News

FDA Warning Letter Statistics 2013 with regard to Process Validation / Qualification / Calibration

In previous GMP News, we presented FDA "Findings" in the complex topics validation / qualification / calibration in manufacturing with regard to medicinal products. Read the News to get the analysis of the 37 Warning Letters.

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Cleaning Validation Requirements in Asia

Since the nineties, cleaning validation has been one of the main validation topics discussed by the pharmaceutical industry and API manufacturers. Because of growing globalisation, countries in East Asia (Tiger States and Panther States) have also become interesting as consumer countries of APIs and/ or medicinal products. What about requirements on cleaning validation there? Read more here.

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FDA publishes Guideline Draft on the Registration of Production Sites

In our News from 11 September 2013, we reported about FDA's initiative to identify production sites according to a  uniform system. The topic seems to be crucial for the FDA as it has now released the draft of a "Guidance for Industry" entitled ... Read on.

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ASEAN Countries publish Draft of a Guideline on Process Validation

The member states of the Southeast Asian association (ASEAN) have released the draft of a process validation guideline under the management of Singapore. The title is "Guidance for Quality by Design as an alternative Approach to Process Validation". The document is composed of 10 pages and is very much in line with... Read more here.

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Results of ECA´s Validation Survey regarding the revision of Annex 15

With the finalisation of the new FDA Guidance on Process Validation in 2011, a validation life cycle has become state of the art. Accordingly it is planned to partly revise the process validation approach in Europe as well. The European Medicines Agency (ECA) has already issued a concept paper with regard to the EU Annex 15 and asked for comments; Reason enough for the ECA to set up a survey to find out the industry’s thoughts on the planned revision. Find out more about the results. 

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WHO publishes Draft on Revised Process Validation Guideline: Validation Life-Cycle Required

The WHO has published a proposal for the revision of its supplementary guideline on GMP validation (Annex 7: non-sterile process validation). The document composed of 11 pages introduces a validation life-cycle and is ... read more here.

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Qualification Guideline ASTM E2500 revised

The ASTM norm E2500 should provide a modern and alternative approach to qualification. The classical qualification levels DQ, IQ, OQ, PQ are not mentioned anymore but Subject Matter Experts (SMEs) who should take care of the organisation of verification. Moreover, Good Engineering Practice (GEP) is highly valued. The norm has now been revised. Read more here.

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How many Validation Runs are State-of-the-Art today?

For many years the "magical three validation runs" completed successfully were regarded as state-of-the-art in order to be able to define a process as validated. But in the new FDA Guidance on Process Validation no number of validation runs is mentioned any more. How many runs are state-of-the-art today? Read more.

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Second Publication of PDA's Technical Report on Process Validation

From time to time the Parenteral Drug Association (PDA) releases so-called "Technical Reports" (TR) on GMP topics. They provide useful and up-to-date information on the respective topic. The newly published Technical Report No. 60 deals with the topic "Process Validation". Read more here.

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Validation on the move: How should the Annex 15 of the EU GMP Guide be revised?

Together with the EMA Process Validation Guideline the Annex 15 should also be revised. A very vague concept paper is available which the EMA is requesting comments for. Now we would be interested in finding out what your thoughts are with regard to the planned revision. For that purpose the ECA has prepared a brief questionnaire. Read more.

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