Drug Product Drug Substance
Quality-GMP-Compliance

1.Leading to Site Master File Preparation ( It is a requirement from MoH for site GMP approval )

It is prepared with the contribution -information from the below departments

• HR

• Engineering & auxiliary technical services

• Quality

• HSE

• Regulatory Affairs

• Manufacturing

• Maintenance

• Formulation

• Warehouse

 

With the following contents:

• General Information about the site

• PERSONNEL

• PREMISES AND EQUIPMENT

• DOCUMENTATION

• PRODUCTION

• QUALITY CONTROL

• CONTRACT MANUFACTURE AND ANALYSIS

• SELF INSPECTION

• BATCH RELEASE SYSTEM

• General and Detailed Organizational Structure

• Layout for Site and Production Areas

• Layout for PW System

• Layout for HVAC Systems

 

 

2. Gap Assessment: Site visit at each quarter period and prepare a report including the actions to be completed with the relevant timeline

3. Leading to SOP Preparation for Quality Assurance , Laboratory operations and HSE

4. Support SOP preparation on Production , Engineering, Warehouse, Supply Chain Management, Regulatory Affairs etc.

5. Leading the activities on equipment qualification and validation (belonging to both manufacturing and laboratory equipment which effect the quality of the product )

6. Implement the procedure on water validation to be used in manufacturing and laboratory area

7. Implement the procedure on analytical method transfer between the laboratories

8. Implement the procedure on Manufacturing Transfer

9. Personally train the employees on

 

• Quality Culture& Data integrity

• GMP Fresher

• HSE Topics

• Good Documentation Practice

• Cleaning validation at production area and equipments including the sampling and dispensing area( as a preventive action to avoid cross contamination risk considering the multipurpose manufacturing )

• Cleaning Validation at laboratory

• Technology Transfer

• Supplier Qualification

• Human Error Reduction

• Quality Risk Assessment

• Compliance in pharmaceutical manufacturing

• Annual Product Quality Review Procedure

• Self Inspection

• Change control management

• Deviation & Investigation

• Investigation of Laboratory OOS results

• Quality Management

• Batch Record Control & Realease product

• Laboratory Management

• Real Quality Incidents

• Pharmaceutical Quality Audits

• Cross Contamination Risk Analysis in multipurpose plant

• E compliance assessment

​

10. OTHER TOPICS

Support the site in

1. Implementation of data security system at each area ( computerized and noncomputarized )

2. Supplier Performance and Certification Programme

3. Implementation of SAP/ Quality Module

4. Inspection Readiness

5. Cross Contamination Risk Analysis

6. Productivity Improvement

7. Stability Management