Information

General information

  • Class 10k Quarterly Audit:

  • Conducted on

  • Location of audit

  • More information about location:

  • Wockhardt staff attending:

  • Additional attendees:

  • Additional attendees:

Class 10k areas - overall score

Autoclave corridor G37

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

  • Issue identified
  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

Wash up area G49

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

  • Issue identified
  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

Rear of Huber G48

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

  • Issue identified
  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

Component prep G47

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

  • Issue identified
  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

Corridor G54 (escape hatch to doors)

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

  • Issue identified
  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

Mobile vessel storage G100

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

  • Issue identified
  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

Formulation 2 G89

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

  • Issue identified
  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

Cartridge 2 washer G87

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

  • Issue identified
  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

Cartridge 1 washer G55

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

  • Issue identified
  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

Amp 2 washer G56

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

  • Issue identified
  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

Amp 1 washer G57

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

  • Issue identified
  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

Freeze drier airlock G59

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

  • Issue identified
  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

Freeze drier Plant G58

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

  • Issue identified
  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

Corridor G53 (office/air lock to doors)

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

  • Issue identified
  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

Vial line washer G60

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

  • Issue identified
  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

Formulation 1 G61 / G62 / G63

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

  • Issue identified
  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

Changing room G36

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

  • Issue identified
  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

Outer changing room G35

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

  • Issue identified
  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

Additional notes

  • Observations made unrelated to areas listed

  • Additional notes

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