Mostafa Mohamed Nassar has over 20 years of experience in pharmaceutical production management, including sterile and non-sterile areas. He is currently the Production Manager at Grand Pharma in Egypt, where he helped start new production lines, develop quality systems, and increase productivity five-fold. Previously, he held production management roles at Adwia and Medical Union Pharmaceutical, where he helped start new sterile facilities and improve quality levels. He has a BSc in Pharmacy from Tanta University and extensive training in sterile manufacturing techniques.
GMP is important to ensure that businesses produce safe food to the public. Businesses in the food industry have a legal and moral responsibility to prepare food that is safe for the consumer. By not implementing adequate good manufacturing practices (GMP), a food business can risk several negative consequences.
The implemented of GMP on food and medicine industry's.
Most of the time it has been seen that the GMP content of the food industry related is very low so we have make a little effort. This makes will content available to students easily.
Objectives and policies of c gmp, layout of building and servicesSharwari Sapate
Pharmaceutical Quality affects every individual. Therefore GMP is required to ensure the quality of the particular drug or dosage form. In this presentation you will go through some basic information about cGMP and layout of buildings.
Common ways to avoid frequent gmp errorsKiran Kota
Presentation on avoiding the GMP errors with some controls and actions which are mentioned in the same which may help the industry on current trends of regulatory inspections.
Current Good Manufacturing Practices in Food IndustryPECB
Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to the quality standards. There are many risks: unexpected contamination of products, causing damage to health or even death; incorrect labels on container, etc. This webinar will guide you through all of the requirements, steps you need to take going from concepts to implementation of appropriate measures.
Main points covered:
• Current good manufacturing practice (CGMP) requirements
• A Quality Management System for medical devices Required By FDA (Food & Drug Association) USA
• From Concepts to implementation
Presenter:
This webinar was presented by PECB Certified Trainer, who is also a senior consultant, trainer and coach in Occupational Health and Safety, Mr. Raza Shah.
Link of the recorded session published on YouTube: https://youtu.be/9ZTtnAQn3HQ
A brief presentation on the current good manufacturing practices employed in the manufacture of pharmaceuticals in the US.
Comprises of all aspects of good manufacturing practices
Quality of drugs is basically responsibility of manufacturers & GMP guidelines are a means to assure very quality.
Draft of GMP regulations was prepared in 1975 which could be finalized & implemented in 1988, in form of amended schedule M.
It embraces Rule 71,74,76 & 78 under D & C Rules 1945.
To achieve objectives of GMP, licensee shall comply with requirements of GMP as laid down in Schedule M.
Part I deals with GMP relating to factory premises, & Part II deals with plant & equipment for manufacture of drugs.
I am Seeking an opportunity in gulf area & Egypt , multinational organization
where I can gain practical experience and develop my skills to achieve professional and personal targets.
I have got advanced experiences at QMS ( ISO9001-ISO17025- ISO22000 / HACCP ) and processes establishing, compliance verification and systems auditing
Quality and Food Safety Auditor, GLP, GMP, Hygiene.
. I am14 year Experienced in Quality, HSE, R&D & Manufacturing Operations , Exposure in Multiproduct category i.e Pure natural Mineral water , Juices Beverages,Dairy, Fruit & Vegetable canning, Tomato concentrate processing,
I am Seeking an opportunity in Gulf area & Egypt , multinational organization where I can utilize my experience and my skills to enrich and develop my professional and personal targets."
A Dynamic Professional with over 14 years’ experience in Quality Management, Food Safety & Lab & CHAMICAL & MicrobiologyFOOD, innovation Management, , Cost saving & Supplier Development, Packaging Development, Co- manufacture & Co-Pacer Health and Nutrition, Food Regulations, Crisis Management, Contours improvement and People Management, leadership management, Team work
Expert in Quality Management Systems, GMP, HACCP,ISO 22000, Crisis Management,Risk Assessment,, Innovation, Management, Consumer Complaint, Product & Process Validation & Supplier development & Compliance and Regulatory
Smooth functioning of Microbiology section. Ensure quality of analytical tests performed. Provides technical assistance to market on Microbiology issues
GMP is important to ensure that businesses produce safe food to the public. Businesses in the food industry have a legal and moral responsibility to prepare food that is safe for the consumer. By not implementing adequate good manufacturing practices (GMP), a food business can risk several negative consequences.
