Main description:

Provide readers and front line health care products manufacturers, R&D management and biotech laboratories all the information they need to know to develop a GMP oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements
Covers basic quality concepts and the elements of vendor's assessment, qualification and approval required by the pharmaceutical educational institutions and professional certification bodies
Provides stepwise guidance on how to evaluate, audit, qualify and approve an API and packaging material manufacturer and supplier to enhance the GMP within the industry
Provides ready to use regulatory documentation, e.g. letter of commitment, Questionnaire, SOP etc. required for API and Packaging Materials contract
Provided material can be easily tailored to incorporate changes to add in-house vendor's qualification requirements

Contents:

1. Finding and Partnering Active Pharmaceutical Ingredients Vendor. 2. Selection of API Vendors and the impacts on Drug products. 3. Approach, Team formation and Planning. 4. Site Standard Operating Procedure for vendors approval. 5 Vendors evaluation records list. 6. Vendors Document check list. 7. Declaration and Quality Commitment. 8. Self-evaluation Questionnaire. 9. Self Evaluation Questionnaire Sterile Bulk Mfg. 10. Quality Agreement. 11. Covering letter for Supplier. 12. Quality Agreement for Generic APIs. Chapter 13. API Audit checklist TOC. 14. Audit report. 15. Cell lines Vendors Selection for Biological products. 16. Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients