Quality assurance regulatory

The validation is therefore not complete until there is a detailed description of the method and records of the validation study. A responsible person needs to sign that the method meets the requirements, i.e. it is fit for purpose . The documentation facilitates the consistent application of the method, within its scope and defined performance parameters. This, in turn, helps ensure that when the method is applied in different laboratories or at different times, the measurand is the same and that the measurement results are comparable. Documentation is also required for quality assurance, regulatory and contractual purposes. 

In order to prepare for a PAI, the company usually sets up an independent audit of the facilities well before the formal PAI. This audit, usually carried out by the company s own Quality Assurance/Regulatory Compliance groups, often assisted by... 

To gain buy-in and input from all the key functions at the start of development (such as Pharmaceutical Development, Safety, Clinical, Manufacturing Operations, Quality Assurance, Regulatory and Marketing)... 

This Is the proceedings from a 1993 specialty conference addressing laboratory data and stringent water Quality standards. Topics bidude quality assurance, regulatory trends, effident data management, and instrumentation update. 

The use of these techniques is an important element of industrial policy since they contribute to the creation of a business friendly regulatory environment allowing the combination of measures taken for internal organisational reasons and obligations of certification without lowering the level of safety to be achieved. Wlienever possible a choice between product control and quality assurance procedures is offered to manufacturers. 

The audit also emphasizes the self-regulated nature of the industry and the ideal relationship between the agency and the industry. In theory and effective practice, a biomedical company utilizes its quality assurance (QA) unit (in this case, supplemented by credible Part 11 auditors) to maintain control of safety, effectiveness, and quality. The FDA can then review the quality system (QS) and spot-check the other systems such as laboratory or production for most efficient regulatory oversight. In effect, the QA regulates the company and the FDA regulates the QA. 

The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs [standard operating procedures] to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s). ... 

Sponsor companies use quality assurance units independent of the clinical research group to audit medical operations. Their role is to ensure that regulatory standards and company policies and procedures for clinical research are being followed in all countries where research is being conducted. 

The textbook on Pharmaceutical Drug Analysis would enormously serve the undergraduates, postgraduates, researchers, analytical chemists working in the Quality Assurance Laboratories, new drug development, production and control, teaching, or regulatory authorities. 

Dissolution is becoming one of the most commonly automated functions in the modern pharmaceutical development and quality assurance (QA) laboratory. To the experienced dissolution analyst the reasons seem obvious. Dissolution methods are time-consuming and require a significant amount of labor. Beyond the cost of labor, the true cost of increased regulatory requirements and documentation can be better managed through automation. Additionally, the increased pressure to... 

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