SARQA Benchmarking Team - GMP 2015-11-19 Joanna Norin & Vesna Gaborit
Agenda 1. Benchmarking group - How does it work? 2. Good Distribution Practice 3. Document Management
GMP Benchmarking group Who we are Anna Åkesson Charlotte Styles Lena Öjstedt Joanna Norin Ingrid Sjöberg Vesna Gaborit Viveca Frising 3
GMP Benchmarking group Snapshot 4 Members Companies R&D/Commercial Size Location Anna Åkesson R&D+Comm Small Lund Charlotte Styles R&D+Comm Small Mölndal Lena Öjstedt R&D Large Helsingborg Joanna Norin R&D+Comm Medium Denmark Ingrid Sjöberg Ingrid Sjöberg Quality Assurance AB R&D+Comm Small Malmö Vesna Gaborit R&D Large Mölndal Viveca Frising R&D Small Denmark
Benchmarking What is it? Benchmarking the process of identifying and learning from Good Practices in other organisations 5
Benchmarking group What is it? 1. How did it start? 2. Benchmarking Code of Conduct 3. How we work? 4. What preparations are required; questionnaire etc. 5. What happens at the F2F meeting 6. Topics 6
Benchmarking group What is it? 1. How did it start? Seven members from SARQA (Swedish and Danish companies) joined the team in 2009. Membership have changed during the years. Objective was to meet regularly F2F and once a month TC. 2. Benchmarking Code of Conduct Principles of preparation, contact, exchange, confidentiality. 3. How we work? F2F meetings twice/year. TC only if needed. Topics agreed in advance. 7
Benchmarking group What is it? 4. Preparations Questionnaire prepared by 1-2 volunteers. Sent for review. Responses ready before the meeting. 5. Topics that have been discussed Release process CAPA Deviation KPI PQS Change Control Audit 8
Benchmarking group What is it? 6. What happens at the F2F meeting Meeting at the company or home. Every question and response is being discussed. Objective is to summarise the outcome at the meeting. New topics to discuss are agreed as well as where an when to meet. 7. Are you interested in starting a new benchmarking group? Homogenous vs Heterogeneous group What type of topics do you want to cover Size is important 9
10 Good Distribution Practice
Good Distribution Practice In total 60 questions in relation to Good Distribution Practice were assessed in the following categories -Overall Quality Management -Personnel -Premises and Equipment -Operations -Complaints, Returns, Recalls -Outsourced Activities, Self Inspection and Transportation 11
Distribution Overall Does your company have a guideline for distribution? If so, does it (taken from 2013/C 343/01) -Apply to finished products? Yes Yes -Apply to APIs/drug substances?? Majority yes -Apply to IMP? Majority yes -Require distribution performance to be assessed in Management Quality Review? -Allow quality risk management to be applied? Yes If no it s assessed indirectly Yes Does your company hold an MIA Manufacturing license with a WDA Warehouse Distribution Authorisation included? Yes 12
Distribution Personnel Is there a Responsible person assigned? Is the responsible person or the company contactable 24 hours a day? Are all staff involved in warehouse activities trained in GMP/GDP? Does the training cover Initial Refresher Counterfeit Hygiene Are warehouse cleaners trained in GMP/GDP Yes Yes/ company contactable Room for improvement regarding training Yes Majority Are transporters/ couriers trained in GMP/GDP (or pharmaceutical awareness?) Not by us, assessed through supplier audit 13
Distribution Premises and Equipment Is the warehouse area (areas) temperature mapped? -Did the mapping cover seasonal highs and lows? -Did the mapping consider sources of heat/cold? Is the warehouse area temperature controlled 15-25 C, 2-8 C, -20 C, Deep Freeze Is the warehouse humidity controlled? If so, what limits apply? Which products are physically segregated in the warehouse? How is unauthorised access prevented? How frequently is pest control assessed? Are poisonous baits allowed in the warehouse? Do despatch areas protect from the weather? Are inbound and outbound separated? Are food, drink, tobacco or private medicines allowed in the warehouse? Majority yes, season highs and lows not always mapped Yes, as applicable Majority No Depends on system E-system only rejected/hazardous Access cards Atleast quarterly One answer Yes One answer No One answer No No 14 Are there windows in the warehouse? Are the temperature/humidity sensors in the warehouse calibrated? Are there restrictions to what types of pallets are allowed in the warehouse? If so, are Are warehouse computerised systems validated? Is all warehouse measuring equipment qualified? No Yes Yes Challenges Challenges
Distribution Documentation + Operations + Complaints Is good documentation practice followed in the warehouse? What information do records of receipts contain? What information do records of outbound shipments contain? What is the archiving duration for warehouse documentation and records? Yes for all All have procedure for receipt check All have procedures for shipments info 6 years to forever Are warehouse service providers qualified? E.g. pest control etc. Is there a damage check upon receipt? Is there a check of release of (only relevant for comparators) by a Qualified Person by the MA holder (when different to the company)? Do the company s products bear safety features? Dir. 2011/62, not for IMP. Is there a counterfeit awareness policy? How regularly are routine stock inventories performed? How quickly are expired goods removed from stock? How is destruction documented? Yes Yes Yes (N/A for some) No Majority No Monthly - Annually Challenges Challenges Is there a complaints procedure? Is there a recall procedure? Is it possible to allow returns back to stock for sale/distribution? No - Yes Yes Assessed as free from damage, transport known 15
