RENATA LIMITED

Kashor General Facility

Kashor, Hobirbari, PO: Seed Store, Bhaluka, Mymensingh-2240, Bangladesh

Material Information for Packaging Materials

Format No.: KGF/FOR/QC/022/01 Ref. Doc. No.: KGF/SOP/QC/007 Effective From:

! Each and every field is required, unless otherwise directed.

DO NOT PRINT THIS QUESTIONNAIRE

! Please complete this questionnaire on your suitable device by typing on the allowable area and clicking on
the empty boxes for Choice questions. Upon completion, save the document and send it back to Renata
Limited. Send the required annexures by scanning them as separate pdf file(s).

Name of Manufacturer / Supplier : Transcraft Limited

Site Address : Nayabari, Kanchpur, Narayanganj.

1.0 DETAILS OF PACKAGING MATERIAL TO BE SUPPLIED

Category Primary ✘ Secondary

Printing Printed Un-Printed N/A ✘ Printed ✘ Un-Printed N/A

Aluminium Top Foil HDPE Bottle ✘ IFC and CC Shipper Label

Alu-Alu Bottom Foil Polypropylene Closure ✘ Insert Shipper Carton
Material Type
PVC Film LDPE (Poly Bag) ✘ Adhesive Label Temper Seal
(Select any
PVDC Film Cotton Coil Others: Click or tap here to enter text.
one type)
Aclar Film Silica Gel Canister
Others: Click or tap here to enter text.

Chemical Name Click or tap here to enter text.

2.0 DETAILS OF PACKAGING MATERIAL (PRIMARY AND SECONDARY)

: Yes
If No, please provide Manufacturer Name and Site
Are you the manufacturer of the above material(s)? Address:
Click or tap here to enter text.

: Yes
Is this material manufactured in dedicated plant? If No, please provide a list of other materials:
Click or tap here to enter text.

: Yes
If No, please mention here:
Will you supply the material directly to Renata
Material will be stored (at supplier’s site) before
Limited from your site?
delivery
Any explanation: Click or tap here to enter text.

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 RENATA LIMITED
Kashor General Facility
Kashor, Hobirbari, PO: Seed Store, Bhaluka, Mymensingh-2240, Bangladesh

Material Information for Packaging Materials

Format No.: KGF/FOR/QC/022/01 Ref. Doc. No.: KGF/SOP/QC/007 Effective From:

2.0 DETAILS OF PACKAGING MATERIAL (PRIMARY AND SECONDARY)

Inner packaging Outer Packaging

Packaging Mode for delivery of the Poly Bag ✘ Shipper Carton Poly Bag ✘ Shipper Carton

material Paper Bag N/A Paper Bag N/A

Other: Other:
Click or tap here to enter text. Click or tap here to enter text.

3.0 ADDITIONAL INFORMATION REQUIRED FOR PRIMARY PACKAGING MATERIAL

Synthetic / Semi-synthetic
Origin of the material Mineral / Vegetable
Animal
Choose an item.
If Yes, please mention their name:
Is this material made up of more than one component?
Click or tap here to enter text.

Pharmacopoeia: USP BP EP
Specification In-house Specification (Please provide a
copy as annexure)
Pharmacopoeia: USP BP EP
Test Methods / Method of Analysis In-house Method (Please provide a copy as
annexure)
Choose an item.
Do you perform testing of every batch of your incoming Raw
If Yes, please provide a copy of COA as
Materials?
annexure.
Choose an item.
Do you perform testing of every batch of Finished Product you
If Yes, please provide a copy of COA as
provide to Renata Limited?
annexure.
Choose an item.
If Yes, please enclose specification limits and
Do you perform Microbiological Test(s) of this material?
method used for microbiological testing as
annexure.
Choose an item.
Is there a registered DMF / CEP available for this material? If Yes, please provide DMF / CEP Ref. No.:
Click or tap here to enter text.

If there is no DMF / CEP, do you have technical dossier, for the Choose an item.
material? If Yes, please provide a copy as annexure.

Choose an item.
Any special instruction regarding sensitivity of the material? (e.g. If Yes, please mention here:
Moisture sensitive, light sensitive) Click or tap here to enter text.

No special storage condition is required

Storage condition Below 25C
2C – 8C
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 RENATA LIMITED
Kashor General Facility
Kashor, Hobirbari, PO: Seed Store, Bhaluka, Mymensingh-2240, Bangladesh

Material Information for Packaging Materials

Format No.: KGF/FOR/QC/022/01 Ref. Doc. No.: KGF/SOP/QC/007 Effective From:

4.0 LIST OF REQUESTED INFORMATION TO BE SENT WITH THE COMPLETED MATERIAL INFORMATION

Type of Document Annexure Number

GMP Certificate (with valid expiry date) Click or tap here to enter text.

Certificate of Analysis (COA) Annexure 1

TSE/BSE Declaration Click or tap here to enter text.

Material Safety Data Sheet (MSDS) Click or tap here to enter text.

Method of Analysis (MOA) / Standard Test Procedure (STP) Annexure 2

Specification Click or tap here to enter text.

Label Specimen Annexure 3

Declaration of Elemental Impurities Click or tap here to enter text.

Site Master File (SMF) Annexure 4

Manufacturing License (with valid expiry date) Annexure 5

Manufacturing Process Flow Chart Annexure 6

Artwork/Drawing Click or tap here to enter text.

SOP on Container Closure System Click or tap here to enter text.

List of Products Manufactured at the site Click or tap here to enter text.

Melamine Free Declaration Click or tap here to enter text.

Material Stability Data (with both long term and accelerated data) Click or tap here to enter text.

Non-GMO Declaration Click or tap here to enter text.

Halal Certificate Click or tap here to enter text.

ISO Certificate Click or tap here to enter text.

Stringent Regulatory Authority (SRA) Certificates Click or tap here to enter text.

Other Certificates (except SRAs and Local Regulatory Certificates) Annexure 7

Storage and Transportation Declaration Click or tap here to enter text.

US Type lll DMF number Click or tap here to enter text.

Composition of Resin/Colorant Click or tap here to enter text.

Technical/Quality Agreement Click or tap here to enter text.

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 RENATA LIMITED
Kashor General Facility
Kashor, Hobirbari, PO: Seed Store, Bhaluka, Mymensingh-2240, Bangladesh

Material Information for Packaging Materials

Format No.: KGF/FOR/QC/022/01 Ref. Doc. No.: KGF/SOP/QC/007 Effective From:

4.0 LIST OF REQUESTED INFORMATION TO BE SENT WITH THE COMPLETED MATERIAL INFORMATION

AQL documents including the criteria set for critical, major and minor defects Annexure 8

5.0 VERIFICATION
Thank you for providing the information requested in this document.
RENATA LIMITED must be notified of any changes that invalidate the responses on this document.

This document has been completed by:

Name : Mr. Abdul Halim

Designation / Job Title : Marketing manager

Telephone : 01716759263

Fax : Click or tap here to enter text.

Email : abdul.halim@transcombd.com

Date Completed : 18.07.2024

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