Supplier qualification

2. WHY CERTIFICATION OF VENDOR IS REQUIRED?
1 . G M P R e q u i r e m e n t .
2 . I t C a n H e l p D e l i v e r H i g h Q u a l i t y A n d S a f e
M e d i c i n e s .
3 . P r e v e n t R e c a l l s
4 . P r e v e n t D e a t h s .
5 . P r e v e n t A d v e r s e E v e n t s
6 . P r e v e n t S e r i o u s I l l n e s s
B u t I n S o m e C a s e s T h e S t a n d a r d s E x p e c t e d W e r e
N o t M a i n t a i n e d . L i k e F o r E g

3. 1. In 2008 Heparin case, intentionally API was contaminated with Bogus
substance oversulphated chondrotin sulphate, causing 150 fatalities in
U.S.
2. Contamination of glycerin with Diethylene glycol which led to deaths
due to uncontrolled distribution of glycerin.
U.S. :year 1937: 107 deaths
Bangladesh : Year 1990: 300 deaths
Haiti : year 1996 : 88 young children
Panama: Year 2006 : 136 deaths
1. Gentamycin sulpahte contaminated with unknown source caused 65
deaths in USA in 1994 and 1999.
The main aim of business is to generate profit which indirectly
leads to purchase of low quality raw material in low cost and of
substandard quality.

4. • It is the responsibility of manufacturer
of API and medicinal products to certify
the vendor.
• Vendor should also qualify the supplier
from whom he procures the raw
materials.
• All the documents from vendor and
manufacturer are verified during audit.

5. The Materials Are Classified Into 4 Categories Depending Upon Its Criticality
In API Manufacturing And Risk To The Patients.
ICH Q9 Can Be Used For Assessing The Criticality Of Risk To Patients.

6. Steps For Supplier Qualification
1. Supplier Selection.
2. Due diligence.
3. Quality assessment of all suppliers.
4. Change Control and Production assessment.
5. Supply chain security.
6. On going monitoring and evaluation.

7. 1. Supplier Selection
• User requirement specifications should be provided to purchase on the basis of which the
vendor will be selected.
• URS will contain Name of Product including its chemical name, CAS number, Specifications
and quantity required.
• Information like
- Manufacturing, Packaging, labeling details,
-MSDS,
-Analytical test methods to examine the sample against the specified criteria are to be
requested from the supplier.
-lead time to produce,
-delivery time,
-quality system certificate,
-residual solvent certificate,
-TSE/BSE evaluation,
-Gluten free declaration,
-Melamine free certification,
-GMO certification
• The material supplied by vendor should comply with the specification.

8. Categorization Of Raw Materials
Group 1 : Acids, bases, solvents, filter aids ,petroleum based raw
materials, naturally occurring raw materials, packaging materials,
water systems, utilities like nitrogen or compressed air.
Group 2: Catalyst , enzymes, chemical building blocks etc.
Group 3: API Starting materials

9. Criteria for critical raw materials, API, registered intermediate have
been identified.
-Assurance of supply
-Quality & Regulatory compliance
-Cost and procuremnt aspects
Technical/Innovation aspects
-Communication capabilties & responsivensess
Appendix2_SupplierS_checklistfinal.xlsx

10. 2. Due Diligence
Applicable for critical raw materials
Appendix3_Ddiligence_checklist.xls
Based on the report received like if proper procedures are not
followed or does not exist and if the issues are critical quality or
GMP issues then it is to be escalated to seniors.

11. 3. Quality Assessment
Appendix4_SupplierQualityQuestionnaire.doc
SupplierQuestionnaire_SectionA_General_Info_modified.doc
SupplierQuestionnaire_SectionB_BSE_TSE.doc
SupplierQuestionnaire_SectionC_GMO.docx
SupplierQuestionnaire_SectionD_Allergen.doc
SupplierQuestionnaire_SectionE_QualityQ.docx
SupplierQuestionnaire_SectionF_Packaging.doc

12. 4. Change Control And Production Assessment
1. Initiation of Change
2. Mechanism for Review of Change
3. Execution of Change:
4. Evaluation of Change:
5. Closure of the Temporary Change Control Package:
6. Preparation for Ongoing Monitoring:

13. CHAPTER 5. SUPPLY CHAIN SECURITY
• The entire supply chain from the manufacturer to the customer should be assessed and qualified from a
quality perspective.
like for e.g. For temperature/ humidity sensitive materials, the use of data loggers should be considered
in order to have documented evidence that the product was stored at the required conditions during
transportation.
Changes on the original container should be avoided e.g. while repackaging, relabeling. It can cause risk
of alteration or contamination.
Packaging Requirements :
Tamper-resistant packaging closure should be used by the manufacturer.
A manufacturer-specific design of the seal is recommended to be used.
The use of unique seals is to be considered.
For this the type of seal required by the manufacturer to the customer is to be conveyed.
Label Evaluation:
The customer should evaluate the label.
the label on the material should match with the reference label provided by the manufacturer.
The labels need to be in line with ICH Q7, 9.42/43 for APIs & registered intermediates. hence also need to
indicate
The label should indicate the name, address of the manufacturer and special storage/transport conditions ,
identification code of the product, batch number, quantity of contents and the expiry date. In case of a retest
date, this may be indicated on the COA.
Assessment of the CoA against an authentic manufacturers CoA.