CURRENT GOOD LABORATORY PRACTICES
|
|
- Junior O’Connor’
- 6 years ago
- Views:
Transcription
1
2 CURRENT GOOD LABORATORY PRACTICES BY MUHAMMAD TANWEER ALAM (DIRECTOR) B.Pharm.,M.Pharm.,L.L.B.,M.D, M.R.S.H.(Eng),M.P.P.S, Ph.D, D.Sc.
3 WOULD YOU? TRUST THE ANALYTICAL RESULTS FROM YOUR LABORATORY, IF YOUR OWN AND FAMILY S LIFE DEPENDS ON THEM?
4 WHAT IS cglp? cglp is concerned with the organizational PROCESSES and CONDITIONS with which the laboratory studies are PLANNED, PERFORMED, MONITORED, RECORDED AND REPORTED cglp TO ANALYSIS ASSURES THE QUALITY AND INTEGRITY OF DATA IN TAKING FINAL DECISION REGARDING QUALITY OF DRUG.
5 Philosophy of G.L.P TRUST AND CONSISTENCY ESTABLISHMENT OF ANY SPECIFICATION, STANDARDS, SAMPLING PLAN, TEST PROCEDURE OR ANY OTHER LABORATORY CONTROL PROCEDURE INCLUDING ANY CHANGE. FGA WORKING UNDER THE DRUGS ACT AND RULES FRAMED THERE UNDER WITH PHARMACOPOEIA AND (AWKM)
6 GOOD LABORATORY PRACTICES BASIC REQUIREMENT OF G.L.P HIGHLY QUALIFIED TECHNICAL COMPETENCE WELL EQUIPPED GOOD INTERNAL ORGANIZATION AND COORDINATION OF THE ACTIVITIES OF THE VARIOUS SECTION OF THE LABORATORY COORDINATION WITH OTHER STAKE HOLDER
7 Current Good Laboratory Practices (c.g.l.p) COMPETENCE OF ALL ANALYST: Knowledge of basic chemical principles, theories and laboratory techniques as gained in the courses of pharmacy, chemistry or other allied sciences. Handling of common instruments like balances, U.V, ph meter, FTIR, HPLC, G.C, A.A, Dissolution, D.T apparatus etc, required in compendial procedures. Adequate knowledge of cglp To establish laboratory safety procedures Communication of laboratory results in written reports with in stipulated times under Drug Act and rules
8 Grading of analysts This primarily based on skills or competence of an analyst
9 GRADE:1 Knowledge of basic chemical principles, theories and laboratory techniques Use of common equipments such as balances, ph meter, Melting Point Apparatus, Refract meter, Autoclave, Polar meter, Moisture Analyzer, required to use according to procedures Adherence to laboratory safety procedures Application of required testing procedures Communication of results in writing Can analyze raw materials and finished products under guidelines of their supervisors
10 Grading of Analysts GRADE:2 In addition to that of grade one, the analyst should have attained: Knowledge of the use of the more advance equipment, such as computerized HPLC/GC/IR, automated dissolution apparatus. Knowledge of cglp Can independently analyze samples using established and validated analytical procedures
11 Grading of analysts GRADE: 3 In addition to that of grade 2 the analyst should have: Knowledge of regulatory policies and requirements Experience in analysis of samples, using compendial or monographic procedures Knowledge of validation techniques and criteria for method acceptance Can select and apply the appropriate analytical method Can develop new methods or revise existing methods after validation Participate in collaborative studies at inter or intra laboratory level Can supervise the proficiency of analyst
12 Grading of analysts GRADE: 4 In addition to that of grade 1to 3 analyst should have: Knowledge of the use of advanced instruments such as FTNIR, A.A, NMR, TOC etc. Isolation, Purification and identification of Microorganism & Toxicological studies on animal etc Planning of work for more efficient use of resources by using Two Channel and Four Channel Recorder for intact organs. Knowledge of statistical methods for data evaluation Leadership of a large group of analyst Can make a stability plan and perform the testing accordingly Able to standardize the reference standards
13
14 Grading of analysts GRADE: 5 In addition to all qualities, including highest experience of Drugs Control Administration Good administrative qualities Good knowledge of Drugs Act and Rules Can conducts the collaboration studies including Audit & Inspections Can evaluates new laboratory methods and S.O.Ps. Can evaluate and review test reports. Expertise in troubleshooting Acts as a team leader. Principally Men, Machine, Material Analyst.
