This major PHSS conference will address the key challenges in sterile product manufacture and processing of intermediates that require low bioburden control following risk based initiatives from a regulatory, Pharmaceutical/ Bio-pharmaceutical industry and healthcare pharmacy perspective.

Following a key note presentation from an MHRA Expert GMDP Inspector proving a perspective on GMP regulation changes and regulatory expectations there will be a panel discussion on Annex 1 version 12 and industry comments collated in the targeted consultation process that concludes on 20 May with PHSS as one of the targeted consultation commenting platforms.

9 June 2020 at The Mere Spa & Golf Resort, Manchester, UK

Challenges in sterile product manufacturing and processing of intermediates requiring low bioburden control.

Challenges in Sterile product and intermediates manufacturing – impact of GMP Regulation changes including Annex 1

• Separation barrier technologies; Modern Modular and Flexible Aseptic filling platforms for both liquid fill products: biologicals and lyophilised products: cytotoxic.

• Improved intervention and access control to reduce risks from human interventions.

• Digitalisation of EM data for analysis, trending and reporting for real time knowledge and proactive approaches to contamination control.

• Integrity testing of the sterile product fluid path considering tubing, single use systems and pathway after the sterilising filter where PUPSIT applies.

Conference presentations will cover aspects of Annex 1 revision that reflect requirements for improved assurance of sterility, including;

GOLD SPONSOR SILVER SPONSOR

FREETO

MEMBERS

9.00am

PHSS Chair, Jenni Tranter, welcome and overview of conference sessions.

9.15am - 10.00am

Challenges in Sterile product manufacture to GMP: MHRA GMDP inspectors point of view on GMP regulation changes and regulatory expectations.

10.00am - 11.00am

Discussion panel Q&A – Annex 1 Version 12 challengesand implementation. Discussion panel to include, GMP inspectors/ Auditors, QPs, Key opinion leaders from industry and Healthcare Pharmacies.• Annex 1 version 12, the key changes from first draft published in first Stakeholder consultation process.• Review of PHSS collated comments sent to the European Commission as part of the Targeted Second consultation process (ending 20 May 2020). • Discussion on regulatory expectation and impact on Stake holders of Annex 1 revision.• Discussion on readiness and implementation of Annex 1 revision.

11.00am - 11.45am

Coffee, Continued discussion, Networking and viewing exhibition.

11.45am - 12.40pm

Case study of fully integrated paperless access control and automation interaction between EM data, intervention tracking system and Aseptic process filling batch reports. SPEAKER: PATRIZIA MUSCAS, Sterility Assurance Research Scientist: Eli Lilly, Italia.Aseptic process filling in RABS barrier technology with a Grade B background that includes operator interventions into the barrier system at set up of sterilised parts before the barrier is closed and for filling operations requires a Quality by Design approach to minimise risk of contamination in the Cleanroom surrounding environments, in the barrier at open door set-up and during closed aseptic processing.

All set-up, inherent and corrective interventions involving operators present a contamination risk so access control, intervention logging become a key part to risk management.

The presentation follows a case study at Eli Lilly Italy where paperless access control is implemented together with automation interactions that connect interventions and EM data during Aseptic filling operations in RABS barrier technology with associated batch records. 12.40pm - 1.40pm

Lunch, Networking and viewing exhibition.

1.00pm - 1.30pm

Demonstration in Conference area; Swabs as a method of surface monitoring for complex surfaces in Aseptic processing applications. Demonstration by representatives of Copan.

Challenges in Sterile product manufacture to risk based GMP

Programme

1.40pm - 2.20pm

Presentation: Aseptic process filling: Case study Eirgen Ireland.Overview of a Modern Modular and Flexible Aseptic process filling line for filling different product typesincluding biologicals and lyophilised products requiring aseptic containment. The presentation includes an overview of where QRM is applied to adapt generic GMP whilst achieving an equivalent or higher standard of contamination control (Annex 1 requirement).

