SHILPA MEDICARE LIMITED, UNIT-III

Page 1 of 4
Vendor Surveillance form for Packaging Materials

General Information
Name & address of Manufacturing Site with
contact Nos. / E-mail
(Complete address of the site where the drug is
produced)

Name & address of supplier with contact Nos. /

E-mail

GST Number(Applicable for Indian entities)

Name of the material

Type of material □ Primary □ Secondary □ Tertiary □ Printed

□ Glass □ Plastic □ Rubber □ Others

Material of Construction (MOC)
If others, specify: _________________________
Storage condition of the material

How many sites are used to manufacture this

material? List the addresses of each site used
(Attach the list, if required)
Production Capacity of Plant:
- During Plant Installation
- Currently Available
No of employees
- Total
- Quality
Do the site / product have any national /
international regulatory approvals?
(If yes attach a copy of each certificate)
DQA/014-F02/01
 SHILPA MEDICARE LIMITED, UNIT-III
Page 2 of 4
Vendor Surveillance form for Packaging Materials

Is DMF available? If Yes, Please write the DMF

number and mention the date of last updated
(If yes attach a copy of acknowledgement letter)

List of other materials processed at site

(Attach the list, if required)

Quality Management System

Are job descriptions available?
-Frequency of revision

Is there a procedure for cGMP training?

Is internal auditing/ Self-inspection available?

Is there a written procedure for change

management?

Is there procedure for line clearance?

Is there a written procedure to handle deviations /

incidents & to notify customer.

Is there a written procedure to handle customer

complaints?

Is there a procedure for handling recall / return

goods?

Do you subcontract work to any third party, if yes

provide details.
Are subcontractors approved & audited?

Do you have the procedure for inprocess checks

and sampling plan?

Is there a written procedure for control of

approved artwork and colour shade cards?

Is there a written procedure for handling of dyes?

Facility & Equipment

Is each area of operation is separated physically
or partially in a manner to prevent mix-ups?

DQA/014-F02/01
 SHILPA MEDICARE LIMITED, UNIT-III
Page 3 of 4
Vendor Surveillance form for Packaging Materials

Is there a proper labeling system to avoid mix-

ups?

List of Machinery (attach)

Product Management & Safety Measures

Chemical composition of material

Drawing of material (attach)

Certificate of qualitative & quantitative

compliance of resin & additives (Attach)

Material Safety Data Sheet (MSDS) Available

(Attach)

Tick the below as applicable (Applicable documents shall be attached)

Source of origin Yes No Not Applicable
Organic volatile impurities/ Residual solvent Yes No Not Applicable
TSE/BSE free statement Yes No Not Applicable
Allergens/ Hypersensitivities statement Yes No Not Applicable
Gluten free statement Yes No Not Applicable
Melamine free statement Yes No Not Applicable
Elemental Impurities statement Yes No Not Applicable
Nitrosamines Impurities assessment report Yes No Not Applicable
Food grade certification Yes No Not Applicable
Non toxicity certification Yes No Not Applicable
Natural rubber free / latex free certificate Yes No Not Applicable
Ink edibility certification Yes No Not Applicable
Pack Supply Specification available (Attach)
___________ (Yes / No / Not applicable)
Specifications, Samples, COA are available
(Attach) ___________ (Yes / No / Not applicable)
Compatibility Water Vapour Transmission Rate
study data (Attach) ___________ (Yes / No / Not applicable)
Is there a procedure for analysis of metal ion /
heavy metals?

DQA/014-F02/01
 SHILPA MEDICARE LIMITED, UNIT-III
Page 4 of 4
Vendor Surveillance form for Packaging Materials

Is there a procedure for extraction profile in case

of primary packing material? (If yes, Attach
Report)

In case of Ready to Use rubber stoppers, attach

the below documents
- Sterilization method
- Sterilization process validation report
- Site details of sterilization process
o FDA approval for Sterilization process
site?
o cGMP/Debarment certification
o GDUFA Self-Identification/ Establishment
registration status
o DUNS/ FEI number of that establishment
o RTU stopper sterilization process DMF
o Extractable report

Is identification test complies with EP / USP /

other specification? Mention.

Sign & Date :

Name :

Designation :

Company Seal :

For SHILPA MEDICARE LIMITED

Remarks by DQA/ CQA/ QAD/ SCM/ FDD:

Checked by / Date: Verified by / Date:

Sign & Date (DQA/ CQA/ QAD) :

Is vendor audit required? ___________ (Yes / No)

Note: Use additional sheets wherever required

DQA/014-F02/01