15
16
17 Desirable Qualities Of An Analyst 1. Possesses aptitude and attitude of mind become a competent analyst 2. Enjoy his assignment with pride 3. Punctual and disciplined 4. Has pleasant personality 5. Well organized and methodological 6. Has initiative, drive, creative, and urge and ability to interact 7. Flexible and appreciates other s view point 8. Imbibes confidence in his colleagues 9. Ability to work independently and as a member of team 10.Plans his work for efficient use of time and resources 11.Can complete his assignment (practical and written) in a give time frame
18 Desirable Qualities Of An Analyst 12. Pays full attention to details (theoretical and practical) 13. Can identify the cause of and solve the problems 14. Able to think and evaluate scientifically and critically 15. Question what he is doing and why? 16. Always more than willing to improve quality of his work 17. Possesses the experimental skills 18. Has sound knowledge of basic chemical principles, physical aspects and sound knowledge of Microbiology & Pharmacology 19. Able to follow oral and written instructions 20. Sound knowledge of cglp 21. Knowledge of method validation techniques as a criteria for method and test reports acceptance
19 Desirable Qualities Of An Analyst 22. Sound knowledge of common compendial procedures 23. Knowledge of operations, calibration, and maintenance of common analytical instruments 24. Adherence to established laboratory safety procedures while performing his analytical functions 25. Good presentation and communication skills
20 Role of Government Analyst Testing of Raw material & suspected drugs To manage the sample integrity program Handling of Results Out of specification Instruments calibration Analyst training program Method development program Writing of procedures and product specification Writing of SOPs and calibration procedures Overall monthly and quarterly review certification / accreditation programs Final issuance of test report.
21 Role of Director Overall responsibility of admin and control of organization Overall in process inspections for cglp. Approval of MOT & SOP other than pharmacopoeia (if any) Determination of products defects (if any) Handling of complaints and technical discussions with T.As/ A.Cs/ADCs/DDCs/D.C/D.G/Secretary/Minister Level. Internal GLP Audit Internal fortnightly PERs and Annual PERs of Staff and Officers working. Overall Laboratory control and to give Direction on daily basis Direct reporting to Drug Controllers, Director General Health, Secretary & other authorities.
22 REGULATORY CONTROL OF MARKETED DRUGS Sample Statistics JAN 2008 Dec Received Analyzed Standard Substandard Spurious
23
24 FUTURE PLAN OF MY INSTITUTION 1. Long term Plan for strengthening of Central Drugs Laboratory, Government of Pakistan, Karachi. 2. Research and Development in support with Central Research Fund from Ministry of Health, Islamabad. 3. Complete test/analysis of all API (Active Pharm. Ingredient) 4. Quality control of Phytomedicines and other alternative medicines which are commonly marketed in Pakistan. 5. Establishment of Pharmacological and Toxicological testing. 6. Further accreditation and certification of CDL by world renown authorities 7. Further to strengthen the Human Resource with good governance.
25 THANKS TO FACULTY OF PHARMACY REPRESENTATIVE OF INDUSTRY, EMINENT SCIENTIST & MY COLLEAGUES
JOB SPECIFICATION. The Laboratory Analyst reports to the Process Quality Manager and interacts as necessary with key stakeholders:
JOB SPECIFICATION Job Title: Reporting To: Function: Job Location: Laboratory Analyst (Days) Process Quality Manager Quality, Technical & Blends Coleford Overview and Job purpose The timely sampling, testing
More informationGood Manufacturing Practices Purpose and Principles of GMP. Tony Gould
Good Manufacturing Practices Purpose and Principles of GMP Tony Gould Why GMP? Provides a high level assurance that medicines are manufactured in a way that ensures their safety, efficacy and quality Medicines
More informationWHO PUBLIC INSPECTION REPORT (WHOPIR) Quality Control Laboratory
SOP 408.4 Annex D 20, avenue Appia CH-1211 Geneva 27 Switzerland Tel central +41 22 791 2111 Fax central +41 22 791 3111 www.who.int WHO PUBLIC INSPECTION REPORT (WHOPIR) Quality Control Laboratory Part
More information1028 Heslerton Road, Dunsandel, Canterbury
Position Reports to Chemistry Technician Chemistry Team Leader Company Synlait Milk Ltd Date: August 2014 Location 1028 Heslerton Road, Dunsandel, Canterbury Purpose In the initial phases this position
More informationAnnex 13 WHO guidelines for preparing a laboratory information file
World Health Organization WHO Technical Report Series, No. 961, 2011 Annex 13 WHO guidelines for preparing a laboratory information file Background The WHO Expert Committee on Specifications for Pharmaceutical
More informationResponsible to: REAch2 Inspiration Ltd Senior Health & Safety Coordinator.
Health & Safety Officer Job Description Primary Location: Scientia Academy Principal Purpose of Role: Health & Safety Officer Responsible to: REAch2 Inspiration Ltd Senior Health & Safety Coordinator.
