GOOD LABORATORY PRACTICES PDF

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Good laboratory practice training manual for the trainer: a tool for training and developed a Good Laboratory Practices (GLP) series in , comprising a GLP . PDF | Standards for laboratory investigations; GLP principles are defined by the EC (I) as: “principles of good laboratory practice, that are consistent with the. Good Laboratory Practice (GLP) is a quality system concerned with the organizational process and the conditions under which a study is planned, performed.


Good Laboratory Practices Pdf

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Preface After more than twenty years of use Good Laboratory Practice, or GLP, has attained a secure place in the world of testing chemicals and other “test. towards OPPI Good Laboratory Practices (GLP) Guidelines. Members of Technical Committee, Mr. G.K. Nair, Technical. Advisor, Associated Capsules Pvt. Ltd. All brand names and product names used in this book are trade names, service marks, trademarks A Handbook of Human Resource Management Practice.

More importantly, quality and clients expectations could be compromised.

With hundreds to thousands of specimens moving through a laboratory per day, unclear labeling of FDA GLP compliant studies and corresponding specimens could result in specimens being run under the incorrect set of regulations, thus compromising client expectations.

Based on the small initial number of FDA GLP studies expected, there was not a justified business case for incorporating model one. Therefore, Pacific Biomarkers developed a third model that has allowed for significantly more efficient use of resources and more thorough documentation for all clients.

The two main goals in developing this model was to first maintain a laboratory environment where specimen preservation, high quality testing, quality systems, and efficiency continue to be the priority.

Second, develop streamlined approaches in the non-laboratory departments for incorporating the additional project set-up, result reporting, and quality assurance oversight required for FDA GLP studies. Pacific Biomarkers set up a two pronged approach to address both goals. The technicians were able to focus on executing the testing, instead of trying to determine which set of regulations were needed for a particular batch of specimens. This maintained the streamlined operations Pacific Biomarkers currently employed throughout the CAP production facility, satisfied FDA GLP requirements, and resulted in a higher quality of documentation for all of our clients.

This served two purposes. First, to make a clear distinction to our FDA GLP clients that these documents covered the sample analysis that Pacific Biomarkers was responsible for, not the full study.

FDA GLP regulations require data audits and critical phase inspections QAU observing execution of various procedures during a study whereas CAP regulations require an internal auditing program focused on systems.

Due to the study specific nature of the FDA GLP critical phase inspections, these cannot be used to satisfy the CAP requirements without breaching client confidentiality.

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There are elaborate, highly precise analytical technologies utilising HPLC or enzymatic reactions, there are some semi-quantitative means of roughly estimating glucose levels e. Any of these methods may be performed in a GLP-compliant way, if it were ascertained by the presence of Standard Operating Procedures that the way in which these tests were performed would be standardised to an extent that would make it possible to reconstruct the whole way of obtaining the results.

It is clear, however, that - according to the level of precision required by the scientific purpose of the study - the scientific evaluation, and finally the safety assessment, would reject any study performed with a methodology unable to produce results with the required degree of precision. There may be many more examples to be collected from all kinds of studies: Any of these possible ways of assessing some property of the test system can be conducted to GLP standards, and the science behind the method is important only with regard to the purpose of the investigation and to the demands on the precision of the data to be obtained.

Thus, GLP is primarily intended to ensure data quality and integrity and is not concerned in a direct way with scientific issues; but in the application of GLP the scientific aspects of safety studies are indirectly addressed as well. There are, however, two firm determinants which can be used to define the necessity for application of the principles of GLP.

They have to be applied in combination in order to determine whether or not for any specific study or study type strict adherence to GLP would be mandatory. These test items are frequently synthetic chemicals, but may be of natural or biological origin and, in some circumstances, may be living organisms.

Good laboratory practice (GLP) for safety tests on chemicals

GLP is thus applicable to safety studies in two major areas: Effects on human health and on the environment. These two areas may share some types of studies that have to be conducted in order to test the safety of the respective test item, but other study types may exclusively be required for one or the other area.

