Vendor Evaluation SOP

Vendor Evaluation SOP

1.0   PURPOSE:

1.1.         To evaluate/approve product/material to verify their compliance with GMP, quality, cost and delivery issue(s).

2.0    SCOPE:

2.1.         It covers foreign and local vendors of all products and materials purchased (except promotional items) once the vendor is approved, it is considered an important player of ______ Pharmaceuticals team.

3.0   RESPONSIBILITY:

3.1.      Director

3.2.      QC Manager

3.3.      Admin Manager

3.4.      QA Manager

4.0    PROCEDURE:

4.1.      General:

4.1.1.   Multiple approved vendors are maintained whenever possible to ensure material availability of all items.

4.1.2.   Sufficient quantity of Raw / Packing materials is taken from new vendors.

4.1.3.   These samples are provided to Quality Control Department for testing and analysis.

4.1.4.   In case of new product after approval of QC Department sample is provided to R&D Department for trial batch.

4.1.5.   In case of running product after detailed QA sampling and approval by QC / R&D vendor evaluation report is issued and the vendor is informed.

4.1.6.   Annually review the quality attributes and prepare the trend analysis.

4.2.      Selection Criteria for Vendor of Active Pharmaceutical Ingredients (API):

4.2.1.   The Vendor of API will provide the following for approval/Qualification:

4.2.1.1.            COA of said API.

4.2.1.2.            API Stability data.

4.2.1.3.            MSDS of the said material.

4.2.1.4.            Valid GMP certificate.

4.2.1.5.            Sample of 3 different lots (If material of vendor is approved from USFDA/ WHO/ ICH then these samples may be omitted).

4.2.1.6.            CoA of 3 different samples of 3 different lots.

4.2.1.7.            Preferably reference standard of said materials along with of impurities. In case of non-availability of reference standard working standard will be provided along with COA.

4.2.1.8.            Validated analytical method (in case of non-compendial API)

4.2.1.9.            Customer list for cross reference.

4.2.1.10.          Any Accreditation from USFDA /WHO /ICH 

4.3.      Selection Criteria for Excipients Vendor:

4.3.1.   The vendor will provide the COA of materials.

4.3.2.   Customer list will also be provided for cross reference.

4.4.      Selection Criteria for Primary Packing Material Vendor:

4.4.1.   Sufficient quantity of each item along with printing specimen (Where applicable) is taken from new vendors.

4.4.2.   Specifications of material i.e. Al foil will be provided before Qualification.

4.4.3.   Where applicable drawing will also be provided.

4.4.4.   Machine trial where applicable will also be performed.

4.4.5.   After being satisfied with the information provided by the vendor and evaluation of items by the QC, the vendor is approved or rejected for that item.

4.5.      Selection Criteria for Secondary Packing Material Vendor:

4.5.1.   Client list / Brochures / Details are asked from the vendors.

4.5.2.   Preliminary study / review of the above information will be done by the purchase department.

4.5.3.   The vendor should be capable for designing the packing components.

4.5.4.   The vendor will be bound to provide specifications of card, paper etc.

4.5.5.   He will also provide Master Copy of design as reference.

4.6.      Condition under which an on-site audit of a local vendor will become mandatory:

4.6.1.   All local API (Active Pharmaceutical Ingredients) manufacturer to be visited and Vendor Evaluation Checklist are to be filled in case of non compliance of conditions mentioned in section 2.

4.6.2.   In case of non API vendors, if there are repeated complaints of quality/delivery.

4.6.3.   In case of packing components compliant of mix up of different packing components is observed.  

5.0    REVIEW FREQUENCY:

SOP will be reviewed at least annually.

6.0      RISK ANALYSIS:

EVIDENCES OF RECORDS & REFERENCES			API Vendor Approval (F-07-010)
FORMAL KPIs (Key Performance Indicators)			No. of vendors approved or rejected,
GENERAL RISKS			CONTROL   MEASURES		CUSTODIAN
Risks	Impact
Vendor approved without fulfilling any of the requirements	Product quality will suffer	Do not qualify the vendor until unless all necessary data/items have been provided		QA Manager/ QC Manager
Machine trial has not been performed for packing material	Material may get problematic while on machine	Always perform a machine trial for all those packing materials whose trial is necessary and recommended
Vendor audit has not been done after non-compliance	Chances of repetition of non-compliance and product may suffer	Auditing the vendor is a must condition whenever a non-compliance observed regarding material