Vendor Audit

for capsules and sterile products

1. BHARATI VIDYAPEETH COLLEGE OF PHARMACY, SECTOR-8, C.B.D. BELAPUR, NAVI MUMBAI- 400614 AUDITING OF VENDORS AND PRODUCTION DEPARTMENT:-CAPSULES AND STERILE PRODUCTS pREPARED BY , PRAVADA NAMDEO PATIL roll no. – 30 Guided by: Dr. Varsha Jadhav Mam quality assurance technique ,2019-2020 1

2. CONTENT Vendor Audit Benefits Of Vendor Audit Selection of Vendor Procedure for vendor audit Capsule and it’s manufacturing Sterile products and it’s manufacturing Checklist for vendor audit of capsule and sterile product 2

3. VENDOR AUDIT A vendor audit is a vehicle used by pharmaceutical companies , and other large companies as well, to inspect and evaluate a vendor's quality management system, as well as its practices, products, and documentation to reduce cost and improve quality. 3

4. BENEFITS OF VENDOR AUDIT Cost saving Process improvement Risk Reduction Relationship building Help management to achieve objectives 4

5. SELECTION OF VENDOR 5 Identification of new product/service Vendor request recording Recorded Vendor selection Cancelled Selected/Request for quotation Vendor evaluation Evaluated Vendor negotiation Negotiated Vendor service delivery Delivered Vendor service termination Terminated

6. PROCEDURE FOR VENDOR AUDIT 6 Planning:- On time delivery Order response time Product quality Reporting:- Identified performance problems Vendor rankings Audit Management:- Quality manuals Quality policy and procedures Current certifications Review:- Company review report of audit

7. CAPSULE 7 DEFINITION:- Capsules are solid unit dosage forms in which one or more medicinal substances are enclosed within a small shell or container generally prepared from a suitable form of gelatin. This gelatin is either Hard or soft depending on the formulation. So they are classified into Hard gelatin capsule Soft gelatin capsule

8. MANUFACTURING PROCESS FOR CAPSULE 8

9. STERILE PRODUCTS DEFINITION:- The products that are going to be infused directly into the bloodstream or body tissue are called sterile products. 9

10. MANUFACTURING PROCESS FOR STERILE PRODUCTS 10

11. AUDIT FOR CAPSULES AND STERILE PRODUCTS PREMISES:- Design & Layout Of Facilities Plant Safety & Security Sanitation PERSONNEL:- Hygiene Staff Qualification Staff Training VALIDATION:- Validation Of New Master Formula Validation Of Equipment And Instrument DOCUMENTATION/RECORDS:- Labels Process documents SOP’S SAMPLES STABILITY STUDY DRUG RECALL ANNUAL PRODUCT REPORT 11

12. CONTINUED..... FOR STERILE PRODUCTS:- MANUFACTURING AREA Equipment Instrument calibration Raw Materials PURIFIED AND WATER FOR INJECTION STERILIZER/ OVEN LOADING ROOM ENVIRONMENTAL MONITORING ASEPTIC BATCHING AREA FILLING ROOM Sanitization of sterile area Inspection Terminal Sterilization P ackaging 12

13. CONTINUED....... FOR CAPSULE MANUFACTURING Equipment Instrument Calibration PACKAGING Packaging Materials Packaging Operations Labels And Labelling Operation REPEOCESSING FINISHED PRODUCT CONTROL WAREHOUSING/ DISTRIBUTION ENVIRONMENT, HEALTH AND SAFETY As Per ISO 14001:2015 13

14. REFERENCE file:///H:/m%20pharm%202nd%20sem%20notes/presentation/raw%20materials/Overview%20of%20Vendor%20Audit%20Activity%20-%20IIA%20(For%20Distribution).pdf https://www.google.com/url?sa=t&source=web&rct=j&url=http://www.dra.gov.pk/docs/news/gmp_audit_checklist-2018.docx&ved=2ahUKEwi0wM6B9e7mAhUTgOYKHQ_qDJoQFjAAegQIAhAB&usg=AOvVaw37acWdWdjYwcbHg5ZZUGjY 14

15. THANK YOU 15