QA systems

It is important to distinguish between a safety policy and a safety manual - these are not the same thing, but are often found combined. The safety policy will refer to the manual for details on technical points. The main problem is that the likelihood of a document being read is inversely proportional to its length and complexity Current opinion is that safety policies should be shorter rather than longer, and accompanied by explanatory manuals. 

Some employers have devised their safety policy as part of a documentation system set up for BS EN ISO 9000 and 14000 purposes, and there is much to commend an integrated approach to the management of safety, health and quality. However, it must be remembered that possession of an adequate safety policy is a legal requirement, and the law v/ill not be complied with if the safety policy is hidden or hard to find so that it is not effectively brought to the attention of all employees as required by the Act. 

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Figure 9.9 The principle of applying a full quality assurance (QA) system to minimise product failures and reduce costs.

Production QA System Certification Certification based on auditing against a quality system standard for production final inspection (e.g. ISO 13485 - design control) Product QA System Certification... 

The EC type-examination is the process that the manufacturer may use to obtain independent verification that a design conforms to essential requirements, when a certified QA system has not been applied to the design process. The manufacturer must submit an application to the notified body, accompanied by documentation on the device design and physical samples of the device. The Notified Body examines the... 

EC verification provides an alternative to the model of establishing a certified production QA system. Independent testing of either all devices, or a statistically representative sample of each batch, is conducted by or on behalf of the Notified Body, which then issues a certificate of conformity for the tests conducted. This is not a popular option due to the costs involved. The procedure is not capable of providing adequate assurance as to the sterility of devices. Instead, an assurance of sterility must be based on the application of a production QA system to the sterilisation process. 

At its core, each manufacturer must have a QA system appropriate to the manufacture of pharmaceutical products. Essential elements that such a system should address are summarised in Figure 11.6. 

Quality assurance system - maintain an effective pharmaceutical QA system... 

QA is an important aspect of any technical study. It is particularly crucial in an LSMBS, because several hundred participants, widely separated geographically, are involved. The analytical laboratories typically have standard provisions for QA inspections and reviews, and the field phase management organization is also likely to have standard provisions for QA inspection and review. Shoppers, however, are typically external to study management and analytical laboratories and, thus, are not directly covered by existing QA systems. The study design must include a means by which the field phase, i.e., sample collection and shipment by the shoppers, is made to comply with QA requirements. 

Since a usual customer is not able to judge the suitability of a QA system in a laboratory, a formal recognition by a competent third party increases customer s confidence... 

The error of an analytical result is related to the (in)accuracy of an analytical method and consists of a systematic component and a random component [14]. Precision and bias studies form the basis for evaluation of the accuracy of an analytical method [18]. The accuracy of results only relates to the fitness for purpose of an analytical system assessed by method validation. Reliability of results however has to do with more than method validation alone. MU is more than just a singlefigure expression of accuracy. It covers all sources of errors which are relevant for all analyte concentration levels. MU is a key indicator of both fitness for purpose and reliability of results, binding together the ideas of fitness for purpose and quality control (QC) and thus covering the whole QA system [4,37]. 

Application New methods, required for full vahdation and standardization, first prerequisite for IQC and QA Routinely used (validation and/ or standardization methods), recommended within IQC and QA system... 

We will document the identified analytical methods, numbers and types of samples, and appropriate QC requirements in the SAP, prepare the Laboratory SOW, and send it to at least two laboratories for competitive bidding. To be thorough in the selection process, we should request that the laboratories supply with their price proposal a description of their technical capabilities and sample throughput capacity and the QA Manual that documents the laboratory QA system. This information may not be necessary if a laboratory has been providing analytical services to us in the past, but it will be a prudent practice if new laboratories are among the bidders. 

To achieve the required quality, the chemist should be involved from the beginning of the process, when the needs of the users of results are defined, until the final report is delivered. In practice, therefore, the analytical chemist has to be consulted at every stage of the process sample selection, sample storage, and transport procedures, the parameters to be analyzed, and the level of accuracy and precision necessary for an adequate response to be given. This will enable the analyst to set up a scientifically and economically adapted and accepted measurement procedure for the intended purpose as required by the QA system. Moreover, implementation of this system must guarantee that all necessary QC measures can be anticipated, so that the entire quality cycle is under control.4... 

A QA system describes the overall measures that a laboratory uses to ensure the quality of its operation. Typical items include suitable equipment, trained and skilled staff, documented and validated methods, calibration requirements, standards and RMs, traceability, internal QC, PT, nonconformance management, internal audits, and statistical analysis. 

With an appropriate QA system in place, a laboratory is in a position to assure customers that it has adequate facilities and equipment for carrying out particular measurements. Moreover, the laboratory should be able to demonstrate that analyses are performed by competent and authorized staff according to well-described procedures and validated methods. Well-designed and properly implemented QA supports a laboratory to ensure that the delivered results are valid and fit for a stated purpose. 

Clearly, QC activities are an essential element of a QA system. Moreover, all these activities should be planned and well documented, and QC data should be analyzed so that corrective action can be taken whenever needed. QC activities mean comparisons of results and their uncertainties with quality criteria and/or reference data, and typically are done by... 

The International Standards Organization (ISO) definition of audit is Systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which agreed criteria are fulfilled. The bottom-line goal of the software developer audit process is to allow you to assess the developer s quality assurance (QA) system. 

In business terms, auditing of software developers will allow you to assess the vendor s technical competence, vendor reaction to your company s user requirements specification (URS), vendor QA system adequacy, supplier experience with GXP systems, and quality level of vendor-prepared validation and qualification protocols. In short, vendor auditing is a regulatory expectation and auditing provides a means of assessing the supplier s ability to deliver a validatable system that will achieve the requirements of your company s URS. 

Routine established D, I, O, and P qualified15 Critical compliance and quality system QA approval Adhere to cGMPs Adhere to NDA claims Established range for reconciliation and accountability Support label claim established Formalized QA system... 

Issuing and controlling all the documentation in the QA system, including the Quality Manual. 

In many cases, studies in tropical matrices have not been carried out using Quality Assurance (QA) systems, leading to the question of confidence in the data produced. For diis reason it is important that laboratories reporting pesticide residue data have an adequate QA system. 

United States, Australia, Canada, the Nordic countries, and the World Health Organization (WHO). The ICH guidance defines QA as All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with GCP and the applicable regulatory require-ment(s). Quality control, on the other hand, is defined as The operational techniques and activities undertaken with the QA system to verify that the requirements for quality of the trial-related activities have been fulfilled. 

Drug regulation and QA systems. Information support for pharmaceutical regulation. Guidance for control and use of psychotropics and narcotics. 

The CRO should have an appropriate quality assurance (QA) system. 

The QA system and the person(s) responsible for QA should operate independently of those involved in the conduct or monitoring of the trial. 

Today, customers expect catalyst production to be certified by a quality system, i.e. ISO 9000, ISO 14000 or QS 9000. Thus, identification of the critical parameters is necessary for obtaining a reliable QA system. 

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