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Quality Management System in Pharmaceuticals

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The pharmaceutical industry is one of the heavily regulated manufacturing firms. Quality management systems have a direct impact on the ultimate quality of finished products. The quality of these products, however, does not only reflect on legislative requirements but the essence and efficiency of the pharmaceutical practitioner.

Because of the significance attached to pharmaceutical industries, just like the food industries, they are directly used by consumers either for local application or internal consumption. The quality, safety, and efficacy attributes of these pharmaceutical products must, for this reason, be guaranteed so that the consumer’s health is not compromised. To ensure that high quality and safety is guaranteed, there is a need for high-quality pharmaceutical industries.

Pharmaceutical industries are bound to comply with the global life science quality standards while engaging either in the production, supply, or consumption of pharmaceutical products. There are globally recognized bodies that regulate the quality of drug substances and drug products.

Having a good understanding as well as implementing appropriate quality management system is a prerequisite for every kind of dealer in this pharmaceutical sector in to fulfill the regulatory as well as the ethical responsibility of incorporating management of identity, safety, purity, quality, and efficacy of the finished medicinal products.

For most biotech and pharmaceutical companies, however, management of training, business processes, and documents are nightmares to them. In this article, we are going to explore the quality management systems and how one should explore them and manage the operations successfully.

Application

The component of the quality manufacturing system in pharmaceutical products can be applied in the pharmaceutical Development for:

• Formulation development (container/closure system)

• Manufacture of investigational products.

• Drug substance development

• Development of analytical method

• Delivery system development (where needed)

• Manufacturing process scale-up and development

Beneficiaries of Pharmaceutical Quality Systems

R&D Document Authors: In addition, efficient quality management systems easily issues out author documents from compliant templates. The authors need not to worry about reworking the documents to match the templates. Word 2007 users can create, revise, and even redline the documents without having to leave Word while using the new systems’ toolbar. R&D Managers (Clinical, Regulatory, and Pre-Clinical): They can use the different types of quality management pharmaceutical software systems like master control, to search, organize, and take inventory of different study documents within the secure, and centralized quality management system. With the automated routing and approval functionality of quality systems, managers can with ease oversee the project teams comprised of resources from the various departments, as much as the teams might be working on various projects at the same time. The advanced pharmaceutical quality management systems also enhance correspondence from different regulatory agencies, suppliers, and CROs, linked with the appropriate documentation. With effective quality management systems, the PDFs having content bookmarks can be automatically generated for either document control functions or regulatory submissions. Since most of the pharmaceutical quality management software is complete and connected systems, authors don’t need to constantly cycle across the different disparate systems (from word to e-mail and then to document management system, and so forth) so as to locate or revise a document, and then submit it for review or approval – quality management systems such as master control permits such actions to be undertaken within the single integrated system.

Management: On part of life science organizations, pharmaceutical quality systems are known in providing comprehensive solutions disregard of the existing in-house capabilities. Should it be that the organization is in need of training on the system’s functionality or needs assistance on system configuration to match the specific needs, pharmaceutical quality management systems can be modeled with any service level required, or the support the organization needs. An organization in need of expert knowledge can have quality management’s skilled advisory team to analyze the circumstances so as to clearly map and develop these requirements.

Manufacturing/Operations: These systems easily tracks all specifications, nonconformance, and deviations throughout the development cycle. Pharmaceutical management systems provide that all appropriate personnel gains training on the most up-to-date work instructions and SOPs. Equally, these systems automate training tasks and facilitate the ease locating of training records within the centralized system.

Clinical Personnel: Within the clinical precincts, the pharmaceutical quality management systems rids the management from the cases of paper filing backlogs that result in “black holes ” of documents which are almost impossible to find. Now that the quality management systems are electronic and automated, the searching of archives for trial documentation (IRB information, or protocols) is simple. CVs, electronic document copies, e-mails, etc., from different study sites, can be readily accessed in a single and centralized system.

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