With the deadline for compliance of the revised GMP closing in, the clean room industry has been witnessing a real boom in the project orders from the pharma companies. As the user industry is increasingly going for current GMP specific quality maintenance with emphasis on layout designs, air filtration systems and water purification standards, this allied sector has spawned a large market for supply of tailor-made accessories, including floors, windows, doors and light fittings for the pharmaceutical industry.

The companies, which are GMP ready or in process of being GMP compliant are paying considerable attention for civil works particularly floors, windows and light fittings because of a variety of options available in the market. While the large drug manufacturers have hired dedicated technical staff to ensure that GMP is complied, the medium and small enterprises have approached consultants for advice on the plant design specifications that need to be followed to implement GMP, A K Murthy, director, MJ Associates, pharma project engineering consultants, told Chronicle Pharmabiz.

While civil works form a major portion of the project cost, ventilation/ air-conditioning costs form 20 per cent and water purification amounts to 5-7 percent of the total project cost.

A handful of Karnataka's small scale sector may not be able to abide by Schedule M before December 2003 because of the high cost of modernisation and the lack of a proper price conversion cost they get from their customers which is not adequate to upgrade the facility. The general perception among such units is that high level of automation is not required for their business development.

It is difficult to have totally automated plants in India because companies are not into production of a single stream of products like those in the US. Instead, 30 to 40 products are manufactured, making it difficult for units to standardise their production methods.

But with globalisation, pharma companies directly interact with the customers who are keen to know the production standards followed by pharmaceutical companies in India. As a result, the regulatory authorities send their panel of inspectors to check the facility and companies have no choice but to go in for GMP or US FDA, UK MCA and TGA-Australia to bag international orders, he said.

In the two years, small-scale units have understood the impact of globalisation and in order to survive, they have gone in for GMP. Units in Karnataka are conscious of their brand image in the domestic market and as third party manufacturers for the MNCs they need to maintain high quality production standards.

Murthy, with over four decades of experience in the pharma production line went on to set up MJ Associates to support the pharmaceutical sector with mechanical and chemical engineering expertise required during the design of the manufacturing units.

Facility design is one component of GMP, said Murthy and MJ Associates gets involved with the company right from the concept stage, which includes selection of a site for pharma production.

Until a few years ago, GMP was discussed as a basic requirement for approvals from regulatory authorities. Today, GMP is a concept in pharma production management as batch after batch products have to be manufactured to preset standards. There are trained people and quality control instruments to provide consistent reproducibility and repeatability in performance with a standard benchmark.

GMP also insists that the quality manufacturing equipment and the environment standards in the plant. The machines used for production must be stainless steel clad with no paint. The machines should be designed in a way that it can be dismantled, cleaned and reused. Pharmaceuticals being a dynamic industry, strategies of the companies alter with the trends in the market and expansion plans are expected continually, which initiates further scope in the growth of plant design specifications for pharma project engineering specialists.