QUESTIONNAIRE. for RECOGNITION of GOOD LABORATORY PRACTICE. SRI LANKA ACCREDITATION BOARD for CONFORMITY ASSESSMENT. Instructions to the Applicant:

Transcription

1 SRI LANKA ACCREDITATION BOARD fr CONFORMITY ASSESSMENT QUESTIONNAIRE fr RECOGNITION f GOOD LABORATORY PRACTICE Instructins t the Applicant: 1. Please fill the questinnaire n yur wn judgment f activities related t GLP. 2. Prcedures need nt always t be dcumented and may be in the frm f Guidelines and Frmats.

2 SLAB RECOGNITION PROGRAMME OF GOOD LABORATORY PRACTICE QUESTIONNAIRE This questinnaire is a self-assessment check list t assess the readiness f yur labratry r test facility fr an assessment by SLAB. Questinnaire Cmpleted By Name: Psitin: Name f the labratry/test facility: Signature: Date: Title: Questinnaire fr GLP Dc N : GLP-FM (P) -02 Issue N: 01 Date f Issue: Rev N: 01 Date f Rev : Page: 1 f 8

3 1. Test Facility Management System Des yur Labratry have a GLP Manual and relevant Prcedures Yes N * (See Page 8 fr the cntents f a GLP Manual) Des the manual cntain / refer t? Scpe f test system/ studies GLP Statement with Chief Executive/Study Directr s Endrsement Dcument Cntrl Prcedure (Internal and External) Prcedure fr Cntrl f Recrds Crrective Actin Prcedure Preventive Actin Prcedure Prcedure fr Review f study requests Prcedure fr Handling f Cmplaints Prcedure fr Cntrl f Nn-cnfrming Wrk Internal Auditing Prcedure Management Review Prcedure Quality Assurance Prgramme Prcedure fr Training Prcedure fr safe Handling f Test Equipment Prcedure fr Calibratin f Test Equipment Prcedure fr Handling f Test Items Jb Descriptins Please enclse a cpy f the GLP manual Yes/N Des the Labratry maintain Recrds fr Recrds f Review f Requests Recrds related t maintenance f Equipment Recrds f Quality Assurance Training Recrds Recrds related t Cmpetence Develpment Title: Questinnaire fr GLP Dc N : GLP-FM (P) -02 Issue N: 01 Date f Issue: Rev N: 01 Date f Rev : Page: 2 f 8

4 2. Accmmdatin Brief Descriptin f the Testing Facility (Please include number f rms, apprximate size f them and any special features) Please enclse a sketch f the testing facility layut. Is Envirnmental Cntrl Necessary? Yes N If s, is the testing facility air cnditined? Yes N Cntrl achieved by: Temperature range = 0 C Relative Humidity Range = % Temperature is mnitred : Relative humidity is mnitred : Cntinually Occasinally Nt at all Cntinually Occasinally Nt at all Title: Questinnaire fr GLP Dc N : GLP-FM (P) -02 Issue N: 01 Date f Issue: Rev N: 01 Date f Rev : Page: 3 f 8

5 3. Equipment and Reference Materials/Items Equipment Inventry Is there an up-t-date inventry f all items f equipment? Yes N Calibratin Are items f measuring and testing equipment/items calibrated regularly? Yes N Are recrds kept f these calibratins? Yes N Is there a well-defined system fr scheduling future calibratins? Yes N Are reference materials r Standard cntrls verified/calibrated? Yes N In-huse Checks Is ancillary equipment checked regularly? Yes N Are recrds kept f these checks? Yes N Is there a well-defined system fr scheduling future checks? Yes N 4. Standard Operating Prcedures Are Standard Operating prcedures technically validated? Yes N Is there a prcedure fr methd validatin? Yes N Please enclse the cpies f standard perating prcedures. Title: Questinnaire fr GLP Dc N : GLP-FM (P) -02 Issue N: 01 Date f Issue: Rev N: 01 Date f Rev : Page: 4 f 8

6 5. Sampling Is sampling relevant t the scpe perfrmed in the test facility? Yes N Are there dcumented prcedures fr sampling? Yes N 5.1 Sampling Prcedures Are prcedures fr receipt, identificatin, stabilizatin, strage and retentin f samples dcumented? Receipts Yes N Identificatin Yes N Stabilizatin and preservatin Yes N Strage Yes N Retentin Yes N Are prcedures fr preparing standards slutins and materials dcumented? Yes N 6. Quality Assurance Prgramme Has the labratry develped a Quality Assurance Prgramme Yes N Des the labratry participate in PT r inter labratry cmparisn prgrammes Yes N What internal prcedures are used t mnitr the validity f Standard Operating Prcedures? Intra-labratry prgrams? Details: True blanks Check samples Replicates Standard additins Standard reference materials Title: Questinnaire fr GLP Dc N : GLP-FM (P) -02 Issue N: 01 Date f Issue: Rev N: 01 Date f Rev : Page: 5 f 8

7 Have precisin data and limits f detectin (Where relevant) been Calculated fr all methds based n internal quality cntrl data? Yes N Are these recrded? Yes N 6.1 Uncertainty f Measurement Has the labratry estimated uncertainty f measurement fr the studies applied? Yes N 6. Recrds f Study Data and Reprting Hw is Study Data Recrded? In wrkbks Prfrma wrksheets Ink r ball pen Pencil Plain paper Hw Frequency are Calculatins & Data Transfers Checked? Full check n all calculatins and transfers Regular partial check % (Enclse statistical justificatin fr partial checks) Occasinal checks (Nt acceptable) N regular check (Nt acceptable) Hw is Test Data Stred? In wrkbks In files Pr-frma wrksheets On cmputer Other (details please) Is There a validated cmputerized system? Yes N Title: Questinnaire fr GLP Dc N : GLP-FM (P) -02 Issue N: 01 Date f Issue: Rev N: 01 Date f Rev : Page: 6 f 8

8 Can Test Data be readily retrieved starting frm? Client name Date f study Prject name Reprt Issued Other (specify) 6.1 Reprting Is a Reprt issued fr each study? Yes N 7. Miscellaneus Have yu enclsed cpies f? Applicatin fr recgnitin Measurements/Tests fr which recgnitin is sught. Labratry s GLP Manual & Prcedures Manual. Examples f jb descriptins and training recrds. An rganizatinal chart. A sketch f the layut. Equipment list. Standard Operating Prcedures and test methds. Examples f quality assurance data. Examples f sample register page and relevant test recrds. Cpy f a final study reprt. Internal audit reprt and crrective actin recrds. Management review recrds. Title: Questinnaire fr GLP Dc N : GLP-FM (P) -02 Issue N: 01 Date f Issue: Rev N: 01 Date f Rev : Page: 7 f 8

9 8. Cntents f GLP Manual The cntents f a GLP Manual will include but may nt be limited t the fllwing. Reference shuld be given t the prcedures r ther references, where ever necessary. Intrductin t Test Facility/Organizatin References Definitins f Terms Scpe f Study and GLP GLP Statement Organizatin and management Staff respnsibilities and Authrities Review f Study Sampling Quality Assurance Prgramme Facilities Apparatus, Materials and reagents Test systems Test and reference standards/items Standard Operating Prcedures Study planning and management Perfrmance f Study Reprting f Study Strage and retentin f recrds, materials and reprts Title: Questinnaire fr GLP Dc N : GLP-FM (P) -02 Issue N: 01 Date f Issue: Rev N: 01 Date f Rev : Page: 8 f 8