compliance with regulations, procedures, and analytical science. We focus on what the review of [...]

Hybrid CDS applications are pervasive in analytical laboratories. However, they are the worst possible solution because you must synchronize and manage two incompatible data formats: paper printouts and electronic records. [...]

The U.S. Food and Drug Administration (FDA) recently issued an updated version of its Compliance Policy Guide for Pre-Approval Inspections (PAI). If you are not aware of the impact on analytical procedures and data included in regulatory submissions, then please read on., One of the U.S. FDA's Compliance Program Guides (CPG), numbered 7346.832, is entitled Pre-Approval Inspections. This document is used to guide and inform inspectors conducting this type of inspection before [...]

Data integrity has been the subject of many 'Focus on Quality' columns over the past few years (1-5). However, we have never mentioned, let alone discussed, data quality. In many [...]

This is the ninth article in a series on data integrity focus in the regulated chromatography laboratory (1-8), and there was also a six-part series on data integrity in 2018 [...]

Since the Able Laboratories data falsification case in 2005 (1), there has been a regulatory focus on the lack of data integrity with chromatography data systems. This scrutiny has focused [...]

In the first seven parts of 'Data Integrity Focus,' we have focused on a few elements of data integrity (1-7). In this part, we will look at an essential requirement [...]