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Stepping up to Pharma – Contractor processes and Good Documentation Practice (GDP)

“The benefits are two-fold: It increases competition and ensures that during large resource-intensive projects there are qualified resources available to ensure other works on site remain unhindered!” – Ilija P, Engineering Services – Process & Mechanical @SPN Consulting

Often MEP (Mechanical, Electrical, Plumbing) contractors qualified specifically for pharmaceutical works are scarce. So whether MEP contractors are looking to diversify into the pharmaceutical industry or pharmaceutical companies want to expand their MEP contractor pool, SPN Consulting can assist.

Misconceptions

  • Common responses from MEP contractors regarding the pharmaceutical industry:
  • “We don’t have expertise in that area, it’s too difficult!”
  • “We have no idea how to go about determining the gaps in our procedures!”
  • “It’s too much paperwork, we don’t know where to start!”
  • Common responses from pharmaceutical companies regarding developing their MEP contractor pool:
  • “It’s too time consuming!”
  • “We don’t have the resources to oversee their development!”
  • “We don’t have the experienced personnel to assess their processes!”

Compliance

Placing pharmaceutical compliance in the “too-hard basket” by those looking to enter it is due to a lack of understanding and fear of the unknown. By taking a systematic approach to compliance, there are a number of steps that MEP (e.g. mechanical, welding, fabricating) contractors can take to minimise the risks they’re exposed to:

  • Assess the current state – what we do (activity), how we do it (process) and how we document it (traceability).
  • Assess the required state – what we need to be doing, how we need to be doing it and how it needs to be documented.
  • Outline a change procedure with a continuous development mindset, (i.e. Plan, Do, Check, Act)

By assessing the difference between the current & required states for the activity, the process and the traceability, one can determine a step-by-step approach suited to the company to roll out these changes. When executed, this exposes the contractor to a completely new industry, or industries.

Benefits

The results are mutually beneficial for both MEP contractor and client:

  • The MEP contractors get considered for work outside of their core industries and over time becomes another efficient, reliable asset for the client;
  • The client facilitates a degree of flexibility and freedom by increasing competition. This in turn enables quotes/tenders are of a competitive nature and extends the pool of qualified contractor personnel that can be called upon as required.

The overall benefits are sure to positively impact the manufacturing / processing industry as it enables the MEP contractor to build on existing capabilities, garner a comprehensive understanding of manufacturing requirements and ultimately improve efficiency and workmanship across industries.

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