More informationInternational. Recruiting Briefing
International Recruiting Briefing 1 1. Chia Tai Group Senior Swine Veterinary Positions Available Position Title: National Supervisor of Swine Veterinary Services Regional Supervisor Swine Veterinary Services
More informationProcess Technician. Position Type: Full time
Position Type: Full time Location: Experience: Education: London, Ontario 2-3 Years College Diploma Process Technician Starlim North America is a global leader in the manufacturing of silicone parts specializing
More informationTHE UNIVERSITY OF BRITISH COLUMBIA
THE UNIVERSITY OF BRITISH COLUMBIA POSITION DESCRIPTION 9929 January 26, 2018 SB BUSINESS TITLE: EMPLOYMENT GROUP: JOB FAMILY: JOB CODE: VP/FACULTY: DEPARTMENT: PAY GRADE: SALARY LEVEL: Associate Director,
More informationSubpart B Organization and Personnel, 21 CFR Responsibilities of the quality control unit.
FDA inspections continue to focus on CGMP violations related to basic GMP controls. A survey of Warning Letters issued in 2013 on CMC (Chemistry / Manufacturing / Controls) violations reveals an emphasis
More informationASCENDIA PHARMACEUTICALS Aspiring for Better Medicine
ASCENDIA PHARMACEUTICALS Aspiring for Better Medicine Ascendia Pharmaceuticals, founded in 2012, is a privately-owned, speciality pharmaceutical company dedicated to developing enhanced formulations of
More informationContact:: (609) Details please visit our website:
SunGen Pharma aims to create a healthier future for patients while increasing shareholder value through the development and introduction of quality, affordable generic products by experienced, passionate
More informationEUROPEAN INDUSTRIAL PHARMACISTS GROUP. Guidance on CPD for QUALIFIED PERSONS
EUROPEAN INDUSTRIAL PHARMACISTS GROUP Guidance on CPD for QUALIFIED PERSONS EIPG Guidance on CPD for QP Continuing Professional Development for Qualified Persons, Technical Directors and other Responsible
More informationOverview of Good Food Laboratory Practices
Overview of Good Food Laboratory Practices Dr. Anne Bridges Technical Director, AACC International International Workshop & Training Program On Good Food Laboratory Practices Jointly Organized By Food
More informationBrief Introduction of Aburaihan Company Organization Policy Organization Chart Qualified Human Resource Production Department Engineering Department
1 Contents Brief Introduction of Aburaihan Company Organization Policy Organization Chart Qualified Human Resource Production Department Engineering Department Sanitation and Environment Protection Documentation
More informationProcess Technician. Position Type: Full time
Position Type: Full time Location: Experience: Education: London, Ontario 2-3 Years College Diploma Process Technician Starlim North America is a global leader in the manufacturing of silicone parts specializing
More informationJournal of Chemical and Pharmaceutical Research
Available online www.jocpr.com Journal of Chemical and Pharmaceutical Research ISSN No: 0975-7384 CODEN(USA): JCPRC5 J. Chem. Pharm. Res., 2011, 3(6):88-98 Conduct of Inspections for Pharmaceutical Manufactures
More informationPosition Technical Advisor-BCC, Bangladesh Grade D2. & Location Activity, Plan International Based in Dhaka, Bangladesh
Job Description Position Technical Advisor-BCC, Bangladesh Grade D2 Department Programme: Advancing Adolescent Health (A2H) Date 25 February & Location Activity, Plan International Based in Dhaka, Bangladesh
More informationPROCEDURE - CO-CURRICULAR PROGRAM, PHILOSOPHY AND GOALS
PROCEDURE - CO-CURRICULAR PROGRAM, PHILOSOPHY AND GOALS 2150P In relation to the Co-Curricular Philosophy and Goals, established in Policy 2150, these indicators or general objectives have been developed
More informationDIPLOMA IN MECHANICAL ENGINEERING EDUCATIONAL OBJECTIVES AND OUTCOMES
PROGRAMME OUTCOMES 1. An ability to apply knowledge of mathematics and science in identifying, formulating and solving engineering problems. 2. An ability to understand the application of drafting software
More informationDr. D. S. Rathore Rajasthan Pharmacy College
Good Laboratory Practice Dr. D. S. Rathore Rajasthan Pharmacy College Jaipur GLP? Good Laboratory Practice (GLP)( ) Is the managerial concept of quality system concerned with the organizational process
More informationPharmaceutical Reference Standards: Overview and Role in Global Harmonization
