QAS-031 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 490

abc Pharmaceutical comPany

ANNEXURE C (FOR NONSTERILE)
MANUFACTURING FACILITY
SELF-EVALUATION QUESTIONNAIRE

3rd Manufacturing Facilities, Equipment, and Control Yes No N/A

1. Are lubricants and nonproduction materials properly controlled to

prevent contamination?   

2. Are the manufacturing procedures formalized, controlled, and validated?   

3. Are current specifications readily accessible for the employees?   

4. Are production areas that are very dusty or unique in regard to

contamination properly controlled with exhaust systems or other

methods of decontamination?   

5. Are any special requirements for specific operator apparel (masks,

gowns, etc.) being violated?   

6. Are waste materials clearly identified in proper containers?   

7. Are the ceiling fixtures and pipes free of accumulated dirt, dust, and

paint chips to prevent contamination of packaging materials?   

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