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Automation Trends in Pharmaceutical Manufacturing
- Govind Srinivasan, Senior Market Analyst, Technology Services Group, TAKE Solution

The pharmaceutical manufacturers have had to look at innovative ways to become more efficient and agile. This article explains how drug manufacturers can drive more competitive advantage into their operations by applying enhanced and improved automation technologies into drug manufacturing.

Pharmaceutical companies worldwide are facing challenging times due to a large number of patent expiry, high cost and long lead time to bring out new drugs, pricing regulations, global competition, regulatory norms, stringent quality protocols, etc. The regulatory authorities have become very stringent on deviations and are subjecting all manufacturers to strict quality norms. Any product recall for an organisation is very expensive and also exposes the organisations to additional scrutiny by regulatory authorities.

Pharma companies are taking every effort to improve efficiencies in all steps of manufacturing, packing and distribution. Automation and integrated systems are being planned to effectively address manual data entry and errors.

Key Challenges in Pharma Manufacturing
Most Pharma manufacturers have implemented manufacturing/packaging line management automations and backend ERP applications. The major area of weakness is integration such as manmachine integration, manual operation & its verification, automated data collection, and B2B to suppliers & distributors. Some key challenges typically faced by many pharma companies are:
  • Automating integration with suppliers for managing and controlling supplies & labeling of raw materials.
  • Ensuring that all incoming materials have been sampled and tagged for usage.
  • Dispensing of right ingredients to manufacturing lines.
  • Dispensing right quantity of ingredients after considering the exact propensity of material.
  • Ensuring compliance of all designed manufacturing process and control checks with appropriate escalations.
  • Creating & maintaining batch manufacturing records electronically.
  • Ensuring ePedigree Regulations compliance.
  • Controlling final product labeling so that it matches with the packaged drug.
Pharma companies are employing a range of technologies and applications to address these challenges. Some of these technologies include:
  • Supplier integration portals.
  • Barcode & RFID technologies.
  • Enterprise Mobility for automated data collection and operation control.
  • Automated data collection from the process control system.
  • Upgrade manufacturing lines to include high speed printers and camera.
  • Document management systems.
Automation Opportunities
There are several opportunities for automation across pharma manufacturing processes as given below:

Vendor Collaboration Portal: This portal enables seamless, efficient electronic business with your supplier partners, maximises control and compliance, and increases visibility into your business ecosystem while adhering to XML and other messaging standards. Pharma companies can also enable and control all barcodes and labels printed on raw material which will make receiving of material at the manufacturing facilities easy.

Pre-Manufacturing Processes: These processes cover material receipts, sampling, warehousing & dispensing functions. ERP along with specialised applications like laboratory information management and quality management systems, address the requirements of these functions. Some pharma companies have also automated their operations by using Enterprise mobility interfaces via handheld computers/scanners to capture data at the point of action and to post data to ERP for achieving real-time visibilities to the operations. These mobility applications help to extend the power of ERP to the hands of operational personnel for enhancing productivity and accuracy.

The mobility applications assist the warehousing and QA personnel to ensure all materials including samples to be barcoded and appropriately labelled. It also ensures storing of material in correct locations and dispensing of material based on FEFO (First Expiry First Out) method after considering any partially issued drums.

Manufacturing & Packaging Processes: Most of the Manufacturing & Packaging processes automation is based on Line Control Systems and the required record keeping is maintained manually. The manual operations are mostly performed with very limited automated verification. There are significant opportunities to automate the manual operations starting from verification of input materials dispensed for a work order, data collection in each manufacturing step via direct machine interfaces and automation of in-process verification using barcodes and handheld computers. Electronic Batch Management Records (eBMR) will bring in a new dimension of analysing the historical data.

The ePedigree Regulations and the centralised Track and Trace repository require significant changes to the manufacturing lines to enable high speed printing of serialisation data and scanning to collect data to maintain the required parent-child relationship. The application software needs to generate the required serial numbers and maintain the events based on EPCIS standards. There are also changes to packaging specifications to meet the requirements of anti-counterfeiting measures.

Distribution Processes: The Distribution Processes ensure that the manufactured drugs reach the warehouses and finally pharmacies/hospital for patient consumption. The Enterprise Mobility applications have changed the landscape in this area to collect data at the point of action and post data to the back-end applications for real-time visibilities. The Track & Trace repository established in the previous step is also used to record packaging status during distribution and also facilitates serialisation verification by consumers and any intermediaries.

Conclusion
There is significant progress in technology & software applications to ensure productivity and real-time visibilities to the operations. Many leading Pharma companies have enhanced robustness, reliability and safety to their products and operations by adopting these advanced technologies. Another important factor that needs attention is change management to business processes and people. The regulatory oversight and audit have also increased during recent times and it is critical to implement system so that organisations are always audit-ready.