Matthew Borer, Ph.D., Advisor Pharmaceutical Reference Standards: Overview and Role in Global Harmonization 3rd DIA China Annual Meeting Beijing, China, 16-18 May, 2011 What is a Pharmaceutical Reference
More informationJOB DESCRIPTION. DATE: August 2017 Senior Regulatory Affairs Scientist. Regulatory Affairs Assistant Manager RESPONSIBLE FOR (PEOPLE): N/A
JOB DESCRIPTION DATE: August 2017 POSITION: Senior Regulatory Affairs Scientist BUSINESS UNIT: Central Services LOCATION: Craigavon REPORTING TO: Regulatory Affairs Assistant Manager RESPONSIBLE FOR (PEOPLE):
More informationA Compilation of WHO GMP Audit Points
A Compilation of WHO GMP Audit Points Collected from WHOPIR of 28 companies Part VIII of VIII Current article Part VIII Support QMS Prepared and Submitted By: Edited by : A. Jwalakanth B.Pharm, MBA (Aus)
More informationKnow-how and Best Practice to Serve our Clients
BioChem Analytical Laboratory Know-how and Best Practice to Serve our Clients BioChem Analytical Laboratory Leading in all Disciplines One laboratory, three disciplines: Everything under one roof - competent,
More informationEXCELLENCE ANALYTICAL CHEMISTRY
EXCELLENCE IN ANALYTICAL CHEMISTRY An Independent laboratory run by scientists for scientists Doris Butterworth Managing & Technical Director www.butterworth-labs.co.uk 2 Contents Butterworth Laboratories
More informationGood practices in quality control in pharmaceutical industry - Overview of regulatory guidelines
Review Article Good practices in quality control in pharmaceutical industry - Overview of regulatory guidelines Chagi Venkatesh*, S. B. Puranik ABSTRACT Good practices in quality control (QC) department
More informationJANCO S INFORMATION TECHNOLOGY JOB FAMILIES... 3 JANCO IT JOB FAMILY CLASSIFICATION... 9
JANCO S INFORMATION TECHNOLOGY JOB FAMILIES... 3 POSITION DESCRIPTION STRUCTURE... 3 POSITION PURPOSE... 3 PROBLEMS AND CHALLENGES... 3 ESSENTIAL POSITION FUNCTIONS... 4 JOB PROGRESSION - TRADITIONAL...
More informationPolestar Power Industries (Pharma Division) Pioneer Manufacturer Of Beta-Lactum & Cephalosporin
Polestar Power Industries (Pharma Division) Pioneer Manufacturer Of Beta-Lactum & Cephalosporin R Polestar Power Industries (Pharma Division) Vill. Damuwala, Haripur Road, Barotiwala, Tehsi l Baddi, Distt.
More informationCertification program "Quality Mark TMT" Checklist initial surveillance inspection
Certification program "Quality Mark TMT" Checklist initial surveillance inspection Name and site of factory Date of inspection Inspection performed by (name, company) present factory representatives Person
More informationLibrary Guide: Active Pharmaceutical
Library Guide: Active Pharmaceutical Ingredients (API) Table of Contents Overview...3 Sample Curriculum...5 Course Descriptions: A Step-by-Step Approach to Process Validation (PHDV79)...7 A Tour of the
More informationEMPLOYMENT OPPORTUNITY
EMPLOYMENT OPPORTUNITY The National Social Security Fund (NSSF) is positioning itself to be the Social Security Provider of Choice in Uganda. With our shared purpose of being the Social Security Provider
More informationRegulatory Expectations, Standards & Guidelines
Regulatory Expectations, Standards & Guidelines Regulatory Requirements Pharmacopeias Good Automated Manufacturing Practice (GAMP) 21 CFR Part 11 and Annex 11 Consequences of Non-Compliance 22 Regulatory
More informationSTANDARD OPERATING PROCEDURES. Handling and working with Analytical Standards
Page: 1 of 6 1.Purpose The purpose of this Standard Operating Procedure is to establish a standardized procedure of using United States Pharmacopoeia (USP) standards, detailing the procedure of qualification,
More informationPFI Standards Program. Developing a Written Quality Management Program
PFI Standards Program Developing a Written Quality Management Program It is recommended that this presentation be viewed in conjunction with PFI Standards Program Document Pellet Fuels Institute Residential/Commercial
More informationEXCELLENCE ANALYTICAL CHEMISTRY
EXCELLENCE IN ANALYTICAL CHEMISTRY Whatever your needs, Butterworth will work in partnership with you to develop a bespoke solution that will fit your precise requirements, which will be delivered to you
More informationJournal home page: RESEARCH ARTICLE
Journal home page: http://www.journalijiar.com INTERNATIONAL JOURNAL OF INNOVATIVE AND APPLIED RESEARCH RESEARCH ARTICLE QUALITY AUDIT AND GMP INSPECTION OF PHARMACEUTICAL INDUSTRY WITH REFERENCE TO USFDA;
More informationSAN ANTONIO HOUSING AUTHORITY
