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The article presents a summary of what the author wrote 30 years ago about data integrity. He discusses the aim of the first column which was to consider data integrity within an automated chromatography laboratory, sample labels and other disasters, and analytical instrument qualification. Also mentioned are blank forms and master templates and laboratory information management systems (LIMS) projects and data integrity.

The term orphan data is used frequently in the context of data integrity. What does it mean for chromatography data systems? How can we prevent or detect orphan data? [ABSTRACT FROM AUTHOR]

What do the draft publications ICH Q2(R2) and Q14 for analytical procedure validation and development mean for a regulated good manufacturing practice (GMP) laboratory? Are they consistent with the approach taken by the United States Pharmacopeia (USP) <1220> on Analytical Procedure Life Cycle? Why does it take the ICH two documents to describe what the USP can do in one? [ABSTRACT FROM AUTHOR]

A balance printout is a fixed record, and is also called static data. But how static are static data when the weight is used in a chromatographic analysis? Also, have some regulatory data integrity guidance documents failed to comply with their own regulations? [ABSTRACT FROM AUTHOR]

Qualification and calibration of high performance liquid chromatography (HPLC) chromatographs is a regulatory requirement, but how proscriptive should guidance be? [ABSTRACT FROM AUTHOR]

In September the World Health Organization (WHO) issued a new guidance document on Good Chromatography Practices. What guidance does it contain and is it useful? Has the document failed its system suitability test (SST) acceptance criteria? [ABSTRACT FROM AUTHOR]

In September the World Health Organisation (WHO) issued a new guidance document on Good Chromatography Practices. What guidance does it contain and is it useful? Has the document failed its SST acceptance criteria?. [ABSTRACT FROM AUTHOR]

This article uses case studies to explore the use and misuse of spreadsheet calculations in conjunction with a chromatography datasystem (CDS) in regulated GXP laboratories. What wonders of non-compliance will we find? How and when should spreadsheets be used in chromatographic analysis?. [ABSTRACT FROM AUTHOR]

One of the biggest failures with purchasing chromatograph systems and chromatography data system (CDS) software is either the total lack of or poorly written user requirements. So, how can you write acceptable requirements? Is specifying a chromatograph the same as software?. [ABSTRACT FROM AUTHOR]

Chromatographic peak integration continues to be a major regulatory issue and was first discussed in this column in 2015. Is the approach to manual intervention and manual integration outlined still acceptable in the light of regulatory citations and guidance documents published since then? [ABSTRACT FROM AUTHOR]

This is the final part of a trilogy looking at the impact of the new USP <1058> on analytical instrument qualification (AIQ) on data integrity in a regulated chromatography laboratory. This part will focus on the performance qualification (PQ) portion of the 4Qs model and, specifically, monitoring and requalification of chromatographs. [ABSTRACT FROM AUTHOR]

This is the second of three articles looking at the impact of the new United States Pharmacopeia (USP) <1058> on analytical instrument qualifi cation (AIQ) on data integrity in a regulated chromatography laboratory. This part focuses on how the laboratory should supervise the execution of operational qualifi cation (OQ) protocols by a third-party service provider. The principles described also apply to in-house metrology departments. [ABSTRACT FROM AUTHOR]

This is the first of three articles looking at the impact of the new United States Pharmacopeia (USP) <1058> chapter on Analytical Instrument Qualification (AIQ) on data integrity in a regulated chromatography laboratory. In part 1, user specifications for chromatography systems and the relationship between users and suppliers will be discussed. [ABSTRACT FROM AUTHOR]

The article examines the essential of accurate data acquisition as component of data integrity. Application of component to a chromatograph and a chromatography data system (CDS), is highlighted. An overview is also provided on the proper setup of an instrument and function test of the system suitability for electronic records protection and electronic signatures validation.

The article presents questions and answers related to the revision of the U.S. Pharmacopeia (USP) general chapter, including reason behind revision of USP, the importance of instrument qualification, and poor software validation guidance.

The authors discuss metrics for monitoring data integrity within a chromatography laboratory, from the regulatory requirements to practical implementation. [ABSTRACT FROM AUTHOR]

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

One of the common threads in the six data integrity guidance documents published to date is the need to control any blank forms used in regulated GXP laboratories. This month's "Questions of Quality" is focused on how to interpret the regulator's requirements for this topic. We also pose the question: Is paper the best way to record regulated data? [ABSTRACT FROM AUTHOR]

In the world of data integrity, the focus is typically on the data and the numbers. How can technology, such as a laboratory information management system (LIMS), help to ensure data integrity? [ABSTRACT FROM AUTHOR]

This article describes the prospective validation of a chromatography data system used for quantitative Good Laboratory Practice studies within a contract research organization. An outline of the overall process and the documentation produced to support the data system validation is presented. [ABSTRACT FROM AUTHOR]

The article focuses on the use of primary record in Good Manufacturing Practices (GMPs) in Great Britain. Information about the issuance of data integrity guidance from drug regulator Medicines and Healthcare products Regulatory Agency (MHRA) in 2015, is provided. Also highlighted is the complete information in GMPs of U.S. Food and Drug Administration (FDA).

