ASTM E2500 APPROACH, Process Equipment Suppliers and Qualification SMEs

by Zoltan Langosco Di Langosco, Global Senior Sales Manager & Technology Provider @PQE Group

ASTM E2500: a new approach to Validation

ASTM E2500 is a standard relating to the specification, design and verification of Pharmaceutical and Biotechnological manufacturing systems and equipment. It is applicable to equipment, systems/processes, utilities, laboratory systems, I.T. and automation systems that may affect product quality and patient safety.
The ASTM E2500 standard was first published in June 2007, and re-approved in 2012. It is in line with international regulatory requirements like ICH Q8, ICH Q9, ICH Q10 (Pharmaceutical Development/”Quality by Design”, Quality Risk Management, Pharmaceutical Quality System). This approach broadly used in the USA and supported by the FDA, is also being rolled out in Europe, particularly by manufacturers to rationalize their system test phases reduce their Time to Market.
ASTM E2500 has a number of similarities with the traditional V-model process, however the tests to be carried out no longer follow a rigid FAT/SAT/IQ/OQ/PQ sequence as described in EU GMP Annex 15, they are now brought together under the single term “Verification” and can be more rationally organized and efficiently adapted to each context.


ASTM E2500

ASTM E2500: The ASTM E2500 model is hinged around 4 steps, 4 cross-functional processes as well as 3 key players

4 steps:


Requirements: they are the documentary foundations of the verifications. It is important that the user needs and the critical aspects are clearly defined by expert SME’s and should include product knowledge, knowledge of the manufacturing process, regulatory requirements as well as the company’s in-house requirements.

Specification & Design: This step is aimed at verifying that supplier and project various users have taken into account the solutions proposed by suppliers and they are clearly understood.

Verification: Based on two major principles: “the right test” carried out at the “right time” = “right first time” test to be conducted. If carried out too soon the validity of its results may be undermined by modifications, carrying out tests too late undermines the project schedule.
Tests are only repeated if necessary or in the event of a change, therefore, some tests may be conducted at the supplier’s site, either totally or partially and some tests may be delegated to suppliers as they are experts in their own systems.

Acceptance & Release: prepares the system for operational implementation. During this step, a summary document will be implemented listing all tests carried out, the dates they were carried out and their status. The system concerned can then be transferred to the following step.
Should reservations remain at the point of transfer, they should only concern non-critical aspects and resolution dates must be defined.


4 cross-functional processes: 

Good Engineering Practices: well-defined and shared organization from project start facilitates its implementation as well as undefined organizational operations at the start of a project will inevitably result in technical problems.

Quality Risk Management: A product-focused risk analysis is carried out to identify, at the earliest possible stage all the critical parameters from a product quality / patient safety point of view (CQA, CPP) allowing the early verification of critical aspects of the system / installation from a GMP point of view.

Design Review: a step by step phase based on the supplier’s design documents to ensure the system design meets needs. It is aimed at reducing the need for any modifications following handover of the system to end users, as well as avoiding repeat tests following a modification. This process should be repeated whenever there is a design change.

Change Management: in the ASTM E2500 approach, the change management process will start earlier conducting tests at the supplier’s site avoiding test duplications, if effectively managed.

3 Key Players: 

Subject Matter Experts: play a crucial role in ASTM E2500 approach. Essential from the start of a project, they contribute to the definition of needs, identification of critical aspects, system design review, the drawing-up of the verification strategy and choice of the acceptability criteria. The SMEs will also take the lead role in the Quality Risk Analysis approach.

Suppliers: the main system experts, may be asked to conduct certain verification tests aimed at achieving the “right test” executed “at the right time” (“right first time”) objective more easily. Within the framework of ASTM E2500, suppliers play an essential role. They have to be familiar with the principles of ASTM E2500 and trained in regulatory requirements, particularly concerning good documentary practices.

QA: controls and focuses on critical aspects of the processes and systems in particular, it validates all verification acceptance criteria.


ASTM E2500: Conclusions & Fundamental Glossary

In conclusion: ASTM E2500 is an approach that covers the entire project involving many players from the needs definition phase allowing earlier verification and execution of the right tests at the right time.
The Validation’s role serves as a bridge between engineering and QA and becomes more important when adopting a Risk-Based Approach because they better understand the system’s intended use and its risks, so they can easily ascertain and justify why certain testing is being conducted while other functions are not tested based on Risk Assessment.
If ASTM E2500 is the body of the company’s validation strategy, the validation department becomes the heart of this body.

ASTM: American Society for Testing Material
C&Q: Commissioning & Qualification
CPP: Critical Process Parameter
CQA: Critical Quality Attribute
CQV: Commissioning Qualification Validation
FAT: Factory Acceptance Tests
GEP: Good Engineering Practices
GMP: Good Manufacturing Practices
IQ: Installation Qualification
OQ: Operational Qualification
PQ: Performance Qualification
QA: Quality Assurance
SAT: Site Acceptance Tests
SME: Subject Matter Expert
TTM: Time to Market

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