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Pharmaceutical Manufacturing and Packing Sourcer

Brick by Brick

Monday 6 April 2015 saw the UK's new Construction (Design and Management) (CDM) Regulations officially come into force, marking the beginning of a six-month transitional period before the deadline date of 6 October. But what do pharmaceutical manufacturers planning construction projects need to know?

Current Situation

Despite the fact that the UK’s pharma market is the ninth largest in the world, making a greater contribution to the economy than any other sector, growth rates have nevertheless slowed in recent years. R&D capital expenditure by pharma companies in the UK fell by around £359 million, from £496 million in 2002 to just £137 million in 2012; while in pharmaceutical manufacturing in particular, capital expenditure declined from a peak of £1 billion in 2001 to just £422 million in 2012 (1). According to the AMA Research: Pharmaceutical and biotechnology construction sector report – UK 2014- 2018 analysis: “The greatest barrier to capital investment in the UK over the last few years has been the lack of fi nancial incentive to locate new manufacturing… plants in the country.” With this in mind, trends are beginning to reverse. The North East of England Process Industry Cluster, which represents a large number of pharma companies based in the region, has committed to investing £7 billion into the area by the end of the year, as well as attracting some 16,000 new employees – all of which is likely to include the upgrade of existing (and construction of new) facilities.

Nationally, the government has also announced plans for £200 million worth of capital projects in the sector during the period covered by the AMA Research report. In addition, leading pharma businesses are beginning to announce expansion plans, meaning that they will now fi nd themselves with greater responsibility for health, safety and welfare in construction projects than ever before, due to the CDM regulatory changes.

Construction remains one of the most dangerous industries – with workers four times more likely to be killed at work than those in any other sector – and the CDM Regulations seek to improve compliance with a raft of essential health and safety legislation. Although the technical standards covered by Part 4 of the updated regulations remain largely unchanged from the guidance related to CDM 2007, there are several notable changes that apply to all commercial businesses of any size, and will therefore affect pharmaceutical manufacturers.

Overseeing the Project

With the position of CDM coordinator now obsolete, manufacturers must take an overseeing role in their construction projects with the support of the principal designer (PD) – which can be an organisation or an individual who is responsible for the preconstruction phase and oversees design and planning – and principal contractor (PC) throughout the project. These roles must now be filled where there is more than one contractor working on a project, regardless of size or duration.

Initially, manufacturers must ensure the PD and PC have the necessary skills, knowledge, experience and organisational capability to manage health and safety risks. Pre-construction information must then be compiled by the client and issued to all parties, providing critical and high-risk information. This is crucial in allowing them to guarantee that the relevant welfare facilities are in place, and that health and safety arrangements are implemented with regular reviews as the project progresses. The PD will develop the health and safety file, but the project owner must take reasonable steps to ensure that both the PC and PD comply fully with all their duties and adhere to all relevant UK legislation, including the Health and Safety at Work Act, Work at Height Regulations and Reporting of Injuries, Diseases and Dangerous Occurrences Regulations.

It is also now the job of the pharmaceutical manufacturer to make sure the PC prepares a thorough construction phase plan (CPP) for all relevant projects, which outlines the health and safety arrangements, along with site rules and measures to control the hazards and risks specific to each location. In contrast to the previous regulations, a CPP is now required for all construction projects – regardless of the duration of the build or the number of workers on site. It must also be completed if there is only one contractor (and therefore no PC).

Construction Definitions

For the purposes of the CDM Regulations, ‘construction’ is defi ned as any building, civil engineering or construction work covering extensions, alterations and conversions, as well as complete new builds – and this also applies to demolitions. This definition is important as refurbishment projects are growing – the JLL/Glenigan Commercial Construction Index reported that refurb projects saw an increase of 8.7% to a value of £10.8 billion in the period covered by the Index, exceeding the growth in new build schemes (4.7%, £11.9 billion).

Furthermore, pharma manufacturers now have a responsibility to inform the regulatory body, the Health and Safety Executive, of larger construction projects via an F10 form, if the project is either expected to last more than 30 days and have more than 20 workers on site at any one time, or will exceed 500 days in total.

For projects which began before 6 April but have not yet moved into the construction phase, a PD must still be appointed. If a CDM coordinator is already in position, they can continue in their role up until the fi nal deadline of 6 October; however, if the project extends beyond this date, they must be replaced by a PD by 6 October – at the latest – to ensure compliance.

Accepting Responsibility

As the pharma industry comes under increasing pressure to develop new chemical compounds, and as more sophisticated manufacturing technology is required to fulfil this demand, the design and construction of cleanrooms, labs and production facilities will inevitably have to evolve. The need for more highly specialised, bespoke R&D and manufacturing facilities will see a growing number of pharma companies looking to progress construction projects, meaning it is essential for them to be up to speed on the responsibilities placed upon them by the amended CDM Regulations.


1. AMA Research: Pharmaceutical and biotechnology construction sector report – UK 2014-2018 analysis

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Todd Hallam, Environmental Health and Safety Director at specialist high-care construction company Chalcroft, joined the business in 2005. He is a Chartered Member of the Institution of Occupational Safety and Health, as well as a member of two UK Safety Groups. Todd’s extensive experience in the construction industry throughout Australia, Japan and the UK provides a versatility of knowledge applied in a pragmatic way. His role at Chalcroft includes interpretation and implementation of legislative requirements, in addition to developing and maintaining management systems. Todd works closely with all stakeholders to ensure that company and client requirements are met, maintained and, where possible, exceeded.
Todd Hallam
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