Class 10k Quarterly Audit 2015

General information

• Class 10k Quarterly Audit:

• Conducted on

  Date

• Location of audit

  Class 10k full area

  Partial 10k area due to:

• More information about location:

• Wockhardt staff attending:

  Select Sam Leah Emma Crowther John Hancock Dave Hughes Andrew Jones Emma Chard

  • Sam Leah
  • Emma Crowther
  • John Hancock
  • Dave Hughes
  • Andrew Jones
  • Emma Chard

• Additional attendees:

• Additional attendees:

Class 10k areas - overall score

Autoclave corridor G37

• Satisfactory

  Yes

  No

  Not inspected

• Reason for non inspection

• Was there a specific issue identified to resolve?

Issue identified

• Detail of issue

• Image of issue

  Media

• Responsibility to resolve:

  Area supervisor

  Engineering

  During system shutdown

  QA

  Microbiology

Wash up area G49

• Satisfactory

  Yes

  No

  Not inspected

• Reason for non inspection

• Was there a specific issue identified to resolve?

Issue identified

• Detail of issue

• Image of issue

  Media

• Responsibility to resolve:

  Area supervisor

  Engineering

  During system shutdown

  QA

  Microbiology

Rear of Huber G48

• Satisfactory

  Yes

  No

  Not inspected

• Reason for non inspection

• Was there a specific issue identified to resolve?

Issue identified

• Detail of issue

• Image of issue

  Media

• Responsibility to resolve:

  Area supervisor

  Engineering

  During system shutdown

  QA

  Microbiology

Component prep G47

• Satisfactory

  Yes

  No

  Not inspected

• Reason for non inspection

• Was there a specific issue identified to resolve?

Issue identified

• Detail of issue

• Image of issue

  Media

• Responsibility to resolve:

  Area supervisor

  Engineering

  During system shutdown

  QA

  Microbiology

Corridor G54 (escape hatch to doors)

• Satisfactory

  Yes

  No

  Not inspected

• Reason for non inspection

• Was there a specific issue identified to resolve?

Issue identified

• Detail of issue

• Image of issue

  Media

• Responsibility to resolve:

  Area supervisor

  Engineering

  During system shutdown

  QA

  Microbiology

Mobile vessel storage G100

• Satisfactory

  Yes

  No

  Not inspected

• Reason for non inspection

• Was there a specific issue identified to resolve?

Issue identified

• Detail of issue

• Image of issue

  Media

• Responsibility to resolve:

  Area supervisor

  Engineering

  During system shutdown

  QA

  Microbiology

Formulation 2 G89

• Satisfactory

  Yes

  No

  Not inspected

• Reason for non inspection

• Was there a specific issue identified to resolve?

Issue identified

• Detail of issue

• Image of issue

  Media

• Responsibility to resolve:

  Area supervisor

  Engineering

  During system shutdown

  QA

  Microbiology

Cartridge 2 washer G87

• Satisfactory

  Yes

  No

  Not inspected

• Reason for non inspection

• Was there a specific issue identified to resolve?

Issue identified

• Detail of issue

• Image of issue

  Media

• Responsibility to resolve:

  Area supervisor

  Engineering

  During system shutdown

  QA

  Microbiology

Cartridge 1 washer G55

• Satisfactory

  Yes

  No

  Not inspected

• Reason for non inspection

• Was there a specific issue identified to resolve?

Issue identified

• Detail of issue

• Image of issue

  Media

• Responsibility to resolve:

  Area supervisor

  Engineering

  During system shutdown

  QA

  Microbiology

Amp 2 washer G56

• Satisfactory

  Yes

  No

  Not inspected

• Reason for non inspection

• Was there a specific issue identified to resolve?

Issue identified

• Detail of issue

• Image of issue

  Media

• Responsibility to resolve:

  Area supervisor

  Engineering

  During system shutdown

  QA

  Microbiology

Amp 1 washer G57

• Satisfactory

  Yes

  No

  Not inspected

• Reason for non inspection

• Was there a specific issue identified to resolve?

Issue identified

• Detail of issue

• Image of issue

  Media

• Responsibility to resolve:

  Area supervisor

  Engineering

  During system shutdown

  QA

  Microbiology

Freeze drier airlock G59

• Satisfactory

  Yes

  No

  Not inspected

• Reason for non inspection

• Was there a specific issue identified to resolve?

Issue identified

• Detail of issue

• Image of issue

  Media

• Responsibility to resolve:

  Area supervisor

  Engineering

  During system shutdown

  QA

  Microbiology

Freeze drier Plant G58

• Satisfactory

  Yes

  No

  Not inspected

• Reason for non inspection

• Was there a specific issue identified to resolve?

Issue identified

• Detail of issue

• Image of issue

  Media

• Responsibility to resolve:

  Area supervisor

  Engineering

  During system shutdown

  QA

  Microbiology

Corridor G53 (office/air lock to doors)

• Satisfactory

  Yes

  No

  Not inspected

• Reason for non inspection

• Was there a specific issue identified to resolve?

Issue identified

• Detail of issue

• Image of issue

  Media

• Responsibility to resolve:

  Area supervisor

  Engineering

  During system shutdown

  QA

  Microbiology

Vial line washer G60

• Satisfactory

  Yes

  No

  Not inspected

• Reason for non inspection

• Was there a specific issue identified to resolve?

Issue identified

• Detail of issue

• Image of issue

  Media

• Responsibility to resolve:

  Area supervisor

  Engineering

  During system shutdown

  QA

  Microbiology

Formulation 1 G61 / G62 / G63

• Satisfactory

  Yes

  No

  Not inspected

• Reason for non inspection

• Was there a specific issue identified to resolve?

Issue identified

• Detail of issue

• Image of issue

  Media

• Responsibility to resolve:

  Area supervisor

  Engineering

  During system shutdown

  QA

  Microbiology

Changing room G36

• Satisfactory

  Yes

  No

  Not inspected

• Reason for non inspection

• Was there a specific issue identified to resolve?

Issue identified

• Detail of issue

• Image of issue

  Media

• Responsibility to resolve:

  Area supervisor

  Engineering

  During system shutdown

  QA

  Microbiology

Outer changing room G35

• Satisfactory

  Yes

  No

  Not inspected

• Reason for non inspection

• Was there a specific issue identified to resolve?

Issue identified

• Detail of issue

• Image of issue

  Media

• Responsibility to resolve:

  Area supervisor

  Engineering

  During system shutdown

  QA

  Microbiology

Additional notes

• Observations made unrelated to areas listed

• Additional notes