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Records  Management  and  Decommissioning  Project  at  

Manufactoring  Plant  at  Comazzo  (Italy)  

ü Project  stages  -  Records  Management  -  Decommissioning  of  GMP  equipment  and  systems  

ü Resources  /  Dura:on  ü Other  Project  Ac:vi:es  ü Acknowledgements    

Table  of  Contents  

Project  Stages  

ü Records      Management  

 

•  Plant-­‐Wide  Documenta:on:    -­‐  Batch  Records    -­‐  SLC  documenta:on    -­‐  Non  GMP  Records  

•  Samples:    -­‐  Stability  Samples    -­‐  Reten:on  Samples  

ü Decommissioning  of  GMP  Equipment  and  Systems  

 

•  Quality  •  Manufacturing  •  Packaging  •  Warehouse  •  U:li:es  

Records  Management:    Plant-­‐Wide  DocumentaGon  

 General  Tasks  

Iden:fy  Records  Type  at  Facility  

Locate  Records    Storage  Areas  

Assess  State    of    

Documenta:on  

Inventory      Documenta:on  

Archive    Documents  

Archive  Log    Comple:on  

Palle:zing  and    shipping  *  

documenta:on  

*EAD: External Archiving Documentation – MGM Outsourcing Documental Division

Records  Management:    Samples  

**MGM Warehouse and ***MGM Stability Warehouse

Locate  and    iden:fy    samples  

 General  Tasks  

   Samples  Assessment      (Iden:fica:on  of  receiving  site      and  shipment  condi:ons)  

Iden:fica:on  and    segrega:on    

of  reten:on,  NO    reten:on  and  stability  samples    and  shipment  to  destroy*  

Genera:on  of    Samples  Archive  Log  

Samples  boxing    and  palle:zing  

Reten:on  Samples**    and    

Stability  Samples***  Shipping    

       Records  Management    

 

Batch  Records  

SLC  DocumentaGon    and  Non  GMP  

Records  •  2061  Binders  

Inventoried  •  500  Binders  

Destroyed  •  709  Boxes  

Shipped    

Plant-­‐Wide  DocumentaGon  

Samples  

RetenGon  Samples  

Stability  Samples  

•  6567  Binders  •  800  Binders  

Destroyed  •  2357  Boxes  

Shipped  

•  9567  Samples  •  2054  boxes  of  Reten:on  

Samples  and  7  boxes  of  Stability  Samples  

2061   =  8628  

ARCHIVED    BINDERS  

Total  

Binders  

6567  +  

Records  Management:  Summary  

Boxes  

709   =  5127  

ARCHIVED    BOXES  

+   2357  

Batch  Records  

SLC  and  Non  GMP  DocumentaGon  Samples  

2061   +  

0   +  

Decommissioning  of  GMP    Equipment  and  Systems  

Decommissioning    Assessment  

Save  Data?  

Checklist  

Decommissioning  plan  

No  

Yes  

Hardware  

Logbooks  

Calibra:ons  

SLC  

SOP’s  

Manuals  

Hardware   Logbooks   Calibra:ons  

SLC   SOP’s   Manuals  

Sodware   Electronic  records  

Paper  records  

Backups/Virtual  Images  

Delete    Electronic  Data  

Make  data    accessible  

Decommissioning  of  GMP    Equipment  and  Systems  

Stages  for  Decommissioning  Equipment  or  

Systems  

Post-­‐approval  

ExecuGon  

Pre-­‐approval  

CreaGng  decommissioning  document  and  data  treatment  

Assessment,  collecGon  &  reading  documentaGon  of  the  equipment    or  system.  

UGliGes  

Decommissioning  Documents  

Department   DPs   CLs  

28  

17   52    TOTAL    87  

Manufacturing  and  Pakaging  

4  

Quality  

20  

15  

0  

2  

Images   Memos  

8  

1  

0  

9  

 9   9  

Equipment  

512  

Project  Resources  Average/DuraGon  Summary  

32  months  

January  2011-­‐September  2013  

3  MGM  resources  

1,5  site  resources  

Resources  (full  Gme)  and  duraGon:  

Resources  /DuraGon  

0

2

4

6

8

MGM  Resources

Site  Resources

DuraGon  

Resources  

Resources  /AcGviGes

Activities

Resources  

DuraGon  

AddiGonal  Support  AcGviGes  

EMEA  QUALITY  OPERATIONS:  -­‐ Memo  Quality  Assurance      TSA:  -­‐ User’s  Manuals  and  EHST  documenta:on  copy:  942  manuals  and  50  binders  -­‐  Batch  Records  for  Comsumer  Complaints  Inves:ga:on  -­‐  SLC/Non  GMP  documenta:on  copied:  35  binders  -­‐  Training  Records  copied:  5  binders  

AddiGonal  Support  AcGviGes  

TSA:  

-­‐  Calibra:ons  and  logbooks  copied:  all  from  July  2012  

-­‐  Site  Master  File  cleaned  and  given  to  buyer:  20  word  

documents  

-­‐  SOPs  cleaned  and  given  to  buyer:  396  word  documents  

-­‐  Records  management  support  during  Regulatory  Inspec:on  

AIFA