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SOP for Product Registration

Standard operating procedure for products registration and the documents required for it to submit in FDA and procedure to submit.


To lay down a procedure for product registration.


This procedure is applicable to the registration of the products in the manufacturing facility.


Executive Quality Assurance 
Manager Regulatory Affairs


Technical Head


5.1 Marketing team will take initiative to the requirement of the registration of new product (exiting product in the country from last four years or more) for the company team will make a proposal for the future sale of the product and report will be submitted to the board of the management of the company.
5.2 Once management board takes the decision about the registration of the new product then the board will send written information to company head with regard to the registration of a number of new products.
5.3 Company head will send a copy to quality assurance department and regulatory department and a formal meeting will be held with all concern department heads for the procedure of registration and will set time period to get the license.
5.4 Regulatory department will prepare the application for the registration of the new product. After completion of approval form, license fees will be submitted in the local treasury.
5.5 Regulatory department will make the meeting with quality assurance head and give the list of technical requirement for approval.
5.6 Quality assurance department will get the details of the product from drugs book to get the following information with regard to the product.
5.6.1 Date of the launch of drug and drug product in the country
5.6.2 Parallel name of the product
5.6.3 Pack size of the product
5.7 QA department will also prepare the following technical data in support of the registration form.
5.7.1 Generic name
5.7.2 Product name
5.7.3 Strength of the drug in drug product
5.7.4 Testing procedure
5.7.5 Processing procedure (Manufacturing instruction)
5.8 After getting all technical data regulatory department takes up the job of completing the necessary formalities with the FDA.
5.9 Regulatory department will take the follow up after submitting the registration application.
5.10 A product once approved by FDA, its approval is circulated to the various department for information and necessary action at their ends.


6.1 SOP - Standard Operating Procedure
6.2 QA - Quality Assurance
6.3 FDA - Food and Drug Administration

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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