Sanitization and hygiene in pharma industry

1. SANITATION & HYGIENE
Describe the sanitation and hygiene practices to
avoid contamination of the manufacturing of
products with respect to :
a. health condition of the staff;
b. good personal hygiene;
c. avoid direct physical contact with product;
d. restricted activities within controlled areas;
e. measures to prevent contamination by staff

2. Sanitization, Hygiene and
storage
 Made by Kashish Wilson
 Assistant Professor
 MM College of Pharmacy
 MM(DU) Mullana,Ambala

3. PRODUCTION
Describe the control of manufacturing process with
respect to the following :
a. Checking and verification of starting materials (r.m.,
p.m., and water)
b. Traceability of starting materials to the
product
c. Handling of rejected materials
d. Batch numbering system
e. Weighing and measurement
f. Production process
g. Labeling and packaging
h. Finished product: Quarantine and Delivery

4. Responsibilities
Originator
 Request , Proposes the change
 Design check list
 All relevant document to be
checked
 Involvement expected till the
end.
 Documentation

5. Reviewer
 Verifies everything including cross
references
 Emphasis on operational compliance and
regulatory aspects communication
 Addressing conflicting issues , bringing in
agreements
 Prepare final agreed version for approval

6. Responsibilities
Approval
Traces all activities with time
frame
Resolution of comment
Overview in totality
Ensure approval for
implementation

7. Objective
 Consistency in manufacture and
assurance of quality
 Regulatory complaints
 Facilitating … continuous …
improvement
 Building…. Successful….. Lot…
Histories….
 Systemizing… preventing and
corrective action
 Guard business practice

8. STORAGE
Specify the requirements concerning storage of
materials/ products with respect to the following
a. Space, design, security and cleanliness
b. Storage of quarantine stocks
c. Storage of hazardous substances
d. Conditions of storage area
(e.g. temperature & relative humidity)
e. Receiving of incoming materials
f. Stock control (e.g. FIFO principle, proper
labeling on the container)