The term “pharmaceutical operations” encloses a great variety of different activities, covering at 360 degrees all the different aspects of the production and distribution of medicinal products.
The final goal of operations management is to guarantee the put in place of the proper marketing procedures, in accordance with cGMPs. From the supply and qualification of raw materials to production processes, from quality control to logistics and distribution, according to modern business models the entire flow is coordinated by the industrial function usually identified as “operations management”, which monitors all the different manufacturing activities under a single umbrella.
The operations manager has to deal with a very complex and delicate pool of activities, critical for the efficiency of the entire structure of the company. Optimization and efficiency of the processes using “lean” methodologies are among the mostly used approaches in recent years, much more typical so far of sectors such as the automotive industry than of the pharmaceutical industry. Despite the great amount of legislation that regulates the development and commercialisation of a new medicine in all its aspects, there are still few attempts to provide a comprehensive framework for the operations management. The nature of the final product is itself critical with this respect, in terms of the quality needed in order to protect the final user of the medicinal product.
The International Society for Pharmaceutical Engineering worked to fill this gap and presented during its 2016 Annual general meeting the new guideline “Operations management: Good practice guide“. The non-profit association of the Life Science sector represents more than 18,000 pharmaceutical professionals operating in manufacturing in ninety different countries. We have interviewed Giuseppe Ravizzini, Group engineering and maintenance manager and Group industrial operations manager at Recordati, and Marzio Mercuri, Corporate director of Engineering and sustainability at Polpharma, who coordinated the drafting and publication of the guideline.
From the idea to the guideline
The initial idea originated from Giuseppe Ravizzini, who less than a decade ago was studying the lean manufacturing techniques to better understand their content. «I realized that the pharmaceutical industry was very underdeveloped from this point of view. I then decided to launch an initiative on the ISPE website, on the page where each member can propose a new guideline. In my opinion, ISPE had not yet published a document that took into account the cross-cutting issues of manufacturing from the point of view of the plant manager or production engineer. The point was no longer to optimize the individual departments or functions but the overall system, from a lean perspective, bearing in mind that the sum of partial optimizations not always gives the best overall result», says Ravizzini. Marzio Mercuri adds that all previous guidelines published by ISPE were single-issue, there was no guide available which horizontally linked the knowledge coming from all different functions operating within the pharmaceutical technical context.
The idea was shared with ISPE, that already a decade before the proposal already considered the topic and dropped it, because the time was not yet ready for a mode of interaction and information exchange typical of the web. «Everyone was keeping for himself the information, especially the not purely technical one, which also related to management», adds Ravizzini, which began to build the working group on the basis of all different professional skills of the members of the scientific society. It is at this point that Marzio Mercuri started his collaboration with the project, where he played a key part in creating and coordinating the team. «We created task teams that included people working in different countries, from the United States to Croatia, in middle and senior management positions. The team initially compiled a guide index, a task that required some time being the working groups not very homogeneous. It had been clear from the beginning that the importance of the guide should not be to emphasize a topic at the expense of another one, but to focus on all issues as coherently and homogeneously as possible», says Mercuri.
From the general to the particular
The drafting of the guideline began in 2011; its contents were divided into four main chapters plus the introduction: strategy of production along the entire supply chain, management of manufacturing operations and of issues and technologies related to them, key performance indicators (KPI) and continuous improvement. This last aspect, which includes lean and six sigma techniques, is particularly new for the pharmaceutical world, that until a few years ago was very reluctant, according to Giuseppe Ravizzini, to implement this type of approach as it appeared to conflict with the good manufacturing practices. «GMPs seemed to be the exact opposite of continuous improvement. For an “old school” plant manager it was often better not to touch anything, even if doing so would not had improved the productivity or efficiency of the plant. But it would had avoided problems, inspections or requests of authorization. I think that today it is accepted that it is possible to do many things even in the pharmaceutical field – emphasizes Ravizzini –. The chapter on KPIs is a unique characteristic of the new Good Practice Guide: in pharmaceuticals, there is no other guideline discussing operational excellence. We analysed how the KPIs should be designed, what are the best pharmaceutical benchmarks at the global level for each type of business». Key performance indicators are also discussed in relation to the various functions represented in the company, with the goal of generating a “tree” index system starting from the general targets to end with a more specific view of the individual disciplines.
«The first goal we set was to create a document that could become a common platform for the entire industry. We had been very careful in identifying a series of keywords in the guide, so that this vocabulary might become a common heritage of the entire industry. Operations involve different functions, in this way everybody can have a better understanding of the whole process», adds Mercuri. This last point often might represent a weakness in many situations, says Giuseppe Ravizzini, since functions beyond the corporate senior management often have a vision of business activities limited to their area of expertise. «Often you cannot see what is happening around you and how much the work of each one impacts on the other functions and altogether. We wanted to give an idea of how to manage the entire system and the levers that can be used to “regulate” the trade-off between the various functions», adds the expert of Recordati.
As further support, the guideline also contains an appendix listing acronyms and definitions that are recurrent in the pharmaceutical industry.
A wide application is possible
Manufacturing excellence is a common goal of all industrial sectors and, in that sense, the new guideline might also be applied to other industries that share common goals as for health targets and quality of production. «In my view, the Good practice guide could be used both in medical devices and nutraceuticals, as well as in the food industry – explains Mercuri –. In order to constantly increase the efficiency and quality of processes, it is important to have a “screen” in front of us to monitor all the parameters influencing them in the context of operations».
The target of ISPE is to make accessible the guideline not only to the industry, but also to the university, being the place for training of the future professionals of pharmaceutical production. «I am not referring only to the pharmaceutical technology, but also to the training in chemistry or engineering – tells the expert –. The guide is primarily a “knowledge book”, a text that has to provide knowledge. It could then become a tool for managers, if they are interested in a specific topic for a particular function».The great variety of companies’ dimensions and business models that characterize the pharmaceutical sector was also included in the analysis, which tried to balance the different standards and needs, such as those pertaining big pharma or the generics industry. «The use of the guideline should not be monolithic and standardized, but adapted according to the type of pharmaceutical company, the size, geographical location and corporate culture – adds Mercuri –. We can use the paradigm “plan-do-check”, where the plan is research, the do is the production, the check is the end customer that controls the quality of the product, under the surveillance authorities. We paid attention to distinguish, for example, the peculiarities of research and development performed within a big pharma company or a generics company», adds Marzio Mercuri. At the production level the in-house management is completely different from the out-sourcing to external companies, the world in rapid growth of contract manufacturing operations (CMO). «We tried to consider all different aspects of the modern management of a production system, which can consist of one or more plants, but can also include several contract manufacturers in a production network», tells Ravizzini.
To test the effective correspondence of the system drafted by the guideline to different types of industrial environments, ISPE also launched among its members a survey by sending a questionnaire. The goal of the initiative is to test the correctness of the values chosen for the key performance indicators identified in the document; the results of the survey are not yet available at the time we are writing the article.