The implemented of GMP on food and medicine industry's.
Most of the time it has been seen that the GMP content of the food industry related is very low so we have make a little effort. This makes will content available to students easily.
Objectives and policies of c gmp, layout of building and servicesSharwari Sapate
Pharmaceutical Quality affects every individual. Therefore GMP is required to ensure the quality of the particular drug or dosage form. In this presentation you will go through some basic information about cGMP and layout of buildings.
Common ways to avoid frequent gmp errorsKiran Kota
Presentation on avoiding the GMP errors with some controls and actions which are mentioned in the same which may help the industry on current trends of regulatory inspections.
Current Good Manufacturing Practices in Food IndustryPECB
Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to the quality standards. There are many risks: unexpected contamination of products, causing damage to health or even death; incorrect labels on container, etc. This webinar will guide you through all of the requirements, steps you need to take going from concepts to implementation of appropriate measures.
Main points covered:
• Current good manufacturing practice (CGMP) requirements
• A Quality Management System for medical devices Required By FDA (Food & Drug Association) USA
• From Concepts to implementation
Presenter:
This webinar was presented by PECB Certified Trainer, who is also a senior consultant, trainer and coach in Occupational Health and Safety, Mr. Raza Shah.
Link of the recorded session published on YouTube: https://youtu.be/9ZTtnAQn3HQ
A brief presentation on the current good manufacturing practices employed in the manufacture of pharmaceuticals in the US.
Comprises of all aspects of good manufacturing practices
Quality of drugs is basically responsibility of manufacturers & GMP guidelines are a means to assure very quality.
Draft of GMP regulations was prepared in 1975 which could be finalized & implemented in 1988, in form of amended schedule M.
It embraces Rule 71,74,76 & 78 under D & C Rules 1945.
To achieve objectives of GMP, licensee shall comply with requirements of GMP as laid down in Schedule M.
Part I deals with GMP relating to factory premises, & Part II deals with plant & equipment for manufacture of drugs.
I am Seeking an opportunity in gulf area & Egypt , multinational organization
where I can gain practical experience and develop my skills to achieve professional and personal targets.
I have got advanced experiences at QMS ( ISO9001-ISO17025- ISO22000 / HACCP ) and processes establishing, compliance verification and systems auditing
Quality and Food Safety Auditor, GLP, GMP, Hygiene.
. I am14 year Experienced in Quality, HSE, R&D & Manufacturing Operations , Exposure in Multiproduct category i.e Pure natural Mineral water , Juices Beverages,Dairy, Fruit & Vegetable canning, Tomato concentrate processing,
I am Seeking an opportunity in Gulf area & Egypt , multinational organization where I can utilize my experience and my skills to enrich and develop my professional and personal targets."
A Dynamic Professional with over 14 years’ experience in Quality Management, Food Safety & Lab & CHAMICAL & MicrobiologyFOOD, innovation Management, , Cost saving & Supplier Development, Packaging Development, Co- manufacture & Co-Pacer Health and Nutrition, Food Regulations, Crisis Management, Contours improvement and People Management, leadership management, Team work
Expert in Quality Management Systems, GMP, HACCP,ISO 22000, Crisis Management,Risk Assessment,, Innovation, Management, Consumer Complaint, Product & Process Validation & Supplier development & Compliance and Regulatory
Smooth functioning of Microbiology section. Ensure quality of analytical tests performed. Provides technical assistance to market on Microbiology issues
I am seeking to obtain a position with a progressive, large international company or organization offering responsibility, advancement& individual growth.
•To find a career opportunity that would utilized abroad range of my experience
•To work in a dynamic & corporate environment, which will enable me to apply my expertise and problem solving skills, gained through advanced tertiary qualifications, work experience & international accreditations, to the best benefit of organization thereby achieving symbiotic growth
I am seeking to obtain a position with a progressive, large international company or organization offering responsibility, advancement& individual growth.
