Vendor validation,Qualification of vendor,Qualification criteria for vendor validation,

1. REVIEW OF TECHNICAL
SEMINAR ON VENDOR
VALIDATION
Present By-
Ranjit Pandey
Asst.QA Manager
QA Department

2. OVERVIEW
 2 Days technical seminar was conducted with
technical cooperation with PTB Germany from
21st Nov to 22nd Nov 2019.
 Organized by APPON Quality Circle
 Participant from TIME Pharma:
Diwas Adhikari and Ranjit Pandey
 German Speakers: Dr. Irmgard Buchkremer-
Ratzmann and Dr. Christina Foerg-Wimmer
 This is one of the topic of Annual Training Calendar. 2

3. CONTENTS:
 Introduction
 Why vendor validation
 Area of Vendor validation
 Method of vendor validation
 Requirement for vendor validation
 Vendor Monitoring
 Vendor Evaluation by quantitative assessment
 Disqualification of vendor
 Conclusion
 Previous APPON training Overview 3

4. INTRODUCTION
Validation:
Validation is the process of establishing
documentary evidence demonstrating that a
procedure, process, or activity carried out in
testing and then different unit maintains the
desired level of compliance at all stages
Vendor:
Collective term for Manufacturer and supplier
4

5. INTRODUCTION
Vendor validation:
It is documented evidence and process of
evaluating and approving potential
supplier by quantitative assessment.
or/
provide an appropriate level of confidence
that vendors are able to supply consistent
quality of materials, components and
services in compliance with
regulatory requirements
5

6. WHY VENDOR VALIDATION?
As a finished product manufacturer,
we are highly dependent on the quality
of substances, material, equipment,
utilities, and service providers.
6

7. WHY VENDOR VALIDATION?
To ensure that patients worldwide and at
any time can have confidence in the
quality, safety and efficacy of medicines
Cases with very serious consequences
 - Heparin case in the US (oversulphated
chondoitin sulphate)
 - Contaminated glycerin with diethylene glxcol
(e.g. in Bangladesh more than 300 deaths)
 - Nitrosamines in Sartans, Ranitidine API 7

8. 8

9. RANITIDINE AND SARTAN
 Impurities- NDMA(N-Nitrosodimethylamine),
Nitrosamine
 Sources Environmental contaminant
 Sodium Nitrate is used for cure the Meat and produced
Nitrous acid ,Degradation of protein produces
Diethylamine.
 Nitrous acid and Diethalamine react and produce
NDMA.
 NDMA produces by ranitidine and Sartans molecule in
same way.
 NDMA is Carcinogen. if more than 0.32 PPM
 So impurity profile should be check before use. 9

10. WHY VENDOR VALIDATION?
To reduce financial risk
Costs for complaint / route cause analysis
Costs for recall
Costs for destruction of material
Indirect costs because of damaged reputation
Indirect costs because quality of materials
and services may influence the robustness of
our manufacturing process or analytical work
10

11. WHY VENDOR VALIDATION?
Regulatory requirements
Almost all GMP or GDP regulations include
requirements for vendor validation
>Medicine Registration Guidance (issued under
Drug Registration Regulation)
• Chapter 1.5. Import of raw material (including
packaging material) ,Documents required:
manufacturer/supplier/certificate of origin and release
profile of modified R/M and Vendor qualification
> National and international Guidelines
(WHO, ICH)
11

12. WHY VENDOR VALIDATION?
12

13. WHY VENDOR VALIDATION?
Supplier or customer commitment to a
long term relationship.
Information sharing.
Joint agreement on specifications
 Performance measurement and
feedback.
Customer confidence in both way
13

14. IMPORTANT AREA OF VENDOR VALIDATION
Utilities
Machineries
Reagents/Laboratory materials etc.
Packaging material
Active pharmaceutical ingredients
Excipients
Intermediate products (e.g. pellets)
14

15. METHODS OF VENDOR VALIDATION
Sample request and testing
Questionnaire
Site visit (On site Audit)
 Trend Analysis
15

16. REQUIREMENT FOR VENDOR VALIDATION
 Documents
- User Requirement Specification(URS).
- Vendor Assessment Questionnaire.
- Approved vendor list.
- Vendor Qualification Form
 Responsibility
-Purchase head (identify potential supplier).
- Production and R&D(URS and trial material)
- QC (check URS , test sample)
-QA (Monitor, approve URS, periodic evaluation)
 Validation team:
-QC,QA/RA,STORE,PURCHASE,PRODUCTION and R&D 16

17. 17

18. INITIALLY QUALIFICATION OF VENDOR
18

19. QUESTIONNAIRE AND SITE VISIT (AUDIT)
Information required from
manufacturer:
Name & address of manufacturing site
Name & address of corporate office
 Company profile
 Copy of WHO –cGMP/Facility
Compliance to monograph
 DMF
 Brief manufacturing process, flow chart
 Statement on process validation
 Long term vision 19

