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Approval of vendors (Packing Materials)



To lay down a procedure for approval of new vendors for packaging materials.

  • SCOPE:

This SOP is applicable to all new manufacturer / suppliers of packaging materials


Purchase, QC and QA personnel shall be responsible to follow the procedure mentioned in this SOP.


QA Head shall be accountable for compliance of the procedure mentioned in this SOP.


Vendor Assessment Form – Packaging materials                                                          – Attachment–I

Supplier Assessment Form – Packaging materials                                                        – Attachment–II

Approved Vendor List for Raw Materials (Packing material)                                    – Attachment – III

Image result for packing material


For any new Primary or secondary packaging material, QC personnel will send the specifications to the Purchase personnel.

Purchase personnel will find out the manufacturers / suppliers for the said material & will find out whether they can supply the material.

Purchase personnel will then send the specifications to the prospective manufacturer / suppliers & ask for at least one purchase samples along with their COAs.

This will be then forwarded to QC for analysis.

QC will analyze the samples & rate them in order of Quality of material.

This information will be sent to Purchase personnel.

Purchase personnel will then discuss the commercial terms with the suppliers & finalize the suppliers in order of rating.

All these suppliers will be then sent a Vendor Assessment form if they are abroad.

If the vendor or supplier is having their own assessment report, it shall be considered valid only after review and approval at Pharma company.

If they are nearby & if their audit can be conducted,  QA and Purchase person will audit the suppliers manufacturing site to see their facilities & systems.

The audit will be conducted to see that there is no contamination & mix up in the said material especially primary packaging material & there are systems in place to ensure that the supplier will be able to supply the material of the required quality consistently. If the audit compliance is more than 75 % & the supplier agrees to comply with other deficiencies in a given period of time, then the supplier can be considered for qualifying as Approved Vendor.

Based on the audit observations, the supplier will be considered for taking trial batches of formulations using material (primary packing material) from this supplier to see the container closure compatibility with the product.

Some batches of formulation using the new primary packaging material will be taken, analyzed & subjected to accelerated stability studies.

If the trial batches are found to be complying in all respects including stability studies, then QA will send a report to Purchase personnel for making this vendor as APPROVED VENDOR.

This vendor will be added in the Approved Vendors List.

The commercial batches taken with the material used from this vendor will be subjected to Stability studies.


In House


QA: Quality Assurance

QC: Quality Control


Quality Assurance Department

Quality Control Department

Purchase Department


Version Number Effective Date Reason for Revision
00 New SOP



Vendor Assessment FormPackaging materials

A. General Information
1. Name of the material to be taken from the vendor
2. Name of the company & Address
3. Telephone No.
4. Fax No.
5. E-mail ID
6. Contact person(s) .
For Technical :

For Commercial :

7. Total Mfg. Capacity per month
8. Strength of Key Departments:

–          Production .-          Quality Control / Assurance / ОКК / ООК

9. Name of other material/s manufactured at site.
10. Name of major customers for material under question.
11. Is the facility certified by any agency or body for quality system?
12. If yes, specify the name & provide us with a copy of your current certificate(s).


