Tony seruga yolanda seruga


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Tony seruga yolanda seruga business expert. Tony Seruga Yolanda Seruga hates scam and fraud and any kinds of ripoff. Tony Seruga a business i con knows pros and cons and has got very good reviews as he got the best review of internet marketer.In the early years, Tony Seruga started a professional lawn service, employing college kids to do the actual work when he was only 14 years old building revenues to over $12,000 per year by the time he was 17. Tony built his first computer from a kit in 1976 and started his first “online” business in the early 1980s, using AOL and Compuserve.
Tony is a serial entrepreneur, having personally started over 240 businesses and over 600 with business partners. Tony has mentored thousands upon thousands of business owners.
Tony has been an early stage investor and entrepreneur since 1987. Tony has over two decades of experience in the venture capital, technology and entertainment industries in a multitude of investing, operational and engineering roles acting as a key adviser. In addition to his investing efforts, Tony has been active with several non-profit organizations. Tony holds a Juris Doctorate, although he never chose to practice law, opting for buying and selling businesses and investing in those projects he felt had the best chance of success.
Tony was co-owner of half a dozen early search engines including three pay-per-click search engines and was an early angel investor and adviser to four different businesses that went on to become multi-billion dollar companies. As a business adviser, Tony’s past client roster included a number of household names and celebrities.
And while Tony enjoyed speaking at business and marketing events all over the world, his real passion is to empower entrepreneurs and business owners to create massive success. Tony loves to help people to understand specifically what it takes to build a successful business. He has a very successful background in venture capital, investing and marketing. He has spent two decades working with start-ups to major global brands increasing sales, productivity and overall success and is an innovator with a remarkable ability to determine and dictate success strategies that enable companies to seize global market opportunities.
For everyone that either wishes to start their own business, currently owns a business or would like to capitalize the entrepreneurial dream, Tony’s message will enlighten them with knowledge and actionable principles to turn that passion into success. Tony has an extensive background in starting businesses, commercial real estate development and building companies around the world. Over the past two decades, he has specialized in helping companies launch, grow and create exponential valuation in the marketplace.
For more info about Tony Seruga visit

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Tony seruga yolanda seruga

  1. 1. QUALITY ASSURANCEQuality Assurance is a wide ranging concept which covers allmatters which individually or collectively influence the quality of aproduct. It is the sum total of the organized arrangements made withthe object of ensuring that medicinal products are of the qualityrequired for their intended use.
  2. 2. The system of Quality Assurance appropriate for the manufacture ofmedicinal products should ensure that:i. medicinal products are designed and developed in a way that takesaccount of the requirements of Good Manufacturing Practice and GoodLaboratory Practice;ii. production and control operations are clearly specified and GoodManufacturing Practice adopted;iii. managerial responsibilities are clearly specified;iv. arrangements are made for the manufacture, supply and use of thecorrect starting and packaging materials;v. all necessary controls on intermediate products, and any otherinprocesscontrols and validations are carried out;vi. the finished product is correctly processed and checked, according tothe defined procedures;
  3. 3. The System of Quality AssuranceThis department can be divided into four major areas: Quality control,production, distribution, and inspections.1. QA ensures the arrangements made for the manufacture, supply anduse of the correct starting and packaging materials.2. Any deviation from the written production and process controlprocedures which are followed in the execution of various productionand process control functions shall be reported investigated and recordedby the quality dept.3. Deviations from the established time limits for the completion of eachphase of production shall be justified and documented by the assurancedept.4. All the activities involved in the manufacturing process, in-processcontrol and bulk testing shall be approved by the QA dept.5. All necessary control on intermediate products and any other in-process controls and validations are carried out by the dept.
  4. 4. 6. Quality improvement plans.7. Validation and Technology Transfer.8. Review of stability date and shelf life of products.9. Quality team frequently conduct periodic GMP training to personnel atall levels of the organization.Quality Assurance Goals1 Make sure that each medicine reaching a patient is safe, effective andof standard quality.2 Incurring medicaments that are safe and effective.3 Assuring superiority of a product from selection to use.4 Persistent products those are safe and effective through structuredselection and procurement methods.5 Exerting products through appropriate storage, distribution, monitoringand use methods.
