Thurloch OCriodain

About This Presentation

Title:

Thurloch OCriodain

Description:

Room Classification: close correlation between the EU grading classification and ... The requirements for steam quality in autoclaves is defined through the ... – PowerPoint PPT presentation

Number of Views:39

Avg rating:3.0/5.0

Slides: 15

Provided by: Cla6166

Category:

more less

Transcript and Presenter's Notes

Title: Thurloch OCriodain

1
Recent Developments in Guidelines for Aseptic
Processing Applications and Practical Issues

Thurloch OCriodain
29th Septemebr 2005

2
Recent Guidelines

EU Revised Annex 1
Manufacture of Sterile Medicinal Products
September 2003
FDA Guidance For Industry
Sterile Drug Products Produced by Aseptic
Processing Current Good Manufacturing Practice
September 2004

3
Benefits to manufacturers of the new guidelines

Equivalence of standards between US and EU
Room Classification close correlation between
the EU grading classification and the particulate
classes referenced by FDA.
Media Fills Section 42 reads like an abstract of
the detailed discussion in the FDA guideline.
Clarity of expectations a number of issues
previously implied and accepted as unwritten
rules, are now clearly stated.

4
Issues with the new guidelines

Language and interpretation
What is not included
Differences between agencies
EU and US
Within EU

5
Language and Interpretation

Example 1
A continuous measurement system should be used
for monitoring the concentration of particles in
the grade A zone, and is recommended for the
surrounding grade B areas. (EU Annex 1, Section
3, Note (a))
What is the meaning of recommended as a
regulatory term?

6
Language and Interpretation

Example 2
The at rest state is the condition where the
installation is installed and operating, complete
with production equipment but with no operating
personnel present. The in operation state is
the condition where the installation is
functioning in the defined operating mode with
the specified number of personnel working. (EU
Annex 1, Note 3)

7
Process Simulations (Media Fills)
Bulk solution
Fill - Finish
Packing
Distribution
8
Process Simulations (Media Fills)
Bulk solution
Fill - Finish
Shipment
Storage
Packing
Distribution
Typical point of sterility control
9
Process Simulations (Media Fills)

In this situation, can the entire operation be
represented in one media simulation, or are
several required?

Bulk solution
Fill - Finish
Shipment
Storage
Packing
Distribution
Point of sterility control for some products
10
SIP Systems

SIP interpreted as
Steam in place
Sanitise in place
Sterilise in place
The requirements for steam quality in autoclaves
is defined through the application of standards
EN285 and/or HTM 2010. What is the requirement
for steam quality in an SIP system?

11
Differences between agenciesEU and FDA

Settle plates
An expectation in the EU guideline
An option in the FDA guideline
5 µm particles
EU has a clear expectation of zero particles as
the norm
FDA has no requirement

12
Differences between agenciesEU and FDA

Pre-sterilisation bioburden limits
EU limit is 10 cfu/100ml
(CPMP/QWP/486/95)
A pre-filtration bioburden limit should be
established.
(FDA Guideline of 2004)

13
Differences between agenciesWithin EU

Steam sterilisation
IMB references HTM 2010 for autoclaves
MHRA references EN 285 for autoclaves
Some agencies reference only EN 554 for the
sterilisation process.
5 µm particles
EU has a clear expectation of zero particles as
the norm. The procedure for handling exceptions
is not clear.

14
Conclusion

The moves towards consistency of regulatory
requirements is progressing, but slowly.
To achieve consistency of practices between EU
and US, and within the EU will require further
work.
There are aspects of the regulations yet to be
clarified. Until that happens, risk assessment
and consideration of the science will be the
guiding principles for the industry.

Write a Comment

User Comments (0)