Central Drugs Standard Control Organisation (CDSCO), Zonal Office, S. R.
Nagar, Hyderabad
Checklist for screening the documents for issue of NOC to manufacture ApprovedNnapproved New Drugs in Form 29 for the purpose of examination, test & analysis (Excluding for Clinical Trial Purpose, for drugs other than Biologicals/Medical Devices/Diagnostic Kits)
FOR'FINISHED FORMULATION
Name and Address of the firm
Date of Receipt of Application Purpose of Application
I S.No.
Parameter
a) Intent of application
Status
Page
Remarks
1
4 5
Yes/No Yes/No b ) C) Name of the drug. Yes/No I I I d) Class ofthe drug ( YesAVo e) Indication of drug I Yes/No I 1 f) Dosages & strength of the formulation I Yes/No g) Route of Administration ( Yes/No h) Composition of Product I Yes/No / i) Address of facility where drugs is to be Yes/No 'I 1 manufactured List of equipments with ID Nos. - Mfg and QC Yes/No separately of premises layout plan in A3 size & Yes/No I 1 manufacturing process with equipment location1 1 1 I . Site Master ~ i l e List of SOPSfor Manufacturing process YesINo List of SOPS for Analytical procedures
1,
I
i
7
& identification of equipments use & proposed batch size List of staff their qualification & experience
Yes/No
18
10 11
12
13
Details of raw materials used in the manufacturing Yes/No process Details of the tests which to be performed with the Yes/No drug (list of standard testing procedures) S ~ ~ Yes/No Published literature of the D ~ O D O formulations Status of drug whether approvedlunapproved new Yes/No drug Yes/No Undertaking from the actual manufacturer that drug will not be used for clinical trial/commercial (in an affidavit) Yes/No/NA Permission from Narcotics Commissioner of Indiaepartment of Animal Husbandry (if drug belongs to Narcotics1 Veterinary )
Submitted by: Name: Designation:
Opinion: On scrutiny of the submitted documents vide Letter No. ...........,the aforesaid documents are submittedlyet to be submitted.
..
............................... dated
Scrutinized by: Name: Designation:
Verified By: Name: Designation:
Central Drugs Standard Control Organisation (CDSCO), o Nagar, Hyderabad Zonal Office, SoR
Checklist for screening the documents for NOC for export of Approvedl UnApproved New Drugs/ Banned drugs from India. Name and Address of the firm
:
&34keof Receipt of Application
Purpose of Application
I- S No. - '
I
I
I
I
!
I
I
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Parameter Corering letter a) Intent of application b) Index with page numbers i c) List of products to be exported d) Name of the drug c) Dcs.zge form ' f) Composition and strength g) Pack size 11) Quantity i) Country to be exported j) Place of manufacturing k) Signed and stamped by the authorized I signatory (Name and designation) 1) Name and address of the firm S 'e t i Master File n) Manufacturing Process Flow with equipment
I-P
1I
Status YeslNo YesINa YeslNo YesINo Yes/No Y es/No YeslNo YeslNo Yes/No YesINo Y es/No YeslNo
Page Nos.
Remarks
I
I
1
I
I
YeslNo YeslNo YeslNo YeslNo Yes/No
1
I
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location - - - -- - - --
I
I
'1
Purchase OrderNalid Export Order a) From foreign buyer in the name of manufactu~erlin the name of trader b) If in the name of trader (Letter from trader in the name of manufacturer is required to be submitted along with application signed by the competent authoritylperson with valid purchase order No. and recent date not more than 6 month prior to the application made by the firm) c) List of products to be exported
Yes/No/NA
YesINo YeslNo.
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I
L..-
e) Dosage form
.
I
-.
3.
4. 5.
6.
7.
8.
9.
Composition & Strength Pack size Quantity Signed by the competent authority with specific destination point of the importing countrv Status of application whether approved / unapproved I new drug I Manufacturing License issued by - SLA for the earlier specified ~ x ~ o NOC r t if any ) Details of quantities of the drugs produced, details I regarding each consignment dispatched, remaining ( stocks of the drug and related raw materials and I intermediates in hand for the earlier specified Export NOC issued if any. Manufacturing License for the required location to manufacture the drug for export purpose Performa Invoice from importing country for ( Unapproved API used in drug formulation, signed by the idmpetent authority should be addressed to ( manufacturer mentioning the required quantity of bulk drug Registration Certificate for Banned drugs from specific importing country along with composition and strength of the drug should be provided in the name of manufacturer. Undertaking by the manufacturer
f) g) h) i)
Submitted by: Name: Designation:
Opinion: On scrutiny of the submitted documents vide Letter No. the aforesaid documents are submittedlyet to be submitted.
............................... dated .............,
Scrutinized by: Name: Designation:
Verified By: Name: Designation:
