Products and Services
RSS
ISPE Baseline® Pharmaceutical Engineering Guides
ISPE
Over the next several years, ISPE plans to publish a total of nine Guides to help forge a better understanding of basic requirements with government regulations of facilities. While FDA guidelines were and are available, the Guides aim to narrow down their wide range of interpretation, thus controlling unnecessary costs while maintaining accepted standards of quality.
The Baseline® Guide Series contains five vertical guides which address specific types of facilities and four horizontal guides which apply to all facility types.
Vertical Baseline® Guides
Volume 1: Bulk Pharmaceutical Chemicals (Published June 1996)
Volume 3: Sterile Manufacturing Facilities (Published January 1999)
Volume 6: Biopharmaceuticals (Coming Soon!)
Volume 7: Packaging, Labeling, and Warehousing Operations (Under Development)
Volume 9: Laboratories (Under Development)
Horizontal Baseline® Guides
Volume 2: Oral Solid Dosage Forms (Published February 1998)
Volume 4: Water and Steam Systems (Published January 2001)
Volume 5: Commissioning and Qualification (Published March 2001)
Volume 8: Maintenance (Under Development)
Volume 1: Bulk Pharmaceutical Chemicals Baseline® Guide
In its 10 chapters, the Guide establishes a baseline for the design of new BPC facilities that will facilitate regulatory compliance. It offers a consistent interpretation of GMP requirements, while still allowing a flexible and innovative approach to facility design, construction, commissioning, and validation. In addition, the Guide covers bulk active, bulk intermediate, and bulk excipient facilities, and also may be applied to sterile and aseptic bulk manufacturing.
The key concepts defined and used as a basis for this Guide include:
· critical process step
· product exposure
· level of protection
· critical parameters
· critical instruments and systems
· good engineering practice
· enhanced documentation
When published, the BPC Guide incorporated comments received from companies and individuals worldwide over a six-month period. The Guide's Task Team recently has re-formed to update and revise the original Guide.
Volume 2: Oral Solid Dosage Forms (Published February 1998)
Many Oral Solid Dosage (OSD) facilities run multiple products in processing areas designed for quick turnaround without unacceptable risk of product exposure, (i.e., dust and cross-contamination). Additionally, potent or toxic active ingredients are becoming increasingly common and present their own design challenges. The Oral Solid Dosage Baseline® Guide assists professionals by establishing consistent and minimum parameters for facility design, which address these concerns and meet GMP requirements.
In addition, the Guide provides engineers and professionals in the pharmaceutical industry with consistent guidance on the design, construction, and commissioning of OSD facilities, equipment, and systems. The Guide covers facilities manufacturing oral solid dosage forms (i.e., tablets, capsules, and powder) and also may be applied to clinical supply facilities. It is not intended to address the manufacture of vitamins, excipients, sterile products, topicals, oral liquids, or aerosols.
The key concepts defined and used as a basis for this Guide include:
· proper application of facility design and procedures to provide GMP compliance
· non-GMP technology and its impact upon facility design and costs
· contamination risk as assessed by the manufacturer
· design conditions versus operating range
· good engineering practice (GEP)
· enhanced documentation
Volume 3: Sterile Manufacturing Facilities (Published January 1999)
The Sterile Manufacturing Facilities Baseline® Guide addresses the design, construction, commissioning, and qualification of facilities designed for aseptic processing of formulated products. The Guide is designed for use by industry for the design, construction, commissioning, and qualification of new or renovated aseptic/sterile manufacturing facilities.
This Guide covers facilities for aseptic processing and terminal sterilization of formulated products, generally for parenteral use. It is applicable to formulations that use active ingredients devised from either conventional chemistry or biopharmaceutical processing. It is not applicable to bulk pharmaceutical chemicals, however, some parts may be relevant for facilities that produce sterile bulks, for sterile manufacture at development scale, medical devices, or other sterile products. It also should be noted that the purpose of the Guide is not to give guidance on production of clinical materials.
The Guide is primarily intended for facilities that meet regulatory requirements in order to supply the US market and follows US standards and references. The Guide also may be helpful to manufacturers that need to meet European requirements.
The key concepts defined and used as a basis for this Guide include:
· GMP critical parameters and critical devices
· terminal sterilization
· aseptic processing area
· protection of the product
· flow of people and materials
· integrated facility design
· barrier isolation technology
· consistent HVAC terminology
· HVAC principles
· in-operation condition for HVAC
· selection of materials and finishes
· good engineering practice (GEP)
· direct impact systems
· enhanced documentation
· indirect impact systems
Volume 4: Water and Steam Systems (Published January 2001)
This Guide is intended for the design, construction, and operation of new water and steam systems. The purpose of this Guide is to focus upon engineering issues and provide cost-effective water and steam systems. The Guide is intended primarily for regulatory compliance for the domestic US market, and follows US standards and references. Issues relating to Europe are discussed in the Guide's appendix.
