Project Management - An Overview Project management is a modern concept.
Earlier (and even today) assignments in the defence and construction industry used to be project based. Hence, project m anagement assumed lot of significance for in those sectors. Today, its importanc e has become manifold and is being applied in such diverse industries and organi sations as pharmaceuticals, chemicals, banking, hospitals, accounting, advertisi ng, law, state and local governments and the United Nations Organisation. The concept of global village and the advent of globalisation of indigenous econ omies worldwide have made the business in all the sectors to become extremely co mpetitive, more result oriented, structurally lean and technologically sophistic ated. Cost reduction, process optimisation, capacity utilisation, reduction in t he number of employees and such other strategies have become a common practice a ll over. However, the corporates are still not satisfied with the productivity o f their organisations. It is here that project management comes into focus. Exec utives have finally realised that project management and productivity are relate d, both trying to make better utilisation of the existing resources. Project & Project Management Before understanding project management, one must begin with definition of a pro ject. A project can be considered to be any series of activities and tasks that have a specific objective to be completed within certain specifications and in b etween defined start and end dates. A project will normally have funding limits. It consumes resources such as money, human resources and equipment. Project management may be defined as 'the planning, organising, directing and co ntrolling of company resources for a relatively short term objective that has be en established to complete specific goals and objectives.' The project managemen t work will have identified people working for it. This may be called as project team. It will be lead by a project manager. Normally, the project management te am members are drawn from different departments. They will be chosen by the top management depending upon the objectives of the selected project. Broadly speaking, project management involves the following stages: 1) Project planning 2) Project monitoring, and 3) Reporting These three stages in turn include such items as: Project planning: - Stating the objectives of the project to be undertaken - Definition of work requirements - Definition of quantity of work - Definition of resources needed such as funds, materials, machines, new facilit ies and human resources, and - Determining time frame for the overall project and also scheduling its various stages Project monitoring: - Tracking progress - Comparing actual progress to the predicted or planned one - Analysing impact - Making adjustments (without compromising with the objectives of the project) - Keeping a check on budget utilisation Reporting: The project manager has to make a comprehensive report at the end of the project
. The report has to be presented to the top management of the company or the pla nt. Normally, a project report will be a summary of all the activities taken by the project management team to implement the planned project. It gives the neces sary information and inputs to the top management for future decisions so as to make better planning for the future projects and identify the areas of concern. Therefore, managing of a project can be considered as successful if the project objectives have been achieved: - Within the given time frame - Within the allotted budget - At the desired performance/technology level - While utilising the assigned resources in a better way (i.e., both effectively and efficiently) The project planning work is done by the project manager. However, the objective s part of the planning will be decided by the top management of the company or t he plant depending upon the nature of the work. Potential benefits The potential benefits from project management are the following: - Identification of functional responsibilities - Avoidance of continuous reporting to and monitoring by the top management - Identification of time limits for scheduling of work - Measurement of accomplishment against plans - Early identification of potential problems - Improvement in budgeting of funds and allocation of resources for future plann ing - Knowing when the objectives can be met or even exceeded Obstacles The project management can become successful only by overcoming the following ob stacles: - Complex nature of the project - Customer's special requirements i.e., other than the expected ones or the rout inely asked ones - Changes in the organisational structure and the project management team - Project risks - Changes in technology - Changes in the desired outcome or specifications while working for a pre-deter mined project - Change in the priority status of the project Importance of project management in pharmacy The pharmaceutical industry is an extremely competitive sector. The very nature of drug development cycle or product development through its different stages an d the competition amongst the pharmaceutical companies to ensure an early produc t launch to capture the market are just a few of the reasons to appreciate the g rowing importance of project management in the pharmaceutical industry. The conc ept of project management is beneficial in the following areas: - Clinical Research - Drug Development - Clinical Research Operations - Quality Assurance - Regulatory Affairs - Biostatistics - Pre-clinical Development
Formulation Development Technology Transfer Process Improvement Cost Reduction
