Introduction Recently, the pharmaceutical industry has grappled with an increased cost in production partly because of uncertainty with regards to the necessities for regulatory compliance. Of particular interest is the validation of particularly the automation systems as well as the accreditation of Practices for Heating, Ventilation and Air Conditioning (HVAC). Initially, the existence of many yet acceptable interpretations of these regulatory requirements led to confusion between manufacturers leading to inconsistencies in processing practices. With the inception of these practices, a part from increased costs in production, there has been a decrease in the rate at which new products come to market. (World Health Organization, 1997) In the year 1994, a body representing the pharmaceutical engineers in conjunction with both the International Society for Pharmaceutical Engineers (ISPE) and the Food and Drug Administration (FDA) agreed on a common course that led to the creation of Baseline Pharmaceutical Engineering Guides. These guides are aimed at aiding pharmaceutical manufacturers “in the design, construction and commissioning of facilities that comply with the requirements of FDA” (ISPE Baseline Pharmaceutical Engineering Guides for New and Renovated Facilities, 1999). As such, pharmaceutical industries are required to meet the current good manufacturing practices (cGMPs) which ought to coincide with the entire governing laws and policies. The joint interpretation of these regulations is important for the purpose of consistency, flexibility and enhancement of innovative approach in the design, construction and validation. The scope of this guideline is limited to the development of new products as well as the existing ones which tend to have limited baseline description. However, these guidelines are not intended to substitute the existing laws and regulations which apply to the same. To supplement this document, there is need to incorporate the existing laws and regulations to the same for the purpose of completeness. Basically, this guide owes its guidance from the following sensitive parameters: the critical processing step, product exposure, level of protection, critical parameters, critical instruments and systems, Good Engineering Practice (GEP) and enhanced documentation. With regards to critical processing step, this is significant in defining consistent regulatory requirements and as such, it specifies the extent of product exposure and the level of protection. However, due to environmental regulations upon a specific methodology employed, standard operating procedures (SOPs) are used hence; this enhances flexibility in manufacturing designs thereby reducing the processing costs within the regulatory requirements. With regards to critical parameters, this has an effect on the quality of a product. This ought to be identified, regularly checked and controlled to maintain the product quality. In order to identify these parameters, manufacturers should have knowledge about the processing steps and as such document the rational for afterward examination. Critical parameters define critical instruments and systems and just like the parameters, they require in