Review of ISPE's Baseline Guide for Oral Solid Dosage Forms - Pharmaceutical Technology

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Review of ISPE's Baseline Guide for Oral Solid Dosage Forms
The author outlines the key concepts of ISPE's recently revised Baseline Pharmaceutical Guide for New and Renovated Facilities. This article is part of a special supplement on Excipients and Solid Dosage.

Pharmaceutical Technology
Issue 34, pp. s6-s12

Product and processing. The ISPE OSD guide provides guidance on process and equipment choices for OSD forms in new or renovated pharmaceutical manufacturing, formulation development, and pilot-plant operations, which includes associated equipment pertinent to product quality and facility design. Material characteristics and properties, material handling, cleaning, and maintenance are also addressed. The guide also considers the application of PAT and manufacturing execution systems (MESs). The guide uses decision trees to evaluate the options to a baseline operation and equipment-training selection for various process requirements and material types (14). Separate guides from ISPE offer differences between European, Japanese, and US practices as they relate to active pharmaceutical ingredients (20) and for packaging, labeling, and warehousing facilities (in draft form as of publication of this article).

Architectural considerations. The ISPE OSD guide provides requirements to be considered for OSD facility design and construction for building programs, building layouts, space definition, details, and finish materials. These aspects of the facility are developed in the context of CGMP, risk, and process requirements to establish baseline guidance and parameters (15).

Process support and utilities. The ISPE OSD guide discusses the categorization of mechanical systems used in OSD pharmaceutical manufacturing. There are two broad categories: process-support systems and utility systems. The guide discusses the categorization of mechanical systems using a risk-based approach methodology to offer a robust methodology for the identification of process support and utility systems. The guide also provides a method for the determination of system applications and the selection of resulting commissioning and qualification strategies with relevant examples for each type of system. Other considerations that impact system design, including user requirements, engineering-design elements, and start-up requirements also are addressed. The discussion also focuses on GEP for utility-system design. Approaches for multiple-use requirement scenarios also are addressed. A listing of typical OSD utility systems is provided with general descriptions and requirements for each system (5).

HVAC. The ISPE OSD guide provides the GMP requirements for HVAC systems. It provides guidance on the design of HVAC systems based upon clearly defined user requirements (e.g., level of product protection, product and process requirements, and architectural design). Non-GMP requirements, such as operator protection, expectations on monitoring, energy efficiency, and safety requirements, also are addressed (16).

HVAC systems can help mitigate risks, both GMP and non-GMP risks. HVAC designers should understand CGMP regulatory requirements and also be familiar with industrial HVAC requirements as defined in various documents by the American Society of Heating, Refrigeration and Air-Conditioning Engineers and the American Conference of Governmental Industrial Hygienists. Knowledge of all local construction codes, the National Fire Protection Association standards, environmental regulations, and Occupational Safety and Health Administration regulations is assumed. The design and installation of the HVAC system should comply with these requirements and all applicable building, safety, hygiene, and environmental regulations (16).

Electrical requirements. The most important issues to be addressed in an OSD facility from an electrical perspective are:

  • Cleanability of all exposed electrical equipment
  • The use of flush lighting wherever possible
  • Making all conduits and raceways hidden (i.e., not exposed) in the production areas.

Although the degree of electrical requirements may differ based upon the level of protection required, the cleanability of the exposed electrical equipment is the primary concern of electrical systems in an OSD facility (17).

Electrical-power-distribution systems do not directly affect the quality of OSD drugs and hence are not critical systems and are not subject to regulatory oversight and validation requirements. The equipment that produces and controls the pharmaceutical processes and provides clean and controlled environments for the manufacturing areas for OSD pharmaceutical drugs, however, requires a source of electric power and an electrical-power-distribution system that is reliable and maintainable (17).

A properly designed electrical distribution system should provide reliable electricity to the OSD pharmaceutical equipment. The ISPE OSD guide provides design and maintenance criteria to assist in the proper design of an electrical system to provide reliable electrical service (17).


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