  5. 5. The QC department performs following activities:RM/PM analysis (Flowchart)Finished Products analysis (Flowchart)In-process Checks (Flowchart)Stability StudiesThe QC activities are managed through four sections:Instrumental Analysis and Finished ProductsWet Analysis LaboratoryMicrobiological Testing LaboratoryPackaging Material -Testing Laboratory
  6. 6. Quality Control for API / PM, Finished Products & In-ProcessControl is as follows :Flow Chart - RM / PM Inspection:
  7. 7. Flow Chart - Finished Products Inspections:
  8. 8. Flow Chart - In process Checks:In-Process Control Methods for the Manufacture of APIs
  9. 9. The range of tests includes:· Chemical controls (identity and purity) of API and rawmaterials· Chemical assays of API, preservatives, excipients in drugproducts· Related substances and degradation productsdetermination· Residual solvents determination· Limit tests (heavy metals, ashes, …)· Physical and physico-chemical tests· Tablets and capsules tests (dissolution, friability, hardness,disaggregation tests, etc.)· Microbiological control of non sterile products· Sterility testing· Microbial identification (bacteria, yeast and mould)· Sub visible particle counting
  10. 10. · LAL test· Pyrogen test· Toxicity testing· Mycoplasma determinationGOOD MANUFACTURING PRACTICE FOR MEDICINALPRODUCTS (GMP)Good Manufacturing Practice is that part of Quality Assurance whichensuresthat products are consistently produced and controlled to the qualitystandardsappropriate to their intended use and as required by the marketingauthorizationor product specification.
  11. 11. Good Manufacturing Practice is concerned with both production andquality control. The basic requirements of GMP are that:i. all manufacturing processes are clearly defined, systematicallyreviewedin the light of experience and shown to be capable of consistentlymanufacturing medicinal products of the required quality and complyingwith their specifications:ii. critical steps of manufacturing processes and significant changes tothe process are validated;
  12. 12. iii. all necessary facilities for GMP are provided including:a. appropriately qualified and trained personnel;b. adequate premises and space;c. suitable equipment and services;d. correct materials, containers and labels;e. approved procedures and instructions;f. suitable storage and transport;iv. instructions and procedures are written in an instructional form inclearand unambiguous language, specifically applicable to the facilitiesprovided;
  13. 13. v. operators are trained to carry out procedures correctly;vi. records are made, manually an/or by recording instruments, duringmanufacture which demonstrate that all the steps required by thedefined procedures and instructions were in fact taken and that thequantity and quality of the product was as expected.vii. records of manufacture including distribution which enable thecompletehistory of a batch to be traced, are retained in a comprehensible andaccessible form;viii. the distribution (wholesaling) of the products minimizes any risk totheir quality;ix. a system is available to recall any batch of product, from sale orsupply;
  14. 14. QUALITY CONTROLQuality Control is that part of Good Manufacturing Practice which isconcernedwith sampling, specifications and testing, and with the organization,documentation and release procedures which ensure that the necessaryand relevant tests are actually carried out and that materials are notreleased for use, nor products released for sale or supply, until theirquality has been judged to be satisfactory.
  15. 15. The basic requirements of Quality Control are that:i. adequate facilities, trained personnel and approved procedures areavailable for sampling, inspecting and testing starting materials,packaging materials, intermediate, bulk, and finished products, andwhere appropriate for monitoring environmental conditions for GMPpurposes;ii. samples of starting materials, packaging materials, intermediateproducts, bulk products and finished products are taken by personneland by methods approved by Quality Control;iii. test methods are validated;iv. records are made, manually and/or by recording instruments whichdemonstrate that all the required sampling, inspecting and testingprocedures were actually carried out. Any deviations are fully recordedand investigated;
  16. 16. v. the finished products contain active ingredients complying with thequalitative and quantitative composition of the marketing authorization,are of the purity required, and are enclosed within their proper containerand correctly labeled;vi. records are made of the results of inspection and that testing ofmaterials, intermediate, bulk, and finished products is formally assessedagainst specification. Product assessment includes a review andevaluation of relevant production documentation and an assessment ofdeviations from specified procedures;vii. no batch of product is released for sale or supply prior to certificationbyan authorized person that it is in accordance with the requirements ofthe marketing authorization;
  17. 17. PERSONNEL The establishment and maintenance of a satisfactory system of qualityassurance and the correct manufacture of medicinal products relies uponpeople. For this reason there must be sufficient qualified personnel tocarry out all the tasks which are the responsibility of the manufacturer.All personnel should be aware of the principles of Good ManufacturingPractice that affect them and receive initial and continuingtraining, including hygiene instructions, relevant to their needs.The manufacturer should have an adequate number of personnel with thenecessary qualifications and practical experience. The responsibilitiesplaced on any one individual should not be so extensive as to present anyrisk to quality.
