PACKAGING SUPPLIER QUESTIONNAIRE

FSMAN/REC/021 Date: 08-09-2016

Please complete and return to PT Trijaya within 7 days.

SUPPLIER :

DATE :

Section 1 : Supplier Details

1.1 Full name of supplier

1.2 Business type

Manufacturer Processor Packer

Distributor Warehouse Importer

Other

1.3 Business Address:

Post Code:

Tel No: Fax No:

e-mail address:

As above If not complete address below

Manufacturing Address:

Post Code:

Tel No: Fax No:

e-mail address:

1.4 Company contacts

Managing Director

Technical Director

Technical Manager

Emergency Contacts 1) 2)

Emergency Numbers 1) Mobile:

 For contact above 2) Mobile:

1.5 Products supplied to PT Trijaya

1.6 Number of employees Full Time : Part Time:

1.7 Are you accredited to a recognised industry standard? e.g. Y N

ISO9002

If yes, please supply copies of certification documents

1.8 Do you have a fully documented company policy and procedures Y N

to control pharmaceutical quality and safety?

1.9 Who is responsible for contacts with us concerning quality matters?

Section 2: Manufacturing Arrangements

2.1 Was the manufacturing premises purpose built for pharmaceutical Y N

handling?

2.2 Give details of the type and nature of the surrounding industry

2.3 Is waste removed from site by a recognised waste control Y N

contractor?

2.4 Do you have a glass and hard/brittle plastic register? Y N

2.5 Do you have a documented glass and hard plastic breakage policy Y N
on site?

2.6 Do you have a written cleaning schedule for all areas of the Y N
factory?

2.7 Do you have a contract cleaning arrangement? Y N

2.8 Are cleaners trained to comply with all health and safety aspects Y N
of chemical handling?

2.9 Do you employ you own engineering staff? Y N

Section 3 : Procedures for supplier approval

3.1 Do you have a documented supplier approval system? Y N

3.2 Do you audit raw material suppliers? Y N

3.3 Do you only use approved suppliers? Y N

3.4 Do you require raw material suppliers to complete pharmaceutical Y N

safety questionnaires or quality surveys?

3.5 Do you require test certification and/or certificates of Y N

conformance from your suppliers?

3.6 Do documented specifications exist between you and your Y N

suppliers?

Section 4 : Quality Control Procedures

4.1 Have you undertaken hazard analysis (HACCP) of your Y N

processes? (defining and documenting areas of potential risk to the
product and monitoring them)

* PLEASE PROVIDE EXAMPLE DOCUMENTATION OF

THIS SYSTEM

4.2 Do you inspect all incoming raw materials? Y N

4.3 Do you carry out tests on incoming raw materials? Y N

4.4 Are raw materials passed by quality control before being Y N

handled?

4.5 Do you maintain up to date product specifications for all Y N

products?

4.6 How is quality monitored throughout processing/production? Y N

4.7 Do you have documented calibration procedures for measuring Y N

instruments?

4.8 What system of weight checking do you use? Minimum

Average

Both
Section 5 : Packaging, Labelling and Shipping Aerosol

5. 1Do all your finished products pass test packaging of aerosol cans?

Leak test

Dispertion of valve

Thermal shock

Tamper resistant

Compatibility of package with the drugs

Microbiology

Other :

5.2 If containers are reused, are they cleaned via validated cleaning Y N
procedures and inspected before use?

5.3 Is each bag/container labelled with the lot/batch no.? Y N

5.4 Do you keep records of all shipments to customers, including Y N

batch number and quantity?

5.5 Do you use your own transport for shipping to customers or do

you use a contractor?

Supplier- Owned

Contractor

5.6 If you use a contractor, Do you have an agreed contract between Y N

parties which specifies required shipping conditions for packaging of
aerosol?

5.6.1 If yes, have they been evaluated? Y N

5.7 Is the shipping temperature controlled? Y N

5.8 Have stability studies for temperature controlled shipments been Y N

performed?
5.9 Are written instructions available for

Packaging components of aerosol? Y N

Packaging operation of aerosol? Y N

Labels and labelling? Y N

5.10 Does the labelling procedure emphasise special precautions to Y N

prevent unintentional mix-up or substitution?

5.11 Do you maintain lot separation during packaging? Y N

5.12 Are you prepared to meet packaging and labelling aerosol cans Y N
requirements from your customers?

5.13 Does your labelling indicate:

 Name and quality? Y N

 The site of manufacturing? Y N

 The lot number? Y N

 Our order number? Y N

 Our code number? Y N

5.14 Do you use re-usable containers? Y N

5.14.1 If yes: Do you have procedures to take special precautions to Y N

avoid cross-contamination in this case?

5.15 Do you have your own transportation system? Y N

5.16 Do you have a Quality/Safety selection system for contracting Y N

carriers

5.17 Do you have a regular carrier for your goods? Y N