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ASTM E2500 | A Guide for Pharmaceutical and Biopharmaceutical Manufacturing System

What is ASTM?

ASTM (currently known as ASTM international) means "American Society for Testing and Materials" is a devloper of international voluntary consensus standards. 

What is ASTM E2500?

The intent of this guidance is to make the implementation process for GMP systems cost-effective and a value-added activity. It is based on a scientific and risk-based philosophy that focuses on the risk to the patient integrated with good engineering practices.

This guide is applicable to all elements of pharmaceutical and biopharmaceutical manufacturing systems including: good manufacturing practice (GMP) utility equipment, process equipment, supporting utilities, associated process monitoring and control systems, and automation systems that have the potential to affect product quality and patient safety.

The following key concepts are mentioned in the guide:

  • Risk-based Approach
  • Science-based Approach
  • Critical Aspects of Manufacturing Systems
  • Quality by Design
  • Good Engineering Practice
  • Subject Matter Expert
  • Use of Vendor Documentation
  • Continuous Process Improvement

The evaluation of risk to quality should be based on scientific knowledge and ultimately link to the protection of Product and process

Where science‐based approach means ‐ “Product and process information, as it relates to product quality and patient safety, should be used as the basis for making science‐ and risk‐based decisions that ensure that the manufacturing systems are designed and verified to be fit for their intended use.”

Quality by design (QbD) concepts should be applied to ensure that critical aspects are designed into systems during the specification and design process.

Examples of product and process information to consider include: CQAs, CPPs, process control strategy information, and prior production experience. Critical aspects of manufacturing systems are typically functions, features, abilities, and performance or characteristics necessary for the manufacturing process and systems to ensure consistent product quality and patient safety.

Subject Matter Experts are defined as those individuals with specific expertise and responsibility in a particular area or field (for example, quality unit, engineering, automation, development, operation. They should take the lead role in the verification of manufacturing systems as appropriate within their area of expertise and responsibility.

Typical Areas of SME

  • Process Scientists – determine CQAs and CPPs
  • Engineering/Technical – specification, verification
  • Automation SME – develop, verify, and optimize automation and process control elements
  • Quality – develop and approve verification plans with other SMEs; compliance with site QMS
  • Manufacturing personnel – operability, SOPs

The decision and justification to use vendor documentation, to support the verification of critical aspects of the manufacturing element should be documented and approved by SMEs

Project requirements that relate to product quality are defined in ASTM E2500‐07 as:

  • Product knowledge
  • Process knowledge
  • Regulatory requirements
  • Company quality requirements

This standard has been developed with input from industry and with the support of the FDA, EMEA and GAMP and was approved in May 2007, published in July 2007 and reapproved in 2012 (with no significant change).

It is concluded that this guideline is intended to satisfy international regulatory expectations in ensuring that manufacturing systems and equipment are fit for intended use, and satisfy requirements for design, installation, operation, and performance.

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