Modular and Flexible filling platforms with increasing automation have been a major development in the industry over the last years with increasing use of pre-sterilised containers and single use systems. Such an approach places the central focus on filling process operations on the Filling platform as most of the requirement for sterilisation processes are out-sourced. These fully automated technical systems provide a fully integrated filling platform under barrier technology with fully integrated environmental systems. Flexibility is provided to process different product closure formats for different product types (hazardous and non-hazardous, liquid fil or Lyophilised) all achieved with configurable pre-designed modules.

The use of NTT: Not-Touch-Transfer for entry of pre-sterilised containers to the Grade A filling zone is an alternative methodology to conventional GMP requiring a QRM approach. This presentation also overviews the areas where conventional GMP is adapted via QRM for Annex 1 compliance.

JOINT SPEAKERS: DERMOT O’RIORDAN, Business Development Manager Eirgen Waterford Ireland. STEFFEN SAVERSCHEL, Groninger GmbH. JAMES DRINKWATER, F Ziel GmbH.

2.20pm - 3.00pm

Presentation; Digitalisation of Environmental monitoring data with software analysis for trending and reporting on batch record together with deviation events. Digitalisation of data and data management with integrity and data sharing between different platforms is one of the objectives of Pharma 4.0 (next Generation Pharma) as more and more integrated automation and instrumentation combine to improve quality, risk management and efficiency of processes.

EM data and the knowledge it provides is an essential part of confirming a state of environmental control is established and compliant through process operations with detectability of deviation events and adverse trends. This presentation introduces a new software platform that supports the increasing requirements for improved information, knowledge and response to undesirable changes in conditions and possible contamination events that impact product release.SPEAKER: ANDREW DAVIES, Managing Director Microgenetics UK

3.00pm - 3.30pm Coffee/ Tea break in exhibition area.

3.30pm - 4.15pm

Presentation: QRM Approach Applied to Define a SUS Integrity Control Strategy and Associated Control Technologies.Patrick Evrard (TBC) Sr. Principal Engineer, Single-use Technologies, Technical Communication and Regulatory Strategy, Pall Biotech.For Aseptic process filling the product pathway using single use systems integrates sterilising filtration, SUS product bags and tubing through to filling needles. Although PUPSIT may be applied to the fluid sterilising filter(s) assurance of sterility requires the complete fluid pathway to be verified for integrity. New technological solutions have been developed to meet these ‘full’ fluid path integrity test requirements with acceptance criteria for integrity tests correlated against risk of microbial ingress. This presentation defines a QRM approach with technological solutions to support a Contamination Control Strategy (CCS) for Filling pathway assurance of sterility.

4.15pm - 4.45pm

Update on PHSS development of Clarity on GMP guidance’s from James Drinkwater: Head of PHSS aseptic processing and Bio-contamination special interest group;• Preparation of a Contamination Control Strategy (CCS) – case study based.• Preparation of an Aseptic – Containment Strategy (ACS) – case study based.• NTT: No-Touch-Transfer Qualification Part A) Pre-sterilised container manufacture and supply chain. Part B) Filling line qualification of NTT and included in APS/Media fills.• Definitions for airflow protection and alignment of definitions for: UDAF, Localised UDAF and Grade A air supply.• Leak integrity classes for Pharmaceutical Filling Isolators. • EM risk assessments at the design (DQ) stage when setting EM sample locations and type that require technical integration into the Filling platforms that employ barrier technology.• Airflow visualisation: CFDs, Smoke studies and LR Method. • Continuous particle monitoring with Compliance and Event monitoring together with a trend predictor (adverse event warning) with trend reporting. 4.45pm

PHSS Chair's thanks and closing remarks.Exhibition area with exhibitors who can provide further knowledge and support with technologies and essential supplies in sterile product manufacturing.International attendees are encouraged to engage with the challenging area of risk based GMP, European regulatory perspectives and industry key opinion leaders.

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