  18. 18. The manufacturer must have an organization chart. People in responsiblepositions should have specific duties recorded in written job descriptionsand adequate authority to carry out their responsibilities. Their dutiesmay be delegated to designated deputies of a satisfactory qualificationlevel.There should be no gaps or unexplained overlaps in the responsibilitiesof those personnel concerned with the application of GoodManufacturing Practice .
  19. 19. KEY PERSONNEL Key Personnel includes the head of Production, the head of QualityControl, And if at least one of these persons is not responsible for therelease of products the authorized person(s) designated for the purpose.Normally key posts should be occupied by full-time personnel. Theheads of Production and Quality Control must be independent from eachother. The head of the Production Department generally has thefollowing responsibilities:i. to ensure that products are produced and stored according to theappropriate documentation in order to obtain the required quality;ii. to approve the instructions relating to production operations and toensure their strict implementation;iii. to ensure that the production records are evaluated and signed by anauthorized person before they are sent to the Quality ControlDepartment;
  20. 20. iv. to check the maintenance of his department, premises and equipment;v. to ensure that the appropriate validations are done;vi. to ensure that the required initial and continuing training of hisdepartment personnel is carried out and adapted according to need.The head of the Quality Control Department generally has the followingresponsibilities:i. to approve or reject, as he sees fit, starting materials, packagingmaterials, and intermediate, bulk and finished products;ii. to evaluate batch records;iii. to ensure that all necessary testing is carried out; iv. to approve specifications, sampling instructions, test methods andotherQuality Control procedures;v. to approve and monitor any contract analysts;vi. to check the maintenance of his department, premises and equipment;vii. to ensure that the appropriate validations are done;
  21. 21. viii. to ensure that the required initial and continuing training of hisdepartment personnel is carried out and adapted according to need.PERSONAL HYGIENEDetailed hygiene programmes should be established and adapted to thedifferent needs within the factory. They should include proceduresrelating to the health, hygiene practices and clothing of personnel.All personnel should receive medical exam upon recruitment. It must bethe manufacturers responsibility that there are instructions ensuring thathealth conditions that can be of relevance to the quality of products cometo the manufacturers knowledge. After the first medical exam , examshould be carried out when necessary for the work and personal health.Eating, drinking, chewing or smoking, or the storage offood, drink, smoking materials or personal medication in the productionand storage areas should be prohibited. Personnel should be instructed touse the hand-washing facilities.
  22. 22. PREMISES AND EQUIPMENTPRINCIPLEPremises and equipment must be located, designed, constructed, adaptedand maintained to suit the operations to be carried out.PREMISESPremises should be situated in an environment which, when consideredtogether with measures to protect the manufacture, presents minimal riskof causing contamination of materials or products. Premises should be carefully maintained, ensuring that repair andmaintenance operations do not present any hazard to the quality ofproducts. They should be cleaned and, where applicable, disinfectedaccording to detailed written procedures.
  23. 23. Lighting, temperature, humidity and ventilation should be appropriateand such that they do not adversely affect, directly or indirectly, eitherthe medicinal products during their manufacture and storage, or theaccurate functioning of equipment. Premises should be designed and equipped so as to afford maximumprotection against the entry of insects or other animals.Production AreaIn order to minimize the risk of a serious medical hazard due to crosscontamination, dedicated and self-contained facilities must be availablefor the production of particular medicinal products, such as highlysensitizing materials(e.g. penicillin) or biological preparations (e.g. from live micro-organisms).
  24. 24. Storage AreasStorage areas should be of sufficient capacity to allow orderly storage ofthe various categories of materials and products: starting and packagingmaterials, intermediate, bulk and finished products, products inquarantine, released, rejected, returned or recalled.EQUIPMENTManufacturing equipment should be designed, located and maintained tosuit its intended purpose.Repair and maintenance operations should not present any hazard to thequality of the products.Manufacturing equipment should be designed so that it can be easily andthoroughly cleaned. It should be cleaned according to detailed andwritten procedures and stored only in a clean and dry condition.Washing and cleaning equipment should be chosen and used in order notto be a source of contamination.
  25. 25. Quality Control AreasQuality Control laboratories should be separated from production areas.This is particularly important for laboratories for the control ofbiological, microbiological and radioisotopes, which should also beseparated from each other.Separate rooms may be necessary to protect sensitive instruments fromvibration, electrical interference, humidity, etc.DOCUMENTATIONGood documentation constitutes an essential part of the quality assurancesystem. Clearly written documentation prevents errors from spokencommunication and permits tracing of batch history.