It is important, however, to stress that this restriction to tests on safety, and amongst these to such tests only which are intended for submission to Regulatory Authorities, would not mean that the essential principles from the GLP regulations should not be applicable to any other study or type of study; 26 Part I: Let us therefore first dissect these prerequisites for the full, mandatory application of the GLP Principles.

While the OECD Principles leave it at this general expression, the FDA guidelines go somewhat further, in that they expressly exclude testing on humans and on human material from the requirement of GLP. In their definitions 21 CFR The guidelines of Good Clinical Practice GCP mostly do not deal expressly with the question under which one of the available or applicable quality systems the laboratory investigations haematology, clinical chemistry, pharmacokinetics within a clinical study should be conducted.

The ICH Guideline for Good Clinical Practice ICH, for instance mentions in the list of essential documents that have to be available before the start of a clinical trial in paragraph 8. Although, or maybe because, GLP is not explicitly mentioned, the opinion that the respective quality system should be equal to the Good Laboratory Practice is finding therefore its advocates. Certainly, there are aspects in the rules of GLP which could profitably be employed also in the conduct of laboratory investigations within the context of clinical trials.

However, to mandatorily require a laboratory, which is analysing samples from clinical trials, to be officially acknowledged as complying with GLP would lack the support of the wording and the intentions of the Principles of GLP. This was interpreted by the concerned clinical analytical laboratories, and the GLP monitoring authorities alike, that the intention of this guideline was to require these bioanalytical laboratories to introduce GLP and to seek inclusion in the respective national compliance monitoring programs.

This additional workload to both parties was seen by them as exaggerated and unwarranted. Since the determination of bioequivalence in a pharmaceutical preparation has no obvious, immediate connection to safety, but serves to demonstrate, for the purpose of granting a marketing permit, the practical interchangeability of a new with an already registered preparation, the GLP monitoring authorities were of the opinion that this type of investigation would not be covered by the scope of the GLP Principles, an interpretation to which the EMEA finally had to agree.

There is another side to this first delimitation: It is only through the possibility of reconstructing each and every activity and process within a study, that the accuracy and precision of the data reported may be judged. This aspect also makes it clear that GLP is not the instrument with which the conduct of a safety study according to high scientific standards can be warranted.

Laboratory testing that is performed in a non safetyrelated way, e. Laboratory testing which is performed with the view of demonstrating the efficacy of the test item in its prospective use is also not a case for GLP, and neither would be the organoleptic evaluation of processed foods.

Also, work done to develop chemical methods of analysis or the first validation trials for an analytical method are another case in point: However, GLP has to be applied to the chemical procedures used to characterise the test item, to determine its stability, and to determine the homogeneity and concentration of its mixtures with any vehicle used in the application to the test system.

Likewise, chemical procedures used to analyse specimens e. The data to be generated under GLP have to have a connection to the assessment of safety for either of the two fields of human health or for the environment.

In this regard there are apparent differences between these two fields which, however, are the logical extension of the differing safety aspects of certain data. The physical-chemical parameters of a pharmaceutical chemical substance might thus not be considered as related to an assessment of human health risks, and therefore the respective studies would not be mandatorily conducted under GLP. In another context, the investigation of the pharmacodynamic properties of a chemical substance which may determine its efficacy in a therapeutic indication will not be conducted under GLP.

It is clearly I. These are dealt with in this guideline as follows: Results from secondary pharmacodynamic studies conducted during the compound selection process may contribute to the safety pharmacology evaluation; when there is no cause for concern e. In some circumstances, results of secondary pharmacodynamic studies may make a pivotal contribution to the safety evaluation for potential adverse effects in humans, and these are normally conducted in compliance with GLP.

Therefore, clinical studies in humans as well as in animals do not have to be conducted under the stringent conditions of GLP. With regard to the second requirement for the applicability of GLP, the submission of the data generated to a Regulatory Authority, an analogous dissection can be done from two angles: On the one hand according to the type of study, and on the other hand according to the nature and utilisation of the item to be studied.

In relation to this second point, the scope of the OECD GLP Principles mentions pharmaceutical products, pesticide products, cosmetic products, veterinary drugs, food and feed additives, and industrial chemicals as examples of items possibly subject to testing under GLP. Insofar as these products will have to be licensed, registered or approved for marketing by an appropriate Regulatory Authority, safety studies on these products and their ingredients have to be conducted under the strict rules of GLP.

