Auditing of vendors and production department

1. AUDITING OF VENDORS AND
PRODUCTION DEPARTMENT
CAPSULES AND STERILE PRODUCTS
Arpit Rajaram Suralkar
M Pharmacy (Quality Assurance)

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

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.

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

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

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

7. CAPSULE
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
1. Hard gelatin capsule
2. 2. Soft gelatin capsule
• STERILE PRODUCTS
The products that are going to be infused directly into the bloodstream
or body tissue are called sterile products.

8. AUDIT FOR CAPSULES AND 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