SAN ANTONIO HOUSING AUTHORITY Director of Internal Audit Salary $88,545.60 Annually Location San Antonio, TX Job Type Full-Time Department Central Office - Internal Audit Job Number 2016-00196 Closing
More informationACCOUNTING OFFICER JOB/POSITION SUMMARY
ACCOUNTING OFFICER Under the general supervision of the Finance Manager, fulfills a variety of general accounting tasks related to the maintenance of books of accounts of the company; data entry on automated
More informationSUPPLIER QUALITY MANUAL
Work Instruction Standard Locknut, LLC Supplier Quality Manual Doc. No. SQM-01 Page 1 of 11 Initial Date 11/1/2009 Rev. 4 Prepared By Dwight Beaty Revised By Shannon Smith Rev. Date 9/12/12 Approvals Purchasing
More informationINFORMATION TECHNOLOGY ANALYST Classified Position (Non-Exempt Status) Classified Office, Technician & Business Services Salary Schedule Range 82
CLASS SPECIFICATION INFORMATION TECHNOLOGY ANALYST Classified Position (Non-Exempt Status) Classified Office, Technician & Business Services Salary Schedule Range 82 DEFINITION To perform professional
More informationAssistant Finance Director
Assistant Finance Director Class specifications are intended to present a descriptive list of the range of duties performed by employees in the class. Specifications are not intended to reflect all duties
More informationNational Animal Supplement Council
NASC established a Preferred Supplier Program for companies who wish to provide products and services to NASC member companies, including raw materials (ingredients), contract manufacturing (dosage form
More informationManual 042 Water Quality Standard
1 Purpose Manual 042 Quality Standard To describe the quality standards required for the production, distribution, use and testing of water used in the manufacture of manufactured materials. 2 Scope and
More informationValidation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)
Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH) *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY!
More informationCareer Bands, Career Levels, Functions and Disciplines
Career Bands, Career Levels, s and s General Overview This section provides job matching documentation used for this survey report. Career Band Summary Descriptions for the Supervisory/Management Career
More informationControl Environment Toolkit: Internal Audit Function
III. MODEL DOCUMENT: INTERNAL AUDIT DEPARTMENT CHARTER ADOPTED BY THE AUDIT COMMITTEE OF THE COMPANY MEETING MINUTES NO OF 20 SIGNATURE OF THE CHAIRPERSON OF AUDIT COMMITTEE DATED THIS DAY OF, 20 Approved
More informationDepartment of Pathology and Laboratory Medicine UTHealth Medical School The Individual Development Plan for Professional Development Dec.
Department of Pathology and Laboratory Medicine UTHealth Medical School The Individual Development Plan for Professional Development Dec. 2014 Purpose of the Individual Development Plan The Individual
More informationOMCL Network of the Council of Europe QUALITY ASSURANCE DOCUMENT
OMCL Network of the Council of Europe QUALITY ASSURANCE DOCUMENT PA/PH/OMCL (05) 49 DEF CORR UNCERTAINTY OF MEASUREMENT - PART 1 Full document title and reference Document type Legislative basis Uncertainty
More informationGUILFORD COUNTY SCHOOLS JOB DESCRIPTION JOB TITLE: PROGRAM ADMINISTRATOR II LOGISTICS & PAYROLL TRANSPORTATION DEPARTMENT GENERAL STATEMENT OF JOB
GUILFORD COUNTY SCHOOLS JOB DESCRIPTION JOB TITLE: PROGRAM ADMINISTRATOR II LOGISTICS & PAYROLL TRANSPORTATION DEPARTMENT GENERAL STATEMENT OF JOB Under limited supervision, provides specialized technical
More informationCareer Planning and Development Tools
Career Planning and Development Tools June 29, 2015 Original publish date: 2/29/12 Revision 1 date: 10/16/14 Revision 2 date: 6/29/15 Purpose of Tools Clearly describe typical career paths and job classifications
More informationManual 058 Out of Specification Results Investigation
1 Purpose The purpose of this Guideline is to provide guidance for the investigation and response to Out of Specification (OOS) laboratory test results. 2 Scope and Applicability This Guideline applies
More informationCareer Ladder Editable Template
Career Ladder Editable Template This template is meant to be a guideline only, and can be edited to fit your organizational requirements or limitations. Job Classification: Laboratory Managerial Series
More information. JOB VACANCIES. Possess a Degree / Diploma in Agricultural Science / Forestry/ Plantation Management.
