QAS-012 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 283

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SOP No.:
Issued on:
Revision No.:
Initiator name:

FACILITIES/MAINTENANCE

1. Are there procedures and logs to assure sanitation and pest control?

2. Are adequate washing facilities with hot/cold water, soap, clean, toilets, air driers, or single
service towels provided?

3. Is the lighting in all areas adequate?

4. Are adequately constructed waste container located in the appropriate area?

5. Is there a designated area for eating, drinking, and smoking?

6. Is there a formal maintenance schedule of manufacturing equipment? Is it kept visibly near
each piece of equipment?

7. Are there positive pressure differentials with all doors leading into less clean areas?

8. Are the positive atmospheric control calibrated and monitored?

VALIDATIONS

1. Have support systems (such as compressed air, vacuum, water) been validated (certified)?

2. Have the environmental control systems been validated (certified)?

3. Have all cleaning procedures been validated?

4. Do all the validation packages include

a. A detailed description of the item/system (including flow diagrams)?

b. The intended function of the system?

c. Installation qualification information?

d. Operational qualification information?

e. A preapproved validation protocol?

f. Cleaning validation protocol?

g. Explanation of any deviations made to the original signed-off protocol?

h. Execution of cleaning validation protocols and report?

i. Validation results?

j. Quality assurance approval of validation?

5. Is there a formal change control system that addresses changes to validated systems and
includes QA review/approval?

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