by - OBJECTIVE
To lay down the Cleaning Procedure for medicament manufacturing area.
- SCOPE
This procedure is applicable for cleaning procedure of medicament manufacturing area in Production Department situated.
RESPONSIBILITY
Production Chemist & operator : To follow the procedure
ACCOUNTABILTY:
QA & Head Production : For system compliance
- PROCEDURE
There are two types of cleaning carried out for the cleaning of medicament manufacturing area.
5 TYPE “A” CLEANING: Type “A” cleaning is done in case of Manufacturing Area of different Products. Area clean by clean plastic broom and finally wet mop with lint free cloth soaked in disinfectant solution. (2.5% Dettol / Savlon or 70 % Isopropyl Alcohol). This cleaning covers weighing balance outer and inner side of platform and monitor, inner surface area of booth glass, window, door and other surrounding area. Follow type “A “cleaning immediate after the completing of the Manufacturing Area of the First product / material.Switch off the Equipment /Instrument.
Dry mop the entire surface of the safe working zone with clean lint free cloth
Dry mop the surface of all the articles, Equipment and platform, grills.
Ensure that manufacturing area free from powder residue /stuck dust.
Wet mop the entire booth with the disinfectant solution (2.5 % Dettol, 2.5 Savlon & IPA70%).
Wet mopping should include the floor, safe working zone equipment surface, grills,
Clean the SS bins, stands and other articles with dry mop.
- Clean the pallets kept in the materials staging room by dry mopping with lint free cloth followed by wet mopping with disinfectant solution.
- Clean the floor under the pallets.
Note: Rotate the disinfectant (2.5% Dettol, 2.5% Savlon & IPA 70%) every fifteen days.
TYPE “B” CLEANING: Type “B” cleaning shall be done in case of the same Composition
But of different batch numbers. In this case mop with dry lint free cloth followed by vacuum cleaning of the equipment platform, entire inner surface and SS table and other articles, which are kept in safe working zone. The cleaning shall also include grill, side & top, and the entire surface of the manufacturing area.
- Follow Type “B” cleaning immediately after the completing of Product Batch over.
- Switch off the Equipment /Instrument.
- Ensure all the materials containers and other accessories are removed from medicament manufacturing Area.
- Use dry lint free cloth to dry mop the entire inside surface of all medicaments manufacturing Area.
TRAINING
Trainer : Head – Production Department
Trainees : Staff and machine operator of production and QA chemist.
DISTRIBUTION
Master Copy : QA Department
Controlled Copy : Production Department
Display Copy : Production Department
ATTACHMENTS
Nil.
- REFERENCES
In-house
ABBREVIATION
| Abbreviation | Extended Form |
| EG | Engineering |
| SOP | Standard Operating Procedure |
| QA | Quality Assurance |
| WH | Warehouse |
| NA | Not Applicable |
| MB | Microbiology |
REVISION HISTORY OF CHANGE
| Sr. No. | Date | Revision Details | Revision No. |
