Columns | Column: Focus on Quality

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.

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 it be simplified?

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?

Are the integrated Analytical Instrument Qualification (AIQ) and Computerized System Validation (CSV) new approaches to the qualification and validation of laboratory systems, or are they more of the same?

The publication of a new FDA compliance policy for pre-approval inspections (PAIs) introduces a new objective to inspect research and development in pharmaceutical development. We explore how this could influence the PAI process now.

Now that the draft FDA guidance on computer software assurance (CSA) is out, we can see what it is—and is not.

A look at two ICH draft publications reveals that the EWG has much revision work to do for these publications to fully cover the validation lifecycle process.

It is traceability that shows that the ALCOA criteria does not exist in individual silos, but that they all interact with and are dependent upon each other.

We continue our explanation of the new PIC/S data guidance.

In the first article of a two-part series, the new PIC/S guidance is discussed, with particular focus on the scope, data governance, and paper records.

Computerized system validation (CSV) has an uninspiring reputation for being a slow, no-value-added activity that only wastes time and delays the implementation of new software. Is that an accurate portrayal? And is it a necessary evil?

“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.

The calibration and qualification of analytical systems is a journey, not an event.

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. That work can be very expensive—far exceeding the cost of ensuring compliance in the first place.

Spreadsheets are often used to perform GMP-related calculations, but can lead to serious problems and unnecessary risk. We explain why the use of spreadsheets is heavily discouraged in a regulated laboratory environment.

When using infrared (IR) instruments in a regulated laboratory, it is essential to conduct meaningful performance qualification (PQ) tests to maintain compliance.

The Food and Drug Administration (FDA) has issued an updated version of its Compliance Policy Guide for Pre-Approval Inspections (PAI). This article will guide you on this policy’s impact on analytical procedures and data included within regulatory submissions.

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.

Analysis of FDA Form 483 observations and warning letters for infrared spectrometers reveals a range of data integrity problems and a lack of laboratory procedures for the technique. Is your laboratory in the same situation?

In the current data-integrity–centric world, is outsourcing your spectroscopy work a good idea? To answer this question, one must consider several factors.

Regulatory definitions can be confusing at all levels. In this article clear definitions of raw data are clarified and compared. A discussion of static and dynamic data is given along with a detailed summary of the impact of these terms on raw data.

The password paradox states that simple passwords are simple to remember but easy to break, but complex passwords that are difficult to hack are also difficult to remember. Is there a better way?

Does a one size fits all data life cycle meet laboratory requirements for data integrity? No! The reason is that there are many different types of analytical procedures and this requires a flexible analytical data life cycle.

We live in a new world where users must specify what they want their analytical instruments to do. This discussion will help you figure out how to make sure you get what you need.

Good practice (GxP) regulations require an instrument maintenance and use log. Have spectroscopy laboratories and software suppliers emerged from the Middle Ages yet?

It has been 20 years since 21 CFR 11 came into effect. And with increased emphasis on data integrity, an audit trail is essential for spectroscopy software. Why then do many audit trails fail to meet regulatory requirements?

The new version of United States Pharmacopeia general chapter “Analytical Instrument Qualification” became effective August 1, 2017. What does this mean for you?

Data integrity requires a multilayered approach that runs throughout a regulated organization. Here we discuss the laboratory level.

Data governance requires a multi-layered approach that runs throughout a regulated organization from top to bottom.  Although data governance features in the majority of GxP data integrity guidance documents, the approach to the topic should be business-driven rather than regulatory-driven.

Raw data is a term that is often used in both good manufacturing practice (GMP) and good laboratory practice (GLP) laboratories but can create confusion and misunderstanding.  What exactly does it mean and what records are within the scope of the term?

In April 2016, the FDA issued a draft guidance for industry on data integrity and compliance with cGMP. What does this mean for the laboratory?

Data integrity is currently the hottest topic in regulated laboratories. Understanding what constitutes data integrity and the interactions between the layers is the challenge to ensure that data are accurate, correct and complete. Are you up to the challenge?

Some parts of the FDA’s new draft guidance for Development and Submission of NIR Analytical Procedures are reviewed and critiqued. What’s in it for spectroscopists?

A current hot topic in regulated GXP laboratories is data integrity. Recently, the UK regulator issued an industry guidance on this subject that requires the establishment of a data governance system, part of which is data integrity training. Easy to say, but how do you do it?

A proposed update to USP on Analytical Instrument Qualification (AIQ) has been issued for public comment. Here, we identify the changes that are proposed and their impact on the AIQ process of analytical instruments and laboratory computerized systems.

This month we discuss ISO Guide 80, "Guidance for the In-House Preparation of Quality Control Materials." This practical guide is worth reading, and its contents should be compared with your current working practices. In addition, we look at options for the preparation of working solutions from stock solutions to see the errors that could occur.

The European regulations on good manufacturing practices (GMPs) - Annex 11 - are having a strong influence on good laboratory practice (GLP) and good clinical practice (GCP).

The European regulations on good manufacturing practices (GMPs) - Annex 11 - are having a strong influence on good laboratory practice (GLP) and good clinical practice (GCP).

Recently, regulators in both the United States and United Kingdom issued guidance concerning laboratory data integrity that followed serious noncompliances found during inspections. Here, we explore what this guidance means for spectroscopy systems used for analysis in regulated laboratories and derive some common-sense guidance that you can follow.

A closer look at the U.S. Pharmacopeial Convention's (USP) draft general chapter <1029> on good documentation practices.

A review of the United States Pharmacopeial Convention (USP) stimulus paper on the revision process to adopt quality-by-design principles for the development, validation, and operation of analytical procedures used for good manufacturing practice (GMP) analysis - and how it compares to a draft guidances by the Food and Drug Administration (FDA) for industry on validation of analytical and bioanalytical procedures.

When a laboratory - particularly a regulated GxP laboratory - contemplates using the cloud, finding a suitable supplier is critical

A risk assessment helps determine the amount of qualification and validation work necessary to show that instruments and computerized laboratory systems are fit for their intended purpose. Here's how to do it.

In pharmaceutical contract manufacturing, the work of analytical scientists is covered by a quality agreement, which is prepared by personnel in the quality control or quality assurance department and focuses on the laboratory analyses provided. But what exactly are quality agreements, why do we need them, who should be involved in writing them, and what should they contain? Here, we answer those questions.

A look at what the requirements are for "complete data" for laboratories working under the FDA GMP regulations. We also review the observations listed by inspectors on 483 forms from 2006 to 2012, to assess the common mistakes companies make.

Answers to common questions about operational qualification (OQ) software

A look at how the term commercial off-the-shelf can be abused in marketing literature.

Guidelines for writing standard operating procedures in a laboratory and best practices for their use.

A discussion of the various options for cloud computing, avoiding the marketing hype and focusing on the potential advantages and disadvantages for your laboratory

Here's what needs to be done to harmonize these two documents.

Continued discussion of the periodic review process, including how to conduct a review, the use of checklists, and reporting the outcome

Annex 11 to the EU's updated GMP regulations calls for periodic re-evaluation of computerized systems. This is what you need to know about the new rules.

The revisions to GMP Annex 11 are examined in terms of the impact on computerized spectrometry systems operating in regulated GMP laboratories.

Where is the dividing line between a simple mistake and falsification?

It is just over two years since USP <1058> on Analytical Instrument Qualification (AIQ) became effective. To coincide with the American Association of Pharmaceutical Scientists (AAPS) Meeting in New Orleans this month where a roundtable discussion on the subject will be held, here are my views.

How good is documentation supplied by a vendor to support the qualification of an instrument or the validation of a laboratory computerized system?

Bob McDowall looks at the different life cycle models that apply in the laboratory to GAMP software categories 3, 4, and 5.

Getting the best business value from a spectrometer requires knowledge of the instrument and its operating abilities, any attachments, the sample including sampling procedure and presentation, and the software. All of these elements must be pulled together by a skilled and knowledgeable spectroscopist. Unfortunately, this is not always the case in many organizations.

The new FDA Commissioner wants a strong FDA and is backing her words with action by initiating a program that cuts the time that firms must respond to 483 observations from 30 to 15 business days. Not only is the time halved but the response must be complete. Therefore it is better and cheaper to be compliant than not.

The GAMP (Good Automated Manufacturing Practice) guide version 5 was released in March 2008 and one of the changes was that the classification of software was revised - again. This column will look at what the changes mean for the laboratory and whether all of these should be implemented.

In this column, Bob McDowall discusses the impact of USP general chapter 1058 on the spectroscopy laboratory.

The second part of this column series on traceability matrices looks at some of the practical ways of tracing requirements from the user requirements throughout the life cycle documents.

Tracing requirements from a user requirements specification throughout the life cycle is not only a very effective business tool to save time and effort in validation projects but also a regulatory expectation. This first installment of a two-part column series looks at the principles of a traceability matrix.

Columnist Bob McDowall discusses the role of a validation master plan (VMP) for summarizing a laboratory's approach to computer validation.

In this "Focus on Quality" column, we will look at the overall GMP changes and then ask the following question: Why has the laboratory not been included in the proposed changes?

Paper is easy to archive, but what about archiving electronic records? What do you do with all the electronic records that are generated? In this month's installment, columnist Bob McDowall explores the issue of electronic records management and looks at the recent guidance issued by the OECD for GLP laboratories.

Using information provided by guidance documents from outside the spectroscopy laboratory can be very useful when trying to meet the regulations that we must follow.

Columnist Bob McDowall discusses operating system security patches.

Columnist Bob McDowall discusses the use of audit trails in the software applications used to control spectrometers that acquire, interpret, and report results from analyses. An effective audit trail is imperative to ensure the integrity of the data and the conclusions reached by the spectroscopist.

Columnist Bob McDowall takes an NIR spectrometer through the process outlined in his November column, in which he suggested an integrated approach to equipment qualification and computerized system validation for spectroscopy systems.

Columnist Bob McDowall proposes an integrated approach to the combined issue of equipment qualification and computerized system validation for spectrometers that combines the qualification, day-to-day calibration, and maintenance of the instrument with the validation of the software for a system?s intended purpose.

A simplified risk analysis methodology is needed for the validation of commercial software used in the regulated laboratory. In this column, the author takes a look at two alternative approaches.

This month's "Focus on Quality" presents a critique of the GAMP Good Practice Guide. And while columnist Bob McDowall finds much to recommend in the guide, he finds much more cause for concern.

Accurate and precise time and date stamps are critical to ensuring integrity of the data and results generated by each computerized system used in any spectroscopy laboratory.

The author continues his discussion of the principles involved in the backup and recovery of electronic records. This installment looks at the written procedures associated with this process for a spectrometer operating in a regulated laboratory.

Part IX of the series discusses backup and recovery, which are essential to the process of ensuring data security and integrity.

Part VIII of the series covers change control and its importance in maintaining a system's validation status.

This column discusses training and system documentation, and how to write a validation summary report.

The author discusses how to identify some of the performance qualification tests to apply to spectrometry software, how to write the test procedures and instructions, and how to execute the actual testing.

This installment of the ongoing series discusses performance qualification of software in regard to system requirements.

An installment of the Focus on Quality column.

Part three in the author's ongoing series about validating spectrometry software.

Columnist R.D. McDowall discusses the process of validation of spectrometry software.