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Who Trs 937-Annex2

Who Trs 937-Annex2

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10/21/2012

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© World Health OrganizationWHO Technical Report Series, No. 937, 2006
Annex 2
Supplementary guidelines on good manufacturingpractices for heating, ventilationand air-conditioning systems fornon-sterile pharmaceutical dosage forms
1. Introduction2. Scope of document3. Glossary4. Protection4.1 Products and personnel4.2 Air filtration4.3 Unidirectional airflow4.4 Infiltration4.5 Cross-contamination4.6 Temperature and relative humidity5. Dust control6. Protection of the environment6.1 Dust in exhaust air6.2 Fume removal7. Systems and components7.1 General7.2 Recirculation system7.3 Full fresh air systems8. Commissioning, qualification and maintenance8.1 Commissioning8.2 Qualification8.3 MaintenanceReferences
 
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1.
Introduction
Heating, ventilation and air-conditioning (HVAC) play an important rolein ensuring the manufacture of quality pharmaceutical products. A welldesigned HVAC system will also provide comfortable conditions for op-erators. These guidelines mainly focus on recommendations for systemsfor manufacturers of solid dosage forms. The guidelines also refer to other systems or components which are not relevant to solid dosage form manu-facturing plants, but which may assist in providing a comparison betweenthe requirements for solid dosage-form plants and other systems.HVAC system design influences architectural layouts with regard to itemssuch as airlock positions, doorways and lobbies. The architectural compo-nents have an effect on room pressure differential cascades and cross-con-tamination control. The prevention of contamination and cross-contamina-tion is an essential design consideration of the HVAC system. In view of these critical aspects, the design of the HVAC system should be considered at the concept design stage of a pharmaceutical manufacturing plant.Temperature, relative humidity and ventilation should be appropriate and should not adversely affect the quality of pharmaceutical products duringtheir manufacture and storage, or the accurate functioning of equipment.This document aims to give guidance to pharmaceutical manufacturers and inspectors of pharmaceutical manufacturing facilities on the design, instal-lation, qualification and maintenance of the HVAC systems. These guide-lines are intended to complement those provided in
Good manufacturing  practices for pharmaceutical products
(1) and should be read in conjunc-tion with the parent guide. The additional standards addressed by the pres-ent guidelines should therefore be considered supplementary to the generalrequirements set out in the parent guide.
2.
Scope of document
These guidelines focus primarily on the design and good manufacturing practices (GMP) requirements for HVAC systems for facilities for the man-ufacture of solid dosage forms. Most of the system design principles for fa-cilities manufacturing solid dosage forms also apply to other facilities suchas those manufacturing liquids, creams and ointments. These guidelines donot cover requirements for manufacturing sites for the production of sterile pharmaceutical products.These guidelines are intended as a basic guide for use by GMP inspectors.They are not intended to be prescriptive in specifying requirements and design parameters. There are many parameters affecting a clean area condi-tion and it is, therefore, difficult to lay down the specific requirements for one particular parameter in isolation.
 
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Many manufacturers have their own engineering design and qualification stan-dards and requirements may vary from one manufacturer to the next. Design parameters should, therefore, be set realistically for each project, with a viewto creating a cost-effective design, yet still complying with all regulatorystandards and ensuring that product quality and safety are not compromised.
The three primary aspects addressed in this manual are the roles that theHVAC system plays in product protection, personnel protection and environmental protection (Fig. 1).
Figure 1
The guidelines address the various system criteria according to the sequence setout in this diagram
GMP, Good manufacturing practice.
GMP MANUFACTURINGENVIRONMENT
Contamination(product & staff)Prevent contactwith dust Avoid dustdischargeProtect from productcross-contaminationPrevent contact withfumes Avoid fumedischargeCorrect temperature& humidity Acceptable comfortconditions Avoid effluentdischarge
SYSTEMSSYSTEM VALIDATIONPRODUCTPROTECTIONPERSONNELPROTECTIONENVIRONMENTPROTECTION

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