. JOB VACANCIES In line with our expansion programme, we would like to invite dynamic and suitable individuals to join us on board for the following positions:- 1. SENIOR PLANTATION CONTROLLER Possess
More informationUPPER COASTAL PLAIN COUNCIL OF GOVERNMENTS JOB DESCRIPTION, 2018 POSITION TITLE: EXECUTIVE ADMINISTRATIVE ASSISTANT GENERAL DESCRIPTION OF DUTIES
UPPER COASTAL PLAIN COUNCIL OF GOVERNMENTS JOB DESCRIPTION, 2018 POSITION TITLE: EXECUTIVE ADMINISTRATIVE ASSISTANT GENERAL DESCRIPTION OF DUTIES Under general direction, the purpose of the position is
More informationAssociate Director, LM Bioanalytical Services
Associate Director, LM Bioanalytical Services Overview: Responsible for leading method development, method validation/qualification and sample testing in large molecule bioanalytical service group, with
More informationJob Description. To participate in department shifts including early and late cover, night duties and weekends as required.
Job Description Job Title: Location: Reporting to: Accountable to: Senior Biomedical Scientist Microbiology, TDL North West London Deputy Head of Microbiology Head of Microbiology Job Summary: In co-operation
More informationRegistration and renewal of the credential certificate for registration
Registration and renewal of the credential certificate for registration 1. Qualification of the applicant: 1.1 Must be a holder of the license to manufacture or import the psychotropic substances of category
More informationNovartis Business Services HR University Relations. Chemical and Analytical Development. Early Talent Program
Novartis Business Services HR University Relations Chemical and Analytical Development Early Talent Program 2 CHEMICAL AND ANALYTICAL DEVELOPMENT CHEMICAL AND ANALYTICAL DEVELOPMENT 3 Chemical and Analytical
More informationInspection Trends. American Society for Quality Richmond, VA Section March 8, 2016
Inspection Trends American Society for Quality Richmond, VA Section March 8, 2016 Brooke K. Higgins, Senior Policy Advisor CDER / Office of Compliance Office of Manufacturing Quality Division of Drug Quality
More informationOUT OF SPECIFICATION. SASIDA YOOSOOK 4 April 2014
OUT OF SPECIFICATION SASIDA YOOSOOK 4 April 2014 ISO 17025:2005 4.9 Control of nonconforming testing and/or calibration work 4.9.1 The laboratory shall have a policy and procedures that shall be implemented
More informationCRITICAL ASPECT ANALYTICAL TEST REVIEW
CRITICAL ASPECT ANALYTICAL TEST REVIEW Jakarta 14 December 2017 Speaker: HERU PURNOMO, ST QC WORK FLOW Start Sample Received (In-Process & Finished Good) Testing Review Lab Result Yes No Non Conformance
More informationLaboratory Scientist
Apprenticeship standard Laboratory Scientist Work Based Learning Guide August 2015 Purpose of document This work based learning guide contains the detailed specification of the skills, knowledge and behaviours
More informationSenior Wastewater Treatment Plant Operator
Class specifications are intended to present a descriptive list of the range of duties performed by employees in the class. Specifications are not intended to reflect all duties performed within the job.
More informationCity of Redwood City Public Works Services Department RECYCLED WATER SPECIALIST
City of Redwood City Public Works Services Department RECYCLED WATER SPECIALIST DEFINITION Under General direction, takes the lead in the City s recycled water use program; contacts potential new customers;
More informationLABORATORY COMPLIANCE
1 LABORATORY COMPLIANCE Jeanne Moldenhauer Vectech Pharmaceutical Consultants, Inc. Farmington Hills, MI INTRODUCTION Implementation of the Systems-Based Inspection Guideline for drug manufacturers in
More informationCASITAS MUNICIPAL WATER DISTRICT
JOB TITLE: Water Quality Specialist CLASSIFICATION: Non Exempt REPORTS TO: Water Quality Supervisor SALARY LEVEL: E-30 DATE: 12/15/2017 Definition: CASITAS MUNICIPAL WATER DISTRICT Under general direction
More informationJOB DESCRIPTION. Biomedical Scientist Haematology/Blood Transfusion
JOB DSCRIPTION Job Title: Location: Reporting to: Liaises with: Biomedical Scientist Haematology/Blood Transfusion Core Laboratory/Rapid Response Laboratory Head of Haematology and Transfusion Laboratories
More informationStandard Communications, Inc.
