Ogundele Olorunfemi has over 10 years of experience in quality control and laboratory analysis. He has worked for various companies analyzing raw materials, products, and effluents to ensure safety and quality standards. He holds an MSc in Chemistry from the University of Lagos and is pursuing further education in Supply Chain Management. He has published several research papers on transition metal complexes and their properties. He is a member of the Chemical Society of Nigeria and has held leadership roles in student organizations. References are available upon request.
EU GMP Annex 1 – Implications on Filtration and Single Use Technology by Soma...MilliporeSigma
What are the major drivers for the new Annex 1? Join us to know more about implications for Filters & Single Use.
In this webinar, you will learn:
• Closed Processing and Single Use Technology implementation
• Points to consider using Single Use Technology
• Sterile Filtration
The Annex 1 “Manufacture of sterile medicinal products” of the EU GMP Guide is currently being revised. A first draft of the revised version was published in 2017 and released for public comment. The second draft as of February 2020 was open for targeted consultation via stakeholder from selected industry organisations. The current Annex 1 draft emphasises Contamination Control Strategy (CCS) multiple times and as a key consideration.
Excipients selection for high risk formulations Smita RajputMerck Life Sciences
Are you choosing the right excipients for your high risk application? Find out how to select the right excipients and enable your process optimization to improve the total cost of ownership.
In this webinar, you will learn:
• Selection of right excipients for high risk formulation is very critical step
• Low Endotoxin and low bioburden limits are important aspect while selecting raw materials
• Strong regulatory support is crucial for high risk formulation
Excipients selection for high risk formulations like parenteral and ophthalmic applications is very challenging. Excipients should be inert with high purity for such dosage forms because trace amounts of impurities present in excipients can interact with active pharmaceutical ingredient (API) which results in instability of the formulation. This presentation discusses how to select the right excipients for high-risk applications and gives guidance for process optimization by choosing the best combination of filters and excipients to improve the total cost of ownership.
EU GMP Annex 1 – Implications on Filtration and Single Use Technology by Soma...MilliporeSigma
What are the major drivers for the new Annex 1? Join us to know more about implications for Filters & Single Use.
In this webinar, you will learn:
• Closed Processing and Single Use Technology implementation
• Points to consider using Single Use Technology
• Sterile Filtration
The Annex 1 “Manufacture of sterile medicinal products” of the EU GMP Guide is currently being revised. A first draft of the revised version was published in 2017 and released for public comment. The second draft as of February 2020 was open for targeted consultation via stakeholder from selected industry organisations. The current Annex 1 draft emphasises Contamination Control Strategy (CCS) multiple times and as a key consideration.
Excipients selection for high risk formulations Smita RajputMerck Life Sciences
Are you choosing the right excipients for your high risk application? Find out how to select the right excipients and enable your process optimization to improve the total cost of ownership.
In this webinar, you will learn:
• Selection of right excipients for high risk formulation is very critical step
• Low Endotoxin and low bioburden limits are important aspect while selecting raw materials
• Strong regulatory support is crucial for high risk formulation
Excipients selection for high risk formulations like parenteral and ophthalmic applications is very challenging. Excipients should be inert with high purity for such dosage forms because trace amounts of impurities present in excipients can interact with active pharmaceutical ingredient (API) which results in instability of the formulation. This presentation discusses how to select the right excipients for high-risk applications and gives guidance for process optimization by choosing the best combination of filters and excipients to improve the total cost of ownership.
Presentation given by Laurène Haurie from Plateforme Gala in the framework of the Emergence Forum Barcelona
Biocat organized the Barcelona Emergence Forum (April 10-11th, 2014, Congress Palace, Montjuïc) supported by the TRANSBIO SUDOE, a translational cooperation project dedicated to innovation in life sciences in South-West Europe. The Barcelona Emergence Forum contributed to bringing together Academics, Companies, Investment Entities, Technology Platforms and Technology Transfer Offices from Spain, France and Portugal to set up collaborative projects on Human Health & Agro-food Innovation.
More information at: http://www.b2match.eu/emergenceforum2014
Kemwell provides extensive mammalian cell culture-based formulation development services. The labs have the capability of performing complete process development, process optimization, scale-up, technology-transfers and process characterization.
