New PIC/S GMP PE009-13

New PIC/S GMP PE009-13

The New PIC/S GMP Version 13 is finally here and it’s all about the people!

I have a specific interest in what is in the new PIC/S GMP, for example, Chapter 2 (Personnel), it expands and specifies the responsibilities of all personnel.

Let’s look at the New PIC/S GMP together.

The introduction to new PIC/S GMP Version 13, Chapter 2 starts with:

“The correct manufacture of medicinal products relies upon people. For this reason there must be sufficient qualified personnel to carry out all the tasks which are the responsibility of the manufacturer.”

The new version identifies the core to the production of safe, effective medicinal products – the people!

People in your factory and your consultants should (read must) have the right qualifications and practical experience. But that is old news – I mean, that was in the previous version as well. The novelty is in the next sentence:

“Senior management should determine and provide adequate and appropriate resources (human, financial, materials, facilities and equipment) to implement and maintain the Pharmaceutical Quality System and continually improve its effectiveness.”

We can identify a few critical elements in this clause which contribute to the true success of organisations:

  • Senior management is responsible
  • Determined adequate and appropriate resources
  • Provide adequate and appropriate

Without these three elements, it is difficult for an organisation to achieve its operational goals.

The last two almost look the same, but don’t necessarily come together in all organisations.

For example, an organisation may determine the resources needed, but if senior management doesn’t acknowledge or provide those resources, the organisation will not be successful.

This rule works in the opposite direction as well. Senior management may provide resources but if it’s not determined what resources are adequate and appropriate, the assigned resources might be inappropriate, making it difficult for an organisation to be effective in meeting its goals.

Next what else is in the New PIC/S GMP in the chapter about people:

”Senior management has the ultimate responsibility to ensure an effective Pharmaceutical Quality System is in place to achieve the quality objectives, and, that roles, responsibilities, and authorities are defined, communicated and implemented throughout the organisation.”


Now they said it loud and clear. No doubts as to who is responsible!

Senior management….I cannot agree more.

Senior management is responsible for managing an effective quality system. Promoting quality objectives and assigning responsibilities and authorities should be led by the senior management.

From my experience when senior leadership demonstrate actions and behaviour that promotes quality, it does permeate down to all levels.

”Senior management should establish a quality policy that describes the overall intentions and direction of the company related to quality and should ensure continuing suitability and effectiveness of the Pharmaceutical Quality System and GMP compliance through participation in management review.”

What can I say; as far as I see it they write all the right words! Senior management should establish a quality policy…and ensure that it is communicated and understood by everyone! The quality policy should align with the organisation’s strategy, after all that is the whole purpose of the organisation being in business. If you would like to read more about “Cultural Change Methodology as a Competency in this blog

The policy should also be continually reviewed to ensure that it remains effective (and that it still aligns with the organisation’s strategy when the goal posts are shifted).

Well, it goes on, but I think you got the idea.

The senior management is responsible and this must be demonstrated during an inspection.

Values start from the top and permeate down to all levels.

So if you are a senior manager in a pharmaceutical company, know that not only all the people reporting to you are following the standards you demonstrate, it’s also required by the PIC/S that you demonstrate the company’s quality values.

If you enjoyed reading article about the new version of PIC/S you may be interesting in reading about the new requirements for User Requirement Specifications or attending one of our PIC/S GMP training courses.

We have a number of other articles which may be of interest, such as ten tips on how to improve your quality system, or PIC/S update to PE009 – Quality Risk Management.