SOP For GMP training is described in this post which you can follow in the section of the Quality Assurance Department.
OBJECTIVE
This procedure is established to provide guidelines for GMP training. The SOP is an overview of basic GMP concepts and emphasizes the importance of understanding and following government regulations. This SOP will give a good background to promote regulatory compliance and at the same on-the-job training.
SCOPE
This SOP is applicable to all departments at plant. This SOP applies to the process of specifying, designing & generating training related good manufacturing practices.
RESPONSIBILITY
All HODs are responsible for the implementation of the SOP on GMP training.
AREAS FOR GMP TRAINING
Quality Assurance
Premises
Sanitation and Hygiene
Personnel
Validation
Documentation/Records
Vendor Qualification
Change Control Program
Stability Studies
Drug Recall
Annual Product Review
Audits /Complaints Management
Production (Manufacturing Area)(oral/sterile) & Packaging
Calibration of instruments or Measurement Systems
Sampling of raw material, inprocess & finished products
Raw material/ storage of starting and finished products
Production and in-process controls
Reprocessing
Finished product Release /Control
Warehousing/distribution
Environment, Health & Safety
CARRYING OUT GMP TRAINING
INHOUSE TRAINING
An in-house GMP training schedule will be developed by GMP training Incharge and the training sessions are to be conducted within a calendar year.
For GMP training, an appropriate expert/ trainer will be selected on a specific topic (in the light of experience, education & specialty of that trainer).
All the selected participants are informed through IOM having the information of the trainer’s name, topic of lecture, date, time & venue.
Attendance sheet containing names of all participants is to be circulated & all the participants must sign that sheet.
GMP training Incharge record all the courses conducted for GMP training.
Details must include:
Title of the GMP training
Date/s of training
Trainer’s name
Names of employees attending training
Assessment
results, where appropriate
Method of training should be by lecture (audio visual).
A proper record of the GMP training is to be kept in the specific training file.
SOPs RELATED TO GMP TRAINING
Inprocess checks during capsule filling
Inprocess checks during aseptic filling in sterile area
Inprocess checks during powder filling
Inprocess checks of Blender
Inprocess checks of Blister machine
Inprocess checks of coating pan
Inprocess checks during tablet compression
Packaging line clearance
Area /machine clearance
Sampling of raw material
Sampling of finished products for control samples
Product recall system
Inprocess checks before start of aseptic filling
Inprocess checks during dispensing of raw material
Control of measuring devices
Handling of customer complaints
Batch manufacturing record, review and reconciliation
Swab test
Sampling of inprocess products
Entering/leaving the production area through change rooms
Physical inspection of incoming consignments of raw material
Disposal of Expired Drugs/Return drugs products/ rejection during Inprocess
Physical inspection of containers of sterile raw material before transferring to sterile area
Release of Finished Product for sale
Destruction / Disposal of Expired/Near to expiry raw materials
Autoclave leak test
Microbiological testing of filtered nitrogen
Validation of ampoule and vials washing
Validation Master Plan (VMP)
Quality Assurance deviation Control management
Integrity testing of HEPA filters
Self inspection for GMP compliance
Good Manufacturing Practice audit
Product identification and traceability
Sanitation program
Cleaning validation protocol (dry vials filling machine)
Process validation protocol (Dry heart sterilization)
Process validation Protocol (Autoclave)
Media Fill Trial Protocol
Document & record control
Manufacturing process validation
Validation of sterilizers (moist/dry)
Product quality review
Sampling Of Raw Material (Sterile)
Standardization of Volumetric Solution and Reagents
Destruction of Used Media
Sterility Testing
Good Laboratory Practices in QC Lab
Working Reference Standard (Wrs.)
GLP In Microbiology Lab
Analytical Method Validation
Stability Studies
Reagent Preparation & Standardization
Internal Change Management
Sampling Of Packaging Material
Disposal of Waste
Dispensing of raw material against Manufacturing order
Storage and Handling of Sterile Materials
Waste/ scrap receipt and disposal procedure
Storage and Handling of finished Products
Preservation of products
Procedure for Pest/Rodents Control
Procedure For Insecticide Control
To avoid cross contamination
Disposal of rejected inprocess goods and packing materials
Batch reprocessing & reworking
Entry protocols for sterile, Cephalosporin and steroid area
Cleaning validations for change over from psychotropic to general area and vice versa
Health & Safety
TRAINING ASSESSMENT AND EFFECTIVENESS
Training effective evaluation should be done by the GMP training Incharge.
Where possible, some written / soft copy of training material may be given to the trainees for reference and guidance.
A written or oral test may be given with four weeks of training by the GMP training Incharge.
Designing assessments and documentation i.e. ensuring the content and level of assessment is linked to the training conducted; ensuring the assessment questions are appropriately worded.
Training report showing results of written / oral test, if conducted, to be prepared by the GMP training Incharge.
It is the responsibility of the GMP training Incharge to correctly record the assessment of a trainee.
The GMP training Incharge is responsible to maintain training records for QA.
The result of the test to be reported to each participant through the respective HOD.
TRAINING COORDINATION AND PROMOTION
It is the responsibility of the management to conduct GMP training in consultation with QA Manager & the
GMP training Incharge. GMP training Incharge will be responsible for the promotion and awareness of the GMP training areas to the employees.
Tags:
QA SOP