Integrity Bio is a protein formulation development, fill finish, and drug delivery CMO. Injectable formulations include protein,antibody, vaccine, and peptide. http://www.integritybio.com
Quality by Design Principles Applied to Sterilizing Filtration by Michael PayneMilliporeSigma
Key regulatory documents and regulatory thinking now includes quality by design (QbD). This webinar focuses on how to integrate practical QbD activities into the process and analytical aspects of sterile medicinal product sterilizing filtration and qualification.
In this webinar, you will learn to:
• Focus on practical QbD terms and approaches
• Highlight critical product quality aspects of sterile medicinal products
• Develop design and control spaces for sterilizing filtration
• Easily integrate QbD into the process and analytical operations in early phase development and into manufacturing phase production
Abstract:
Final sterilizing filtration is the last operation in downstream processing to assure the sterility of medicinal products. Poorly defined product attributes process parameters may attract regulatory scrutiny, affect final product sterility and patient safety. A better understanding of QbD concepts and principles allows for better process and analytical monitoring and control at both early and final phase production. The webinar will show how currently available process cGMP information can be practically incorporated into QbD product quality attributes and process parameters. This is especially vital for the third party conducted laboratory work such as bacterial retention and leachable studies.
Page | 30
TESTS CONDUCTED IN MICROBIOLOGY LABORATORY OF ACI
❖ Bacterial endotoxin test (BET/LAL test/ Pyrogen Test)
❖ Microbial limit test for non-sterile pharmaceutical products (syrup, suspension, cream,
ointment, gel, tablet and raw materials)
❖ Microbiological assay of antibiotics
❖ Sterility test of sterile pharmaceutical products
❖ Sampling of water (purified water, potable water and water for injection)
❖ Sampling of raw materials
❖ Total organic carbon analysis (water for injection, purified water)
❖ Chemical analysis of water
❖ Environmental monitoring, settle plate
❖ Personal hygiene monitoring
❖ Surface monitoring
❖ Liquid borne particle count for WFI
❖ Preservative efficacy test
Media Used:
NON SELECTIVE MEDIA SELECTIVE MEDIA
R2A Agar Xylose Lysine Deoxycholate
Sabouraud dextrose agar Brilliant green lactose bile broth
Tryptone Soy Agar Bismuth sulphite agar
Tryptone Soy Broth
Eosine methylene blue agar
Thioglychollate medium Cetrimide agar
MacConkey agar
Triple sugar iron agar
Mannitol salt agar
Enterobacteriaceae enrichment broth
Page | 31
Figure 11: Selective & Non selective media used in ACI
BACTERIAL ENDOTOXIN TEST
PRINCIPLE
BET test is used to detect or quantify bacterial endotoxins that may be present in the sample
to which the test is applied. Endotoxin is a toxic substance found in the outer cell membrane
of Gram negative bacteria (Lipopolysaccharide, LPS) when they disintegrated. The gel clot
method is a qualitative or semi-quantitative method, which detects the endotoxin based on
clotting of the Limulus Amoebocyte Lysate (LAL) reagent in presence of endotoxin when
incubated. LAL reagent is prepared from lysate of the circulating amoebocytes of the
horseshoe crab Limulus polyphemus. When exposed to minute quantities of endotoxin, the
lysate increases in opacity, viscosity and forms gel depending on the concentration of
endotoxin. The concentration of endotoxin required to cause the lysate to clot under standard
conditions is the labeled sensitivity of LAL reagent.
Good Laboratory Practices: General Provisions, Organization and Personnel, Facilities,
Equipment, Testing Facilities Operation, Test and Control Articles, Protocol for Conduct
of a Nonclinical Laboratory Study, Records and Reports, Disqualification of Testing
Facilities
Good laboratory practices
introduction
reasons behind the creation of glp
Objectives of GLP
The OECD
GLP principles
Test facility organizational and personnel
Quality assurance programme
Facilities
Apparatus, materials and reagents
Test systems
Test and reference items
SOPS- Standard Operating Procedures
Performance of the study
Reporting of the study details
Storage and retention of records and materials
What GLP must contain?
Do this for GLP
Benefits of GLP
Conclusion
Diteba is a global leader in complex analytical and bioanalytical testing, providing solutions and services to the pharmaceutical, biopharmaceutical and nutraceutical industries.
We support both large and small molecule testing for various dosage forms including solids, semi-solids, liquids, aerosols and other special dosage forms. Our work is focused in several core areas including: In Vitro Release Rate Testing (IVRT) services; stability storage and testing; method development and validation and QC testing at our fully accredited facility.
