The pharmaceutical sector has been subject to intense competition over the past few decades, and this pressure has not decreased. New, more effective, and scalable operational models are becoming more and more popular as a result of these challenges. One important tactic that the industry has used throughout a wide variety of value-chain operations. One important area where outsourcing is being used more and more is as facilities management, a significant indirect cost component that includes R&D, technical activities as well as commercial buildings.

A large range of tools, raw materials, and processes, which make production exceedingly costly and complex. The corporation is compelled to function in accordance with all of the aforementioned rules and regulations due to state regulations and requirements for manufacturing, distribution, storage, and transportation.

Process optimisation, efficient management, and problem-solving necessitate the following professional services facility companies:

• Keeping industrial spaces, warehouses, and retail locations sterile as a prerequisite for the manufacturing, distribution, and storage of pharmaceuticals.
• Monitoring systems to ensure that business and industrial processes run smoothly security of buildings and surrounding regions to deter medication theft, particularly of prescription ingredients.
• Supplying ventilation systems for the workplace and ensuring that they are operating properly for employee comfort and safety.
• For businesses to operate more profitably and efficiently, separate operations can be automated and integrated into a single automated system.

The success of the outsourced facilities management model still needs to be better understood, even with its increasing adoption. This is especially true in manufacturing and development facilities, which have different needs and constraints than commercial offices, where outsourcing is more frequently used.

A wide range of tasks, from building maintenance and engineering to mailroom operations and utilities-plant maintenance, are included in facilities management. Facilities management at research locations can also refer to services connected to the laboratory, like glassware upkeep, fume hood repairs, and some laboratory equipment calibration. The services covered by facilities-management outsourcing as well as the broad service categories that determine how facilities management is understood in the pharmaceutical sector are included in Table I.

Table 1: Service categories commonly included in contracts for facilities management by ND Global

Activities will establish and provide documentary evidence that:

Facility qualification, which is a part of validation that demonstrates and documents that equipment or ancillary systems are installed correctly, function as intended, and actually produce the expected results; and validation, which is establishing documented evidence that offers a high degree of assurance that the manufacturing processes, including buildings, systems, and equipment, consistently produce the desired results in accordance with predetermined specifications and quality attributes.

• Design Qualification (DQ) – The facilities, equipment, procedures, and auxiliary utilities have all been designed in compliance with GMP regulations.
• Installation Qualification (IQ) – The equipment, facilities, and auxiliary utilities have all been constructed and installed in accordance with their design requirements.
• Operational Qualification (OQ) – The equipment, facilities, and auxiliary utilities all function in line with their intended designs.
• Equipment Performance Qualification (EPQ) – The utilities, facilities, or equipment that may have an impact on the quality of the product operate as planned and satisfy specified acceptance standards. Process validation can start when the facility has been validated (IQ + OQ + Performance Qualification).
• Process Performance Qualification (PPQ) or Process Validation (PV) – A particular procedure will reliably result in a product that satisfies predefined requirements and quality standards.

The first step in launching a project is assembling a team of professionals whose abilities match the scope and scale of the undertaking. The composition of the project team should be determined by the project’s scope, resource needs, and important stakeholders.

Large pharmaceutical corporations have started to take action in this field as a result of taking these aspects into consideration. Leveraged facilities-management outsourcing has been explored by businesses including Pfizer, Merck, Amgen, J&J, Novartis, Eli Lilly, and others.

1. Enhanced productivity and efficiency – Skilled facilities management makes sure that all machinery and systems are kept up to date and operating correctly, which can assist to cut down on downtime and boost efficiency all around.
2. Enhanced security and safety – To help guarantee the protection of staff and guests, a qualified facilities management team can put safety procedures into place and keep up security systems.
3. Risk management – Qualified facilities managers can assist in locating and reducing possible risks, like water leaks and fire dangers.
4. Regulation compliance – A facilities management team can assist in making sure a building complies with all applicable rules and regulations.
5. Management of vendors and contractors – By choosing and overseeing vendors and contractors, a facilities management team can help the company save time and money.
6. Better coordination and communication – Expert facilities management can facilitate the establishment of transparent channels of communication and the administration of diverse assignments and projects, resulting in a more effective and harmonious workplace.

Conclusion – The outsourcing of facility management in the pharmaceutical sector has emerged as a strategic and effective approach for addressing the challenges posed by intense competition, complex regulations, and the need for operational efficiency. The multifaceted nature of pharmaceutical operations, encompassing R&D, technical activities, and commercial buildings, necessitates a comprehensive and specialized approach to facility management. Outsourcing helps mitigate inconsistent processes across sites, ensures regulatory compliance, and addresses challenges associated with headcount restrictions and ageing worker demographics. By embracing sustainable practices, managing vendors and contractors effectively, and fostering better coordination and communication, outsourced facility management contributes not only to operational success but also to the overall satisfaction of tenants, occupiers, and stakeholders. In a rapidly evolving pharmaceutical landscape, the adoption of outsourced facility management models reflects a strategic response to the industry’s dynamic challenges, ensuring sustained growth, compliance, and operational excellence.

How ND Global Can Help: ND Global stands ready to collaborate with pharmaceutical companies, offering expertise in facilities management and validation to elevate operations. From ensuring regulatory compliance to implementing sustainable practices, ND Global’s tailored solutions contribute to the success and longevity of pharmaceutical facilities. Partner with ND Global for a holistic approach to facility management excellence.