A question that keeps raising its head when working in a regulated laboratory is can chromatographers integrate peaks manually? If they can, when can they do it? Also if they can manually integrate, when should they not do it? [ABSTRACT FROM AUTHOR]

What does risk assessment in the context of the life cycle of a high performance liquid chromatography (HPLC) instrument really mean? This instalment of "Questions of Quality" will look at problems with an operational liquid Chromatograph to see if they can be picked up in the performance qualification (PQ) or prevented in the operational qualification (OQ). The relationship between PQ and OQ and the design qualification (DQ) phases of the life cycle are also explored. [ABSTRACT FROM AUTHOR]

Chromatography data systems (CDSs) have had a starring role in many regulatory citations involving falsification and fraud in analytical laboratories regulated by Good Manufacturing Practices (GMP). In this instalment of "Questions of Quality" we will examine the citations and identify the technical and procedural controls required to ensure data integrity within these systems. Although focused primarily on the pharmaceutical industry, the principles described here are applicable to all laboratories working to established quality standards [ABSTRACT FROM AUTHOR]

The article looks at paper versus electronic records in the context of complete data under the U.S. Food and Drug Administration's (FDA) Good Manufacturing Practice (GMP) regulations for quality control (QC) laboratories in the U.S. It considers whether complete data includes the electronic files generated from a chromatographic analysis or just the signed paper printouts. The requirements for complete data for laboratories working under the FDA GMP regulations are highlighted.

US Good Manufacturing Practice (GMP) regulations for quality control (QC) laboratories require that laboratory records shall include complete data derived from all tests. We will explore what is meant by "complete data" in the context of a chromatography data system and, with an analysis of the United States Food and Drug Administration (FDA) 483 citations, explore the problems when a laboratory fails to understand this phrase. We will also consider if complete data includes the electronic files generated during the course of a chromatographic analysis or just the signed paper printouts. This is the first in a two-part column and in the second part we will look at paper versus electronic records in the context of complete data, what happens when things go wrong, and what is the European approach. [ABSTRACT FROM AUTHOR]

The article discusses the importance of software operational qualification standards given by recognized organization for validation of software system for results of the chromatographic methods. It highlights that the recognized organization defines the reference range of different laboratory tests implied for the separation of samples through various chromatographic methods. It also highlights the tests meant for verification of the software validation system for various laboratory tests.

The article offers information on the quality system required for writing procedures of chemical processes. It reports that people who have required education, experience, and training can be called as trained staff member and qualified analysts. It informs that analysts need to follow written protocols which include analytical methods, preparation of mobile phases, and weighing of reference for the conduction of chemical process of chromatography.

The new version of EU GMP Annex 11 has been effective for a year. This update contains some new technical requirements that software must comply with - do your laboratory computerized systems comply with them all? This month's Questions of Quality column looks at the impact of these new regulatory requirements for Good Manufacturing Practice (GMP) laboratories. [ABSTRACT FROM AUTHOR]

The article examines the errors caused by fat finger moments to ensure the integrity of data generated in any chromatography laboratory. It emphasizes that fat finger can be made either on paper or electronically by an analyst. It stresses that errors cause by fat finger moments are normal and cannot be avoided. It stresses that to reduce such errors, there is a need to use software to capture and transfer data automatically and eliminate the manual entry of data.

This column revisits the topic of raw data and electronic records for a chromatography data system (CDS) in light of recent updates in regulations and guidance issued by regulatory agencies and industry bodies. We look at the ways to define what raw data are for a CDS and pose the question: Is it still possible to define paper records as chromatographic raw data? [ABSTRACT FROM AUTHOR]

The article discusses the role of the performance qualification (PQ) in analytical instrument qualification (AIQ). It states that the PQ shows that chromatograph remains qualified and will performs as specified by users in chromatography laboratory. The PQ tests are based on the typical on-site application of an instrument. It also mentions that PQ tests can be modular and focus on a module of a chromatograph.

The author discusses the impact of the Good Manufacturing Practice (GMP) Annex 11 ruling of the European Union (EU) on chromatography data systems (CDSs) in Europe. He states that the 21 Code of Federal Regulations (CFR) 11 legislation requires a CDS to have documentation which is either electronic or photographic. The author expects pharmaceutical companies to urge suppliers to implement corrective actions based on audits of quality management systems.

Part 1 of this article in the July/August issue looked at the regulations and quality standards around system suitability tests (SSTs) and discussed the activities in the data quality triangle. The second part will discuss why SSTs cannot be used for analytical instrument qualification in more detail. [ABSTRACT FROM AUTHOR]

The article discusses the role of system suitability tests (SSTs) in the analytical instrument qualification (AIQ) context and the quality analytical results. The author explores the regulations and quality standards for qualification and calibration of chromatographic instruments including good manufacturing practice (GMP). He explains the ISO 17025 Accreditation, requirements for equipment, and differentiation of GMP regulations and ISO 17025 requirements.

