ERP Report

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Enterprise Resource Planning of a Pharmaceutical Company

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    ENTERPRISE RESOURCE PLANNING OF A

    PHARMACEUTICAL COMPANY

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    INTRODUCTION

    The pharma industry is perhaps one of the most sensitive and critical one with contrasting

    dynamics and updates taking place each day. It is showing a remarkable progress by inventing new and

    cost effective solutions. Not to forget the strict standard codes, governmental policies and flawless

    productivity that compels the industry to incorporate advance technique to strategize their capability. No

    doubt, when effective performance, quality parameters and volume production are the concerns,

    technical advancement is inevitable.

    Today compliances, batch processing, financial transactions, global accounting compliances,

    taxing systems, research methodologies, clinical trials have seen a sea change which gives us the

    glimpse of challenges associated with the unprecedented growth. To meet these new regulations

    documentation, processes, information security play a critical role. This challenge is answered with the

    advanced IT platform called Enterprise Resource Planning or ERP. While usage of ERP software is

    widely accepted in western subcontinent for some time now, but it has caught the attention of Pakistani

    pharmaceutical domain recently. Nevertheless, the introduction of this advance technology platform has

    accelerated a new wave of transformation in the pharmaceutical sector.

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    The flexibility and balanced process management of enterprise resource planning have

    tremendously helped pharmaceutical companies to augment the processes with specific objectives. The

    real beauty of ERP is the industry wide applicability from pharma companies to the end of their supply

    chain. Now when we consider the Pakistans scenario and the complexity of the supply chain the first

    thing we need to acknowledge is that a standard ERP platform may not be relevant here. What we

    need is an integrated solution customized to meet the specific needs of the industry . Here it is

    essential to mention the criticality of the Pakistans pharma industry.

    The success of the industry today depends on the crucial factors like

    Process efficiency Reduced time to market Deep penetration of drug in the remotest part of nation Optimizing the cost Reducing wastage Maintain product availability Remain flexible to meet emergencies

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    Ideally meet these entire criteria while keeping optimum inventory. So a streamlined and

    integrated process can push the growth factor of the industry to higher scale both in terms of production

    and reach.

    Standard Operating Procedures of Pharmaceutical Industry

    Creation and use of GMP equipment logbooks

    HPLC Calibration

    Operation, calibration and maintenance of electronic analytical single pan balances

    Aseptic Technique Guideline for Manual Operation in a Biological Safety Cabinet, under

    Laminar Flow Hood or in a Clean Bench

    Hosting Regulatory Inspections

    Preventive maintenance (PM) procedure

    Annual product review

    Supplier certification program

    Change control system

    Calibration of dissolution test apparatus (USP apparatus 1 and 2)

    Deviations (failure investigations, non-conformance)

    Creating, reviewing, approving and issuing an SOP

    Calibration program

    GMP document management

    Corrective and preventive action (CAPA)

    NDA field alert

    Supplier audit program

    Product Recall

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    Self-inspection program

    Training

    Batch reprocessing and reworking for API (active pharmaceutical ingredients)

    Investigation of complaints

    Handling of OOS results

    Returned drug products

    Classification evaluation approval of cleaning agents

    SOP for refrigerated shipment

    Pest control program

    Handling of chemicals, reagents and solutions in laboratories

    Business Processes within a Pharma Company

    A standard pharma company has to maintain departments right from production, R&D, quality,

    marketing, storing, purchasing, logistics, finance, maintenance, inventory management and control to

    mention a few. The dynamic scenario prevalent in the pharma industry calls for a process which is not

    only optimizes resource but increase productivity, efficiency and quality.

    Needless to say this is the phase when Enterprise Resource Planning (ERP) comes in action. A

    well aligned ERP system reorganizes procurement of resources, minimizes wastages and enhances

    performance manifold times. The software automates complete cycle right from delivery, tracking,

    payments, supply management, analytics and resource management to a holistically developed decision

    support system. In a short span of time ERP has evolved pharma industry drastically by integrating the

    entire business processes, organizational objective and future plans under single umbrella. The genius of

    ERP is its solid architecture, interactivity and industry centric functionality which eases operation while

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    delivering outstanding result. Perfect ERP software aids a pharmaceutical company to gain high ROI by

    minimizing OPEX considerably.

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    Flowchart of Supply Chain Process in a Pharmaceutical Company

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    Distribution & Logistics System

    Marketing & sales

    Point of sales

    Purchasing

    Inventory management

    Logistics

    Human Resources Management System

    Manpower planning & recruitment

    Personnel management

    Training

    Payroll

    Manufacturing & Quality assurance System

    Routing

    Bill of materials

    Master Production Scheduling

    Rough-cut capacity planning

    Capacity Requirement Planning

    Materials Requirement Planning

    Production Order Processing Systems

    Shop Floor Control Systems

    Quality Assurance & Procedures

    Costing & Pricing System

    Financial Management & Control System

    Accounts Receivable (AR)

    Accounts Payable (AP)

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    PDC management

    Fixed Assets Management system (FA)

    General Ledger (GL)

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