To illustrate, technology transfer may be taken as an example. Technology transf er is a process of transferring technology of manufacturing a product from formu lation development department (FD) to production department (PD). It is an inter -departmental exercise having great importance. A success in this activity will give a large scale process of a new product for the company. (Note: Technology t ransfer can also take place between different organisations and from one plant o f a company to another one. In this article, technology transfer from development departments like formulati on development and analytical development to production and quality control has been illustrated with the intention of explaining the benefits of project manage ment as a practically useful tool to attain reach important goals). The senior most executive of the plant (such as vice president or general manage r, GM of operations) forms a team consisting of the managers of the departments of formulation development (FD), analytical development (AD), quality assurance (QA), production (PD), quality control (QC), validation (VL), regulatory affairs (RA) and engineering (EN) for the purpose of technology transfer. The formulato r and the analyst who developed the product and the analytical method respective ly are also included in the team because, these two executives are responsible f or technology transfer on the shop floor. The following are the objectives: 1) To transfer the manufacturing technology of a product developed by FD to PD. 2) To transfer the analytical method developed by AD to QC. 3) To study the process parameters and feasibility of the same for a large scale batch. 4) To train the personnel of PD, QC and MT about the new product and its technic al know-how required at their level for routine work. 5) To decide on any modifications required in either manufacturing and/or analyt ical method. 6) To recommend (on the basis of the outcome of technology transfer) any new fac ilities/machinery required to the top management. The team decides about the following plan of action for successful technology tr ansfer: 1) The formulator has to supervise the manufacturing process on the shop floor a nd educate the production personnel about the product developed and important as pects of the manufacturing process. He has to prepare the master production reco rd (MPR) giving details of manufacturing method, specifications of raw materials , packaging materials, in-process controls and finished product. He will also pr epare a stability study protocol to conduct stability studies, a critical requir ement before commercialisation. 2) The analyst shall supervise the analysis of all the inputs going into the pro duct (including packaging materials - both primary and secondary), in-process sa mples' analysis and finished product's analysis. He has to educate the QC person nel in the process. He has to prepare a detailed procedure to perform the analyt ical method/s developed by him specifically for the product. 3) QA has to ensure compliance of manufacturing process and analysis to the docu ments prepared by the formulator and the analyst. Any deviation will be noted by QA and suitable measures taken in consultation with concerned departments so th at the same problems can be avoided during routine production campaign. They wil l ensure that the raw materials used in the technology transfer batch will compl
y to the specifications given by FD. 4) Production department will be absorbing the technology of a new product and u nderstanding the technicalities so that they understand the manufacturing proces s very well and production campaign will be smooth after commercialisation of th e product. They will also co-ordinate with stores and purchase departments for a vailability of raw materials. 5) QC department will be absorbing the technical know-how of the analytical meth od. This will help them while analysing the samples of raw materials, in-process materials and finished product when the product is commercialised. 6) Validation department will prepare protocols for both process evaluation as w ell as method evaluation for the purpose of validation. They will prepare the pr otocols in association with FD and AD respectively. 7) Regulatory affairs will make use of the data obtained from the technology tra nsfer in suitable documents required to be given to regulatory authorities in th e countries where the company intends to file the product. This will prove that the scale-up activity has been done in a systematic way. RA will also review the MPR and the analytical method with the intention of ensuring that both formula and process of the new product have been the same from lab scale batch to techno logy transfer stage. 8) Engineering department will ensure smooth operation of machinery and utilitie s. They will also become aware of any special requirements like temperature and humidity limits. 9) The timelines are fixed i.e., beginning date and the last date for taking tec hnology transfer batch on the shop floor and analysis work of all samples. Time lines are given fixed for the unit operations as well. Progress of technology transfer will be monitored by none other than VP/GM. The team constituted by him will make available daily report to him. Comparison of a ctual progress to the planned one will be made. Trouble shooting work if any, wi ll be taken very seriously because, filing of the new product may get affected b y it. It will also be helpful while running production campaigns. Finally, a comprehensive report will be prepared by the FD r in some companies) giving details of technology transfer he team members will contribute to the report based on the gned to them. This report will have detailed review of the he purpose of technology transfer and an assessment of the manager (or QA manage work performed. All t responsibilities assi total work done for t same.
Typically, a report on technology transfer includes the following sections: 1) Stated objectives (with which the process of technology transfer started). 2) The envisaged plan of action and a copy of different protocols like process v alidation protocol, analytical method validation protocol, stability study proto col etc. 3) A critical view of the whole process of technology transfer with stress on co mpliance to the pre-fixed parameters. 4) Process deviations if any and the remedial action/s taken and the effects of the same on product quality and process. 5) Analysis of results with the intention of comparing the stated objectives wit h the achieved objectives. Reporting is very important because based on this report, VP/GM will decide abou t future course of action such as recommendation to the top management of the co mpany regarding filing of the new product in various markets (countries). It wil l also establish the credibility of the process and the formulation developed by
FD and the analytical method developed by AD. Thus, project management may be employed to do systematic work and converge the expertise available in different departments. Many times it also happens that pe ople use the principles of project management without being aware of them and at tribute the successful outcome as a matter of luck. Nevertheless, project manage ment is a tremendous tool for successful execution of short time assignments of strategic importance and also overcome the obstacles of departmentalisation and bureaucracy.