There may be differences in national policies and requirements, however: While, e. In the latter case, it will then not be necessary for manufacturers of cosmetic products to apply for a marketing permit; therefore, safety studies concerned with cosmetics would not need to be submitted to a regulatory agency, and there would thus be no legal requirement in these instances for conducting such studies if any are indeed performed under GLP.

However, it has to be stressed that, notwithstanding the lack of a requirement for mandatory and documented adherence to GLP, the basic principles of GLP certainly represent a measure of good study quality, a goal that all testing facilities should strive to attain.

Furthermore, in this world of ever increasing globalisation of industries and products, it would certainly be prudent to conduct any such safety studies under the conditions of the GLP Principles, since it can never be known with certainty whether any such study would, some day in the future or under different legal circumstances, have to be submitted to a Regulatory Authority.

On a second line, there are differences between the extent of mandatory GLP-compliant testing that may not be obvious at first sight. Two examples may illustrate this point. As mentioned in the scope of the GLP Principles, not only pharmaceutical products intended for treatment of human patients, but also the analogous products for animal use should be tested with regard to their safety under the conditions of GLP.

In this latter case there are two different aspects to be considered: The first one is safety for the treated animal itself, but the second one is the human health aspect of possible consumption of products derived from treated animals.

Thus, the GLP Principles should be applied to studies on animal health products dealing with the possible sequelae of overdosage in the target species, with the safety of the product in its intended, therapeutic application to the target species, as well as to tissue residue accumulation and depletion studies.

In an apparent deviation from this general principle, namely that efficacy studies are not required to be conducted under GLP conditions, the US EPA regulations state, that certain efficacy studies on pesticides have to be conducted under GLP, namely when they are considered as required studies by the relevant US Federal Regulations Data Requirements for Registration, 40 CFR It is thus required to apply GLP to the conduct of all studies which support, or are intended to support, pesticide registrations, including studies on product performance, i.

In the area of pesticide registration, the studies intended as final proof of the efficacy of the product would therefore also have to be of demonstrated adequacy, quality, integrity and validity. Similar to the human clinical efficacy trials, where under the rules of GCP the data should be traceable back to the single patients enrolled and investigated in these trials, study reconstruction must be possible also for such pesticide efficacy studies in order to allow the identification of any data of questionable integrity.

The definition of study types that do, and those that don't fall under the provisions of GLP does again very much hinge on the aspects of safety and of regulatory submission. Looking at the second aspect of the applicability of GLP, namely the requirement that only such studies shall come under the rules of GLP which will be submitted to some Regulatory Authority, there are some interesting points to be made.

First of all it will possibly not be definitely known at the time of study conduct whether the respective test item will really make it all the way through to a product submission. Thus, it will be uncertain whether the particular study in question will indeed be submitted to a Regulatory Authority. Therefore, it is really the possibility of submission which will determine whether a study has to be GLP compliant.

However, we would advise that at any time that it is known that the data from a study may be submitted to EPA The data submission may be rejected if the compliance statement indicates GLPs were not followed regardless of whether the data were intended for submission to EPA at the time that the study was performed.

A fine but logical line separates exploratory studies which need not be conducted to the GLP standards from other such studies, where GLP would be regarded as mandatory. Let us assume as an example the various investigations on a chemical substance directed towards testing its properties as a prospective pesticide.

Screening assays in the laboratory which lead to its characterisation as a potential fungicide would be considered as exploratory studies, and these would therefore be exempted from the strict application of GLP. The compound in question would, however, have to prove its fungicidal efficacy under actual conditions of use in the field, and a number of investigations with this product will be undertaken in the field.

Since the purpose of these latter field trials is not confined to collecting data on the actual value of the product in the field, but may be extended to generating data for submission to the licensing authority, if the product would perform to expectations, these field trials would have to be conducted under GLP.

Yet another example may be described: In analytical chemistry, methods have to be developed for the determination of pesticides, their residues and metabolites.

Again, studies performed entirely for internal use would not require compliance with GLP rules, since such method development and validation studies could be regarded as exploratory. On the other hand, studies being performed because they form the required basis for the submission of a product to a Regulatory Authority should be regarded as being subject to the GLP rules.

