Why should pharma & biotech industries adapt MES?

Manufacturing execution system (MES) offers significant advantage over paper-based manufacturing processes.

MES helps pharma & biotech manufacturers to manufacture product with real-time, 360° visibility of weighing & dispensing, manufacturing, packaging, equipment/area usage, that can be used to optimize production efficiency. And its key requirement is digitization of processes.

There are many noticeable benefits of implementing MES in pharma & biotech manufacturing.

Elimination of paper

In regulated industry, everything is documented. Either it is batch record, cleaning record, employee record, deviation record, validation report, maintenance record or calibration record or any other, all these would be  papers. And as per guidelines, all records should be stored at some safe and controlled place for many reasons such as, audits, market complaints, batch recall, research, compliance, stability, etc. And maintaining of these paper records become increasingly tedious, also it is difficult to manage in disasters; there is always a threat of  loss or misplacing some records or even one page.

A MES (ProcessXE) eliminates all this manual documentation and digitizes all processes on shop floor. In digitized form it becomes easy to store, access, review, get ready for audits, segregate batch wise, product wise batch records. Also, all record storage becomes easy with convenient archival & retrieval of records and have control on entire document process with ProcessXE application.

Reduction in time and operating costs

By digitizing end-to-end processes of manufacturing industries; from warehouse, to weighing & dispensing, to production & packaging of goods, can reduce the operating costs by ~30% and overall time by ~80%.

For a sizeable organization following manual BMR (Batch manufacturing record) has its own complexities along with challenges. such as,

  • In raw material & packing material, unexpected problems can hinder or delay the production process which results into unexpected cost and increased time to market

Example: During batch production, there is a possibility of  material mismatch, or incorrect material picked, expired/restricted material dispensed, leading to revoking the batch, which is extra cost. Sometimes batch would have to be recalled  if that batch is already dispatched in the market.

  • Dependent on humans

Example: Firstly, designing and approval of BMR itself requires human intervention up to certain extent. Secondly, crucial part is execution of BMR with manual intervention occasionally can lead to incorrect data entry, Batch production requires human intervention in absence of digitization.

  • Finite scheduling

Example: In absence of digitized or electronic system, planning of batch is always challenging as one cannot keep all round track be it, RM, PM, WIP, area cleaning activity, calibration of equipment’s, and so on. And it can be error prone and sometimes it can lead to deviations.

  • Quality & Compliance

Example: It is obvious that in manual system achieving compliance sometimes becomes tricky as each and every event might not be noted down and or what corrective preventive action/s had been taken with respect to any incident and also, employee turnover. With such events, organizations have to pay in terms of non-compliance of varied degree – observations or 483s or even more drastic to license cancellation or even more severe!

 

Improve visibility

Transparency/visibility is more important when we talk about batch processing. Especially when we talk about regulatory authorized processes. As all batch processes produce  documents, such as batch record, cleaning record, employee record, deviation record, maintenance record, calibration record or validation report, all these would comply with Data Integrity guidelines; ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate) as per regulatory expectations. ProcessXE makes processes smooth & speedy to meet compliance & timelines with lesser efforts & time to have these as electronic records.

Maintaining data integrity can be considered as one of the main reasons why manufacturing industries especially pharma industries have started to adopt MES for their daily manufacturing operations. MES can also reduce number of deviations per batch, reduce human efforts, reduce down-time of equipment by giving 360° visibility throughout the plant processes.

More visibility means improved production, scheduling, reduced time & costs, reduced human & machine efforts, reduced lengthy document process, improved decisions, improved overall production performance & effectiveness.

And this enables shorter time to market!