Pharmaceutical industry has, as the rest of the world, been dramatically impacted by information technology and data processing concepts. There is hardly any area in the industry where the need of computerisation is not felt.

Some years back, companies used to have separate modules for computerising specific activities, e.g. accounts, inventory etc. This too was limited to bigger and middle scale companies.

Now, integrated software systems are being increasingly accepted by pharma manufacturing facilities. Industries are opting to get most of their operations computerised, including production and quality control, sales and distribution, financial accounting, personnel management, training and development etc.

Enterprise resource planning (ERP) software products, including laboratory information management systems (LIMS) are used to improve productivity through the automation of administrative tasks and routine industrial procedures.

Pharma ERP package
A pharma ERP software package integrates all key areas of the pharma business. These may include:

Material resource planning & management: The module maximises planning and management of new production batches by giving managers useful and real time information on the current warehouse activities and stocks for material replenishment. It helps to visualise current stock positions to streamline execution of sales orders efficiently, accurately and in time.

Purchase order processing: It allows full operational control over purchasing decisions and covers all aspects of the purchasing cycle, from placement of order with a vendor to actual receipt of the material. Vendor rate contracts may be defined, indents may be generated and purchase order created against purchase requisition and on the basis of manufacturing plan.

GRN/goods inward: It allows registering materials received directly or against purchase orders and provides the facility to log materials as per schedules defined during purchase order processing.

Inventory management & control: ERP has a comprehensive inventory management system to support total stock control from receipt of materials to their issuance to various production batches. It gives support for strategic long term planning to support projected sales, covering production scheduling and material requirement planning.

Material requisition: This module generates material requisition for the planned batch size, based on the pre defined master formula.

Material issues & returns: It issues materials based on requisition and on last stage closure. The flexibility of the system lets one issue materials on FIFO, LEFO, FEFO or on AR number basis.

Generation of BOM & maintenance of BMR: It permits to generate the BOM and BPR/BMR for each batch depending upon the desired batch size, as well as resource allocation.

Production: ERP allows maintenance of product formula with version/revision control. It also incorporates various reports providing information on real time production records, including cost analysis capabilities of products / batches.

Quality module: ERP quality module facilitates QC support for every operation stage, from receipt and acceptance of raw and packing materials through production of intermediates/ bulk materials and finally to release of finished goods, before shipment.

Sales: It allows to complete quotations offering products-pricing-terms, create sales orders, generate documents for shipping finished goods such as finished goods stock transfers, challans, invoices (domestic and exports).

Utility engineering: This module tracks repair and maintenance tasks carried out on machinery and equipments. It handles maintenance contacts, calibration records and preventive maintenance records. Machine/equipment utilization on real time production data with energy consumptions may be recorded.

Accounts: Integrated accounting module incorporates handling of all accounts. All types of vouchers may be entered such as payments, receipts, contra, journal, sales, purchase, sales/purchase return and debit/credit notes. Consolidated financial reporting is available to print ledgers, trial balance, P/L account and balance sheet.

HR (Human Resource): ERP delivers human resource module with standard functions to maintain employee records, business logics for salary calculation under integrated payroll module, generation of monthly salary. loan provisions advances and insurance.

Working of ERP may be further strengthened by incorporating various modules to generate different kinds of informational reports like trend analysis, vendor rating, stability scheduling and data compilation, reference/working standards management, equipment calibration, reserve samples management, market complaints management, training records, trade returns analysis, chemicals inventory management, project management, tracking for contract services etc.

An ERP using today's information technology, can provide the integrated framework to link all important aspects of the pharma industry and thereby increase the productivity of all functions inside and outside the organisation.

It serves as a viable alternative to various time consuming operations. Besides being highly comprehensive in nature, An ERP is indeed an excellent tool for improving compliance with FDA, GLP and cGMP.

LIMS
A laboratory information management system (LIMS) operates best when results are transferred electronically. However, transfer of data is only one way to the LIMS. The ease of interfacing analytical instruments varies greatly. Thus, instruments with low data capture rates such as chromatographs, AAS and balances can be interfaced. Data can be captured online with well proven peripheral equipment and software.

For identifying and tracking samples, bar code technology can be employed.

Data capture may also involve bi-directional communication, wherein a LIMS may pass a file to an intelligent instrument containing the information to set up and run an assay for a set of samples. After the analytical run, a file with the results may be imported into the LIMS and the results inserted in the appropriate database location.

