Pharmaceutical vendors approval manual : a comprehensive quality manual for API and packaging material approval /: a comprehensive quality manual for API and packaging material approval. (2021)

• Record Type: Book
• Further Information: Note: Erfan Syed Asif.
• Authors: Asif, Erfan Syed
• 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
• Edition: 1st
• Publisher Details: Boca Raton : CRC Press
• Publication Date: 2021
• Extent: 1 online resource, illustrations (black and white)
• Subjects: 615.19; Drugs -- Quality control; Drugs -- Standards; Drugs -- Packaging -- Quality control; Drugs -- Packaging -- Standards; Pharmaceutical industry -- Quality control; Pharmaceutical industry -- Standards
• Languages: English
• ISBNs: 9781000510027; 9781000510003; 9781003189145
• Related ISBNs: 9781032030883
• Notes: Note: Description based on CIP data; resource not viewed.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.