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Vendor Audit
- 1. AUDITING OF VENDORSAND PRODUCTION DEPARTMENT:-CAPSULES AND STERILE PRODUCTS 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 Avendor 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 VENDORAUDIT Cost saving Process improvement Risk Reduction Relationship building Help management to achieve objectives 4
- 5. SELECTION OF VENDOR 5 Identificationof 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:- •Ontime 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:- Capsulesare 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 1. Hard gelatin capsule 2. Soft gelatin capsule
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- 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 STERILEPRODUCTS 10
- 11. AUDIT FOR CAPSULESAND STERILE PRODUCTS PREMISES:- I. Design & Layout Of Facilities II. Plant Safety & Security III. Sanitation PERSONNEL:- I. Hygiene II. Staff Qualification III. Staff Training VALIDATION:- I. Validation Of New Master Formula II. Validation Of Equipment And Instrument DOCUMENTATION/RECORDS:- I. Labels II. Process documents III. SOP’S SAMPLES STABILITY STUDY DRUG RECALL ANNUAL PRODUCT REPORT 11
- 12. CONTINUED..... FOR STERILEPRODUCTS:- MANUFACTURING AREA I. Equipment II. Instrument calibration III. Raw Materials PURIFIED AND WATER FOR INJECTION STERILIZER/ OVEN LOADING ROOM ENVIRONMENTAL MONITORING ASEPTIC BATCHING AREA FILLING ROOM I. Sanitization of sterile area II. Inspection III. Terminal Sterilization IV. Packaging 12
- 13. CONTINUED....... FOR CAPSULE MANUFACTURING I. Equipment II. Instrument Calibration PACKAGING I. Packaging Materials II. Packaging Operations III. Labels And Labelling Operation REPEOCESSING FINISHED PRODUCT CONTROL WAREHOUSING/ DISTRIBUTION ENVIRONMENT, HEALTH AND SAFETY I. As Per ISO 14001:2015 13
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