NOC for Form 29

NOC for Form 29

Test licence is issued for the purpose of examination, test or analysis of biologicals. Prior to obtaining a Test licence, NOC has to be obtained from the CDSCO for the purpose of carrying out test and analysis of Test batches. For doing so, an application is submitted to DCG(I), CDSCO for obtaining the No Objection Certificate (NOC) for Test Batches for test and analysis under Form 29 along with following documents-

1. Manufacturer details Product details
2. Source of MSL/WSL
3. Manufacturing process flow
4. Site Plan
5. List of equipments and testing facility
6. Qualified personnel details responsible for Manufacturing of trial batches.

A Form 29 subject to the following –

(a) the licensee shall use the Biological manufactured under the  licence  exclusively  for  the purpose  of  examination, analysis or test and  shall  carry  on  the  manufacture  and examination, test or analysis at the place mentioned in the licence;

(b) the licensee  shall  allow  any 4 Inspector  appointed under  the  Act  to  enter,  either with  or  without  notice in the premises  where  the  drugs  are  manufactured in order to satisfy  himself  that  only  examination, analysis or test work is being conducted;

(c) the licensee shall keep a record of the quantity of Biological manufactured for examination, analysis or test and of any person or persons to whom the drugs have been supplied.

 

References

1. Guidance document on grant of licence in Form 11 (test licence) for the purpose of examination testing and analysis as per rule 33 of drugs and cosmetics acts and rules 1945. Central drugs standard control organization directorate general of health services ministry of health and family welfare government of India. https://cdsco.gov.in/opencms/opencms/en/FAQ/
2. https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/biologicals/1CDSCOGuidanceForIndustry.pdf. Accessed on 10th June 2016.