Here again, one may observe a difference between the requirements in a drug submission versus a pesticide submission. Pharmacokinetic studies, although being a mandatory part of the submission package for a human or veterinary drug, are exempted from the GLP requirement the exception being the toxicokinetic investigations accompanying toxicology studies. As one part of these non-clinical pharmacokinetic investigations, metabolism and biotransformation studies of the test item are performed which are considered not to be safety related, since the safety of test item and its metabolites is being I.

Therefore, these metabolism and biotransformation studies do not need to conform to the GLP rules. In the pesticide field, however, it will be important, from a safety viewpoint, to gain knowledge about the biotransformation patterns of a compound in treated plants, in soil or in other environmental compartments, as the overall safety of a pesticide which is introduced into the environment will depend also on the activities, nature and fate of any metabolites formed.

These examples have been provided here to illustrate the point that the application of Good Laboratory Practice is not rigidly universal, in that one would be able to draw up a list of studies which are mandatorily subjected to the rules of GLP.

Rather, the necessity to follow the strict regulations of GLP will be determined by the two basic principles of the scope of GLP — the safetyrelatedness of the investigation and the foreseeable submission to an Regulatory Authority — the interpretation of which may, however, under different circumstances lead to different answers and conclusions.

The Pillars of Good Laboratory Practice Every building needs a sound basis, on which to erect its visible structures. Thus, Good Laboratory Practice is based on four pillars which have to support the implementation and daily observance of its Principles: It is not by sheer coincidence that management would be mentioned here in the first place as one of the pillars of GLP.

It is amply borne out by experience that GLP is only as well complied with as it is supported by test facility management's inner conviction. It is not sufficient to draft a nice declaration extolling the virtues of quality in general and of GLP in particular, when in everyday work the wrong cues are given to the test facility personnel 34 Part I: When either the financial means for ensuring GLP conformity are severely curtailed, or when management is looking through the fingers or altogether the other way when a report of the Quality Assurance is asking for corrections that would necessitate some investments, then people will read between the lines of this statement and conclude that only appearances are important, but not the actual compliance, and they will behave accordingly.

On the other hand, a management which is convinced that GLP is a good thing in itself, and not just something that these silly bureaucrats in the government who, in any case, do not have the slightest idea on how to run a business are asking for and nagging about, but has merits of its own, that this system is really worth the efforts which have to be put into it, such a management will be rewarded with a smoothly running GLP system and with the delivery of real quality data and studies withstanding even the most detailed scrutiny by authorities.

Therefore, even if the management of a test facility has nothing to do with the daily compliance with the GLP Principles, and has only to provide for the basic necessities to enable GLP to be implemented, its attitude towards this quality system, and its positive stance towards the efforts and expenses needed, will very much influence the way in which GLP will be observed within the test facility. All this amounts to the requirement that it is the test facility management, who is ultimately responsible for ensuring full compliance with the GLP Principles throughout the facility as a whole.

Good laboratory practice

In order to deliver its responsibility, it will need some mechanism of continuous control. Therefore, an essential management responsibility is the appointment and effective organisation of an adequate number of appropriately qualified and experienced staff throughout the facility, including those specifically required to perform QA functions.

And this management responsibility brings us to the second pillar of Good Laboratory Practice. The second pillar of this building, named GLP, is the Quality Assurance, an internal system for ensuring that the Principles of GLP are observed and that the studies which are conducted at the test facility are complying to the extent necessary with these Principles.

The compliance with the GLP standards in the everyday work at a test facility can only be as good as the critical observational capability of the Quality Assurance inspector on the one hand, and also only as good as the ability of the Quality Assurance manager to succeed in carrying through any objections to the way GLP is handled by I.

For this end, the GLP Principles are regarding the independence of the Quality Assurance from the actual study conduct as a very important issue; from this requirement there can be not the slightest deviation. Any activities that are delegated to Quality Assurance must never compromise the independence of the Quality Assurance operation, and must not entail any involvement of Quality Assurance personnel in the conduct of the study other than in a monitoring role.

