SOP FOR APPLY PERMISSION FOR MANUFACTURING OF NEW PRODUCT
PURPOSE: To lay down the procedure for application for the permission for manufacturing of new product.
SCOPE: This SOP is applicable to describe the procedure for application for the permission for manufacturing of new product.
RESPONSIBILITY: Preparation of SOP: Officer/Sr. Officer of QA Personnel.
Checking and Review of the SOP: Executive/Sr. Executive of QA Personnel
Approval Of the SOP: Head of Department/Assistant Manager
Authorizing of SOP: Head QA/Designee.
QA officer /designee shall be responsible for follow the apply permission for manufacturing of new product.
ACCOUNTABILITY: Head QA shall be accountable for proper implementation of the SOP.
PROCEDURE:
Definition of new drug Product
For the purpose of this Part, ‘new drug’ shall mean and include:
A new substance of chemical, biological or biotechnological origin; in bulk or prepared dosage form used for prevention, diagnosis, or treatment of disease in man or animal which, except during local clinical trials, has not been used in the country to any significant extent and which, except during local clinical trials, has not been recognized in the country as effective and safe for the proposed claim.
A drug already approved by the licensing authority mentioned in Rule 21 for certain claims, which is now proposed to be marketed with modified or new claims, namely, indications, dosage forms (including sustained release dosage form) and route of administration.
A fixed dose combination of two or more drugs, individually approved earlier for certain claims, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in an already marketed combination is proposed to be changed, with certain claims, viz. indications, dosage form (including sustained release dosage form) and route of administration.
Quality control checklist for the application of new product permission:
Firstly, ensure that the new product exist in the pharmacopoeia or not.
Then verify the category of the product i.e. in which category product is existed whether it is in general, Beta-lactam, cephalosporin or narcotic drug category etc.
If it is Narcotic Category, then label claim could meet the specified requirements as per drugs and cosmetic act 1945 and as per GMP norms or not.
Ensure that the strength of product must be as per daily dose required by the human body.
Ensure that dosage form of the product as per pharmacopoeia.
Packing requirements should be matched with the existing market products.
Harmful and adverse drug reactions must be knowledgeable to analyst or checking person.
Finished product dose/ml must be as per pharmacopoeia.
After verifying all the check points by Quality Control department then regulatory department should collect all the verified documents and apply for the permission for new product manufacturing.
Licensee shall maintain records as prescribed under schedule M of the Drugs and Cosmetic Rules, 1945.
REFERENCES
SOP FOR SOP