Vous êtes sur la page 1sur 3

QUALITY ASSURANCE DEPARTMENT

Product name : ___________________________________ Batch Size : _________________________

Lot number : ___________________________________ Operator : __________________________

Mfg Date : ___________________________________ Location : _________________________

Exp Date : ___________________________________

Date: Date:
Inspection Time: Time:
Before production: Operator QAI/PIC

Walls/ceiling are free from cobwebs, molds and dust.


Floor is properly cleaned.
Feeding area is clean and dry.
No traces of granules /powder are left.
The rollers, coding device and die cutting device are cleaned with pressurized
air spray to remove dusts and waste materials.
Roller brush from the feeder is cleaned with liquid detergent, water and
sprayed with 70% ethyl alcohol.
PVC and Foil to be used are first checked and approved by Quality Assurance
Department.
During production: Date: Date:
Time: Time:
Relative Humidity and Temperature of the room are monitored and recorded.
Operator is wearing proper attire (White Lab Gown, Company Scrub suit, hair
cap, Face mask and gloves)
No foreign material is present inside the room.
The In-process tag and clean tag are properly filled up.
Lot no. and expiry date coded in the flaps are checked by both Production
Supervisor and Quality Assurance Inspector.
Leak test is monitored at the beginning of the operation of each product then
followed by every 30 minutes and every after break by the QAI in charge.
All documents are completely filled up.
After production: Date: Date:
Time: Time:
The machine together with its accessories is clean, dry and free from dust and
dirt during storage.
Floor is clean.
Walls and ceilings are clean and dust free.
All necessary equipment parts are properly covered.
A properly filled up clean tag is attached with the equipment.
The blistered products are stored in containers, properly sealed and labeled
and endorsed to coding or packaging or stored inside the process room.
The remaining PVC and foil ,if any are properly returned to warehouse
department together with their material slip

Inspected By/Date: ______________________ Checked By/Date:__________________________


QUALITY ASSURANCE DEPARTMENT
Product name : ___________________________________ Batch Size : _________________________

Lot number : ___________________________________ Operator : __________________________

Mfg Date : ___________________________________ Location : __________________________

Exp Date : ___________________________________

Date: Date:
Inspection Time: Time:
Before production: Operator QAI/PIC

Mixing tank is clean inside and out and sanitized with 70% alcohol.
Floor is properly cleaned.
Feeding area is clean and dry.
No traces of granules /powder are left.
Walls and ceiling are free from cobwebs, molds and dust.
Raw materials to be used are first checked, labeled and approved by the
Quality Assurance.
During production: Date: Date:
Time: Time:
Relative Humidity and Temperature of the room are monitored and recorded.
Operator is wearing proper attire (White Lab Gown, Company Scrub suit, hair
cap, Face mask and gloves).
No foreign material is present inside the room.
The In-process tag and clean tag are properly filled up.
The raw materials are complete.
The manufacturing procedure for mixing is accurately followed.
The operator is being checked and accompanied by QAI during mixing.
All documents are completely filled up, dispensing tags of each raw materials
are attached with the document.
After production: Date: Date:
Time: Time:
The machine together with its accessories is clean, dry and free from dust and
dirt during storage.
Floor is clean.
Walls and ceilings are clean and dust free.
All necessary equipment parts are properly covered.
A properly filled up clean tag is attached with the equipment.
The mixed bulk are properly sealed and labeled.

Inspected By/Date: ______________________ Checked By/Date:__________________________


QUALITY ASSURANCE DEPARTMENT
Product name : ___________________________________ Batch Size : _________________________

Lot number : ___________________________________ Operator : __________________________

Mfg Date : ___________________________________ Location : __________________________

Exp Date : ___________________________________

Date: Date:
Inspection Time: Time:
Before production: Operator QAI/PIC

Mixing tank is clean inside and out and sanitized with 70% alcohol.
Floor is properly cleaned.
Feeding area is clean and dry.
No traces of granules /powder are left.
Walls and ceiling are free from cobwebs, molds and dust.
Raw materials to be used are first checked, labeled and approved by the
Quality Assurance.
During production: Date: Date:
Time: Time:
Relative Humidity and Temperature of the room are monitored and recorded.
Operator is wearing proper attire (White Lab Gown, Company Scrub suit, hair
cap, Face mask and gloves).
No foreign material is present inside the room.
The In-process tag and clean tag are properly filled up.
The raw materials are complete.
The manufacturing procedure for mixing is accurately followed.
The operator is being checked and accompanied by QAI during mixing.
All documents are completely filled up, dispensing tags of each raw materials
are attached with the document.
After production: Date: Date:
Time: Time:
The machine together with its accessories is clean, dry and free from dust and
dirt during storage.
Floor is clean.
Walls and ceilings are clean and dust free.
All necessary equipment parts are properly covered.
A properly filled up clean tag is attached with the equipment.
The mixed bulk are properly sealed and labeled.

Inspected By/Date: ______________________ Checked By/Date:__________________________

Vous aimerez peut-être aussi