47653845 project management

8/6/2019 47653845 Project Management

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Project Management - An OverviewProject management is a modern concept. Earlier (and even today) assignments inthe defence and construction industry used to be project based. Hence, project management assumed lot of significance for in those sectors. Today, its importance has become manifold and is being applied in such diverse industries and organisations as pharmaceuticals, chemicals, banking, hospitals, accounting, advertising, law, state and local governments and the United Nations Organisation.

The concept of global village and the advent of globalisation of indigenous economies worldwide have made the business in all the sectors to become extremely competitive, more result oriented, structurally lean and technologically sophisticated. Cost reduction, process optimisation, capacity utilisation, reduction in the number of employees and such other strategies have become a common practice all over. However, the corporates are still not satisfied with the productivity of their organisations. It is here that project management comes into focus. Executives have finally realised that project management and productivity are related, both trying to make better utilisation of the existing resources.

Project & Project Management

Before understanding project management, one must begin with definition of a project. A project can be considered to be any series of activities and tasks thathave a specific objective to be completed within certain specifications and in between 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 controlling of company resources for a relatively short term objective that has been established to complete specific goals and objectives.' The project management work will have identified people working for it. This may be called as projectteam. It will be lead by a project manager. Normally, the project management team 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 planning2) Project monitoring, and3) 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 facilities and human resources, and- Determining time frame for the overall project and also scheduling its variousstages

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


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. The report has to be presented to the top management of the company or the plant. Normally, a project report will be a summary of all the activities taken bythe project management team to implement the planned project. It gives the necessary information and inputs to the top management for future decisions so as tomake 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 effectivelyand efficiently)

The project planning work is done by the project manager. However, the objectives part of the planning will be decided by the top management of the company or the 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 planning- Knowing when the objectives can be met or even exceeded

Obstacles

The project management can become successful only by overcoming the following obstacles:- Complex nature of the project- Customer's special requirements i.e., other than the expected ones or the routinely 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-determined 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 natureof drug development cycle or product development through its different stages and the competition amongst the pharmaceutical companies to ensure an early product launch to capture the market are just a few of the reasons to appreciate the growing importance of project management in the pharmaceutical industry. The concept of project management is beneficial in the following areas:- Clinical Research- Drug Development- Clinical Research Operations- Quality Assurance

- Regulatory Affairs- Biostatistics- Pre-clinical Development


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y to the specifications given by FD.

4) Production department will be absorbing the technology of a new product and understanding the technicalities so that they understand the manufacturing process very well and production campaign will be smooth after commercialisation of the product. They will also co-ordinate with stores and purchase departments for availability of raw materials.

5) QC department will be absorbing the technical know-how of the analytical method. This will help them while analysing the samples of raw materials, in-processmaterials and finished product when the product is commercialised.

6) Validation department will prepare protocols for both process evaluation as well as method evaluation for the purpose of validation. They will prepare the protocols in association with FD and AD respectively.

7) Regulatory affairs will make use of the data obtained from the technology transfer in suitable documents required to be given to regulatory authorities in the 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 theMPR and the analytical method with the intention of ensuring that both formulaand process of the new product have been the same from lab scale batch to technology transfer stage.

8) Engineering department will ensure smooth operation of machinery and utilities. They will also become aware of any special requirements like temperature andhumidity limits.

9) The timelines are fixed i.e., beginning date and the last date for taking technology transfer batch on the shop floor and analysis work of all samples. Timelines are given fixed for the unit operations as well.

Progress of technology transfer will be monitored by none other than VP/GM. Theteam constituted by him will make available daily report to him. Comparison of actual progress to the planned one will be made. Trouble shooting work if any, will be taken very seriously because, filing of the new product may get affected by it. It will also be helpful while running production campaigns.

Finally, a comprehensive report will be prepared by the FD manager (or QA manager in some companies) giving details of technology transfer work performed. All the team members will contribute to the report based on the responsibilities assigned to them. This report will have detailed review of the total work done for the purpose of technology transfer and an assessment of the 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 validation protocol, analytical method validation protocol, stability study protocol etc.3) A critical view of the whole process of technology transfer with stress on compliance to the pre-fixed parameters.4) Process deviations if any and the remedial action/s taken and the effects ofthe same on product quality and process.5) Analysis of results with the intention of comparing the stated objectives with 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 company regarding filing of the new product in various markets (countries). It will also establish the credibility of the process and the formulation developed by


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FD and the analytical method developed by AD.

Thus, project management may be employed to do systematic work and converge theexpertise available in different departments. Many times it also happens that people use the principles of project management without being aware of them and attribute the successful outcome as a matter of luck. Nevertheless, project management is a tremendous tool for successful execution of short time assignments of

strategic importance and also overcome the obstacles of departmentalisation andbureaucracy.

47653845 project management

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