Distribution Outsourced Activities Are all outsourced warehouse activities subject to contact acceptor/giver agreements? Is the warehouse included in the company s self inspection programme? Are temperature loggers used during transportation? Are there stability based deviation guides for temperature excursions during transportation? If temp loggers are used who downloads and saves the raw data? (is it certain the data can t be altered?) Are dedicated vehicles used? Is the vehicle physical condition assessed before loading? Is the vehicle temperature assessed before loading Are real time temp track and trace devices used for any products? Are the temp loggers used calibrated? Are the temp loggers used single use? Is there a new release of the product upon arrival based on acceptable distribution temperature? Are IMPs treated differently to Marketed Products during distribution? Yes Yes (when internal) Yes - Cold shipment only, For certain countries ambient as well. Yes majority Challenges Yes majority Challenges Challenges No Y+N Y+N Majority when a deviation during transport Y+N 16
17 Document Managment
Document Management (DM) - Documentation No Question Response 1 Finns definition för Document Management, vilken? 2 Finns en övergripande Document Management SOP/- process? 3 Finns befattningen Document Manager eller motsvarande? Inom vilken avdelning? Majoritet (5/7) har inte en definition. Ja 3/7 har inte en DM roll 4 Om ja, vilket ansvar har DM? Inget entydligt (Documentation administrator, Regulatory Doc Managers, Business Systems specialist, QA) 18
Document Management - Documentation No Question Response 5 Finns SOP för Good Documentation Practices? Samtliga (7/7) har en SOP. 6 Finns SOP för Data Integrity? 3/7 har en SOP. 7 Finns en definition för Guideline? 8 Finns en förteckning över ingående dokumenttyper i företagets QMS? (arbete pågår för de som inte har en SOP ) 1/7 har en definition för Guideline 3/7 har en förteckning 19
Document Management Management Support No Question Response 9 Finns stöd från management för DM processen? 10 Ingår DM i ledningens genomgång? Ja (7/7) Ja, hos majoriteten (5/7) Indirekt 11 Finns KPI-data för DM; vilka? 3/7 har ingen KPI data för DM KPI för antal SOPar och SOPs overdue 20
Document Management - System No Question Response 12 Finns det ett Document Management system för alla dokument? 13 Vilka är ansvariga för att sköta systemen? Lokalt? Globalt? Mindre företag har ett system med flera delar. Större företag har flera system. Beror på systemet. Verksamheten eller QA. 21
Document Management - Document review, approval, revision, distribution, archiving, retreival No Question Response 14 Finns en generell process eller är det olika beroende på system/process? 15 Krävs formell review-runda inklusive signering av granskningen? 16 Finns turordning för godkännande? Signerar alltid QA sist? 4/7 generell process 3/7 systemberoende Alla har granskning, men kan vara formell alternativt informell. Majoritet använder informell granskning utanför systemet. QA signerar alltid sist. 22
Document Management - Document review, approval, revision, distribution, archiving, retreival No Question Response 17 Finns det en arkivansvarig? Inom vilken avdelning? Samtliga (7/7) har en ansvarig. (QA, line function, Regulatory) 18 Arkivlokaler; krav på tillträde? Access krävs för inträde. 19 Arkiveringstid: Specificerat för varje dokumenttyp? Samtliga (7/7) har specificerat per dokumenttyp. 20 Finns SOP för arkivering? Samtliga (7/7) har en SOP. 21 Destruktionsrutiner? No (7/7) 23
Document Management No Question Response 24 22 Finns det definition för electronic record? 23 Används elektroniska signaturer? 24 Finns gemensamma krav på format för samtliga dokumenttyper? 25 Finns specifika krav per dokumenttyp? 26 Finns relevanta DM termer definierade, tex primärdata, official copy? 4/7 har en definition 5/7 använder elektroniska signaturer. Ja, för kontrollerade dokument. 5/7 ja 5/7 ja
Document Management - Training No Question Response 27 Vem utbildas på DM processen? Alla som berörs. 28 Vem utbildar? Varierar. 29 Vilka dokumenttyper kräver dokumenterad utbildning (utöver SOPar)? Ingen, QA eller avdelningarna själva. Olika hos samtliga. 30 Hur dokumenteras utbildningen? Fortbildningskort. 25
Document Management - Inspection No Question Response 31 Har företaget tagit ställning till vilka dokument som får visas för en inspektör och hur det ska presenteras? 32 Ingår DM i interna inspektionsprogrammet? Vem inspekterar? Ej tydligt definierat, intern audit rapporter visas ej. Papperskopior tillhandahålls. 2/7 visar i e-system, rutiner finns för detta. Indirekt. QA. 26
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