Pharmaceutical companies are required to implement modern quality systems and risk management approaches to ensure that a procedure, process or activity maintains the necessary level of compliance at all stages to meet the requirements of the Food and Drug Administration, the World Health Organisation, the European Commission and the national agencies responsible for the regulation of the pharmaceutical industry within their jurisdictions. Those agencies produce regulations for good manufacturing practice (GMP) and guides to achieving quality management. The GMP regulations and guides produced by those agencies include within their scope the facilities in which the pharmaceutical products are tested and manufactured, therefore the design and construction of those facilities should be evaluated and following completion, validated in the same way as any other process within the pharmaceutical industry. As a lawyer involved in dispute resolution, in my experience it is during the design and construction of those pharmaceutical facilities that the quality management processes of the pharmaceutical industry clash with the processes of the construction and engineering industry, sometimes with unfortunate results.
Why is this?
The process of designing and constructing a particular manufacturing facility will differ from project to project. Not all site locations are the same, the surrounding infrastructure is unique and user’s requirements differ, so designing and constructing a particular pharmaceutical facility is to some extent like developing a prototype without the opportunity to evaluate the results and modify the prototype for mass production. But that is only true to an extent: the operations and processes which take place within a particular facility are likely to be similar to the operations and processes which take place in other testing and manufacturing facilities either within the same pharmaceutical organisation, or competitor organisations. I also accept that the design consultants and contractors (the delivery team) are likely to be different for each project and consequently it is more difficult to retain the knowledge acquired on one project within the delivery team and transfer it to another project. However, the consultants and contractors employed on pharmaceutical projects invariably specialise in pharmaceutical work and therefore while the constituent members of the delivery team may change those individual members of the team have probably acquired knowledge which is transferable form project to project.
I am of the opinion that one of the reasons why the construction process does not respond well to quality management is because the construction contracts used to procure facilities make no reference to GMP or quality management. The terms of those contracts are used to procure building and engineering works ranging from residential developments through to railways and power stations, and consequently cannot take account of the specific processes of any one industry. For example in relation to quality control, which is vital in the pharmaceutical industry and the underlying purpose of quality management systems and GMP, the standard forms of construction and engineering contracts are virtually silent.
The obligations on the contractor in the JCT Design and Build Contract (which I have seen used in pharmaceutical and medical facilities) are woeful, and consist of the contractor being obliged to “carry out and complete the Works in a proper and workman like manner and in compliance with the Contract Documents… … and Statutory Requirements…” and “…all materials and goods for the Works shall, so far as procurable, be of the kind and standards described in the Employer’s Requirements… … or Contractor’s Proposals”.
The obligation to monitor quality control is upon the employer or his representative, who must issue instructions to open up the works for inspections or tests and then issue further instructions to remove from the site any defective work or materials or goods. If the tests or inspections do not reveal a defect then the contractor is entitled to an extension of time and to loss and expense. There is therefore little incentive upon the contractor to monitor or record the manner in which works are carried out, and no incentive to report deficiencies in the works.
The obligations upon the contractor under the NEC contract are marginally better, and oblige the contractor and the supervisor to notify each other of the tests and inspections they are intending to carry out, and also to notify each other of the results of those tests and inspections. There is also an obligation upon the contractor not to deliver plant and materials to the working areas prior to notifying the supervisor that they have passed the inspection tests required. Both these obligations are however, only applicable to tests and inspections which are specified in the ‘works information’, i.e. the technical information which describes works. If the works information is deficient or where work is not required to be tested or inspected, then the contractor’s duty to correct defects is not dissimilar to the obligations the contractor has to correct defects under the JCT forms of contract. There is no duty to inform the Project Manager or Supervisor of the defects or to record the defect or record the work carried out to rectify it. The employer is, as in the JCT, relying on the technical information to impose what should be a contractual obligation upon the contractor to either carry out quality management procedures or provide the necessary facilities and co-operation so that others can do so.
Is this the answer?
The MF/1 contract recommended by the Institution of Engineering and Technology and the Institution of Mechanical Engineers does go some way towards the incorporating the principles of GMP and quality management within its contract terms. There is a general obligation upon the contractor to design, manufacture, deliver to the site, install and test the plant and the works with due care and diligence, as well as an obligation to test the works and plant on completion and enable the performance tests to be carried out by the employer following completion. This is supplemented by more detailed contract terms dealing with inspection and testing of plant before delivery, testing upon completion and importantly performance testing following completion. The contract still relies upon the technical information describing the works to provide the detail, but the contract goes further than the NEC or JCT to impose contractual, quality management obligations. I believe however, that unless there are comprehensive contractual obligations requiring contractors to follow GMP and quality management then the construction process will continue to respond poorly to GMP principles and procedures.
By Matthew Needham-Laing, Head of Construction & Engineering, Stevens & Bolton LLP
First published in The Pharma Letter, September 2015