Regulatory agencies validation requirements

Some regulatory agencies also require the reporting of adverse effects. Such post-registration monitoring data can supplement and validate risk assessments for pesticides under re-evaluation and provide useful information for further risk mitigation and management. 

Due to the importance of demonstrating the suitability of new analytical procedures described in submission dossiers, in the 1980s many regulatory agencies published requirements for analytical validation, in varying details. The U.S. Food and Drug Administration (FDA) issued two guidelines, one for the applicant,... 

The physician s involvement in clinical research does not end with the completion of the clinical study. Medical reports, clinical study reports, and sections of NDAs must be written. Interactions with regulatory agencies that require the physician s input may occur frequently. Physicians in clinical research may also be called upon to promote new drugs in a scientific environment by organizing symposia and workshops and by reviewing journal advertisements and promotional material for medical validity and accuracy. 

Method validation is discussed in Chapter 7 as it relates to the HPLC methods of analysis. Validation is a process required by law, and the concept is described by regulatory agencies in the guidance documents. The analyst performing method validation is responsible for interpreting the... 

The main disadvantage of a continuous system is the long time required for validation and timely submission of produet applieation to the appropriate regulatory agency. This timeline is drastieally redueed with the use of a batch system of equivalent volumetric productivity. 

A detailed method validation report may not be necessary until submission of the final market application. However, summary reports should be available to facilitate efficient data retrieval and fulfill requests from regulatory agencies for the information when required. 

While validation as a discipline is widely known across the pharmaceutical industry, there are still a significant number of instances in which preapproval inspection results or product recalls identify an insufficient validation program as the root cause of the difficulty. Continued awareness of validation requirements and a diligent application of validation principles will thus help to ensure that pharmaceutical products will be able to be developed and produced with the quality and reproducibility required from regulatory agencies across the world. 

Method validation has received considerable attention in the literature and from industrial committees and regulatory agencies. The international standard ISO/ IEC [1] requires validation of nonstandard methods, laboratory designed/devel-oped methods, standard methods used outside their intended scope, and amplifications and modifications of standard methods to confirm that the methods are suitable for their intended use. The Guidance on the Interpretation of the EN 45000 Series of Standards and ISO/IEC Guide 25 includes a chapter on the validation of methods [2] with a list of nine validation parameters. The International Conference on Harmonization (ICH) of Technical Requirements for the... 

All the discovery stage quantitative and qualitative LC-MS assays (levels I, II, and III), which are used to select dmg candidates for development, are not rigorously validated and are not required to satisfy any of the good laboratory practices (GLPs) guidelines set forth by the regulatory agencies (Shah et al., 2000 Hsieh and Korfmacher, 2006 Jemal and Xia, 2006). 

Computer systems are validated for two important reasons to ensure that good business practices are followed, and to satisfy regulatory agency requirements. 

In the event that the CIP procedure does not proceed in accordance with the validated procedure, a deviation report and investigation would need to occur. Unfortunately, documentation associated with deviations, pharmaceutical exceptions, and failures is often not handled with the extent of detail and urgency required by regulatory agencies. 

The concept of validation came up in the 1970s in association with sterilization procedures and was extended to all steps of pharmaceutical manufacturing procedures. Validation means proving that any and all procedures, processes, equipment, material, operations, and systems comply with the expected performance. Well-planned and well-conducted validation studies constitute GMP principles once they guarantee a consistently safe and efficacious final product. Validation is important for companies, first for QA, and also for cost reduction, decreasing failures, rejection, reworks, recalls, and complaints. The positive aspect of validation is an increase in productivity, as a consequence of a well-controlled process. Validation is required by the regulatory agencies of many countries. 

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