Pharmaceutical sector  

This sector is subject of a variety of laws and regulations that govern the patenting, testing, safety, efficacy and marketing of medications and medical devices. Innovation and science play a crucial role in this highly demanding context where providing safe and effective products is the main priority. 

Good manufacturing practices (GMP) violations identified through routine regulatory inspections are manifold. Regulators do witness some violations, such as the destruction of paper records, the failure to take corrective action to address open investigations into interrupted, missing, deleted or lost data.  

In most cases non-compliance stems from inadequate or poorly implemented procedures, not knowing or not respecting ALCOA. 

Given the increasing challenges and complexity, the Lean Six Sigma improvement and Asset Management Optimization programs in Pharmaceutical are enablers to support the improvement of the internal logistic processes, to optimize OEE and maintain a very high level of organization with minimum risk. 

In addition, digital transformation will help transform current business processes to drive profitability, with a holistic view to ensure the implementation of needed changes throughout your organization.   

Pharmaceutical industry

Asset Management in Pharmaceutical 

Asset Management in a good manufacturing practices (GMP) environment is part of the overall compliance effort of the site, instituted to not only maintain equipment correctly to ensure availability and proper operation, but also to maintain the validated state of equipment used in the utilities, facilities, manufacturing, processing, packing, holding, or testing of a regulated product.  

Manufacturers who are found to be noncompliant repercussions may include: 

  • Production stoppages; 
  • Distribution and import bans; 
  • Regulatory approval delays;  
  • Product recalls; 
  • Lose the trust and good will of the regulators; 
  • Increased scrutiny through more frequent and in-depth inspections; 
  • Personal and corporate prosecutions. 

 

Outside of the regulatory repercussions, companies’ reputations, share prices and profits also suffer. Remediation costs can be substantial, and brands and confidence in industry are damaged. 

By evaluating the Asset Management Status against best practices your company will identify the priorities and weighs to achieve the best balance for all initiatives to implement an adequate Asset Management including digital solutions and business processes that will impact business results: 

  • Reduction of the total costs of operating assets 
  • Reduction of the capital costs of investing in the asset base an asset life cycle cost 
  • Improvement the operating performance of the assets (reduce failure rates, increase availability, etc.) 
  • Reduction of the potential health impacts of operating the assets 
  • Reduction of the safety risks of operating the assets 
  • Reduction of the environmental impact of operating the assets 
  • Maintaining and improving the reputation of the organization 
  • Improvement of the regulatory performance of the organization 
  • Reduction of legal risks associated with operating assets, asset results can be optimized taking into account all the previous listed benefits and determines  
  • Reduction of administrative work wasting time 
  • Reduction of paper usage 

 

Lean Manufacturing and Six Sigma in Pharmaceutical 

Lean and Six Sigma represent a mindset shift. Pharmaceutical sector all over the world have been using Lean Six Sigma principles for years.  

These principles are a framework for thinking and improving, and even people who aren’t experts with Lean and Six Sigma can experience tremendous improvement by just applying the basics to their work, understanding how to satisfy customer expectations and learn how to build upon data and facts and objective analyses. 

 

When evaluating the current status against Operational Excellence, your company will be able to: 

  • Identify the baseline and priorities 
  • Define the project scope,  
  • Expected investment and results, 
  • Define the strategy, plan, methodologies, tools and digital solutions that will be incorporated 
  • Define the implementation plan 
  • Define how it will be standardized 

 

Using, as appropriate, the different methodologies such as 5S, SMED, KANBAN, PROBLEM SOLVING, the Waste reduction will be inevitable, with direct impact on: 

  • Performance improvement 
  • Quality improvement 
  • Increase availability 
  • Increase OEE 
  • Mistake reduction, in an industry where one misstep – even a small one – can have devastating consequences. 
  • Reduction of administrative work wasting time and paper usage 

 

What is ALCOA? 

The ALCOA acronym is commonly used to summarize criteria for ensuring data integrity, whether that data is based on acceptable paper, or electronic records. 

  • Attributable: Who performed the action and when? If a record is changed, who changed it and why? Is there a link to the source data? Have user credentials and permissions been checked. 
  • Legible: Data must be recorded permanently in a durable medium and be readable and understandable. Have recorded data and results been checked before being recorded? 
  • Contemporaneous: The data should be recorded at the time the work is performed and date and time stamps should follow in order. 
  • Original: The information must include the original record or a certified true copy of the original, including all metadata. 

Among other things, metadata for a particular piece of data could include a date/time stamp for when the data were acquired, a user ID of the person who conducted the activity that generated the data, the instrument ID used to acquire the data, audit trails, etc. 

  • Accurate: There should be no errors, or editing performed without documentation of amendments. Data should also be verified as correct. 
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