Month: October 2018

Contamination Control, Risk Management and Change Control

Microbiologists won’t be sequestered in the laboratory, running samples and conducting environmental testing, once the revisions proposed for Annex 1 of the EU and Pharmaceutical Inspection Cooperation Scheme (PIC/S) GMP guides take effect, Annex 1 rapporteur Andrew Hopkins said Oct. 15.

They will have a broader role that includes conducting risk assessments to ensure that sterile products are made as contamination-free as possible, said Hopkins, who is an inspector for the UK Medicines and Healthcare products Regulatory Agency.

Pink Sheet “EU GMP Annex 1 Would Give Microbiologists A Greater Role In Sterility Assurance, Rapporteur Says“

Contamination Control is a fairly wide term used to mean “getting microbiologists out of the lab” and involved in risk management and compliance. Our organization splits that function off from the QC Microbiology organization but there are many models for making it work.

Risk Management is a major part of the new Annex 1, and what they are driving at are good risk assessments with good risk mitigation that involve the microbiologists.

living risk assessments

This is really what is meant by a contamination control strategy which considers the product and process knowledge and skills in pharmaceutical product manufacturing and GMP/ cGMP compliance under the auspices of a Pharmaceutical Quality System (Q10) together with initiatives of Quality by Design (Q8) and Quality Risk Management (Q9).

From this strategy comes:

  • Targeted/ risk based measures of contamination avoidance
  • Key performance indicators to assess status of contamination control
  • A defined strategy for deviation management (investigations) and CAPA

environmental monitoring

When it comes to change management, one of the easiest places to go wrong is to forget to bring the microbiologist in to changes. Based on your strategy you can determine change changes require their assessment and include it in the tool utilized to determine SMEs, for example:

Department Required if the change meets any of the following criteria:
Contamination Control The change impacts environment integrity, conditions or monitoring, including:

  • Changes to a controlled room or area that impact integrity
  • Changes in sampling methodology
  • Construction activities
  • Changes in personnel or material flow
  • The change will result in or modify exposure of product to the environment.

The change can impact microbiological control within a process stream, raw material or process equipment

The changes are to water systems

Don’t Just Tell Employees Organizational Changes Are Coming — Explain Why

To be successful, your story needs to start with the company’s core mission and then offer a compelling and inspiring future vision. You want to answer: How are the changes you make today helping you achieve your vision for tomorrow?
Don’t Just Tell Employees Organizational Changes Are Coming — Explain Why by Morgan Galbraith

I can’t stress enough the importance of proper communication around all changes, from the large transformations on down. Effective communication is effective change management.

I’ve discussed the need to be able to identify changes to strategic plans and use that to inspire, inform, empower, and engage.

changing business environment

Always spend the time on a good communication plan:

Information to Communicate
(What)		 Objective
(Why)		 Target Audience
(Who to)		 Frequency
(When)		 Start Date
(When)		 End Date
(When)		 Media
(How)		 Responsible
(Who from)		 Deliverable Comments
What to people need to know o Determine site readiness to start the project

o Define resource needs and availability

 Tailor the communication to specific audiences. The same information is sometimes presented different ways How often? Start date End Date From face-to-face to all the other communication tools available in the modern workplace. Be creative Who is responsible for completing the communication What will execution look like  

 

Improving But Not Learning by Doing

Alex Tarbok on Marginal revolution wrote “Improving But Not Learning by Doing” looking at a paper “Causal understanding is not necessary for the improvement of culturally evolving technology” — which has interesting things to say to those interested in knowledge management. In short it demonstrates that the complex problems we have today need to be approached multi-dimension approach, in short system thinking is required to do true knowledge management.

Knowledge management Circular_Process_6_Stages (for expansion)

Throughout the six stages we need to be evaluating for complexities and interfaces. It is very easy to think in a silo and then create bigger problems done the line.

The DIKW pyramid is a great resource to keep in mind here.dikw pyramid

  • —Data comprises facts, observations, or perceptions
  • —Information is a subset of data, only including those data that possess context, relevance, and purpose
  • Knowledge is —Information with direction, i.e., leads to appropriate actions
  • Wisdom is the understanding of the why

I know that in many knowledge management models wisdom is often discounted, but that is to our detriment. Quality is often all about the why, whether a regulatory commitment, or a deep understanding of history, or as is relevant here , the relationship between parts of a complex system (or the interrelationship between systems).

Release control process sipoc

Google does not share search terms for privacy reasons, so it is rare that a search term stands out on my blog.

So here you go.

SIPOC for disposition

This is purposefully a high level process.

Quality Review of Records: Batch Record, Packaging Record, the like

Lot Assessment: Evaluation of deviations, of change control and test results; but also of other inputs such as Critical Utilities and Environmental Monitoring Review. Ideally a holistic view.

Lot Disposition: Decision that the product meets all requirements of the GMPs and the market authorization.

Some important regulatory requirements:

  • United States: 21 CFR 211.22(a); 211.22(d)
  • EU: 1.4(xv); 1.9(vii); EU Annex 16
  • World Health Organization: Annex 3-GMP 1.2(g); Annex 3-GMP 9.11, 9.13, 9.15

 

One of the drivers for digital transformation, and a concept at route of the ICHs, is the idea of release by exception. Our systems will be tight enough, our design space robust enough, that most products are automatically released and sent into the market.