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

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Anna Åkesson Charlotte Styles Lena Öjstedt

Joanna Norin Ingrid Sjöberg Vesna Gaborit Viveca Frising

GMP Benchmarking group – Snapshot

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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?

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‘Benchmarking – the process of identifying and

learning from Good Practices in other organisations’

Benchmarking group – What is it?

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1. How did it start?2. Benchmarking Code of Conduct3. How we work? 4. What preparations are required; questionnaire etc.5. What happens at the F2F meeting6. Topics

Benchmarking group – What is it?

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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.

Benchmarking group – What is it?

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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

Benchmarking group – What is it?

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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

Good Distribution Practice

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Good Distribution Practice

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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

Distribution – Overall

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Does your company have a guideline for distribution?

If so, does it

(taken from 2013/C 343/01)

Yes

-Apply to finished products? Yes

-Apply to APIs/drug substances?? Majority yes

-Apply to IMP? Majority yes

-Require distribution performance to be assessed in Management Quality

Review?

Yes

If no it’s assessed indirectly

-Allow quality risk management to be applied? Yes

Does your company hold an MIA Manufacturing license with a WDA

Warehouse Distribution Authorisation included?

Yes

Distribution Personnel

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Is there a Responsible person assigned? Yes

Is the responsible person or the company contactable 24 hours a day? Yes/

company contactable

Are all staff involved in warehouse activities trained in GMP/GDP? Room for improvement regarding

training

Does the training cover

Initial

Refresher

Counterfeit

Hygiene

Yes

Are warehouse cleaners trained in GMP/GDP Majority

Are transporters/ couriers trained in GMP/GDP (or pharmaceutical

awareness?)

Not by us, assessed through

supplier audit

Distribution – Premises and Equipment

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Is the warehouse area (areas) temperature mapped?

-Did the mapping cover seasonal highs and lows?

-Did the mapping consider sources of heat/cold?

Majority yes, season highs and

lows not always mapped

Is the warehouse area temperature controlled

15-25°C, 2-8°C, -20°C, Deep Freeze

Yes, as applicable

Is the warehouse humidity controlled? If so, what limits apply? Majority No

Which products are physically segregated in the warehouse? Depends on system E-system only

rejected/hazardous

How is unauthorised access prevented? Access cards

How frequently is pest control assessed? Atleast quarterly

Are poisonous baits allowed in the warehouse? One answer Yes

Do despatch areas protect from the weather? One answer No

Are inbound and outbound separated? One answer No

Are food, drink, tobacco or private medicines allowed in the warehouse? No

Are there windows in the warehouse? No

Are the temperature/humidity sensors in the warehouse calibrated? Yes

Are there restrictions to what types of pallets are allowed in the

warehouse? If so, are

Yes

Are warehouse computerised systems validated? Challenges

Is all warehouse measuring equipment qualified? Challenges

Distribution Documentation + Operations + Complaints

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Is good documentation practice followed in the warehouse? Yes for all

What information do records of receipts contain? All have procedure for receipt

check

What information do records of outbound shipments contain? All have procedures for

shipments info

What is the archiving duration for warehouse documentation and records? 6 years to forever

Are warehouse service providers qualified? E.g. pest control etc. Yes

Is there a damage check upon receipt? Yes

Is there a check of release of (only relevant for comparators) by a Qualified Person

by the MA holder (when different to the company)?

Yes (N/A for some)

Do the company’s products bear safety features? Dir. 2011/62, not for IMP. No

Is there a counterfeit awareness policy? Majority No

How regularly are routine stock inventories performed? Monthly - Annually

How quickly are expired goods removed from stock? Challenges

How is destruction documented? Challenges

Is there a complaints procedure? Yes

Is there a recall procedure? Yes

Is it possible to allow returns back to stock for

sale/distribution?

No - Assessed as free from damage, transport

known

Distribution – Outsourced Activities

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Are all outsourced warehouse activities subject to contact acceptor/giver

agreements?

