Pharmaceutical Machinery: Standards
The International regulatory requirements for the pharmaceutical machinery manufacturers are as per cGMP, US FDA, MCA standards. For international standard of pharmaceutical machinery Quality systems like ISO-9000, standardization, services, innovation and continuous improvement of design are very essential.
Machines are tailor-made meeting requirements of the pharma industry. Every pharmaceutical company has its own system of procedures for manufacturing and maintenance of its machines, as an effort to meet the latest GMP compliance. Keeping with this line, it would want the machinery manufacturer to follow a set of procedures with proper documentation in the manufacturing. Most of the time, it is the pharma manufacturer, which educates the machinery manufacturer on the latest fashion in the machinery and the upgradation in WHO GMP norms.
As a reward to its better GMP compliance, Indian pharma machinery manufacturers are all set to enter the regulated markets in developed countries. Several Indian Pharma Machine manufacturers have started getting enquiries from Australia, New Zealand, Spain, Norway, Sweden, Finland and some semi-regulated markets like Latin America, Malaysia, Thailand and Indonesia.
Export business is up-gradation in technology, regulatory standards and ultimately quality of drugs manufactured in India. Export to regulated markets implies that the same global standards of manufacture & control are applied to products manufactured here. If the company is exporting to regulate markets, it certainly cannot have two standards of quality in house, one for export and the other for domestic market. The manufacturing facilities in India are thus being upgraded to the standards of the regulated markets.
The Indian machinery makers design most of the equipment meeting the stringent safety and regulatory requirements in various western countries. They have also used the internet and related technologies to promote their products and services, which has led to create more awareness on Indian machinery. India is a host to various trade shows, some only dedicated to machinery.
The pharmaceutical machineries made by India are installed and under operations at all the FDA Approved manufacturing facilities in USA, Australia, Africa, etc. meeting the parameters of complete satisfactions. Looking at the capabilities of Indian engineering companies many international machine manufactures have joined hands with some Indian companies, which has helped the Indian pharmaceutical industry to procure further improved Indian made machinery at a price almost one fourth or one-third the imported technology.