The primary step for Manufacturing is to ensure that API (Drug Substance) Vendor Qualification is complied to manufacture a FDF- Finished Dosage Form / Formulation (Drug Product) which confirms the Product Quality. The same fundamental is applicable to API for which Key Starting Material (KSM) is sourced for API manufacturing.
Every company will have a differnet approach for Vendor Qualification / Supplier Approval Process and the requirements may vary slightly . But the Universal Approach / Global Outlook for VQ would be almost simillar.
For the Benefit of the People who like to know and who wanted to have more about Vendor Qualification/ Supplier Approval Process, herewith I am giving a Brief knowledge update:
For Example, to qualify a API ( Drug substance), and/or for Qualifying a Vendor (Manufacturer) to procure the material , the mere requirements are as follows:
I. Preshipment Sample Evaluation:
3 Consecutive / Continuous Samples submission for testing. Three samples would be more appropriate. Some vendors may give only 2 Samples due to the Cost of Material or for any other reason, but it is to confirm and to ensure that the batches are passing and Manufacturer material is meeting the requirements to Qualify the Vendor. The need is to look to that extent only.
II. As a part of the vendor qualification procedure, the below list of documents to be provided but not limited to:
- Vendor Assessment Questionnaire
- Route of Sysnthesis
- Product List
- Specification and Method of Analysis (STP)
- Elemental Impurities Declaration / Statement / Risk assessment report
- MSDS (Material Safety Data Sheet)
- Residual Solvent Declaration
- Organic Volatile Impurities
- Allergen Declarations/ Genetically Modified Organism (GMO) declaration
- ISO Certificate / any other GMP / Regulatory Approval Certificate (Ex. GMP Certification MHRA, WHO, EDQM, TFDA, TGA etc.).
- Packaging material info (Declaration of Standard Pack type)
- Mfg Process Flow
- Nitrosamines impurity declaration / Nitrosamines. Risk Assessment
- TSE / BSE Declaration
III. Onsite Audit / Physical Audit
In Case, Onsite Audit is not feasible or Viable, then Risk based audit / Remote Audit / Virtual Audit shall be performed.
IV. Quality Agreement (As per APIC Template)
If all the above parameters are complying, then the Vendor is Qualified & Approved.
As per the Business Exigency or Material Urgency, Procurement / Purchase Team and QA / CQA teams shall work together to qualify the vendor at a faster pace subjected to ensuring the Compliance to meet Basic cGMP & Regulatory Requirements.
Other verifications shall be done on different criteria:
A. New Material but Existing Vendor
B. New Vendor and New Material etc.
Again it is based on the Company’s Policy or QA/ CQA Procedures and Business call with Quality Conciousness, decision shall be taken.
Resource Person: Chakrapani K V C
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