Presentation given by Laurène Haurie from Plateforme Gala in the framework of the Emergence Forum Barcelona
Biocat organized the Barcelona Emergence Forum (April 10-11th, 2014, Congress Palace, Montjuïc) supported by the TRANSBIO SUDOE, a translational cooperation project dedicated to innovation in life sciences in South-West Europe. The Barcelona Emergence Forum contributed to bringing together Academics, Companies, Investment Entities, Technology Platforms and Technology Transfer Offices from Spain, France and Portugal to set up collaborative projects on Human Health & Agro-food Innovation.
More information at: http://www.b2match.eu/emergenceforum2014
Kemwell provides extensive mammalian cell culture-based formulation development services. The labs have the capability of performing complete process development, process optimization, scale-up, technology-transfers and process characterization.
Integrity Bio is a protein formulation development, fill finish, and drug delivery CMO. Injectable formulations include protein,antibody, vaccine, and peptide. http://www.integritybio.com
Quality by Design Principles Applied to Sterilizing Filtration by Michael PayneMilliporeSigma
Key regulatory documents and regulatory thinking now includes quality by design (QbD). This webinar focuses on how to integrate practical QbD activities into the process and analytical aspects of sterile medicinal product sterilizing filtration and qualification.
In this webinar, you will learn to:
• Focus on practical QbD terms and approaches
• Highlight critical product quality aspects of sterile medicinal products
• Develop design and control spaces for sterilizing filtration
• Easily integrate QbD into the process and analytical operations in early phase development and into manufacturing phase production
Abstract:
Final sterilizing filtration is the last operation in downstream processing to assure the sterility of medicinal products. Poorly defined product attributes process parameters may attract regulatory scrutiny, affect final product sterility and patient safety. A better understanding of QbD concepts and principles allows for better process and analytical monitoring and control at both early and final phase production. The webinar will show how currently available process cGMP information can be practically incorporated into QbD product quality attributes and process parameters. This is especially vital for the third party conducted laboratory work such as bacterial retention and leachable studies.
Page | 30
TESTS CONDUCTED IN MICROBIOLOGY LABORATORY OF ACI
❖ Bacterial endotoxin test (BET/LAL test/ Pyrogen Test)
❖ Microbial limit test for non-sterile pharmaceutical products (syrup, suspension, cream,
ointment, gel, tablet and raw materials)
❖ Microbiological assay of antibiotics
❖ Sterility test of sterile pharmaceutical products
❖ Sampling of water (purified water, potable water and water for injection)
❖ Sampling of raw materials
❖ Total organic carbon analysis (water for injection, purified water)
❖ Chemical analysis of water
❖ Environmental monitoring, settle plate
❖ Personal hygiene monitoring
❖ Surface monitoring
❖ Liquid borne particle count for WFI
❖ Preservative efficacy test
Media Used:
NON SELECTIVE MEDIA SELECTIVE MEDIA
R2A Agar Xylose Lysine Deoxycholate
Sabouraud dextrose agar Brilliant green lactose bile broth
Tryptone Soy Agar Bismuth sulphite agar
Tryptone Soy Broth
Eosine methylene blue agar
Thioglychollate medium Cetrimide agar
MacConkey agar
Triple sugar iron agar
Mannitol salt agar
Enterobacteriaceae enrichment broth
Page | 31
Figure 11: Selective & Non selective media used in ACI
BACTERIAL ENDOTOXIN TEST
PRINCIPLE
BET test is used to detect or quantify bacterial endotoxins that may be present in the sample
to which the test is applied. Endotoxin is a toxic substance found in the outer cell membrane
of Gram negative bacteria (Lipopolysaccharide, LPS) when they disintegrated. The gel clot
method is a qualitative or semi-quantitative method, which detects the endotoxin based on
clotting of the Limulus Amoebocyte Lysate (LAL) reagent in presence of endotoxin when
incubated. LAL reagent is prepared from lysate of the circulating amoebocytes of the
horseshoe crab Limulus polyphemus. When exposed to minute quantities of endotoxin, the
lysate increases in opacity, viscosity and forms gel depending on the concentration of
endotoxin. The concentration of endotoxin required to cause the lysate to clot under standard
conditions is the labeled sensitivity of LAL reagent.
