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PDA Points To Consider For Aseptic Processing

The document discusses the PDA's ongoing efforts to update its 2003 "Points to Consider for Aseptic Processing" guidance document. A task force composed of industry experts is revising the document to address new technologies, products, and clarifications. The task force aims to issue an initial revision by the end of the year. The revision will provide recommendations on topics like airflow patterns, environmental monitoring, and sterilization methods based on current best practices. The PDA will thoroughly review the document before finalizing and releasing it.

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Kevin Zhao

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0% found this document useful (0 votes)

672 views

PDA Points To Consider For Aseptic Processing

Uploaded by

Kevin Zhao

Available Formats

Download as PDF, TXT or read online on Scribd

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PDA:

Points A Global
to Consider
in the
Association
Manufacturing of
Sterile Products
Gabriele Gori
Global Head, GMP Compliance
and Auditing Novartis Vaccines
& PDA Task Force Co-Chair
Points to Consider in the Manufacturing of
Sterile Products

Disclaimer:
The views and opinions expressed in this presentation are those of the
author and do not necessarily reflect the official policy or position of
Novartis or any of its officers.

Similarly, as the PDA «Points to Consider...» revision is still in progress

and it has not been approved yet per the PDA approval process, the
opinions expressed in this presentation are those of the author and do
not necessarily reflect the official position of PDA .

2
Points to Consider in the Manufacturing of
Sterile Products

Agenda:
•Background
•The PDA Process & Task force
•Some of the points currently included in the revision
•Timelines & Conclusion

3
Points to Consider in the Manufacturing of
Sterile Products

Background
•PDA has almost seventy years of focus and leadership in the best practices for
sterile pharmaceutical manufacturing.

•PDA leadership remains focused on promoting science-based guidance, and

driving greater international harmonization.

•PDA is prioritizing updates for several of our related technical reports, to

ensure state-of-the-art guidance in the manufacturing of sterile medicines.

•PDA has also commented on many of the major regulatory guidances on this
subject over the years, and continues to do so, as the technology changes.

4
Points to Consider in the Manufacturing of
Sterile Products

Background (cont.ed)
•PDA published in 2003 the “Points to Consider For Aseptic Processing”*. Much
has been learned by the industry since the publishing of that document. In an
effort to address the impact of this gained knowledge, the PDA has set up an
expert task force, with the purpose of developing a revision of these PtC.

•PDA believes that this document may be of interest also to Health Authorities
for the update of existing regulations and guidelines, e.g. the Annex 1 of the
European GMPs: a Concept Paper is being developed by EMA (through the
GMP/GDP IWG) which may lead to a revision of Annex 1 or issuance of
additional clarification notes (“Q&A’s”).
Furthermore, a PIC/S WG has been established on this topic and is operative
since August 2014

* PDA Journal of Pharmaceutical Science and Tecnology, 2003 Supplement, Volume 57, Number 2

5
Points to Consider in the Manufacturing of
Sterile Products

PDA Process & Task Force

•PDA has set up a Task Force made up of subject matter experts from industry,
aimed at updating the Points to Consider document to provide
recommendations on current topics, best practices, and areas of clarification
which are important to the manufacturing of quality sterile products.

•Many of the topics have been included as a result of input from PDA members
at conference sessions and meetings. It is the intention of the task force to
issue an initial revision and then to supplement the PtC as additional input is
received from industry and member.

•The scope of the PtC is aseptic processing. It is anticipated that this scope may
be further broadened to include topics related to terminal sterilization and other
related topics, which may be reflected in one or more supplements or
addendums to this revision, published at a later date.

6
Points to Consider in the Manufacturing of
Sterile Products

PDA Process & Task Force (Cont.ed)

•Five guiding and linked principles are the basis for the revision:

 Use of science and risk based approaches

 Use of modern technology
 Re-evaluation of traditional control strategies
 Consider new product/container presentations and therapies
 Support harmonized technical and regulatory language

7
Points to Consider in the Manufacturing of
Sterile Products

PDA Process & Task Force (Cont.ed)

Current PDA “Core” Task Force composition:

• Hal Baseman (Valsource), Co-chair • Phil De Santis (Consultant)

• Gabriele Gori (Novartis), Co-chair • Richard Johnson (PDA)
• Masahiro Akimoto (Toray) • William Miele (Pfizer)
• Marc Besson (Sanofi) • Janie Miller (PDA)
• Jette Christensen (Novo Nordisk) • Rainer Newman (Consultant)
• Veronique Davoust (Pfizer) • Mike Sadowski (Baxter)
• Vincent O'Shaughnessy (Amgen) • Ed Tidswell (Baxter)

Additional experts contributed on special topics, including (but not limited to) the
following: Maik Jornitz (G-Com), Chuck Reed (Weiler), John Shabushnig
(Consultant), and others
8
Points to Consider in the Manufacturing of
Sterile Products

Some of the topics currently* included in the revision

•Airflow Velocity and Patterns
•Uni-directional Flow vs Laminar Flow
•Grade A Environment over Cappers
•Differential Pressure
•Testing of HEPA filters and HEPA filters patching
•Tube length and bend radii for total particulate sampling
•«At Rest» status
•Monitoring of ≥ 0.5µm and ≥ 5.0 µm particles and room classification
•EM Alert & Action Levels setting
•Location and Frequency of monitoring of total particulates and viable
particles
* This is not a comprehensive list. Also, some of the points described in this list may be removed and/or new points added
to the final version of the revised PtC version, based on the on-going review and revision process and the inputs received
from the Industry and Regulators.
9
Points to Consider in the Manufacturing of
Sterile Products

Some of the topics currently* included (Cont.ed)

•Process Simulation Design and Criteria
•Aseptic Personnel Qualification and Disqualification
•Entry of Equipment and Material into the Aseptic Processing Area
•Cleaning and Disinfection
•Heat sterilization as method to prefer
•Use of Biological Indicators
•Steam quality monitoring
•Requirements on pre-filtration bioburden limits
•Sterilizing filter integrity testing (pre-/post-)

* This is not a comprehensive list. Also, some of the points described in this list may be removed and/or new points added
to the final version of the revised PtC version, based on the on-going review and revision process and the inputs received
from the Industry and Regulators.
10
Points to Consider in the Manufacturing of
Sterile Products

Some of the topics currently* included (Cont.ed)

•Manufacturing and Control of WFI

•Sterilization/sanitization of WFI systems
•Isolators/RABS/BFS

11
Points to Consider in the Manufacturing of
Sterile Products

Timelines & Conclusion

•PDA has a strict, comprehensive review process prior to releasing
technical documents, to include a review and approval by the technical
Advisory Boards (SAB, BioAB, RAQAB) and of the PDA Board of
Directors. This to ensure the accuracy and quality of the document.

•As already mentioned, it is the intention of the task force to issue an

initial revision and then to supplement the PtC as additional input is
received from industry and member.

•Initial revision completion targeted for year end.

12
Points to Consider in the Manufacturing of
Sterile Products

Timelines & Conclusion (Cont.ed)

•PDA is devoted to supporting the advancement of technology and
science in the manufacturing and control of sterile medicinal products
•

•With the revision of the 2003 Points to Consider document, PDA wants
to address specific areas that may benefit from clarification, or that could
be updated to reflect current state‐of‐the‐art practices.