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New Version of PDA Technical Report No. 60 on Process Validation Published

The PDA Technical Report No. 60, Process Validation – A Life Cycle Approach, has been in existence since 2013. The document has now undergone extensive revisions. What has changed?

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Equipment Design in the FDA's Focus

The current FDA Process Validation Guidance addresses qualification as Stage 2.1. Under 21 CFR 211.63, the FDA requires, among other things, suitable equipment design. What does this mean in practical terms?

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Call for Presentations - share your Experience at the GMP Forum 2027 in Berlin

Since 2021, the GMP & GDP Forum has taken place every two years, bringing together the European GMP Conference and the European GDP Forum. The next event will take place from 22 to 24 June 2027 in Berlin, Germany. We are inviting interested experts to submit proposals for presentations as part of the GMP programme until 15 October 2026.

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Detailed Analysis of the PIC/S Document 'Recommendations on Qualification and Validation' - Part II

Since September 2007, the PIC/S document PI 006 has been available in Version 3 ("Recommendations on Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation, Cleaning Validation"). The revised Version 4 ("Recommendations on Qualification and Validation") will come into force on 1 October 2026 and significantly expands both its scope and level of detail. What is new Process Validation, other Qualification and Validation topics and Cleaning Validation?

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Detailed Analysis of the PIC/S Document 'Recommendations on Qualification and Validation' - Part I

Since September 2007, the PIC/S document PI 006 has been available in Version 3 ('Recommendations on Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation, Cleaning Validation'). The revised Version 4 ('Recommendations on Qualification and Validation') will come into force on 1 October 2026 and significantly expands both its scope and level of detail. What is new?

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Media Fill - What are the FDA's Issues?

In a recent warning letter, the FDA criticizes an Indian pharmaceutical manufacturer for deficiencies related to “media fills”. Read about the issues the FDA identified during its inspection.

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Revision of PIC/S PI 006 - complete Modernisation of this Qualification and Validation Guideline

On 30 July 2026 the PIC/S announced to publish a new version of document PI 006 about Validation and Qualification. Overall, the document represents a broad modernisation and is closely aligned with the Annex 15 revision 2015. What is new?

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Validation Group Developments January through April 2026

Find out what the ECA Validation Group was working on and accomplished in the first four months of 2026 - in this report.

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ECA Survey: The use of Artificial Intelligence in Equipment Qualification

One of the hottest topics these days, is the discussion about the use of Artificial Intelligence (AI) in the GMP environment. How far much is the use of AI already used in equipment qualification? This we want to know - with this brief survey.

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Unusual corrective Action for Lack of Process Validation

In a recent Warning Letter, the FDA criticised the lack of process validation. What measures is the FDA requiring in this case and how did the company respond?

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