Location via proxy:   [ UP ]  
[Report a bug]   [Manage cookies]                
SlideShare a Scribd company logo
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
Sanitization, Hygiene and
storage
 Made by Kashish Wilson
 Assistant Professor
 MM College of Pharmacy
 MM(DU) Mullana,Ambala
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
Responsibilities
Originator
 Request , Proposes the change
 Design check list
 All relevant document to be
checked
 Involvement expected till the
end.
 Documentation
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
Responsibilities
Approval
Traces all activities with time
frame
Resolution of comment
Overview in totality
Ensure approval for
implementation
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
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)

More Related Content

Sanitization and hygiene.ppt

  • 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)