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Anti-Microbial Reusable Face Mask

Audit Questionnaire

Want to check out the rest of the questions, this will help us serve you better and will not take more than 10 mins
Categories of drugs manufactured at the site (Please select the active ingredient in the manufactured products
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Product with active ingredient from Biological origin or bio technological origin
Specify whether following items are manufactured at the site

Quality

Please provide information on the latest inspections, if any, by the national or international Regulatory Authorities (authority, date, outcome)
Is your Quality Unit (QU) independent from production?

Facilities

Approximate number of employees

Equipment and Manufacturing

Is sterilization a part of the facility or would you choose outside laboratory for sterilization?
Do you procure raw material or starting material from external vendor?

Packaging and Labeling

Do you have packaging facility within the organization?
Do you have in-house labeling system?

Laboratory

Is your Laboratory facility independent from the production?
Is your laboratory accredited?
Do you outsource your laboratory testing or function?

Outsourcing

Do you outsource any of your processes (loan license product, sterilization, etc.)?
Do you use contract manufacturers for the product(s) to be audited?
What is the language of the documentation? (basing on the mention, we can assess the need for a translator at any stage of the project)
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