On the other hand, it is also of utmost importance, that the person appointed to be responsible for Quality Assurance must have direct access to the different levels of management, particularly to top level management of the test facility. Quality Assurance has to be able to bring any deviations from the full observance of the GLP Principles detected in some part of the test facility to the immediate attention of test facility management, in order that corrective actions may be instituted at once and before a Monitoring Authority inspects the facility and finds fault with the way GLP compliance is followed!

Quality Assurance may thus be regarded as the prolonged arm of management, which exercises its control over the GLP compliance within the test facility. However, it has also a bridging role between management and study personnel, in that failure to observe aspects of GLP may, e.

The third pillar of the GLP system consists of one single person!

The Study Director is the one single point of study control and the one single person on whom the whole study hinges from the beginning to the end. His prime responsibility is for the overall scientific conduct of the study and all duties and responsibilities as outlined in the GLP Principles stem from it.

It is well known in all fields of human activities, e. This certainly holds true for the conduct of a study, where, based on this general knowledge, it is absolutely clear that there can be only one Study Director at any given time. If this were not so, then personnel would be liable to receive conflicting instructions for the conduct of the study or for activities connected with it, which, ultimately, may lead to poor implementation of the study plan.

In this regard, the Study Director serves to assure that the scientific, administrative and regulatory aspects of the study are fully controlled. Certainly, some of the duties of the Study Director can be delegated to a 36 Part I: The Study Director has finally to acknowledge this by signing the GLP Statement in the final report of the study he has directed.

Another aspect comes to bear, too, in the person of the Study Director. The Study Director is usually the scientist responsible for study plan design and approval, as well as for overseeing data collection, analysis and reporting, and for drawing the final overall conclusions from the study. In this person, therefore, two worlds are meeting: On the one hand the issue of the formal study quality in terms of GLP and, on the other hand, the complex area of the scientific study quality in terms of design, data significance and assessment.

What Quality Assurance is for the in-house control of adherence to the Principles of GLP, is the National Compliance Monitoring Authority for the international recognition and mutual acceptance of studies and test data.

OECD has recognised the need for this further control instance and provided a framework for the institution of National Compliance Monitoring. Consequently, it recommended that member countries should institute such systems, and in order to promote the comparability in the different compliance monitoring procedures the Council further adopted the Recommendation concerning the Mutual Recognition of Compliance with GLP OECD, C 83 95 Final , These documents, which are also reproduced in this book see Appendices IV.

I and IV. II, pages and , resp. It was furthermore intended that by adherence to the procedures set out in these two documents, national approaches to GLP I.

It stands to reason that only in such a way the most important goal of these OECD Council Decisions, namely the mutual acceptance of safety test data among the OECD member countries, could be reached. It had, however, also to be recognised that there would be a number of problems and difficulties on the way to attaining this goal. It was recognised that the OECD member countries would adopt the GLP Principles and establish compliance monitoring procedures, but that they would do so according to national legal and administrative practices, and according to priorities they would give to, e.

Furthermore, and according to the legal framework for chemicals control in the individual countries, more than one GLP Monitoring Authority, and thus more than one GLP Compliance Programme could be established.

While in other countries all aspects of GLP monitoring can be assembled under the roof of one single GLP Monitoring Authority, there are still others who make use of the possibility of combining GLP Compliance Monitoring further with the monitoring activities in the area of other quality systems, like accreditation or ISO.

Whatever the structure and the function of such a Monitoring Authority, the most important aspect, from an international viewpoint, of this fourth pillar of GLP is the comparability of the monitoring procedures, and of the compliance assessments resulting from them, amongst the various countries and Authorities, since only then, mutual trust is achieved and the mutual acceptance of safety test data will be possible.

How this comparability and equal functioning of Monitoring Authorities is assessed will be described in Section IV of this book. In summary, four pillars support the structure of Good Laboratory Practice.

All of them serve important functions in the context of performing and monitoring safety studies, and all of them need to be based on the strong conviction that GLP is the one mean to achieve quality data.

Certainly, there are other aspects and issues in GLP that may be seen as nearly equally important, and they will be dealt with extensively further on, but Test Facility Management, Quality Assurance, Study Director, and National Compliance Monitoring Authorities are the key positions where real adherence to the Principles of GLP, not only by the letter but by the spirit of them, is determined in the end.

