QAS-031 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 502

abc Pharmaceutical comPany

ANNEXURE D (FOR STERILE)
STERILE BULK MANUFACTURING FACILITY
SELF-EVALUATION QUESTIONNAIRE

5th Documentation Control Yes No N/A

1. Does the facility have an adequate system to control specifications,

test methods, and other documents?   

2. Is there a provision to notify regulatory agencies, clients, and

appropriate disciplines of changes in specification, process, and

test methods?   

3. Are records maintained that identify the reasons for changes

in documents?   

4. Are product development and laboratory records easily available?   

5. Are production records retained for adequate length of time?   

6. Are employee training records maintained for adequate length of time?   

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