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Considerations with dual site production

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There are generally two options available when looking to expand storage capacity – build to develop existing facilities or select a two site solution. What’s right for your pharmaceutical business will depend upon a number of factors.
Disaster Recovery
First let us think about the unthinkable, disaster recovery. For most companies this is a plan that although pertinent to the successful running of any pharma business, should hopefully sit unused and only seriously considered when it is time to review the policy. However, should the worst happen then having two sites will allow you to have greater control of your disaster recovery programme. This is because spare capacity and transfer protocols can be built into each facility to allow transfer of high value stock in the unlikely event that your disaster recovery procedures are required.

Software Location
Ensuring IT systems can be hosted from either site allows the swift transfer of servers and functionality to the opposite location. This is essential to ensure communication to clients and suppliers is available as soon as possible following a disaster as helping to reassure clients of any business interruptions and keeping them up to date with events is vital to the speed of recovery to a business following a disaster. Although a move to cloud hosting for IT is becoming more popular for office and mail functions, making email access in the event of a disaster relatively simple, the operating software required for pharmaceutical companies to operate GMP compliant systems is generally still held on the company servers. Careful consideration must be given to the location of the server software. Generally, a policy of locating the software on the servers in the building with the highest use of that software is a simple approach, however the method of data exchange between the sites is critical as delays on accessing data due to the location of the software can have a major impact on productivity and staff morale.

A further benefit of a two site solution is the ability to provide dual storage locations within a single company and process. This can be particularly useful for companies outsourcing storage of their API, Master Cell Banks and High value stock. For disaster recovery and insurance purposes the material is in two locations, however for the outsourcing company they have one supplier and one quality system to audit and a single point of contact for their stock management.  

Although the overall systems and processes across two sites should operate to a single quality and operating system, different processes across two sites allows tailoring of these processes to fit the individual types of pharmaceutical product handled at each facility. Process flows can be maximised by specifying equipment and expertise to a location depending upon the activities allocated to each site. In addition it is easier to ensure employees are operating to their core competencies and in agreement with their training records if processes are split across two sites. For example, it will be easier to ensure that only appropriately trained employees are handling genetically modified organisms (GMO) or cryogenic products if receipt, storage and dispatch of these products occur at one location. Additionally, testing and development of new products and systems can be easier with split sites as one sight can contain all testing activity with dedicated storage areas, helping to prevent any possible mix up between test and released product.  We find this can be particularly useful for testing controlled temperature shipping systems where test shippers and their cooling panels can look very similar to approved shipping systems. Only receiving the test stock at one location and the operational shipping systems into another site prevents the possibility of mix up at receipt.

Management of staff
The greatest issue with a two site solution is the management of staff.  Ensuring that standards are maintained at the same level across multiple sites requires additional resource both in the audit requirements and in the written procedures. At a single site communication can flow through written processes, but also through observation and conversation, this can lead to small ‘tweaks’ in processes which are controlled at the operating instruction level but not captured at the standard operating procedure level. Unless there is a very robust change control and documentation system across both sites then processes that start out as identical at both locations may drift apart and could possibly lead to issues if products are transferred between facilities.  Much effort also needs to go in to ensuring the sites do not operate in ‘silos’ and make decisions for their site which adversely affect the processes at the other site.
However, as long as the staff and data management issues are recognised and managed by the company as part of the facility development, a two site solution can have significant advantages for any pharmaceutical company and their clients.

Rachel Griffiths is Technical Director for Biotec.
She joined Biotec in 2004, following roles as a Development Scientist, Technical Support Scientist and Product Support Specialist at Ortho Clinical Diagnostics. In her current position Rachel has overall responsibility for the Facility and development of new services and products. Rachel also holds a degree in microbiology and virology from Warwick University. You can email Rachel at or find out more at

By Rachel Griffiths - Technical Director , Biotec Services International

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