Are you familiar with the Verification Guide ASTM E 2500?- ECA Modern Qualification Survey Results

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2/3 May 2024

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Qualification and Validation regulations have changed in both Europe and the USA in recent years. However, many pharmaceutical companies and suppliers are still using previously practiced methods and documentation - although a risk-based approach has become a regulatory expectation. So the overall qualification and validation effort is complicated, expensive and time consuming. “Modern Qualification” is about qualification and validation activities using an integrated approach in close cooperation with suppliers. Thus, the ECA set up a survey to find out to what extent qualification and validation programmes are integrated as actually made possible by the EU Annex 15 and the FDA Process Validation guide – and to what extent suppliers are involved. Altogether 78 persons provided their feedback. Last week part I of the survey results were published. In the following you will find the summary of part II with some questions and answers.

Just as a short revision of who actually participated in the survey: nearly 75% of the respondents are working for companies with more than 200 employees. Another 15% are with companies with 100-200 employees. 50% of the answers came from colleagues in companies manufacturing pharmaceuticals - and 8% each from API manufacturers in biotechnology and chemical. But there were also answers from Medical Devices manufacturers, equipment suppliers and manufacturers producing a great variety of products (Combination Products, drugs and APIs and Medical Devices).

Most of those responding are involved in validation activities and/or QA (32 participants). Three particpants are from qualification and from project management (each). Two consultants also participated in the survey.

Although the ASTM guide E 2500 (Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical  Manufacturing Systems and Equipment) is mentioned in the current FDA Process Validation Guidance, this guide is not well-known. 43% don´t know the guide, 35% don´t use it. This is somewhat suprising, as this guide's goal is to leverage qualification activities.

Who is involved in equipment qualification projects? This was another question in the survey. QA is number one with 92%. Highly involved are also the technical department (91%), production (88%) and the the validation group (73%). Quality Control is involved by 50% and metrology by 30%.

Very interesting are the answers to the question "Where are your QA people located/accompanied in equipment qualification projects?(Please mark all that apply)". Not very surprising - 91% are located in the QA department. But there is also QA personnel located in production (22%) and in the validation department (23%). Even in the technical department QA is located (20%) as well as in the Quality Control department (12%)

Responses to the question "Which issues/topics would you expect in a Modern Qualification Guide/ Where do you see a need for further clarification/standardization?" showed a great variety. Some of the answers are: lean qualification, risk-based approach Good Engineering Practice SAT vs. Equipment Qualification Supplier Documentation, Simplification, clarification on to which extend qualification has to be performed, reduce cost easy to apply, how to use risk assessment to lean the qualification process, how to demonstrate that testing is enough based on risk, FDA acceptance, examples for good/ short / comprehensive qualification for different equipment types would be helpful, retrospective qualification, I would like further clarification concerning PQ activities, guides on how to use supplier testing as part of verification/qualification pack Verification vs Qualification vs supplier,testing vs commissioning, what does a slim qualification look like? Which aspects do I have to consider in the context of a requalification? Who determines the period of a requalification?

Summary: There is room for the improvement of qualification activities. Especially the repetition of tests is still common, and project plans are not frequently used for the organisaton of qualification activities. There is a need for clarification how "Modern (Fast-track) qualification could be handled, as ASTM E 2500 is not widespread in the pharmaceutical industry.

Therefore the ECA has drafted a Good Practica Guide on Modern Qualification - A guide to effective qualification based on Customer - Supplier Partnership.

The complete survey result details will be discussed during ECA´s Modern Qualification and Validation Conference on 11/12 September 2018 in Berlin. There you will get to know ECA´s first public Good Practice Guide about Modern Qualification in more detail - and as a participant you will also get a free copy of it. Further, as member of ECA´s Validation Group you can download the survey results in the members' area. Ánd if you are no member yet, simply apply for membership - it's free of charge.