Good Laboratory Practices: General Provisions, Organization and Personnel, Facilities,
Equipment, Testing Facilities Operation, Test and Control Articles, Protocol for Conduct
of a Nonclinical Laboratory Study, Records and Reports, Disqualification of Testing
Facilities
Good laboratory practices
introduction
reasons behind the creation of glp
Objectives of GLP
The OECD
GLP principles
Test facility organizational and personnel
Quality assurance programme
Facilities
Apparatus, materials and reagents
Test systems
Test and reference items
SOPS- Standard Operating Procedures
Performance of the study
Reporting of the study details
Storage and retention of records and materials
What GLP must contain?
Do this for GLP
Benefits of GLP
Conclusion
Diteba is a global leader in complex analytical and bioanalytical testing, providing solutions and services to the pharmaceutical, biopharmaceutical and nutraceutical industries.
We support both large and small molecule testing for various dosage forms including solids, semi-solids, liquids, aerosols and other special dosage forms. Our work is focused in several core areas including: In Vitro Release Rate Testing (IVRT) services; stability storage and testing; method development and validation and QC testing at our fully accredited facility.
Dear student, Warm Greetings of the Day!!! We are a qualified team of consultants and writers who provide support and assistance to students with their Assignments, Essays and Dissertation. If you are having difficulties writing your work, finding it stressful in completing your work or have no time to complete your work yourself, then look no further. We have assisted many students with their projects. Our aim is to help and support students when they need it the most. We oversee your work to be completed from start to end. We specialize in a number of subject areas including, Business, Accounting, Economic, Nursing, Health and Social Care, Criminology, Sociology, English, Law, IT, History, Religious Studies, Social Sciences, Biology, Physic, Chemistry, Psychology and many more. Our consultants are highly qualified in providing the highest quality of work to students. Each work will be unique and not copied like others. You can count on us as we are committed to assist you in producing work of the highest quality. Waiting for your quick response and want to start healthy long term relationship with you. Regards http://www.cheapassignmenthelp.com/ http://www.cheapassignmenthelp.co.uk/
Deputy Manager QA, working exp in beverage, juice water , sauces ketchup, mayonnaise and Jam & new product development. FSMS , HACCP & FSSC implementation& auditing
III FORO DE TRANSFERENCIA TECNOLÓGICA - BIOTRANSFER.
5 de Junio de 2014, a las 12:45 p.m, en el Salón de actos del Complejo Hospitalario Torrecárdenas de Almería.
1. OGUNDELE OLORUNFEMI
8 Mystic Street
U-Turn, Abule Egba Lagos, Nigeria
Tel +2347062424290
ogundelefemi33.oo@gmail.com.
ogundelefemi33@yahoo.co.uk
CAREER OBJECTIVE:
To be part of a dynamic organization where I can contribute immensely to their
growth and where my experience in Quality Management System (QMS – ISO 9001),
Food Safety Management System (FSMS - ISO 22000), Good Manufacturing Practice
(GMP), Hazard Analysis and Critical Control Points (HACCP), Good Laboratory
Practice (GLP).
EDUCATION: Supply Chain Management ( in view)
Institute Of Supply Chain Management Ogba Ikeja.
MasterOf Science In Chemistry, November 2010
University Of Lagos With Distinction (4.88)
BachelorofScience in Chemistry, June 2008
Lagos State University with second class upper(3.93)
WORKING EXPERIENCES
PZ WILMAR (MAKERS OF DEVON KINGS VEGETABLE OIL/MAMADOR) 2013
LABORATORY ANALYST / QUALITY CONTROL
Hourly analysis of Refinery Olein (vegetable oil), Stearin, Palm fatty acid distillate, Refine
bleached deodorized palm oil ,crude palm oil , wash oil and bleaching earth
Analysis such as Free fatty acid, Colour , Moisture, Iodine value ,Peroxide value, Carotene
content in oil, phosphorus content , anisidine value, Biological oxygen demand, Hardness,
Alkalinity, Acidity, pH, TDS, Conductivity, PET, cloud point, sleep melting point, cold
stability test.
Water and effluent analysis
Ship crude palm oil sampling at tin can island, Truck and Production floor Inspection
Equipment handled include Near Infrared Spectrophotometer, UV spectrophotometer, BOD
Meter , Tinto Meter ,Ash Funace, water bath , COD machine and top load machine
Inspection of On-line Product
Development of international Target Net Weight for Different Weights of Olein
Produced.