There is a new US Food and Drug Administration (FDA) Commissioner who wants a "strong" FDA and she is backing her words with action by initiating a programme 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 also be complete! Be prepared to be compliant and remain compliant with regulations -- or else. [ABSTRACT FROM AUTHOR]

The article deals with United States Pharmacopeia (USP) on analytical instrument qualification (AIQ) in the U.S. It discusses its impact on the chromatography laboratory. It reveals potential problems with USP. It analysis the difference between positioning AIQ versus other laboratory quality checks.

The article focuses on the similarities and differences between the validation techniques for analytical methods for quality control (QC) product analysis and bioanalysis. It cites that the techniques utilized in the QC laboratory identify if the manufactured product meets its specifications and a wide range of analytical methods can be used, such as chromatography, spectroscopy and traditional wet chemistry analysis. It states that several bioanalytical techniques use solid-phase extraction to separate the analytes from the biological sample.

The article explores the meaning of the term Good Laboratory Practice (GLP). It is a formal regulation that was formulated in 1978 by the U.S. Food and Drug Administration that impacted the pharmaceutical industry. GLP was intended to regulate non-clinical laboratory safety studies to ensure that any new molecular entities developed by the pharmaceutical industry were safe before administration to human volunteers and patients in clinical trials.

The article explores the U.S. Food and Drug Administration inspection of the Able Laboratories Inc. chromatography data system (CDS). It has been mentioned that the issues raised by this inspection and the failure of the quality unit and senior management had been addressed. The agency aims to spot and resolve the issue as it highlights lessons that all chromatographers, laboratory management and quality assurance personnel need to learn to ensure that the issues are prevented from reoccurring.

The article discusses the risk assessment methodology used in the validation of laboratory computerized systems in the U.S. According to the author, the modified Failure Mode Effect Analysis (FMEA) risk assessment methodology has been used in most laboratory systems in the Good Practice Guide. FMEA was originally designed for aeroplane designs and was further developed to cover new designs and process.

Guidance to help validation of computerized systems used within regulated laboratories is always welcome but is it always helpful? In the first part, I present an overview of the Guide, different approach to life cycle validation and system classification. [ABSTRACT FROM AUTHOR]

The article discusses analytical balance, a critical element in chromatography laboratory. Some of the factors that need to be considered when placing and setting up a balance include draughts, temperature effects, electrical and electromagnetic interference, magnetic effects and vibration. The article also explores the importance of calibrating the balance throughout the operating range of the balance used by the chromatography laboratory.

The implementation and validation of a new site-wide chromatography data system for a major active pharmaceutical ingredient custom manufacturer provided the opportunity to map and optimize the GMP and ISO business processes to use electronic signatures effectively. This article describes the process optimization and how it integrates with the validation activities of the system. This overall approach provides substantial business benefits from the use of electronic signatures as evidenced by the savings resulting from process improvement and by the fact that the non-GMP laboratories implemented a similar process to analyse and approve results electronically. [ABSTRACT FROM AUTHOR]

This article focuses on the significance of accurate and precise time and date stamp in the operation of the software application and the audit trail. There are some U.S. Environmental Protection Agency's analyses for which time is a critical issue. The sample must be taken and delivered to the laboratory within six hours. If the sample arrives after this time it must be rejected and a new one taken. Time stamps for stand-alone CDS systems are probably best set and maintained manually. Time and date are important elements of data integrity for all chromatography laboratories, and having accurate and reliable date stamps will give confidence in data produced by a system.

This article deals with the question, what is not a chromatograph but can adversely impact one's chromatographic analyses? Balances are used for precise weighing of substances and, as such, are typically used in most chromatography laboratories. Weight or mass is tricky because the two words are used interchangeably, even in the chromatography laboratory. If the balance is not calibrated correctly, the whole chromatographic run could be rejected or, even worse, the error could remain undetected and an incorrect decision reached based on the wrong results. The best chromatograph running the best chromatography data system with optimum chromatographic separation is worth nothing if the balance is incorrectly calibrated or simply faulty. In truth, everything depends on the analytical balance meaning that both weighing and the correct operation are fundamental to any quantitative chromatographic analysis. There is also a subtle impact on technology transfer of chromatographic methods.

Discusses the current status of 21 CFR 11, the Electronic Records and Electronic Signatures final rule¹, which is applicable to pharmaceutical and other U.S. Food and Drug Administration (FDA) regulated industries. Original request of Part II regulation by the pharmaceutical industry to take advantage of electronic signature technology and reduce paper burden; Publication by the FDA of the draft guidance for the industry on 21 CFR 11: scope and applicability in 2003; Non-withdrawal of 21 CFR 11 with a majority of the regulation to be enforced in spite of various changes made.

Examines the implementation of chromatography data systems (CDS) with electronic signatures. Electronic processes in electronic signatures; Benefits of CDS for the pharmaceutical industry; Availability of compliant solutions in electronic signature implementation.

For the first time in 30 years the FDA has issued an amendment to good manufacturing practice (GMP) that becomes effective from April 2008. This article looks at how these GMP changes will affect chromatographers and QA personnel, and questions why the laboratory has been ommited from these proposed changes? [ABSTRACT FROM AUTHOR]