As has been described above, GLP is a quality system which has found mandatory application in the safety testing of any items where the results of such testing will be assessed by some national Regulatory Authority for the purpose of registering or licensing this item. This does not mean that it is to be used exclusively within these defined and restricted boundaries. It has to be emphasised, however, that only those test facilities which on the one hand are working in full compliance with the GLP Principles, and which on the other hand are included in a national monitoring system or program, or are controlled by some national authority may claim official recognition of their GLP compliant status.

Nevertheless, there are a number of instances where test facilities could, or should, adhere to the principles of GLP. The most obvious case is the not so rare one of the test facility, where only very few studies are conducted according to GLP to the fullest extent; most of the studies performed there would either not qualify as safety studies, or they would not be conducted to I. Where there is no obvious need for the application of the full requirements of GLP, e.

However, in such a test facility, it would be of the utmost importance that in all other respects studies would be performed as if they were conducted under GLP: Apparatus should be maintained and calibrated according to the respective SOPs, test systems should be properly located and identified, test items should be characterised and labelled, SOPs should be available for all activities performed at this test facility, the studies should be conducted to the applicable SOPs, the respective raw data should be treated in a manner analogous to those in a GLP study, and all these activities should be properly documented and recorded.

It has been stated at the beginning of this part that there are some misconceptions about the meaning of GLP. As one of these, it has been mentioned, that there is the wrong opinion that a laboratory, which views itself as working according to a good scientific or precision standard, should be able to apply for recognition as a test facility in compliance with GLP. Therefore, formal recognition by a Compliance Monitoring Authority cannot be given to each and every laboratory that claims to work according to these GLP Principles.

However, this misconception may be, after all, not so wrong in its intentions. Other quality systems, such as those of the ISO series or the Accreditation schemes, which may be better suited for, and thus applicable in a more relevant way to the majority of, these cases, are also relying on similar measures as GLP for assuring the quality of the work performed.

If such a 40 Part I: However, if there is no need for submitting to a monitoring program, e. In recent years there have been a number of cases uncovered where not only scientific misconduct, but outright fraud in the context of clinical, university and industrial research has been suspected, suggested or proven e.

The Federal Register of the United States of contains 13 notices of cases, in which the Office of Research Integrity found evidence for scientific misconduct, i. Below, there are some examples which might have a relation to safety studies in the sense that the detected machinations could have occurred also in regulatory testing for non-clinical safety: The situation has not changed much in the past years, as the Federal Register entries for and are demonstrating. Again, there are about a dozen cases uncovered each year, with fabricated data for patients in clinical trials, falsifications in figures for publications and plagiarised data.

Some examples may again serve to illustrate these points: The reason for this apparent increase in scientific misconduct may have two roots: On the other hand, the competition may also encourage or drive any 42 Part I: There, the original patent had apparently been obtained at least in part on the basis of a key experiment which, however, had never been performed Dalton, Let us consider just one small point in the whole area of study conduct, and look at the example of data recording: The GLP Principles require that all original observations are immediately, clearly and legibly recorded.

If there are observations that do not fall into the normal pattern, they nevertheless have to be recorded immediately. The Study Director may then certainly be asked about the significance of these observations, and if the Study Director decides, out of his scientific knowledge or experience, that the observation could be just a spurious incident, he may declare it as such by his dated signature under the reasoned explanation on why this fact should not be considered in the final assessment.

But the fact that the respective observation has been made as originally recorded has to remain in the raw data in a clearly legible form. Even seemingly simple errors, e. The principle of immediate recording of all observations is violated.

If any data are not immediately recorded, where would be the allowable time limit for this? Could the technician, the researcher, the nurse write it down after the coffee break? It stands to reason that, the later such data or observations are recorded, the higher the chance that they will no longer reflect the actual observations: Did it already start to rain, when the field was still being treated, or was it only when the equipment was already safely stowed away and the technician started the car to drive back to the test facility?