•To find a career opportunity that would utilized abroad range of my experience
•To work in a dynamic & corporate environment, which will enable me to apply my expertise and problem solving skills, gained through advanced tertiary qualifications, work experience & international accreditations, to the best benefit of organization thereby achieving symbiotic growth.
A qualified Diploma in chemical Technology 16.5 years of experience in Batch production processes, Industrial Plant Operations, Production Management with Documentation in the Pharmaceutical industries.(Anti-cardiotic drugs, Anti-dandruff drugs, Antibiotic drugs), Food Manufacturing (Nutrition’s)
A qualified Diploma in chemical Technology 16.5 years of experience in Batch production processes, Industrial Plant Operations, Production Management with Documentation in the Pharmaceutical industries.(Anti-cardiotic drugs, Anti-dandruff drugs, Antibiotic drugs), Food Manufacturing (Nutrition’s)
1. Page 1 of 5
Ard-AL-Gameiate,Part 3 , Block 13, flat 2,
, Ismailia, Egypt.
Home: (064) 3 20 70 90
Mobile: 0128-354 55 19
Mail: drmostafaderbala@yahoo.com
Mostafa Mohamed Nassar
Personal Data:
Date of Birth : 14th of July, 1971
Nationality : Egyptian
Religion : Muslim
Marital : Married& have 3 boys
Military : Exempted
Education:
Tanta University – Faculty of Pharmacy– BSC (1994) –good grad.
Work experience:
Production Manager ( sterile & non sterile)in grand pharma
(From 8/2009till now).
Work Achievements:
●startup of sterile area which has 3 lines (ampoule, Eye Ear Drops & vial)
●startup of soft gelatin cap department
●Development solid dosage form department & syrup department.
●Development water station which produces RO, purified & distilled water.
●Development HVAC system to comply with MOH
●Development warehouse (RM, PM, & finished product) to comply with MOH
• Increase productivity from 50,000 units per month to 850,000 units.
• Make modifications in some formulation to decrease the cost of some products or increase
stability for others that failed in stability.
• Make modifications in some machines to increase its production capacities.
• Introduce some new ideas as establishment of new lines as external solution
• Introduce new business opportunities by introduce new toll manufacturing chances for low
production capacities lines.
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• Cancellation extra time work in production to save money& increase productivity in the same
time.
Responsible for:
• Lead the production team to meet company goals of lean manufacturing through decrease lead-
time, downtime, scraps, and increase efficiency, on time delivery , inventory turnover and OEE.
• Supervise more than 100 technicians in different departments as sterile area" ampoules, eye
drops, vials" , solid department" tablet & hard gelatin cap " soft gelatin, Liquid department,
and more than 30 workers in Packaging department.
• Participate in Validation Protocols preparation (IQ, OQ, PQ).
• Maintain metrics to measure performance against business objectives and make necessary
changes to improve performance.
• Provide leadership to drive operational excellence and continuous improvement.
• Participating in the creation, approval & execution of the production plan.
• Issue, review & update of SOPs and batch records for all production departments.
• Ensuring that preventive maintenance is correctly planned, executed and controlled.
• Directly supervise start-up & implementation of new products& new machines.
•Perform technical assignments using good manufacturing practices and principles. To design
and implement manufacturing methods and processes that utilization of manpower, material and
equipment to accomplish assigned production objectives (Safety, Quality, on time Delivery and
Cost).
• Follow up the purchasing department to overcome any delays of raw and packaging materials.
Production Manager for Sterile Products in Adwia.
(From 6/2008to 8/2009).
Work Achievements:
- Startup of new sterile area which has 2 lines (ampoule&vial)& overcome all the problems
which prevent opening & approval from MOH
- reopening of old sterile area& MOH approval after closing it by MOH
Responsible for:
- Work as team work with production planning in production priority plan.
- Responsible for production documents as batch record, S.O.P, employee training, process
validation, machines calibration, finished product delivery to warehouse with documents.
