Quality Assurance and Regulatory Affairs

An effective and safe radiopharmaceutical, suitable for administration to patients, is above all a quality drug. Quality is not an abstract value, but an integrated and complex organizational system, formalized in a Quality Assurance System.

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Quality Assurance oversees the entire production chain, to ensure that pre-established quality standards are always respected. It provides control over the management and correct compilation of the documentation to support the entire life cycle of the drug, the continuous verification that established procedures are being implemented, the management of all the production activities essential to guarantee a product quality and compliance with current regulations (staff training, disposal of hazardous waste, management of deviations and changes, etc …)

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The technical-regulatory apparatus of the pharmaceutical sector is extremely complex and constantly evolving. The authorization procedures for the use and marketing of drugs require numerous steps and the support of a specific competent figure, the Regulatory Affairs specialist. Regulatory Affairs specialists are therefore responsible for overseeing the whole series of authorizations necessary in pharmaceutical production, and applying the regulations so that applications for authorization can be presented correctly, acting as intermediaries between the pharmaceutical company and the authorizing institutions.

BeForPharma makes its team constantly available to the customer to carry out all the routine Quality Assurance activities during radiopharmaceutical production. For example, BFP reports on: Quality System management, POS management, management of deviations and changes, complaints management, management of qualification and validation activities, “risk assessment” analysis, etc. The implementation of an integrated quality assurance system and its maintenance, through outsourcing to a specialized company such as BeforPharma, is a strategic success factor, especially given the very strict regulatory requirements for radiopharmaceuticals.

Establishing a Quality Management System is an extremely complex multidisciplinary activity. The technical competence of the internal operators may not be sufficient to guarantee the healthcare facility an adequate level of quality, while it is necessary to adhere perfectly to the requirements of the regulations. The implementation service of the Quality Management System includes activities such as: the integral drafting of the complete set of procedures governing the activities of the radiopharmaceutical laboratory, the development of validation and qualification programs, staff training, drafting the master documents such as SMF (Site Master File), VMP (Validation Master Plan), and so on.

BeForPharma provides auding and training activities regarding the quality protocols in force at the customer structures.

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The Auding activity provides for a comparison of the protocols adopted by customers with the latest best practices in radiopharmaceutical production and with the reference regulatory system – be it GMP (Good Manufacturing Practices) or NBP-MN (Good Preparation of Radiopharmaceuticals for Nuclear Medicine). Downstream of this analysis, the team detects the deficient aspects and draws up a strategic action plan to comply with the pre-established quality assurance standards.

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The Training activity provides for the offer of specialized training by BFP – both in the GMP (Good Manufacturing Practices) and on the NBP-MN (Rules of Good Preparation of Radiopharmaceuticals for Nuclear Medicine). The operational training activity is designed both for employees of the health facility, who are approaching the legislation for the first time, or the more experienced staff who need a professional update.

Supporting its international customers in the bureaucratic document management of radiopharmaceuticals production, BFP has gained considerable expertise in the regulatory field. Therefore BFP is able, with its team, to analyze the customer’s needs, the initial situation, the regulations to be applied and the guidelines to follow – in terms of laws, decrees, legislative decrees, community directives, community regulations – and develop an exhaustive and personalized analysis of how the authorization procedure should be managed. In this process, BeForPharma produces the dossier, and presents authorization requests on behalf of the client.

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In particular, the company has gained specific experience in dossiers for placing on the market (Marketing Authorization Application, MAA), the activities following the granting of the Marketing authorization and some requests for variation to the marketing authorization.