Yes

Is the warehouse included in the company’s self inspection programme? Yes (when internal)

Are temperature loggers used during transportation? Yes - Cold shipment only,

For certain countries ambient as well.

Are there stability based deviation guides for temperature excursions during

transportation?

Yes majority

If temp loggers are used who downloads and saves the raw data? (is it certain

the data can’t be altered?)

Challenges

Are dedicated vehicles used? Yes majority

Is the vehicle physical condition assessed before loading? Challenges

Is the vehicle temperature assessed before loading Challenges

Are real time temp track and trace devices used for any products? No

Are the temp loggers used calibrated? Y+N

Are the temp loggers used single use? Y+N

Is there a new release of the product upon arrival based on acceptable

distribution temperature?

Majority – when a deviation during

transport

Are IMPs treated differently to Marketed Products during distribution? Y+N

Document Managment

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Document Management (DM) - Documentation

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No Question Response

1 Finns definition för Document

Management, vilken?

Majoritet (5/7) har inte en definition.

2 Finns en övergripande

Document Management SOP/-

process?

Ja

3 Finns befattningen ”Document

Manager” eller motsvarande?

Inom vilken avdelning?

3/7 har inte en DM roll

(Documentation administrator, Regulatory

Doc Managers, Business Systems specialist,

QA)

4 Om ja, vilket ansvar har DM? Inget entydligt

Document Management - Documentation

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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.

(arbete pågår för de som inte har en SOP )

7 Finns en definition för

Guideline?

1/7 har en definition för ‘Guideline’

8 Finns en förteckning över

ingående dokumenttyper i

företagets QMS?

3/7 har en förteckning

Document Management – Management Support

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No Question Response

9 Finns stöd från management för

DM processen?

Ja (7/7)

10 Ingår DM i ledningens

genomgång?

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

Document Management - System

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No Question Response

12 Finns det ett Document

Management system för alla

dokument?

Mindre företag har ett system med

flera delar.

Större företag har flera system.

13 Vilka är ansvariga för att sköta

systemen? Lokalt? Globalt?

Beror på systemet.

Verksamheten eller QA.

Document Management - Document review, approval, revision,

distribution, archiving, retreival

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No Question Response

14 Finns en generell process eller

är det olika beroende på

system/process?

4/7 generell process

3/7 systemberoende

15 Krävs formell review-runda

inklusive signering av

granskningen?

Alla har granskning, men kan vara

formell alternativt informell.

Majoritet använder informell

granskning utanför systemet.

16 Finns turordning för

godkännande? Signerar alltid

QA sist?

QA signerar alltid sist.

Document Management - Document review, approval, revision,

distribution, archiving, retreival

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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)

Document Management

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No Question Response

22 Finns det definition för

‘electronic record’?

4/7 har en definition

23 Används elektroniska

signaturer?

5/7 använder elektroniska

signaturer.

24 Finns gemensamma krav på

format för samtliga

dokumenttyper?

Ja, för kontrollerade dokument.

25 Finns specifika krav per

dokumenttyp?

5/7 ja

26 Finns relevanta DM termer

definierade, tex primärdata,

official copy?

5/7 ja

Document Management - Training

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No Question Response

27 Vem utbildas på DM processen? Alla som berörs.

28 Vem utbildar? Varierar.

’Ingen, QA eller avdelningarna själva.

29 Vilka dokumenttyper kräver

dokumenterad utbildning (utöver

SOPar)?

Olika hos samtliga.

30 Hur dokumenteras utbildningen? Fortbildningskort.

Document Management - Inspection

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No Question Response

31 Har företaget tagit ställning till

vilka dokument som får visas för

en inspektör och hur det ska

presenteras?

Ej tydligt definierat, intern audit

rapporter visas ej.

Papperskopior tillhandahålls.

2/7 visar i e-system, rutiner finns

för detta.

32 Ingår DM i interna

inspektionsprogrammet?

Vem inspekterar?

Indirekt.

QA.

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