The Indian pharmaceutical sector has now developed into a global outsourcing base for manufacturing. The industry’s adherence to good manufacturing practice (GMP) would help to transform it to even greater heights as an international hub for production. The industry has acquired a commendable position in the global pharma market as a supplier of high-quality, low-cost generic drugs and also has moved up the value chain into more challenging segments such as drug discovery and development.
The key factors favouring India are the design and maintenance of GMP compliant manufacturing facilities and meeting global regulatory expectations. The pharma units have introduced Quality Management System (QMS) consistent with global regulatory requirements and customer expectations, managing formulation development and technology transfer by following the concepts of Quality by Design and finally adopting quality systems and risk-based approach for implementation of cGMPs.
The sector has emerged as one of the world’s leading and fastest growing markets which spells excellence in manufacturing. Yet the design, construction, commissioning and validation of a GMP compliant facility pose significant challenges for manufacturers, engineering professionals and equipment suppliers of India. For the production of the same active pharmaceutical ingredients (APIs) use of dedicated equipment and facilities is mandated.
Further, numerous possible facility layouts can be designed depending upon the types of products manufactured in the facility, materials handled, processes employed, equipment used ranging from open type manual processing to highly automated closed type. The manufacturer should plan suitable size, construction, and layout to allow all required production operations to be undertaken. Focus should also be on the required space for movement of personnel, product and equipment, besides being able to effectively clean the premises.
It is of key importance for the manufacturer to provide protection of products from chemical, physical, microbiological and all environmental contamination. A GMP-compliant facility should be primarily aimed at diminishing the risks of cross contamination, in particular by unexpected contaminants and mix-ups. Specific precautions need to be taken to ensure that hazardous materials do not present an unacceptable level of product cross-contamination risk or a risk to personnel or environment. While different approaches can be adopted for a facility design it is important to establish consistent minimum parameters using risk- based approach which meet the GMP requirements; at the same time they do not increase the cost of the facilities due to non-GMP considerations.