Had dog number 15 vomited after dosing, or was it dog number 16? Immediate recording would avoid the occurrence of such insecurities, and these questions would never have to be asked. In every study, be it in research or in development and safety testing, immediate recording of parameters, observations and events is tantamount to good quality of the single data and the whole study.

Thus, this GLP requirement of immediate recording of events and observations can be regarded as a very simple example of where the Principles of GLP could be fruitfully applied and could be of value to every single person in a laboratory or test facility of any kind.

The importance of immediate and precise recording of data can best be illustrated with two details from one of the most illustrious cases of alleged fraud having given rise to a good many headline stories in scientific journals: The case of Tereza Imanishi-Kari, the allegations in which were finally, after ten years of investigations, judged to be unfounded Goodman, This case can be considered very illustrative as it can be demonstrated how the application of some simple rules of GLP could have obviated the need for or at least speeded up the respective investigations.

Out of the nineteen counts of scientific misconduct with which the Office of Research Integrity ORI charged her, two may be taken as especially illustrative of the value of Good Laboratory Practice principles. In the first instance, the investigators charged her with having fabricated the background radiation counts in her notebooks, as the hand-written figures deviated from the randomness to be expected with actual counts from natural background radiation.

The explanation given by her for this deviation from randomness was that the actual figures had been rounded before transcription to the notebook; they did thus not constitute the original observations as 44 Part I: Under GLP, such records in the laboratory notebook would not constitute original raw data. These should have been either filed as such, i. Had this been the case with the data in ImanishiKari's notebook, there would have been no question about the integrity of these background counts, since the reconstruction on how the rounded values had been obtained from the original raw data would have been clearly possible.

The second point to be made is also connected with the radiation counter records. Some of the tapes that had been attached to the notebook pages, which were claimed to represent data obtained at some crucial time point and which supported important aspects in the published paper, were investigated with very great efforts by the US FBI.

Full Text foodborne pathogens are not restricted to any one country, the general information that is presented on the organisms, their ecology, the illness, and food spoilage and preservation is relevant. Even so, it should be noted that significant foodborne pathogens, if not of current concern in the UK, do not receive more than a cursory mention in the text.

Overall, the most valuable parts of the book are found in Part II, especially those chapters that present the practical aspects of food hygiene. The suggested hygienic practices are universally applicable and would be appropriate for all readers. The book contains the text of all 38 presentations and all the posters 53 chapters and an appropriate abstract of all of the sessions.

Information on ring tests, collaborative and inter-laboratory studies, robust statistics and the effect of computers and computer programs on analytical quality assurance is also provided.

The aim of the seminar was to make dairy laboratories in research institutes, control institutes, central testing laboratories and dairy factory labora,'ories The chapter on legislation covers new and newly introduced legislation and directives in the UK and the European Community EC.

Manufacturers shipping into EC countries may find this information useful. Legislation for countries outside the UK and the EC is not covered.Whatever the structure and the function of such a Monitoring Authority, the most important aspect, from an international viewpoint, of this fourth pillar of GLP is the comparability of the monitoring procedures, and of the compliance assessments resulting from them, amongst the various countries and Authorities, since only then, mutual trust is achieved and the mutual acceptance of safety test data will be possible.

The theme of 21 CFR Part 58 is control, oversight, and documentation of the processes used, results obtained, and any issues encountered for all facets of a study, not focused solely on those of the laboratory.

Therefore, even if the management of a test facility has nothing to do with the daily compliance with the GLP Principles, and has only to provide for the basic necessities to enable GLP to be implemented, its attitude towards this quality system, and its positive stance towards the efforts and expenses needed, will very much influence the way in which GLP will be observed within the test facility.

These should have been either filed as such, i. Pacific Biomarkers could be active in studies at any point in time. Furthermore, the strict adherence to the recording requirements of GLP provided the investigators and scientists with an important tool allowing for reconstructing the study, retracing all activities, and tracing the flow of samples, specimens and data. Contrary to the example above, precision of the measurement has not this very critical importance in this situation, as it has for the single patient.

Within a safety testing programme of a new chemical substance, histopathological examination of brain sections was routinely performed. On the other hand, foreseen developments have proven not to be as rapid as previously thought, and therefore, some regulations had to be re-adapted to these not-materialised changes.

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