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A pharmaceutical technology transfer can be defined as the transfer of scientific information, a capability or technological base associated with a drug or from a donor side (knowledge center) to a receptor side (pharmaceutical manufacturing plant) that implies a positive experience learned and perceived by both parties and Comply with all regulatory requirements in terms of performance, quality and safety. Thus the concept of outsourcing and externalization comes into play as an opportunity to delegate activities outside the company as well as end human resources and materials.
This concept or requirement is a response to a series of weak points related to fixed drug development strategies in this article are supposed to be strengthened locally or outsourced as such;
• The development management framework proved inadequate. There is no management educational plan in the executive team
• Lack of equipment and infrastructure. Weak confidence in R&D knowledge
• Lack of introduction of Good Laboratory Practices, GLP, and Good Manufacturing Practices, GMP, guidelines and other quality systems. Lack of understanding of uncontrolled trials and pilot trials
• Dispersion of research efforts. Lack of focus on goals and establishing merger and joint venture strategies
• Update and publicize resources available to all researchers. Lack of motivation and flexibility of researchers
• Lack of communication with regulatory authorities.
Exceptional search for local and regional opportunities. On the other hand, the degree of outsourcing of development activities depends on the company’s strategy. Although the outcome of a priori predetermination is difficult, the outsourcing degree will be higher in terms of development due to the specialization of this activity.
To get a sense of this type of outsourcing, companies observe organizations that conduct potentially interesting research activities. In this sense, development centers are expected to realize the same quality level of activities and comply with GLP and GMP guidelines, which are fundamental to ensure an optimal level of operating and strict quality assurance of established works.
The concept of technological surveillance proves to be an important strategic activity in the development policy of innovative companies. For this reason it seems advantageous to one of these buyers to identify the following aspects to take into account at the moment of outsourcing development functions.
• Experience in business field. It must demonstrate a respectable experience
• Cultural compatibility. It should belong to the same geographical region
• Confidentiality. This should be confirmed by signing a confidentiality agreement
• Relationship with other organizations subcontracted in turn. The same rules apply as in the original contract.
• Financial solvency. Accreditation of a company specializing in such audits.
• Technical competence. Follow-up of a quality plan regarding facilities, equipment, personnel and procedures. A technology transfer policy in drug development can therefore be realized in any aspect of development units – in production facilities as well as with new products, licensed or even already existing products, either with respect to the entire process or a part of it as it is shown. picture
The goal of a technology transfer from a development unit (donor side) and its subsidiaries, licensees, subcontractors or simply to clients (receptor side) is to provide information and procedures that enable the receptor side to start production of a new product, bulk warehouse or finished. drug.
Technology transfer policy formalization can be expected to:
• Company and business objectives are kept
• Produces a positive effect on the quality of the product in question
• Facilitates introduction of new products in the market
• Compliance with regulatory requirements is ensured
• Costs are reduced
On the other hand, drug manufacturing facilities are concerned by technology transfer as they increase their production capacity by working for other companies.
This means an excellent opportunity for specialized companies with underutilized installations or equipment with an absorption degree of more than 50% of their maximum capacity, or with own methods and technologies covering market gaps.