The Water and Steam Systems Baseline® Guide places emphasis on how system design should be determined based upon the quality of feed water, the design of pretreatment and final treatment systems, the storage and distribution system design, and the operation/maintenance procedures. It aims to improve consistency of pharmaceutical water and steam quality throughout the industry as a result of system performance and reliability improvements. In addition, the Guide also provides the user with alternative basic system building blocks to permit reliable and consistent generation of required water or steam quality.
The validation of water and steam systems, which is comprised of commissioning and qualification activities, is not discussed in-depth in this Guide. Where non-engineering issues are covered (i.e., microbiological topics), the information is included to stress the importance of such topics and the impact they have on water and steam system design. Such non-engineering topics are not comprehensively covered.
The key concepts defined and used as a basis for this Guide include:
· methodology for defining the required water quality and configuring a water delivery system
· critical process parameters including temperature, UV intensity, ozone concentration, and circulating systems under positive pressure
· good engineering practice (GEP)
· design options
Volume 5: Commissioning and Qualification (Published March 2001)
This Guide provides advice and guidance that may be applied to all types of facilities, utilities, and equipment found in the healthcare industry. The Guide has incorporated comments from industry representatives from all areas and disciplines, FDA Field Investigators, and personnel from the FDA's Center for Drug Evaluation and Research (CDER).
The Commissioning and Qualification Baseline® Guide focuses on the engineering approaches and practices involved in providing cost-effective manufacturing facilities in a timely manner that meet their intended purposes. Specifically, the Guide addresses the process of designing, constructing, commissioning and qualifying the facilities, utilities, and equipment regulated by the FDA or other health authorities. This Guide is not intended to address any aspect of process/product validation.
The Guide is primarily intended for facilities, equipment, and utilities meeting regulatory requirements to supply the US market and is aligned with US standards and references. It also may be helpful to manufacturers needing to meet European requirements.
The key concepts defined and used as a basis for this Guide include:
· direct impact systems
· indirect impact systems
· system impact assessment
· good engineering practice (GEP)
· commissioning
· qualification practices
· enhanced design review
· installation qualification
· operational qualification
· performance qualification
· consistent terminology
· documentation requirements
Volume 6: Biopharmaceuticals (Coming Soon!)
The Biopharmaceuticals Baseline® Guide is intended to be used for the design, construction, commissioning and qualification of facilities and processes for the production of biotechnology products. For the purposes of this Guide, biotechnology products include large molecules that are not manufactured by means of chemical synthesis, and products produced by means of fermentation and/or recovery, sourced from genetically-engineered organisms.
Volume 7: Packaging, Labeling, and Warehousing Operations (Under Development)
The Packaging, Labeling, and Warehousing Operations Baseline® Guide will be the seventh Guide in the Baseline® series. The Guide will cover, in detail, those topics related to packaging and warehousing which are touched upon by other Baseline® Guides.
The Guide will be broken down into several sections and include topics on regulatory operations, equipment, layout and architecture, HVAC, utilities, electrical, automation and controls, and commissioning and qualification. Each chapter will address general considerations and risk analyses for all three areas of the Guide. In addition, each chapter also will address packaging, labeling, and warehousing separately as well as operations issues needing to be handled differently.
Regulatory considerations including GMPs, OSHA, EPA, and other regulations will be addressed for all packaging and warehousing operations. This Guide will examine equipment, integration, architectural, and MEP considerations. Technology transfer from manufacturing also will be addressed.
Volume 8: Maintenance (Under Development)
The Maintenance Baseline® Guide is intended to be used as a tool for the development, implementation, and execution of a maintenance program in a pharmaceutical environment. It will focus on maintenance in critical and non-critical GxP areas. Where any differences between GMPs, GLPs, GCPs, and other regulatory areas may exist, the Guide defaults to the higher standard to ensure compliance in all such areas.
The writing team has representatives from both Europe and the US, with core teams that meet quarterly. Periodic meetings between the European and US teams coordinate the effort and a sub-team ensures harmonization of the Guide's content. The harmonization sub-team has commenced editing and compiling an initial draft of the Guide. It is anticipated that review phases will include participation by members from both Japan and India.
The Maintenance Baseline® Guide is being written in accordance with both the GAMP Good Practice Guide: Calibration Management and the Commissioning and Qualification Baseline® Guide.
Volume 9: Laboratories (Under Development)
The Laboratories Baseline® Guide is intended to be applicable to quality control, stability, clinical, and basic research laboratories for products in development or marketed for human consumption.
Click here to visit the ISPE Baseline® Pharmaceutical Engineering Guide
