for capsules and sterile products

1. AUDITING OF VENDORS AND PRODUCTION
DEPARTMENT:-CAPSULES AND STERILE
PRODUCTS
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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
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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.
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4. BENEFITS OF VENDOR AUDIT
 Cost saving
 Process improvement
 Risk Reduction
 Relationship building
 Help management to achieve objectives
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5. SELECTION OF VENDOR
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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
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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
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 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
1. Hard gelatin capsule
2. Soft gelatin capsule

8. MANUFACTURING PROCESS FOR
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.
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10. MANUFACTURING PROCESS FOR
STERILE PRODUCTS
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11. 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
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12. CONTINUED.....
 FOR STERILE PRODUCTS:-
 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
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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
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14. REFERENCE
 file:///H:/m%20pharm%202nd%20sem%20
notes/presentation/raw%20materials/Over
view%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/doc
s/news/gmp_audit_checklist-
2018.docx&ved=2ahUKEwi0wM6B9e7mAh
UTgOYKHQ_qDJoQFjAAegQIAhAB&usg=AOv
Vaw37acWdWdjYwcbHg5ZZUGjY
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