The Study in Risk-Based Manufacturing Environmental Control for Non-Sterile Drug Products (English Translation) (single user digital version)

Jun 2021
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There are very few documents available that provide guidance regarding to requirements for non-sterile drug manufacturing. The Kansai Study Group (KSG) of the PDA Japan Chapter (JPDA) published this paper to offer some consensus-based ideas to help pharmaceutical manufacturers establish appropriate, risk-based manufacturing and environmental control systems for quality products.

The KSG conducted a survey of JPDA member companies regarding their current practices in an effort to develop best practices around what environmental controls and maintenance are required for manufacturing non-sterile drug products.

They determined the five most common themes — HVAC systems, facilities, gowning, cleaning, and cleanliness standards — and developed a new approach to the maintenance and control methods of the manufacturing environment based on risks applicable specifically to the manufacture of non-sterile drug products. For each of these themes, a problem is stated, recommendations are proposed, and a rationale is provided.

Notice to Readers
This document was produced and published by the PDA Japan Chapter, and has been translated into English. It does not represent the official viewpoint of PDA, Inc. and has not gone through the PDA Technical Document creation and review process.

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Table of Contents

Table of Contents:

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Introduction and Background
Category I: HVAC
Category II: Facilities
Category III: Gowning
Category IV: Cleaning of Processing Rooms
Category V: Specifications of Cleanliness
Figures and Tables Index