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Ⅲ. Managerial， administrative， commercial and regulatory infrastructure
Q1： Does your pricing policy cover the full cost of each vaccine produced?
□ No
□ Yes
Q2： Does the company have a business plan?
□ No
□ Yes
Q3： If the answer to the previous question is yes what is the period covered by the plan
□ One year
□ Two years
□ Three or more years
Q4： Does the company have a mechanism to conduct research on future demand in terms of types and quantity of products required in the market?
□ No
□ Yes
Q5： Does the company have control to hire and fire staff as necessary
□ No
□ Yes
Q6： Does the company have control over revenues?
□ No
□ Yes
Q7： Does the company have control to set salary policy?
□ No
□ Yes
Q8： Does the company have a regulatory affairs department?
□ No
□ Yes
Q9： If the answer to the previous question is yes， what is the role of the regulatory affairs department
Briefly explain：
Q10： Does the company have a commercial department?
□ No
□ Yes
Q11： If the answer to the previous question is yes， what is the role of the commercial department?
Briefly explain：
IV. Quality Systems including GMP/QA
Q1： Does the company have a maintenance programme in place with allocated budget?
□ No
□ Yes
Q2： Does the company have a Master validation plan?
□ No
□ Yes
Q3： Does the company have an established Quality Assurance Unit?
□ No
□ Yes
Q4： If the answer to the previous question is yes， what is the role of the QA unit?
Briefly explain：
Q5： Is the company inspected for GMP compliance by NRAs from foreign countries?
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