Working document QAS/08.256
1. INTRODUCTION
1.1 This guideline serves to set out the design parameters and inspection criteria applicable to facilities handling hormone products. This guideline’s primary focus is on the air-conditioning and ventilation systems of the facility.
1.2 This guideline is to be read in conjunction with other WHO good manufacturing practice (GMP) guidelines with respect to building finishes, general services installations, etc. This guideline only deals with criteria which are not covered in the other WHO GMP guidelines. Refer to the bibliography for relevant publications which serve as additional background material.
1.3 The areas where this document finds application are all zones where the handling of hormone products could lead to a hazardous situation. This includes research and development facilities, active pharmaceutical ingredient (API) manufacturing, storage, finished product manufacturing, including packing, and product distribution. The collective general term used in the guideline for all these different phases is “hormone facilities”.
1.4 Although this document relates to hormone products, the principles contained herein could be applied to other hazardous products where containment is required.
2. GLOSSARY
2.1 The definitions given below apply to terms used in this guideline. They may have a different meaning in other contexts. Air-handling unit (AHU) Air-handling unit which serves to condition the air and provide the required air movement within a facility. Airlock An enclosed space with two or more doors, which is interposed between two or more rooms, e.g. of differing classes of cleanliness, for the purpose of controlling the airflow between those rooms when they need to be entered. An airlock is designed for and used by either people or goods (PAL = Personnel airlock and MAL = Material airlock). Alert limit Alert limit is reached when the normal operating range of a critical parameter has been exceeded, indicating that corrective measures may need to be taken to prevent the action limit being reached. API Active pharmaceutical ingredient. Cleanroom A room or area with defined environmental control of particulate and microbial contamination, constructed and used in such a way as to reduce the introduction, generation and retention of contaminants within the area, and in which other relevant parameters (e.g. temperature, humidity and pressure) are controlled as necessary.
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