2. Ensure safe Working Environment/Zero lost Work in the Laboratory, and Production
Floor, by Enforcing the use of Personal Protective Equipment (PPE), Good
Housekeeping (GHP), & Good Laboratory Practice (GLP).
Ensure Samples are retained, labeled properly, maintained and easily Retrieved in
case of any Product Incidence Investigation.
Analysis and Inspection of Packaging Material and Raw Material Received i.e Labels,
Caps and Inserts, Resin, Calcium Carbonate, Corrugate, Empty Blown PET Bottles,
Doy Pack and Preforms used in Production of Oil.
Preparation of Reagents, Standardization, and Calibration of Test Instruments.
Validation of Test Methods, Processes and Equipment.
THE LACASERA COMPANY LIMITED {June 2012-April 2013} 2012
WATER TREATMENT ANALYST/CHEMICAL ANALYST
Hourlyanalysisof Water(i.e Chlorine content,IronContent,TDS,WaterPh,Total Alkalinity,
Total Hardness,FlocculationTest}usedinproductionof LaCaseraFruitDrink,and
Interpretation.
Productionof Ozonized Table WaterThroughVariousTreatmentProcess
Calibrationof WaterTreatmentPlant Equipment’s(pHMeter,TurbidityMeter,andTotal
DissolvedSolidsMeter)
AnalysisonBOD,COD and DissolvedOxygen inEffluentWater.
Preparationof ReagentsusedforAnalysis
Laboratory Analysisof Semi andFinishedProducts
Laboratory Analysisof RawMaterialsi.e Preforms,PETBottle,Caps
Water PurificationUsingCationExchanger,Ultra-ViolentSterilizer.
Knowledgeof Submersible Pumps,Surface Pumpand Chemical DosingPumps,
GILBO PHARMACEUTICAL
CHEMICAL ANALYST/QUALITY CONTROL OFFICER 2011
Analysis of Raw Materials, Intermediate and Finished Products
Quality Assurance, Monitoring and Inspection of on-Line Products
laboratory analysis of paracetamol, mist mag, multi-vitamins, vitamin C and blood tonic
UNIVERSITYOF LAGOS NIGERIA 2010
TEACHING ASSISTANCE
Teaching inorganic, organic and general chemistry
Setting examination questions and grading the result
Conducting practical classes and research
STANDARD ORGANISATION OF NIGERIA
QUALITY ASSURANCE (INDUSTRIAL ATTACHMENT) 2007
Checking standard of products
3. Control of non-conformance
Administrative work
RESEARCH PROJECT AND PUBLICATION
Synthesis, Characterization And Antibacterial Study Of Some Transition Metal
Complexes With O-phenylenediamine and 5-bromosalicylaldehyde Schiff Bases.
International Journal of Biological Chemistry 6(1):24-30,2012
Synthesis and biological properties of N2O2 Schiff bases derived
from o-phenylenediamine and substituted salicylaldehydes
Journal of Chemical and Pharmaceutical Research, 2014, 6(6):816-819
Synthesis, characterization and antimicrobial activity of some transition metal
complexe of schiff base derived from O-phenylenediamineand 5-
nitrosalicyaldehyde Der Pharma Chemica, 2014, 6(4):18-22
Physiochemical Analysis Of Effluent discharge From a chemical and a
pharmaceutical companies at Abgara Industrial Area Ogun State 2008.
POSITION HELD
JET president (Saka Tinubu Memorial High School) 2001
Class Governor (BSc Lagos State University Ojo) 2003-2008
Public Relation Officer (BSc Lagos State University Ojo) 2007
General Secretary NCCF(National Youth Service) 2008-2009
Class Representative (MSc University Of Lagos Akoka) 2009-2010
PROFESSIONAL MEMBERSHIP
Member Chemical Society of Nigeria
TRAINING
Food Safety Management Systems (FSMS) 2013/2015
REFEREES
Mrs C.T Onwordi
Lecturer, Chemistry Department
Lagos State University, Ojo Lagos
Tel: 08028299925
Email Teresachiedu@yahoo.com
Dr. Fasina T.O
Lecturer, University of Lagos, Akoka Yaba
Tel: 08023063409
Email tetofash@yahoo.ca