B. Personnel/  –
1. Are regular training programs conducted for personnel? Is the training assessed?
2. Are there records of training?
3. Are all personnel using proper gowning & safety equipment while working in production & warehouse area?
4.  Are people working in production & warehouse free from any contagious diseases / open wounds etc.?
C. Premises –
1. Are measures taken to prevent entry of birds, insects, rodents in the stores & manufacturing area?
2. If the products are manufactured simultaneously; are there measures taken to prevent contamination?
3. Are the premises in cleaned state?
4. Are all area in the premises clearly identified?
5. Is there any sign of seepage or leakage form the walls & roof?
6. Is the production area in good state of repair & free from any cracks in walls / floor?
D. Machines & Equipment
1. Are the manufacturing equipment placed in logical manner to streamline the work?
2. Are all machines identified? Are there proper status labels on each equipment?
3. Do all the equipment have proper status labels?
4. Do machines having preventive maintenance schedule?
5. Is preventive maintenance carried out as per schedule?
6. Are machines cleaned on product change over?
7. Is written procedure for machine cleaning available?
8. Has qualification been carried out for all product related equipment?
9. Are calibration records maintained for product related equipment or instrument?
E. Production  –
1. Are all master prints/dies properly identified?
2. Are issuance records of the same maintained?
3. Are the work instructions displayed for carrying out various activities during manufacturing?
4. Is follow up action taken in case of any abnormalities observed during course of manufacturing of any product? Show any records.
5. Define procedure for artwork approval–
6. Are the text matter & approved design matching performed with approved shade card before going to routine printing & signed copy of the same is kept in records?
7. During in-process check the cutting are checked regularly & records maintained?
8. Are die cut materials stored in defined area & kept segregated product or lot wise?
9. Is sorting of whole lot of pasted cartons or final printed material performed before packing?
10. Are the major equipment / instruments calibrated?
11. Define procedure for issue, use & destruction of printing plates
12. Define procedure for storage/retrieval of positives (art work)
13. Provide TSE/BSE declaration for primary packaging materials.
14. Are cartons printed using gang-run printing process?
F. Quality Systems
1. Is each lot of product checked before release?
2. Are specifications for each product available?
3. Are in-process checks conducted to find & eliminate any defects observed?
4. Are all observations recorded?
5. Are all incoming materials checked as per specification & approved specification available?
6. Is there a sampling procedure for incoming materials ?
7. Are duly approved shade cards available? Does the detailed procedure for shade card approval available and followed?
8. Are customer complaints records available with Corrective action taken?
G. Miscellaneous
1. Is there AHU system?
2. Is there a system of handling Hazardous / Toxic materials?
3. Is proper care taken in storage of inflammable material?


Overall Observations & Conclusions :
Audited By & Date Designation
Auditee & Date Designation



Supplier Assessment FormPackaging materials

A. General Information
1. Name of the material to be taken from the supplier
2. Name of the company & Address
3. Telephone No.
4. Fax No.
5. E-mail ID
6. Contact person(s)
For Technical

For Commercial

7. Number of employees on site.
8. Name of major customers for material under question
9. Is the facility certified by any agency or body for quality system?
10. If yes, specify the name & provide us with a copy of your current certificate(s).


S.No Check Points Observations / Remarks
1 Is adequate space available for storage of materials in facility?  
2 Is facility designed in such a way to prevent the entry of birds, pests, and insects?  
3 Is the facility neat & clean?  
4 Is procedure available to describe entry in the warehouse?  
5 Is lighting / ventilation is proper?  
6 Is appropriate Temperature/Humidity maintained at material storage areas?  
7 Temperature/Humidity records maintained?  
8 Is segregation of materials is adequate?  
9 Is FEFO system available?  
10 Are adequate dedusting arrangements for material containers available?  
11 Are materials stored on pallets?  
12 Physical condition of bags/boxes/containers of stored materials is proper?  
13 Stock registers available?  
14 Are dispatch records available?  
15 Segregated area available for returned materials?  
16 Is there a written procedure for product recall available?  
17 Is there a written procedure available to describe “Preventive Maintenance” of utilities?  
18 Are adequate systems available for safety?  
1 Is written procedure available for cleaning of premises?  
2 Cleaning records maintained?  
3 Is written procedure and records available for Pest Control?  
1 Are training programme conducted for personal?  
2 Training includes personal hygiene?  
3 Is training performance evaluated?  
4 Are responsibilities of personal defined and are they aware to the responsibilities?  


Overall Observations & Conclusions:
Audited By & Date Designation
Auditee & Date Designation


Attachment – III 

Approved Vendor List for Raw Materials (Packing material)




Pharm Company 

Department : Quality Assurance:


Effective Date    Version    Page No. of 




Name of  Material








Prepared By Checked By Approved By
Quality Assurance Officer



Quality Assurance Sr. Officer



Quality Assurance Head










About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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