sop for Vendor approval of packaging

 

1.0 OBJECTIVE: 

1.1 The objective of this SOP is:
1.1.1. To describe a clear guideline for approval of new vendor of Packaging Materials.

2.0 RESPONSIBILITY:

2.1 The Quality Assurance shall be:
2.1.1. Responsible for auditing the vendor for cGMP Compliance periodically in co-ordination with Head – Materials.
2.1.2. Responsible for preparing the vendor audit report and further necessary actions.

3.0 ACCOUNTABILITY:

Head – Technical Operations

4.0 PROCEDURE:



4.1 The packaging Materials, which are being used in the plant is already supplied by approved manufacturer from the mother plant
4.2 However the vendors shall be access periodically i.e. two yearly by Quality Assurance Department as per cGMP requirements

in coordination with materials department.
4.3 In case if there is need of new vendor the Purchase department shall identify any vendor for the supply of packaging materials & intimate to

the Head – Quality Assurance regarding the same.
4.4 Then Questionnaire regarding vendor information shall be given to vendor to fill up and to access the general facility and

GMP approach of the vendor as per Annexure – 1.
4.5 Then a formal audit has to be conducted in conjunction with the Purchase department.
4.6 The team shall visit the vendor-manufacturing site to assess the vendor capability, infrastructure, facilities etc.
4.7 The findings of the vendor audit shall be prepared and shall be sent tot vendor for information and necessary actions.
4.8 After receipt of vendor compliance report, if needed, rechecking may be done depending up on the deficiencies.

4.9 If the packaging material consists of aluminium foil / Rubber Stoppers / Vials / Ampoules / Seals etc. which require machine trials,

then the same shall be carried out with the support of the Production personnel.
4.10 A Summary shall be prepared and based on the report the decision has to be taken for approval for vendor.
4.11 In case the vendor meets all the above requirements, the vendor is declared as approved vendor. A communication to

this effect shall be given to the Purchase Department, Ware House and Quality Control after including the vendor in the approved vendor list.

5.0 REASON FOR REVISION:

This SOP is revised in order to be more effective in Vendor approval procedure.

6.0 Training:

Trainer — Quality Assurance – Head
Trainee — Executive QA & Officer – QC Packaging



7.0 DISTRIBUTION:

Certified Copy No. 1 – Head of Department Quality control
Certified Copy No. 2 – Head of Department – Purchase
Certified Copy No. 3 – File Copy in Quality Control Packaging
Certified Copy No. 4 – Head – Plant Operations
Original Copy – quality assurance

8.0 ANNEXURES:
Annexure – 1 : Vendor Audit Questionnaire.

9.0 REFERENCE:
In-house.

ANNEXURE  – 1

VENDOR AUDIT REPORT

SR. NO.	POINT	OBSERVATION
1.	Objective
2.	Name/Address/Tel.No. of the vendor visited
3.	Name/Qualification/Experience of the person contacted at Site.
4.	Monthly installed capacity of the manufacturing of the product under consideration
5.	Previous years turnover in rupee value
6.	Total quantity of products manufactured in the previous year
7.	FDA License

8.	Major users of the products manufactured by the party alongwith quantity take by them
9.	Total mfg. area available
10.	Manufacturing Facilities
11.	Whether vendor has any foreign collaboration
12.	Standard of GMP & GLP observed by the party
13.	Total Strength of the unit
14.	Any labour unrest faced during last 3 years
15.	Whether Manufacturer has his own Generator?
16.	How is the Power Supply position?
17.	Information about the track record of the Organization

18.	Quality Control/Quality Assurance facilities available with the vendor
19.	Whether In-house Specifications are available with the party
20.	Hygienic Conditions in the Manufacturing Area.
21.	Any Other point which can be considered as an useful information
22.	Joint Recommendation of QA & Materials Department.
CONCLUDING REMARKS :