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The challenges facing in The challenges facing in Pharmaceutical MaintenancePharmaceutical Maintenance

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Philosophy and Key Concepts

“Maintenance programs have long been recognized as critical to the success of the operations they support.

Maintenance has the potential to affect both the quality of products and the compliance of pharmaceutical processes”

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Philosophy and Key Concepts

This presentation discusses the challenges and benefits of applying a science and risk based commissioning and qualification approach within a contract manufacturing organization. Do you have a framework for a risk-based approach for maintenance systems or component best practices?

Fig. From ISPE Good Practice Guide ‐ Maintenance

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Challenge 1 : A risk-based approach to maintenance is not used

A better way is to use a risk-based approach that classifies each piece of equipment in terms of its impact on product quality.

Direct Impact (Product Critical Equipment) Any equipment whose failure may directly impact or affect product quality For example: a mixing vessel

Indirect Impact (Process / System Critical Equipment) Equipment whose failure may indirectly affect process or system performance, thus affecting final product quality or safety For example: the temperature monitor in an autoclave

No Impact Equipment Equipment whose failure will not impact final product quality, safety or the environment For example: the security boom gate at the site entrance

Safety/Environmental Impact System Equipment whose failure may directly affect safety or the environment.

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Challenge 2 : Computerized Maintenance Management Systems (CMMS)

A CMMS system is computer software that helps maintenance teams keep a record of all assets they are responsible for, schedule and track maintenance tasks, and keep a historical record of work they perform.

A CMMS typically performs five GMP-critical tasks:a) Allocating a Unique Identifying Number (UINs) to each piece of equipmentb) Describing the validated plant configurationc) Being the repository of maintenance plansd) Holding records of maintenance activitiese) Scheduling maintenance activities

Selecting the right Computerized Maintenance Management System (CMMS) is an important business decision. Comparing different CMMS software, and then making a purchasing decision, can be difficult and time consuming. However, the reward can be a system that pays for itself within 6 months. Adopting a systematic approach will make the CMMS evaluation process a smooth one.

A CMMS system is computer software that helps maintenance teams keep a record of all assets they are responsible for, schedule and track maintenance tasks, and keep a historical record of work they perform.

A CMMS typically performs five GMP-critical tasks:a) Allocating a Unique Identifying Number (UINs) to each piece of equipmentb) Describing the validated plant configurationc) Being the repository of maintenance plansd) Holding records of maintenance activitiese) Scheduling maintenance activities

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Challenge 3 : Maintenance Plans

Maintenance Planning and Scheduling are key elements that influence the true success of any organization. Many times we have a planner or planner/scheduler, but do not know how to use him or her effectively or efficiently. When we talk about maintenance planning, we are talking about higher wrench time. At this time of economic uncertainty, a higher wrench time equals lower cost, which results in job security for all. Past studies have shown that most companies do not perform maintenance planning effectively thus impacting negatively work effectiveness, wrench time, equipment uptime, equipment reliability, and cost. If we were “Effective in Maintenance Planning”, it would result in Higher Wrench Time and Higher Equipment Reliability.

In Maintenance Scheduling, once we have achieved the discipline required and maintenance plans are completed on time the reliability of facilities and assets increase at a high rate.

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Challenge 4 : Training of the Maintenance Staff

Do your maintenance workers and contractors know the impact of changing a setting on a piece of production equipment? Do they understand the concept of a validated state? Do they know when to involve QA?

It’s hard enough to get them to complete maintenance records, let alone Change Control forms. Yet simple maintenance activities such as changing filters or adding lubricant can dramatically impact product quality.

The GMP regulations require all contractors to be trained appropriately before they enter GMP areas. Developing tight, long term relationships with your contracting suppliers is critical. Their HR systems should trigger GMP training for every new hire. You could request that small contracting companies use a simple checklist when a new hire commences work. "GMP training" could be on that checklist

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Challenge 5 : Equipment Documentation

The ideal here is that all the documentation for a piece of equipment should be in the hands of the maintenance technician before he starts work. Extra marks if he’s read it! This documentation includes: The manufacturer’s operation manual The manufacturer’s installation manual The manufacturer’s service manual Details of the validated state of the equipment, e.g., settings used Any maintenance records Any work instructions or procedures covering the use of the equipment Engineering drawings Process and instrument diagramsThe ultimate system would be to have controlled electronic copies of all these documents that the technician calls up from a wireless tablet PC. Realistically, you are more likely to have paper-based documentation stations within the plant. We recommend that you assign someone to keep manufacturers' documentation up to date (often a simple web search & download). This person can also make photocopies of documentation (never let maintenance staff walk off with the originals) and issue uncontrolled copies of quality documents as needed.

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Challenge 6 : Procedure

“Write a good maintenance procedures is essential to a successful maintenance program”

Policies, procedures and work instructions should exist for all maintenance activities. These documents form an essential training resource for maintenance staff and contractors. This documentation will also be requested by auditors, who know that maintenance is a GMP-risk.

They will ask to see documentation that describes the what, when and how of maintenance. Make sure that you have it and that it’s followed. It’s worthwhile to get a professional technical writer to produce this documentation; this will ensure that the documents are useful and understandable.

Use a risk-based approach to prioritise the documentation needed. The highest risk occurs during times of change, including projects and annual shutdowns. Start by documenting how these are handled.

The documentation system must be kept simple. Say what you are going to do and do what you said. The auditors will ask staff to “show me,” so if the documentation says that you do it, they will ask to see proof of it. They have a practiced eye to detect impractical systems and drill down. You don’t want to be at the bottom of the drilling.

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Challenge 7 : Outsourcing Maintenance

The pharmaceutical industry has faced significant competitive pressures over the past several decades that continue unabated. These pressures have led to interest in and adoption of new, more efficient and scalable operating models. Outsourcing is a major strategy that the industry has adopted across a broad range of value-chain activities.

Maintenance is outsourced for two reasons:– Expertise does not reside in house• Ex. – HEPA filter integrity testing– Finance says it is a good way to save money• Outsourcing firm pays lower salaries and benefits

Results of Outsourced Maintenance:1. Abandon Continuous Improvement2. Reduced responsiveness3. Leading Indicator of Impending Quality Problems• The Vision of Finance to Reduce Costs has taken theplace of any possible Maintenance Vision

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Recap

Don’t let Finance run Maintenance – HAVE A VISION!

Use manufacturer’s expertise when designing processes that use their products

Maintenance deserves an equal place at the Scheduling table with Production