SUDANESE CHEMICAL INDUSTRIES
PLOT 5, B (6) EAST INDUSTRIAL AREA KHARTOUN NORTH, SUDAN
QUALITY
Standard Operating Procedure (SOP) CONTROL
DEPARTMENT
SOP Title: Granulation Area Maintenance Procedures
SOP NO QC/SOP/001 DEPARTMENT QUALITY CONTROL
ISUE DATE EFFECTIVE DATE REVIEW DATE REVITION NO R 03
30/6/2025 01/7/2025 30/6/2027 03 Page: 1 of 6
APPROVAL PAGE
DEPARTMENT QUALITY CONTROL
DOCUMENT NO QC/SOP/001
REVITION R03
ISUE DATE 30/6/2025
EFFECTIVE DATE 01/7/2025
NEXT REVITION 30/6/2027
NAME DESIGNATION DATE/SIGNATURE
DR.Daoud Tajeldeinn QA/QC DEPARTMENT HEAD
Shaza Galal Awad QA OFFICER
Siham Albasheir QC SUPERVISOR
ISUE DATE 30/6/2025
EFFECTIVE DATE 01/7/2025
NEXT REVITION 30/6/2027
Standard Operating Procedures (SOPs)
SOP Title: Granulation Area Maintenance Procedures
SUDANESE CHEMICAL INDUSTRIES
PLOT 5, B (6) EAST INDUSTRIAL AREA KHARTOUN NORTH, SUDAN
QUALITY
Standard Operating Procedure (SOP) CONTROL
DEPARTMENT
SOP Title: Granulation Area Maintenance Procedures
SOP NO QC/SOP/001 DEPARTMENT QUALITY CONTROL
ISUE DATE EFFECTIVE DATE REVIEW DATE REVITION NO R 03
30/6/2025 01/7/2025 30/6/2027 03 Page: 2 of 6
REVITION NO EFFECTIVE REASON OF REVITION
00 1-11-2019 New Document
R1 1-11-2021 Update
R2 11-7-2025 Update
SUDANESE CHEMICAL INDUSTRIES
PLOT 5, B (6) EAST INDUSTRIAL AREA KHARTOUN NORTH, SUDAN
QUALITY
Standard Operating Procedure (SOP) CONTROL
DEPARTMENT
SOP Title: Granulation Area Maintenance Procedures
SOP NO QC/SOP/001 DEPARTMENT QUALITY CONTROL
ISUE DATE EFFECTIVE DATE REVIEW DATE REVITION NO R 03
30/6/2025 01/7/2025 30/6/2027 03 Page: 3 of 6
SOP Title: Granulation Area Maintenance
Procedures
SOP Code: GRAN-SOP-087
Department: Granulation
Version: 1.0
Effective Date: [Insert Date]
1. Purpose | الغرض
To establish procedures for regular maintenance of granulation equipment and area to
ensure optimal operation and compliance with GMP standards.
لتحديد إجراءات الصيانة الدورية لمعدات ومنطقة التحبيب لضمان التشغيل األمثل
واالمتثال لمعايير ممارسات التصنيع الجيدة.
2. Scope | النطاق
Applies to all granulation equipment, utilities, and the production area within the
granulation department.
ينطبق على جميع معدات التحبيب والمرافق ومنطقة اإلنتاج داخل قسم التحبيب.
3. Responsibilities | المسؤوليات
Maintenance Team: Perform scheduled maintenance and repairs.
Production Supervisors: Coordinate maintenance activities with production
schedules.
QA: Review maintenance records and ensure compliance.
تنفيذ الصيانة المجدولة واإلصالحات:فريق الصيانة.
تنسيق أنشطة الصيانة مع جداول اإلنتاج:مشرفو اإلنتاج.
مراجعة سجالت الصيانة وضمان االمتثال:ضمان الجودة.
SUDANESE CHEMICAL INDUSTRIES
PLOT 5, B (6) EAST INDUSTRIAL AREA KHARTOUN NORTH, SUDAN
QUALITY
Standard Operating Procedure (SOP) CONTROL
DEPARTMENT
SOP Title: Granulation Area Maintenance Procedures
SOP NO QC/SOP/001 DEPARTMENT QUALITY CONTROL
ISUE DATE EFFECTIVE DATE REVIEW DATE REVITION NO R 03
30/6/2025 01/7/2025 30/6/2027 03 Page: 4 of 6
4. Procedure | اإلجراءات
4.1 Maintenance Planning:
Develop and maintain maintenance schedules based on
manufacturer recommendations and historical data.
4.2 Preventive Maintenance:
Perform routine checks and servicing of equipment parts,
lubrication, and calibration.
4.3 Corrective Maintenance:
Address equipment breakdowns promptly to minimize
downtime.
4.4 Maintenance Documentation:
Record all maintenance activities, parts replaced, and
observations.
4.5 Safety Considerations:
Ensure equipment is shut down and locked out during
maintenance.
5. Documentation | التوثيق
Maintenance Logs
Work Orders
Inspection Reports
SUDANESE CHEMICAL INDUSTRIES
PLOT 5, B (6) EAST INDUSTRIAL AREA KHARTOUN NORTH, SUDAN
QUALITY
Standard Operating Procedure (SOP) CONTROL
DEPARTMENT
SOP Title: Granulation Area Maintenance Procedures
SOP NO QC/SOP/001 DEPARTMENT QUALITY CONTROL
ISUE DATE EFFECTIVE DATE REVIEW DATE REVITION NO R 03
30/6/2025 01/7/2025 30/6/2027 03 Page: 5 of 6
المالحق.10
– سجل استخدام الجهاز1 الملحق
– سجل المعايرة2 الملحق
– سجل التنظيف3 الملحق
ITEM IDENTIFICATION
Equipment: . Melting point Brand name:
Purchase date: Model/type:
Location within the laboratory: Serial no.
Warranty expiry date:
Manufacturer: Tel:
Address:.
Contact person:
Technical service representative: Tel:
PERIODICITY:
Date Maintenance operation Operator
SUDANESE CHEMICAL INDUSTRIES
PLOT 5, B (6) EAST INDUSTRIAL AREA KHARTOUN NORTH, SUDAN
QUALITY
Standard Operating Procedure (SOP) CONTROL
DEPARTMENT
SOP Title: Granulation Area Maintenance Procedures
SOP NO QC/SOP/001 DEPARTMENT QUALITY CONTROL
ISUE DATE EFFECTIVE DATE REVIEW DATE REVITION NO R 03
30/6/2025 01/7/2025 30/6/2027 03 Page: 6 of 6
FAILURE EVENTS
Date Event Corrective action taken Operator