Standard Communications, Inc. List of Commercial Offerings Labor Categories & Hourly Rates Effective January 1, 2018 315 345 435 465 475 APPLICATIONS SYSTEMS ANALYST - Functional Responsibility: Reviews,
More informationWHO PUBLIC INSPECTION REPORT (WHOPIR) Quality Control Laboratory. Uganda (NDQCL-NDA) Mulago Hill, P.O. Box 23096, Kampala, Uganda. NDA,
SOP 408.4 Annex D 20, avenue Appia CH-1211 Geneva 27 Switzerland Tel central +41 22 791 2111 Fax central +41 22 791 3111 www.who.int WHO PUBLIC INSPECTION REPORT (WHOPIR) Quality Control Laboratory Part
More informationGMP & Quality Assurance. Mayur Sushir Dept of Microbiology MJC
GMP & Quality Assurance Mayur Sushir Dept of Microbiology MJC Introduction GMP ensures that quality is built into the organization & processes involved in manufacture GMP covers all aspects of manufacture
More informationSo many science careers: find your own niche
So many science careers: find your own niche Kristin Breitschopf sanofi-aventis Deutschland GmbH PhD degree and what next? Scientists have a wide range of career options Huge diversity of career opportunities
More informationCAPE FEAR COMMUNITY COLLEGE VICE PRESIDENT OF BUSINESS SERVICES
CAPE FEAR COMMUNITY COLLEGE DEFINITION To plan, direct, and manage the financial activities and operations of the College including preparing for the annual financial audit, overseeing budget preparation,
More informationCONTACT US... Your Partner on the Path of...making a Healthier Mankind. Follow us. Scan for web.
CONTACT US... INDIA HEAD OFFICE 430, DLF TOWERS, SHIVAJI MARG NEW DELHI-110015 INDIA TEL +91 11 4932 1000 FAX +91 11 4932 1024 E-MAIL xlrem@vsnl.com admin@xllaboratories.com WEB PLANT-1 E-1223 PHASE-I
More informationVACANCY ACCOUNTANT - GENERAL. Page 1 of 5
VACANCY ACCOUNTANT - GENERAL Page 1 of 5 CAREER OPPORTUNITY ICBL invites applications from suitably qualified candidates for the position of: POSITION: DEPARTMENT: REPORTS TO: Accountant - General Finance
More informationSHELBY ENERGY COOPERATIVE POSITION DESCRIPTION
SHELBY ENERGY COOPERATIVE POSITION DESCRIPTION JOB TITLE: Manager of Engineering LOCATION: Power Delivery Services FLSA STATUS: Exempt EEO CODE: 01-A REPORTS TO: Senior Vice President Power Delivery Services
More informationMobile No: / Languages: English / Arabic
Bassel Zeidan Mobile No: 00971-52 8457 688 Email:basselzeidan@hotmail.com / basselzeidan@asme.org Nationality: Syrian Languages: English / Arabic Dear Hiring manager, I would like to take this opportunity
More informationDIXIE STATE UNIVERSITY 2017 Staff Employee Annual Review
DIXIE STATE UNIVERSITY 2017 Staff Employee Annual Review Annual evaluation period is the calendar year (January December). Supervisors must evaluate all full-time staff employees who have been in their
More informationSuggested Attributes to Determine Performance Evaluation Ratings
Below are attributes to consider when looking for behaviors that represent an overall rating and/or a rating for each core expectation category. What behaviors define what a 5, 4, 3, and 2 rating looks
More informationETASS II SKILL LEVEL AND LABOR CATEGORY DESCRIPTIONS. Skill Levels
ETASS II SKILL LEVEL AND LABOR CATEGORY DESCRIPTIONS Skill Levels Level Entry I Intermediate II Senior III Principal IV Knowledge/Skill Description Applies fundamental concepts, processes, practices, and
More informationJoanne J. Foss, PhD., OTR/L OTH 5721 Professional Development in OT
Joanne J. Foss, PhD., OTR/L OTH 5721 Professional Development in OT Purpose: To guide the process of professional development: self-reflection and selfassessment, identification of specific individual
More informationQUALITY ASSUARENCE IN THE FOOD CONTROL LABORATORIES
QUALITY ASSUARENCE IN THE FOOD CONTROL LABORATORIES Dr. Amin M. Yousuf Food Safety Consultant General Municipalities Secretariat Abu Dhabi Dr. Quality systems consultant Dr. Mutwakil M. Ahmed Quality systems
More informationPLASTICS and POLYMERS
: SELECT YOUR CAREER INTEREST 45 PLASTICS and POLYMERS The Mid-Ohio Valley enjoys a significant competitive advantage for the plastics and polymers industry. Currently, the region s concentration of plastics
More informationWATER PRODUCTION MAINTENANCE SUPERVISOR
CITY OF REDLANDS WATER PRODUCTION MAINTENANCE SUPERVISOR DEFINITION Under direction, to supervise and participate in the maintenance and repair of the City s water production, treatment, and storage facilities;
More informationAdministrative Analyst/Specialist Non-Exempt
Administrative Analyst/Specialist Non-Exempt Entry to this classification requires general knowledge and skills in the applicable administrative and/or program field with a foundational knowledge of public
More informationPrecision. Proficiency. Proximity.
