Baseline Guides®: A Guide to the Guides

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Baseline® Guides Objectives

  • to reduce cost of producing pharmaceutical products and medical devices while maintaining or improving product quality and consistency
  • to provide consistent guidance for design and construction of manufacturing facilities regulated by the FDA and other health authorities
  • to help prevent misinterpretation of regulations which govern manufacturing operations

The Baseline® Approach

The Baseline® approach identifies features of the facility which may affect the ability to reliably and consistently produce quality pharmaceutical products and medical devices. Features are prioritized to focus upon those which are most critical to the production of safe and reliable products. Investment capital and manpower can then be allocated most productively through intelligent selection of simple and effective systems.

Alternative Designs

The Baseline® Guides address the concept of alternative designs. This aspect of the Guides is critical because it enables the Guides to be adapted to the corporate characteristics of each manufacturer. Where appropriate, Guides identify advantages and disadvantages of design alternatives and provide information to help assess benefits. Alternatives can then be reviewed based upon economics, historical data, and other factors to select an approach consistent with the manufacturer’s product and corporate characteristics. Manufacturers may elect to construct simpler, less capital intensive facilities and utilize procedural controls to maintain quality, or may invest more capital to construct highly automated operations and rely less upon operational procedures to assure product quality. The Guides provide background to accommodate the approach which best fits the specific manufacturer and the needs and economics of a specific product and site location.

How the Baseline® Guides Relate

The Guides are categorized as:

  • Vertical Guides which address specific types of product manufacturing operations
  • Horizontal Guides which address common support systems and functions such as pharmaceutical water or facility commissioning and qualification

Guides that focus upon manufacturing operations include brief sections introducing concepts which are covered in detail in Horizontal Guides.

Revision of Baseline® Guides

The healthcare industry is continually evolving; therefore, the Baseline®; Guides also will evolve. Each Guide will be reviewed and updated periodically. The frequency of revision will be based upon the rate of evolution taking place in that sector of industry. Because the Guides continuously evolve, versions of a specific Guide may not be completely integrated with other Guides.

Dealing with Guide Interrelationships

The Guides were categorized to communicate information logically and in simple terms. In real life, unit operations interrelate and the interactions within a facility can become complex. Proper application of the Guides requires the user to understand these operational relationships and to apply the Guides accordingly.

In addition to obvious overlaps between support system function and operations based Guides, other overlap is possible or even likely. Many pharmaceutical facilities are comprised of manufacturing operations for multiple products and or multiple phases of pharmaceutical processing. Frequently, these facilities have adjacent operations which fall within the realm of several different Guides.

Economic and practical solutions should be considered with regard to common utilities serving adjacent spaces. This is especially true of modifications to existing facilities. System capacities, available space, reliability, and service requirements drive decisions, such as whether to use independent or combined HVAC systems. It may, for example, be more practical and economical to provide WFI quality water when USP grade water is appropriate.

In evaluating common utilities, it is always essential to carefully consider how that utility might realistically communicate contaminants from one operation to another.

While each Manufacturing Operations-based Vertical Guide contains sections on HVAC and similar support functions, support systems often serve more than one type of manufacturing operation. Concepts on which system designs are based are fundamentally the same. Where common systems serve multiple areas, the designer should apply these basic principles to define the requirements and identify appropriate solutions. The designer must understand the impact of the support function on the product and/or process. Critical attention should be given to systems that affect the ability to consistently and reliably produce quality product.

Each specific manufacturer’s situation is different and will require independent analysis to determine best solutions. Often there are several suitable solutions. The alternatives provide flexibility, life cycle cost opportunities, and the opportunity to adapt the facility to likely future needs or specific corporate characteristics.

Last Update: 19 September 2011

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