REVISION DATE: 3 years after effective date or when needed

TABLE OF CONTENTS:

1-HISTORY ……………………………………………………….………………2

2-PURPOSE……………………………………………………………….….……2

3-SCOPE…………………………………………………………………………...2

4-REFERENCES……………………….…………………………………...……..2

5-ABBREVIATIONS AND DEFINITION…………………………….….....……2

6- PROCEDURE……………………………………………………….…..………3

7-RESPONSIBILITY………………………………………………………...……5

8-DOCUMENT REVISIONS…………………………………………..………….5
1-HISTORY:
This is the second version SOP, review and updates the procedure.

2-PURPOSE:
To ensure that all production area is cleaned as per cGMP requirements

3-SCOPE:
This SOP applies in Production area for normal and penicillin production department.

4-REFERENCES:
MDI own generated SOP.

5- ABBREVIATIONS AND DEFINITIONS:

- (SOP) Standard Operating Procedure.
- (MDI) Modern Company for Drugs Industries.
- (QA) Quality Assurance.
- (QC) Quality Control.
- (IPC) In Process Check.
- (cGMP) current Good Manufacturing Practice.
- (PRO) Production.
- (HOD) Head of Department
6-PROCEDURE:
Implementation steps:
 Each department should have its own cleaning workers.
 The head of dept. must be ensure that all cleaning and disinfection material are available
Before a certain time.
 All cleaning & disinfection stages will be monitored by head of department and verified by
IPC.
 Documented all cleaning information by head of department &verified by IPC with sign
and date according to (appendix-1).
 All steps of cleaning and disinfectant according cGMP requirements.

1-Cleaning & disinfection of tablet and capsule departments:

1-1: Floors (daily):

- Remove all waste material from the floor by brush.
- Wipe the floor with water and disinfectants (septol 2% or certimide 2%).
- Cleaned with cleaning material, water and brush.

1-2: Walls (daily):

- Wiping the walls by wet cloth.
- Wiping the walls by ethanol 70% by wall wiper and spray, wipe down the walls, working
from the ceiling line down to the floor.

1-3: Ceiling (Between Batches or when needed):

- Wipe the ceiling with dry cloth.
- Wipe the ceiling using ethanol 70%.
- Clean the light (fluorescence) by wet cloth.

1-4: Doors and glass (daily):

- Wipe with wet cloth.
- Wipe the door’s handle with ethanol 70%.

2: Cleaning &disinfection of syrup &, suspension, cream and ointment departments:

2-1: Floors (daily):

- Remove all waste material from the floor by brush.
- Cleaned the floor with hot water (90ºC) by using brush and wash with hot water.
- Wipe the floor with water and disinfectants (septol 2% or certimide 2%).

2-2: Walls (daily):

- Wiping the walls by wet cloth.
- Wiping the walls by ethanol 70 % by wall wiper and spray, wipe down the walls, working
from the ceiling line down to the floor.
2-3: Ceiling (monthly):
- Wipe the ceiling with dry cloth.
- Wipe the ceiling using ethanol 70%.
- Clean the light (fluorescence) by wet cloth.

2-4: Doors and glass (daily):

- Wipe with wet cloth.
- Wipe the door’s handle with ethanol 70%.

NOTE:
- Disinfectants should be changed from time to time in order to avoid bacterial resistance.
- Cleaning process will verify by IPC and documented in sheet / log book for each
department.

7-RESPONSIBILTY:
- It is the responsibility of the cleaning workers to clean the area as per frequency mention in
the SOP.
- It is the responsibility of the (HOD) and supervisor to monitor and check cleaning process
and sign the cleaning documents.
- It is the responsibility of the (IPC) to verify cleaning process and sign the cleaning
document.
- It is the responsibility of QA for follow up.

8-DOCUMENTS REVISON:

NO. Section Page Initials/date

1 History 2 22-06-2017
Scope 2
Procedure 3-4
Responsibility 5

END OF DOCUMENT

Attachments:

- Cleaning and sanitization for production area (Appendix-1).