overcoming regulatory hurdles

Project bites from in the trenches

A day in a PharmOut consultant’s life

I’m often asked what a typical PharmOut day entails. After recently hearing from one of our consultant’s partners, that they were completely amazed when he told her what he did each day: “Surely you don’t do that?”, “I did not know that PharmOut does that!”, I decided to clear things up by sharing some examples of what the amazing PharmOut team does each day (whilst doing my best to preserve our clients’ confidentiality-don’t try guess, we have over a 1000 clients and its a secret!). We have a diverse range of clients, doing all sorts of exceptional things, and the PharmOut team get to work on some of Australia’s cutting edge health science developments. Here are some recent examples.

Designing a new “dairy” facility

PharmOut was delighted to be selected to design a new dairy plant to extract key proteins (I’m deliberately leaving this vague). Our architecture team worked closely our engineers  to come up with a design that was both beautifully functional – being centered around the process and regulatory requirements, as well as pleasant to work in and representative of the client’s brand.

Other ‘cow’ products

Continuing on the cow theme, PharmOut recently undertook the process design for a bovine serum facility in Canada. We’ve got a lot of experience in the whole dairy / bovine serum / milk protein products area now, having completed projects in Australia, New Zealand, South Africa, Holland, Canada and China. We find that clients in this industry need a lot of support to meet the rigours of GMP regulatory requirements, which are usually much more onerous than the regulatory framework they are used to.

Quality by Design and ANDA applications

A technical transfer project last year involved helping our client with a couple of US Abbreviated New Drug Applications (ANDA) for various generic products (the ANDAs pre-dated QbD and the related drugs are not currently in production).

The plan is to contract the manufacture and packaging of the medicines to a third party Contract Manufacturing Organisation (CMO).  Our team provided consulting services regarding the chemistry, manufacturing and controls (CMC) and cGMP-type requirements; risks and processes related to this type of ANDA supplement; and included the extent of Quality by Design (QbD) principles required for supplements to prior approved ANDAs. We delivered:

  • A process map for the product development phase to ensure that pre-existing data has been collated and assessed, and all relevant process steps, regulatory expectations and risk management strategies have been employed during the “Stage 1 Process Validation” activities.
  • A documented guideline for technical transfer validation, focused on regulatory requirements and desirable elements for stage 1 and 2 validation batches.  The guideline draws on PharmOut’s and the CMO’s industry experience and knowledge, as recommended by independent bodies such as the ISPE / PDA.


Design & construction project moves to next stage

Late last year, PharmOut and partner Logistic Bureau were the successful tenderer for the design and construction of an exciting new 20,000 square metre Australian distribution centre.  Specialising in the distribution of healthcare products the centre incorporates state of the art material handling equipment. Concrete pouring is scheduled to commence soon.

I’m always delighted when a client asks for further work to be done, as it’s proof they were happy with their first PharmOut experience. Since completing the design of the distribution centre, the client has  asked for practical help with their existing facilities. This includes warehouse temperature mapping, 2 to 8 cold room designs, and the implementation of a complete eQMS solution.

How cold is my eski?

From distribution centres to an eski… An interesting request for temperature mapping of an ‘eski’ (portable cooler) caught our team’s attention. Our client has developed a cold chain transport container with temperature tracking capabilities, aimed at the GMP logistics market. They asked PharmOut to help with the development of  supporting documentation and testing i.e. validation, to maximise product storage conditions.

Cleanroom classification for terminally sterilised bio product

Another project involved the manufacturer of a Class II (US) / Class III (EU+AUS) terminally sterilised, implantable medical device from animal origin asking PharmOut to perform a risk assessment and provide consulting support on clean room classification for their medical device based on standards and practical knowledge and industry experience.

HVAC upgrade

PharmOut HVAC Mechanical Engineer James Downing, is currently helping a multi-national manufacturer, based in Melbourne, to upgrade their HVAC system.  The project requires a staged implementation in an occupied building and includes facilitated workshops, design concepts, costing and associated specifications and layouts.

Bovine inspections

PharmOut routinely performs third party inspections and gap assessments both in Australia and across the globe. Bovine serum audits continue to be a niche area, which Seamus Orr, our NSW manager supports. The audits typically occur over one day with our clients predominately based in Europe. This year we have performed inspections in Tasmania, New Zealand and across Australia.

Not just a QMS, thank you Alison

In any month, we have several Quality Management System projects on the go, but PharmOut consultant, Alison Tennent, has been dug in with her current client for a few months now with the scope of an ISO 13485 QMS project broadening to include HR and the SAP validation documentation. With this new company set to launch early 2016, Alison is just the person to get the job done on time and with great results.

Design reviews

You only need to say ‘design review’ and the PharmOut boardroom swells with consultants asking to be involved.

An Australian client is planning a new facility and have progressed to the point where they have shared information and initial site plans with the TGA. The TGA has provided feedback and our client needed to undertake a risk assessment of the material flows and processes through the facility with the aim of identifying potential GMP gaps and associated risks. After an on-site workshop, we worked with the client to determine a mitigation strategy to address the identified risks i.e. modify design, change process, identify technology.

Not so close to home, we have completed many design reviews remotely, including facilities in China, Vietnam, Malaysia, Taiwan, Indonesia, Bangladesh, Pakistan and believe it or not, one in Syria.  As much as we had many assurances in the early days of the project that Aleppo was perfectly safe, we preferred the safety of our headquarters in Melbourne! A remote design review, using today’s modern screen sharing conferencing technologies, has proven to be a popular and cost effective way to support clients.

Change is never easy

An interesting support request this month came from a client in Indonesia, working with an ISO 13485 manufacturing facility and preparing to move to GMP manufacturing and FDA inspection. The need for organisational change management to ensure all members of the organisation understand the quality transition occurring in addition to the facility upgrade has led to PharmOut providing support in stakeholder analysis and communication planning.

Holding the fort, again

Typical of many of our consultants, the ever popular Debbie Parker was recently invited to back-fill a QA manager role so the incumbent could take annual leave. The QA Manager went on leave, comfortable in the knowledge that they had a proven back up in place. Debbie stepped into the role and found herself handing an audit findings letter and supporting the TGA response! Of course, she was able to draw upon her considerable experience and deliver a successful outcome.

Of course the cherry on the top!

Last year, PharmOut also completed the process of guiding another agency towards PIC/S Membership. it’s great to know that we are doing our bit to make medicines safer around the world.

You might also be interested in reading Perception is Reality – Saying Yes to a Client