APR Sept/Oct 2023 - 101

« BIOPHARMACEUTICAL
* Pest control: Even a company with a robust pest control
program could face an infestation if its neighbor is too lax
with its own program, making it critical that all tenants adhere
to the same minimum quality requirements. The agreement
might include rules specifying the frequency of inspections,
who will maintain historical trends, where to place rodent bait
stations, service frequency and other similar details.
* Security: Because regulatory agencies require that all
manufacturing locations be secured, every life sciences
company must outline a security plan to ensure that only
authorized and qualified people can access manufacturing
suites. Security measures may include a variety of physical
controls, such as door locks, as well as security personnel. The
landlord may have a security team that oversees the perimeter
and common areas that are open to the public, such as parks,
but every company must have its own security plan as well.
* Common warehouse: Whether a warehouse is managed by
a landlord or a tenant, it may be open for multiple companies
to use. The quality agreement should outline which sections
of the space are allocated to each tenant, what types of
consumables, materials, products, etc. can be stored there
and any conditions that must be met to provide an adequate
controlled environment. In addition, physical separation
between allocated spaces, such as cages or demising walls,
must be in place between each tenant.
* Quality management system: Each party must have a quality
management system (QMS) in place that documents processes,
procedures and responsibilities for achieving quality policies
and objectives. This QMS will help coordinate and direct
activities to meet company and regulatory requirements while
improving its effectiveness and efficiency on a continuous basis.
The agreement must identify the QMS components that will be
utilized by each party to ensure compliance with regulations
and provision of products, space and services in the most costand
resource-efficient manner.
Of course, it is not enough to simply have a quality agreement in
place. Each party must have a quality assurance group that owns the
agreement and assures that responsible parties complete work per
applicable industry regulations. This group will conduct routine audits
to monitor compliance and take ultimate responsibility for upholding
the company's commitment to quality.
Seizing the Opportunity for
Campus Reinvention
Repurposing a life sciences campus can challenge old notions of
what a campus should look like and demonstrate how modern and
forward-looking spaces can be. I have seen firsthand that enlivening
a campus with social events, amenities and new tenants can create an
environment where talent thrives.
For biopharma leaders, reinvigorating a legacy campus provides an
immense opportunity to fortify quality culture. With a proactive approach
to quality assurance, companies can fulfill compliance obligations
and create a happier, more committed workforce in the process.
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