20. QUESTIONNAIRE AND SITE VISIT (AUDIT)
Information required from
manufacturer:
Specification & methods (including all in
house methods)
 Physical characterization – particle size bulk
density, etc
 Information on impurities (residual solvents,
organic impurities (Nitrosamines))
 Stability data as per ICH guideline
 Container closure system , storage
conditions
TSE/BSE certificate
Declaration on change control
20

21. SIDE REMARK ON BROKERS /INTERMEDIARY
VENDORS(IMV)
If broker is part of the supply chain :
 Is the source clearly defined?
 Does the intermediary IMV buy from the
manufacturer?
 Is the IMV involved in packaging processes?
 Does the IMV do quality controls (issues a
COA)?
If yes, are the samples representative?
If yes, how is the relation between manufacturer
data and vendor‘s data?
 How is data integrity?
21

22. TREND ANALYSIS
Trend analysis is based on the idea that
- what has happened in the past gives traders
-an idea of what will happen in the future
Practice of collecting information and
attempting to spot a pattern
- Review through pharmasolution software
by one click.
22

23. 23

24. 24

25. RISK BASED APPROACH
Any Supply or service of low quality bears a risk:
Risk is increased
 Unsecure supply chains
 Complex supply chains
Therefore, Supplier qualification is a way to manage
the risk (ICH Q9,QRM)
Risk Management Methodology:
 FMEA (failure modes effects analyis),
 FMECA (FME and criticality analyis),
 Risk ranking and filtering (RPN numbering )
25

26. RISK MANAGEMENT
26

27. VENDOR MONITORING
Periodic check the performance of vendor
considering the following aspects
 Number of complaints in relation to total
shipments
 Type and criticality of complaints ;QC results
and trend analysis
 Status of GMP certification
 Monitoring of trends in the production
(deviations, OOS, out of trend results)
 Monitoring of changes at the manufacturing site
(change control)
 Annual report (RM,PM) 27

28. VENDOR EVALUATION BY QUANTITATIVE ASSESSMENT
Supplier scorecard point system:
S.N Focus area Allocated
score
1
Delivery-to meet expected dates as per delivery date.
0-20 points
2
Lead time-time required in between placing order and
receiving material.
0-20 points
3
Quality-it is calculated in parts per million defective
(6sigma concept,benchmarking).
0-20 points
4
Productivity Saving-suppliers’ assistance in helping
to meet our productivity goals
0-20 points
5
Payment Terms-after delivery it may be within 3 to
6 month
0-20 points28

29. VENDOR EVALUATION QUANTITATIVE
ASSESSMENT
The maximum possible score for the Month or Year-
to- is 100 points.
Supplier performance levels:
Supplier is ranked depending upon their ongoing performance:
 Level 1: supplier having 71 points or above is referred as world class and
will be rewarded by new business opportunities.
 Level 2: supplier having ongoing score 51–70 points performing
acceptable level but at the same time assurance team should work to lift
them to level 1 performance by developing them.
 Level 3: a supplier having score 31–50 points kept on conditional level of
performance. Assurance team must work to lift them to achieve level 2 or
level 1 status.
 Level 4: a supplier having score 30 points or below is a restricted
supplier, any time they exist and another alternative source has to be find
out.
29

30. VENDOR EVALUATION BY QUANTITATIVE ASSESSMENT
Quality Rating
30

31. DISQUALIFICATION OF VENDOR
Reasons for the Disqualification of the
vendors can be:
 Down-grading due to results in the annual
supplier evaluation
 Critical findings in regulatory inspections
(WHO, Stringent Regulatory Authorities)
OOS results
Inadequate response to complaints
Material not fit for the purpose
Data integrity
Supply chain 31

32. DISQUALIFICATION OF VENDOR
 Information from Quality Assurance Department (Head):
 Concern department.
 Update Software system
 Vendor
 Supplier disqualification intimation should include:
 name of material,
 Pharmacopeia grade,
 manufacturer,
 supplier (if different),
 reasons for disqualification,
 effective date.
32

33. CONCLUSION
 Approved vendor must have license from regulatory Agencies
 All the documents, reports and contracts must have approved
by authority body from the organization.
 Contract must have approved from both the vendor and our
company.
 COA and IHS report must be in the specification limit and
complies with standard.
 The classification of vendor is accordingly their satisfactory
results of material.
 To avoid complaints and product related problem vendor must
be validated which gives better result and save time and
money.
 Material categories based on criticality and risk based
approached
e.g. Excipient –Release pattern defining product. 33

34. PREVIOUS APPON TRAINING
34

35. 35