Precision. Proficiency. Proximity. Precision Accuracy in testing is paramount to ensuring product safety and efficacy. And fast turnaround times are critical to keeping your project on schedule. With
More informationApproved by Personnel Commission February 2009 POLICE DEPARTMENT PART-TIME POLICE CRIME ANALYST
POLICE DEPARTMENT PART-TIME POLICE CRIME ANALYST GENERAL DUTIES: Under general direction of the Police Captain or Police Chief, perform work of considerable difficulty reviewing, monitoring, developing
More informationYour partner in the pharmaceutical industry
English Micronisation- and milling service Micronised by GfM Your API Particle size (µm) Your partner in the pharmaceutical industry The... always that little bit finer. We are a family business in the
More informationAnnex 14 WHO guidelines for drafting a site master file 136
World Health Organization WHO Technical Report Series, No.961, 2011 Annex 14 WHO guidelines for drafting a site master file 136 1. Introduction 2. Purpose 3. Scope 4. Content of site master fi le Appendix
More informationJob Description. Housing Coordinator Housing Choice Voucher Program (HCVP)
Job Description Housing Coordinator Housing Choice Voucher Program (HCVP) SUPERVISION RECEIVED: The HCVP Housing Coordinator shall work under the direct supervision of the HCV Director and the indirect
More informationHRSD Position Description: Data Analyst
HRSD Position Description: Data Analyst Section I. Position Reference Information a. Department Engineering b. Division Planning and Analysis c. Position Title Data Analyst d. Immediate Supervisor Data
More informationRegional GMP Strengthening Workshop for Indian Pharmaceutical Manufacturers and State Regulators
Regional GMP Strengthening Workshop for Indian Pharmaceutical Manufacturers and State Regulators Focused on GMP in production of Active Pharmaceutical Ingredients and Oral Solid Dosage Forms Organized
More informationThe interface between Good Clinical Practice and Good Manufacturing Practice
1 The interface between Good Clinical Practice and Good Manufacturing Practice your partner in compliance 1 The interface between GCP and GMP Generally, studies are designed and planned by physicians who
More informationInternational Standards for the Professional Practice of Internal Auditing (Standards)
INTERNATIONAL STANDARDS FOR THE PROFESSIONAL PRACTICE OF INTERNAL AUDITING (STANDARDS) Attribute Standards 1000 Purpose, Authority, and Responsibility The purpose, authority, and responsibility of the
More informationInspection of Quality Control Laboratories
Inspection of Quality Control Laboratories PQP Manufacturer's Meeting April 4-5 th 2011, Geneva, Switzerland Stephanie Croft, M.Sc. Technical Officer (Inspector), WHO Prequalification of Medicines Programme
More informationDISTINGUISHING CHARACTERISTICS
Position: T CC Assistant/Custodian Status: Full Time, Non Exempt JOB DESCRIPTION SUMMARY Under the direction of the T CC Building Superintendent, the Mason Transit Authority s (MTA) T CC Assistant/Custodian
More informationPHARMACEUTICAL VALIDATION AND QUALITY MANAGEMENT SYSTEM
Course Title Course Code PHARMACEUTICAL VALIDATION AND QUALITY MANAGEMENT SYSTEM QA204 Lecture : 04 Course Credit Practical : 04 Tutorial : 00 Total : 08 Course Objective To explain the students about
More informationAnalytical Services. Analytical solutions for chemical, pharmaceutical, nutraceutical and cosmetic companies
Analytical Services Analytical solutions for chemical, pharmaceutical, nutraceutical and cosmetic companies Bringing ideas to life We built our Swiss pharmaceutical company on one idea born over 70 years
More informationUniversity of Greenwich JOB DESCRIPTION
JOB DESCRIPTION Job Title: Sustainability Projects Officer Grade: SG6 Department: Estates and Facilities Date of Job Evaluation: Role reports to: Head of Sustainability Direct Reports Student interns Indirect
More informationIMDRF. Final Document. Regulatory Authority Assessor Competence and Training Requirements. IMDRF MDSAP Work Group
IMDRF/ WG /N6 FINAL:2013 IMDRF International Medical Device Regulators Forum Final Document Title: Authoring Group: Regulatory Authority Assessor Competence and Training Requirements IMDRF MDSAP Work Group
More information