- Responsible for batch record documents with cost departments.
- Responsible for production steps product preparation, filling, packaging.
- Responsible for production department managing by configuring with department manager.
- Configuring with quality assurance and quality control in daily, weekly, monthly, half
3. Page 3 of 5
annually and annually tests done on production steps and production department's utilities.
- Responsible as production department for environmental S.O.P and risk assessment and
HESP documents.
- Complete awareness about principles of Good Manufacturing Practice (GMP).
- Good knowledge of the main requirements of the International Organization for
Standardization (ISO 9001& ISO 14001).
In Medical Union Pharmaceutical" MUP” (From 9/1996 Till 6/2008).
1. Section Head in Sterile Area “Amp, Drops, Vial&Aerosol" In Medical Union
Pharmaceutical" MUP” (From 1/2000 Till6/2008).
Responsible for:
•Share in Production daily & weekly plan dividing & prioritization.
•Training of technician on SOPs and basics of cGMP.
•Initiation of SOPs for processes.
•Supervise the filling process including the cGMP requirements.
•Compounding of products& sterilization of all equipment for filling &filtration.
•Planning and executing media fill and aseptic process validation.
•Supervise all processes that happen daily compounding, filling, sterilization, inspection,
labeling& packaging processes.
•Rise up Quality levels & decrease the cost of poor quality.
•Continuously review & apply cGMP to Production sections.
•Revise the all section balances in warehouse.
•Making purchasing orders for the deficient balances.
•Fulfill the production batches as required for release product.
•Dispensing of raw materials.
•Dispensing of Filling & Packaging materials.
•Filling of compounded Batches.
•Pre-Packaging Processes (semi-finished products).
•Packaging of Filled products.
2. Supervisor in Sterile Area "Amp, Drops&Vial" In Medical Union
Pharmaceutical" MUP” (From 9/1996 Till 1/2000).
Responsible for:
- Participate in daily and weekly schedule planning with mangers.
- Weighing of different raw material and excipients for batches.
- Follow up preparation of different formulation and sanitizing agents.
- Participate and passing of media fill activities to control our routine work.
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- Perform most IPC tests needed during all production process.
- Follow up filling of different product and solving of different problems.
- Manage operator and create a team-work environment.
- Revise and check all notebooks and batch record before delivering to QA.
Pharmacist in Central TalaHospital &Fever Hospital (From6/1995 Till 6/1996).
Pharmacist in Private Pharmacy (From9/1994 Till 6/1995).
Courses& Training:
Sterile manufacturing skills presented by Schering Plough International Technical
Operations at Memphis co. For one month----------- November, 1998.
Sterile manufacturing skills presented by Schering Plough International Technical
Operations at MUP co. for one month----------- January, 2001.
Operation: 3 weeks in France: manufacturing of sterile injectable suspension by
Schering Plough International ------------- November, 1999.
Sterile manufacturing skills by MUP training.
Seminar by Getting Pharma on sterilization and validation -------April 1997.
Types of filters, integrity test and aseptic flirtation by Pall.
Types of filters, integrity test and aseptic filtration by Millipore.
Literature on cGMP.
ISO QMS 9001:2000 requirements.
Computer introduction, DOS, Windows and Excel by Ismailia language & computer
center ----- 1/1999 to 3 /1999.
Pharmaceutical clean-room technology by Pharmex ---------March 2007.
Design of pharmaceutical clean room systems for optimized contamination control by
Pharmex presented by Dr.Hanas H. Schichfo( 3 ) days ---------October 2008
Risk control applied to the sterilizing filtration step ----- Pall presentation 2009.
Emergency &firefighting -------- 5/2/2009 & 7/1999
Problem solving & decision making --------- 1/2009
Activities:
Consultant in SEDICO for Pharmaceutical industrial.(2015)
Consultant in SIMATECKfor Pharmaceutical industrial.(2008)
Computer &Languages Skills:
Windows: very good * Arabic: excellent
MS Office: very good * English: very good
Internet Use: very good
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REFERENCES
1. Dr. Samir Sabit
2. Other does will be furnished upon request.