In the Philippines, all medical establishments and outlets applying for a license to manufacture, import, distribute or sell vaccines and other biological products have to comply with these requirements. To be able to get a License to Operate (LTO), all establishments have to be compliant and prove that they are Read more…
Proper storing and handling of vaccines is very important in the medical sector. Each country has specific regulations that must be adhered to, although most of the vaccine handling rules apply internationally. In this article we will focus on the New Zealand regulations for vaccines, but won’t go into details Read more…
Vaccine storage and efficient handling – from the time the vaccine is manufactured until it is administered – is a key component of the immunization programs. Although the specific recommendations for vaccine storage and handling procedures can vary among the Canadian public health offices and immunization programs, there are generic Read more…
Pharmaceutical manufacturing is a strictly regulated process and requires each step to be well documented and precisely followed. The records can be paper-based or electronic. The FDA provides guidelines for manufacturers to be compliant. The 21 CFR Part 11 regulates the use of electronic records and signatures. In previous articles Read more…
An organization can meet the compliance requirements of FDA 21 CFR Part 11 in multiple ways. For example: Using a non-electronic paper-based approach Using a Quality Management System software with compliant document management features Using a Document Management System designed for use across industries Using a Document Management System designed Read more…
What does the FDA requirements 21 CFR Part 11 stand for? It is important to understand it for medical device developers, who are considering entering the US market. There are lots of requirements and regulations in this huge and complex marketplace, in this article we will provide a guide to Read more…
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