Follow
OBJECTIVE To provide a written procedure for on the job training of newly appointed employee of Packaging Area.
SCOPE This SOP shall be applicable for Packaging Area.
ASSOCIATED DOCUMENTS Training.
RESPONSIBILITY/ACCOUNTABILITY
1. Asst. Manager, Production / Sr. Production Officer shall be responsible for training the new appointed personnel.
2. Manager, Production or his/ her Designee shall be accountable for the training procedure.
ABBREVIATIONS AND DEFINITIONS
1. SOP – Standard Operating Procedures
2. GMP – Good Manufacturing Practice
3. QA – Quality Assurance
4. WFI – Water For Injection
PROCEDURE
*** Upon appointment of a new Officer or Worker the Head of Production shall assign Asst. Manager / Sr. Officer as trainer and present the training schedule, level and duration of courses.
*** All personnel performing duties as Officer or Operator in Packaging Area will be required to complete the technical aspects of training presented below:
On job training will cover the following major area (Form No. FTR/013-00)
Pressing Belt Device Including Control Mirror and Lamp Operation
Switch On/Off
Adjustment of Pressure
Checking of Bottle Pressure
Checking Procedure
Documentation
Cleaning
Visual Inspection Device
Switch On/Off
Checking Procedure
Documentation
Cleaning
Labeling Machine Including Label Printer
Switch On/Off
Speed Control
Loading and Adjustment of Label Roll
Label Counting
Setting of Label Printer for Product Information
Documentation
Heat Sealing Machine
Overbag Sealing
Heat Controlling
Jet Printer Operation
Setting of Jet Printer for Product Information on Overbag
Checking of Print
Jet Printer Cleaning
Adhesive Tape Dispenser
Loading of Adhesive Tape in the Dispenser
Assembling of Master carton
Environmental Control and Hygiene Awareness for LVP Production
Importance of Particle Control
Importance of Microbial Control
Preventive Measures against Contaminants
*** After finishing each part of the training, the training sheet (Form No. FTR/013-00) shall be dated and signed by both the trainer and trainee.
*** Upon completion of the training the new employee shall comment on his training.
*** The trainer shall then evaluate the training of the new employee by filling out the individual training card and recommend any actions if required.
*** If knowledge and the confidence level of the trainee are found to be satisfactory, then 4th Phase of training shall be started as per SOP No. IONGE009. The individual training card shall be signed by Head of Department and documented.
*** If knowledge and the confidence level of the trainee are found to be unsatisfactory, the trainer shall recommend for additional training for a further period.
