SECTION

VAL 1200.00

1200.10

YOUR COMPANY VALIDATION STANDARD OPERATING PROCEDURE

SOP No. Val. 1200.10 date: mm/dd/yyyy Approved by:

Effective

TITLE: AUTHOR:

Vendor Certification __________________________________________

Name/Title/Department

__________________________________________
Signature/Date

CHECKED BY:_________________________________________
Name/Title/Department

__________________________________________
Signature/Date

APPROVED BY:________________________________________
Name/Title/Department

__________________________________________
Signature/Date

REVISIONS:
No. Section Pages Initials/Date

SOP No. Val. 1200.10 mm/dd/yyyy Approved by:

Effective date:

SUBJECT: Vendor Certification PURPOSE

To describe the procedure for evaluation of suppliers to ensure that the materials purchased are of consistent quality

RESPONSIBILITY
It is the responsibility of the quality assurance manager to develop the vendor approval system and maintain SOP compliance.

PROCEDURE
After successful vendor auditing, it can be determined whether purchased ingredients and materials can be accepted on the basis of suppliers certificates, with minimized inspections of incoming goods to a certain level. Vendor certification leads to reduction of costs and release times.

VENDOR CERTIFICATION
The vendor certification procedure may include a list of selected vendors, historical review of test results of previous suppliers, and formal inspection on site and decision making.

1. Selection of Vendors to be Certified

The selection of vendors to be certified should be jointly made by the heads of purchasing and production and the quality assurance manager.

2. Review of Historical Data and Test Results

Summarize the quality data of batches delivered during the last 3 years and prepare trend analysis. Report deviations with regard to normal failure levels, out-of-specification situations, and corrective actions. The quality control and quality assurance managers shall review the trend.

3. Site Audit
The quality assurance manager or the system in charge may perform an on-site audit. The audit should specifically:

Determine the accuracy, precision, and reliability of test and inspection data of the vendor. Review the process reproducibility and the batch records for process variations. Perform general GMP compliance inspection. Review the potential for contamination and mix-ups thoroughly.
SOP No. Val. 1200.10 mm/dd/yyyy Approved by: Effective date:

Ensure that vendors in-process controls include the use of statistical process control critical product parameters that are significant and may affect the final product quality Ensure the absence of significant online problems.

4.

Recommendations

It is not essential to perform on-site inspections. As an alternative, evaluation questionnaires can be used. Vendors can also be certified based on an extensive review of historical analytical inspection data and their performance over the last 3 years. Alternatively, third-party audits may be conducted for a predefined period.

5.

Decision on Certification

The data obtained as a result of these reviews and audits shall be reviewed by the QA manager and sent for approval to quality control, production, and purchasing. Final release must be authorized by quality control.

6.

Steps after Certification

After vendor approval, quality control or quality assurance will reduce the number of tests and inspections of incoming goods as agreed in the certification report, e.g., one out of ten batches. For packaging materials certification, it is sufficient to review the results of three suppliers. If during this process of verification no discrepancies appear, the verification may be discontinued. For incomplete certification, a provisional classification report shall be published by the QA manager for components. Materials to be used in production without complete testing must be supported with acceptable certificates of analysis by manufacturers. Active ingredients should be checked for their identity. All deviations regarding purchased materials encountered by production must be reported to the quality assurance manager for referral to the manufacturer or supplier.

7.

Recertification

Recertification of an active and excepient manufacturer may be performed on request. Recertification can be requested by quality control and production. The certification is valid for a period determined by the QA manager. Certification of packaging materials is valid for 5 years.

REASONS FOR REVISION

Effective date: mm/dd/yyyy

First time issued for your company, affiliates, and contract manufacturers