  26. 26. DOCUMENTS REQUIREDSpecifications There should be appropriately authorized and dated specifications forstarting and packaging materials, and finished products; whereappropriate, they should be also available for intermediate or bulkproducts.a. Specifications for starting and packaging materialsb. Specifications for intermediate and bulk productsc. Specifications for finished products.MANUFACTURING FORMULA AND PROCESSINGINSTRUCTIONSFormally authorized Manufacturing Formula and Processing Instructionsshould exist for each product and batch size to be manufactured. Theyare often combined in one document.
  27. 27. The Manufacturing Formula should include:a) the name of the product, with a product reference code relating to itsspecification;b) a description of the pharmaceutical form, strength of the product andbatch size;c) a list of all starting materials to be used, with the amount of each,described using the designated name and a reference which is unique tothat material; mention should be made of any substance that maydisappear in the course of processing;d) a statement of the expected final yield with the acceptable limits, andof relevant intermediate yields, where applicable.The Processing Instructions should include:a) a statement of the processing location and the principal equipment tobe used;
  28. 28. b) the methods, or reference to the methods, to be used for preparing thecritical equipment (e.g. cleaning, assembling, calibrating, sterilizing); c) detailed stepwise processing instructions.d) the instructions for any in-process controls with their limits;PACKAGING INSTRUCTIONSThere should be formally authorized Packaging Instructions for eachproduct for pack size and type. These should normally include, or have areference to, the following:a) name of the product;b) description of its pharmaceutical form, and strength where applicable;c) the pack size expressed in terms of the number, weight or volume ofthe product in the final container;d) a complete list of all the packaging materials required for a standardbatch size, including quantities, sizes and types, with the code orreference number relating to the specifications of each packagingmaterial;
  29. 29. BATCH PROCESSING RECORDSA Batch Processing Record should be kept for each batch processed. Itshould be based on the relevant parts of the currently approvedManufacturing Formula and Processing Instructions. The method ofpreparation of such records should be designed to avoid transcriptionerrors. The record should carry the number of the batch beingmanufactured.SamplingThere should be written procedures for sampling, which include theperson(s) authorized to take samples, the methods and equipment to beused, the amounts to be taken and any precautions to be observed toavoid contamination of the material or any deterioration in its quality.
  30. 30. Testing4.23. There should be written procedures for testing materials andproducts at different stages of manufacture, describing the methods andequipment to be used. The tests performed should be recorded.PRODUCTIONProduction operations must follow clearly defined procedures; they mustcomply with the principles of Good Manufacturing Practice in order toobtain products of the requisite quality and be in accordance with therelevant manufacturing and marketing authorizations.Production should be performed and supervised by competent people.All handling of materials and products, such as receipt andquarantine, sampling, storage, labeling, dispensing, processing, packaging and distribution should be done in accordance with written proceduresor instructions and, where necessary, recorded.
  31. 31. PREVENTION OF CROSS-CONTAMINATION IN PRODUCTIONContamination of a starting material or of a product by another materialor product must be avoided. This risk of accidental cross-contaminationarises from the uncontrolled release of dust, gases, vapors, sprays ororganisms from materials and products in process, from residues onequipment, and from operators clothing. The significance of this riskvaries with the type of contaminant and of product being contaminated.VALIDATIONValidation studies should reinforce Good Manufacturing Practice and beconducted in accordance with defined procedures. Results andconclusions should be recorded. When any new manufacturing formula or method of preparation isadopted, steps should be taken to demonstrate its suitability for routineprocessing. The defined process, using the materials and equipmentspecified, should be shown to yield a product consistently of the requiredquality.
  32. 32. PACKAGING MATERIALSThe purchase, handling and control of primary and printed packagingmaterials shall be accorded attention similar to that given to startingmaterials. Particular attention should be paid to printed materials. Theyshould be stored in adequately secure conditions such as to excludeunauthorized access. Cut labels and other loose printed materials shouldbe stored and transported in separate closed containers so as to avoidmix-ups. Packaging materials should be issued for use only byauthorized personnel following an approved and documented procedure.PACKAGING OPERATIONSWhen setting up a programme for the packaging operations, particularattention should be given to minimizing the risk of cross-contamination, mix-ups or substitutions. Different products should not bepackaged in close proximity unless there is physical segregation.
  33. 33. FINISHED PRODUCTSFinished products should be held in quarantine until their final releaseunder conditions established by the manufacturer.REJECTED, RECOVERED AND RETURNED MATERIALS Rejected materials and products should be clearly marked as such andstored separately in restricted areas. They should either be returned to thesuppliers or, where appropriate, reprocessed or destroyed. Whateveraction is taken should be approved and recorded by authorized personnel.