Oral consideration and laboratory investigations of bleeding and clotting disorder
Laboratory Safety - a creation by a jundullah · PDF fileTopics in Laboratory Safety Risk...
Transcript of Laboratory Safety - a creation by a jundullah · PDF fileTopics in Laboratory Safety Risk...
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Laboratory Safety
Marlia Singgih WibowoSchool of Pharmacy ITB
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Topics in Laboratory Safety
Risk evaluation : pharmaceutical consideration, mikrobiological consideration, risk quantification, risk managementmikrobiological Audit : Laboratory safety in mikrobiology, training, auditorClassification of microorganisms based on risk ofinfection, distribution and its virulent according toWHOManagement of BiosafetyPrevention and management of accident in Microbiology Laboratory
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Mikrobiology Laboratory
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Good Laboratory Practices (GLP)
PrepareManageAuditReport
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Why Audit?
Pharmaceutical Industry has to guarantee their products to be Safe, Qualified and BeneficialAudit is part of Quality Management SystemAs a Control Function against contamination and improvement
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Classification of deficiency (penyimpangan)
Critical DeficiencyMajor DeficiencyOther Deficiency
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Critical Deficiency
Very likely to cause risk to patient, can cause side effect, accident, or deathPossibility : potency of product is not suitable, not pure, unclear identity, or the product is not safe to be consumedProducts should be withdrawn from market
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Major Deficiency
Product is “out-of-specification”The Effect is not directly to patient, but directly to the product quality. In long-term usage with influence the quality and become unsafe Example: broken packaging, etc
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Other Deficiency
Deficiency which including foliation of GMP (Good Manufacturing Practise)Not directly influence the product qualityExample : Lack of Control Card in the Warehouse, etc.
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Audit in Microbiology Laboratory
Microbiology Laboratory’s role in Pharmaceutical Industry is checking the safety of raw material, intermediate and end-productAlso in training and education for the employees, training in Good Contamination Control Practice (GCCP)
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GCCP (Good Contamination Control Practice)
Development of Formula, Process of formulation Design of FacilitiesProblem solvingRisk Assessment (interpretation of microbiological data in relation to products and its risk to patient
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Topics related to audit in microbiology laboratory
Security of AccessDesign and lay-out of laboratoryGood HousekeepingValidation of analytical methodsValidation of equipmentsMaintenance and Calibration of equipmentsMedium for microbial cultures
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Preparation of media
Preparation of raw material Preparation of glasswares and apparatus for making mediaWeighing and Mixing Sterilization of mediaMixing and dispensingLabeling and StorageQuality ControlSupplier /Vendor
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GLP (Good Laboratory Practice)
Receiving Sample and preparation of sampelProcedure of analysisData Management, review and approval
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HACCP
Hazard Analysis of Critical Control Points(HACCP) is a method to guarantee product quality and safetyThis concept is firstly applied at NASA in preparation of astronaut’s food, then was applied by FDA-USA to all Pharmaceutical industries and food industries Identification on every critical control points (CCP) to become main activity in HACCP
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HACCP
Each point of any process is specific in general to have a chance to be contaminated by microorganismRisk of every microbial contamination should be defined and identifiedProcess to be controlled including: preparation, manufacture, distribution, storage, and usage.
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Laboratory Safety
Building : Roof and walls Rooms : Floor, door, window, furniture, cleaning Equipments and Instruments : installing, and cleaningPipes, sewageRaw Materials, intermediates, end product WaterPackaging materials Laboratory coats, hygiene of workersDocuments
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Risk ranking
Risk level = probability of occurrence x severity of occurrenceDegree of probability :5 : Definite or will be happen4 : Very Likely to happen 3 : Likely to happen2 : Very Rarely 1 : Unlikely
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Degree of Severity5 : Fatal4 : Serious accident (need hospitalized)3 : Accident with 3 days off 2 : Small accident (only need First Aid) 1 : No Accident A combination of : degree of probability and severity will indicate the risk level (tingkat resiko) in managing the microorganism
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Risk Level
Risk level 20 – 25 : Catastrophic (prohibited to be done)Risk level 15 – 19 : Serious (need special assessment)Risk level 10 – 14 : Significant (need general assessment)Risk level 4 – 9 : Minor (general assessment)Risk level 1 – 3 : Trivial (no need any written assessment)
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Klasifikasi “Hazard”
Hazard 1 : Biological agent which is unlikely causing human diseases Hazard 2 : Biological agent which can cause human diseases but not contigeous to environment . Usually there are some effective treatment available Hazard 3 : Biological agent which is very likely causing severe human diseases and have a risk to spread to environment , but an effective treatment are available.Hazard 4 : Biological agent which is very likely causing severe human diseases and very quickly spreading to environment, no effective treatment available
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All microorganisms, including bacteria, virus, fungi and parasites that categorized in group hazard 2,3 and 4.Examples : (microbes used in EP 1997 for antimicrobial preservatives)
Pseudomonas aeruginosa (2)Staphylococcus aureus (2)Candida albicans (2)Aspergillus niger (1)Escherichia coli (1)Zygosaccharomyces rouxii (1)
Pathogenic microorganisms
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Assignment :
Summarize some examples of microorganisms which are including in Hazard 1, 2, 3, and 4.