How does LIMS work?
Once a sample is logged into LIMS package, it automatically takes over the further operations and generates the worksheet/protocol sheet/analytical work record. The worksheet comprises of all the tests required to be conducted for the sample (as per the pharmacopoeia as well as in-house specifications). It also has user defined formats for entering readings/observations enabling the user to get away from the necessity of maintaining notebooks as this contains all that information which is required to be maintained as per the FDA requirements.

While carrying out the actual testing, the readings/observations are noted in the worksheet. On completing the test, all the readings/observations are fed into the LIMS software system. The package automatically calculates the results, compares the findings with the standards and also decides about the compliance with the standards. After this, it prints out the certificate of analysis in the prescribed format. If the same fails, it gives reference to the rejection parameters also. It is the LIMS that decides about conformance or non-conformance of a sample with the standards and not the analyst. The integrity of the package is pre established and normally there is no need to check reports.

There are highly flexible test methods in LIMS, which are designed in such a way that with the inbuilt facility, an analyst has to enter only the required inputs (readings/observations), desired output format can be selected and results can be generated in desired options without giving any external formula for calculations. A same test method can be used for any type of product.

Based on whether the sample is passing or failing, it also automatically generates the approval or rejection labels for each and every container.

All product specifications, standard test procedures, standard operating procedures, calibration procedures etc. may be efficiently maintained using LIMS.

It also serves as an important management control tool. It generates various reports including quality control productivity report, analyst performance report, samples pending for sampling, samples under analysis, lab performance etc.

It keeps track of the due dates for re-sampling and also generates a report at regular interval - informing well in advance about the materials due to re-testing.

A LIMS exercises various controls that are important for a pharma industry. For example, approved/rejected labels should be printed only after printing under-test labels. Similarly, approved labels should be printed only when the sample has been declared as of standard quality.

It has ability to perform a variety of ad hoc searches. Use of LIMS package results in saving valuable hours of technical staff, eliminates time spent on calculations, writing and checking reports, thereby utilizing it more effectively to bring about an over all increase in productivity.

Results can be presented graphically, or the LIMS output can be merged with electronic mail facilitating faster distribution of reports.

The LIMS may also interact with other applications such as production information systems or manufacturing systems to provide information for computer integrated manufacture.

Selecting the right vendor
The right vendor and implementer should be able to deliver the required software and/or services in accordance with quality standards and cGMP requirements as expressed in the validation Policies and procedures.

A checklist containing specific statements for the assessment of the vendor's capability and a method for evaluating the results on the basis of a scale may be used.

The capability of a vendor to deliver the required products and/or services may include:

General information
■ When the product was first marketed?
■ What type of industry has purchased this product?
■ How many versions have there been?
■ What quantity of this product has been sold?
■ What is the expertise level?
■ Has there been continued growth of the product and client base.
■ What is the experience in pharma domain?

Business practices
■ Detailed functional specifications are entirely based on the customer's system requirements document
■ The validation of the system is supported by test files and procedures that describe how to verify the performance of the system

Product support & maintenance
■ Support on the customized version of the product is provided subject to the availability of backward technology.
■ All versions of the product on the market are supported.
■ Is the vendor financially stable with adequate and suitable resources available for support and future development of the products?

How to go live?
Adaptation of IT systems in industry needs strategic planning at management level. The user company must clearly know its requirements for computerisation and must delegate the software implementation task to the right people in the organisation. The executives involved in implementation should have thorough knowledge of the operations and should have authority to take critical decisions, when needed.

There are various methods of implementing software systems. The most commonly followed methodologies are pilot run and parallel run. Before actual software run, user company must request the vendor to deploy a pilot software system with complete operational documentation help. The implementation team will thus have technical know-how after trying hands on it and will be able to effectively convey and communicate their specific requirements. This will definitely help in producing surprising results for going live.

Use of information technology is the need of the hour. Software systems are being increasingly accepted as an essential part of a modern, progressive pharma industry. The integrated software products are being used successfully even in the upcoming small and medium pharma companies. Such software packages are now available at affordable prices in India and can be very easily implemented with current level of expertise available with the existing staff.

(The author is managing director of Oasis Infotech, Jaipur. He is also president of Rajasthan Pharmaceutical Manufacturers Association)