GMP News - Validation

27.03.19

Process Validation - FDA criticises Missing Lifecycle

In a Warning Letter recently published, the FDA addressed deficiencies regarding process validation. What did the FDA discover?

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27.03.19

Is the Sanitization Temperature for Water Systems too high?

The most common method of preventing microbiological contamination in a water system is thermal sanitisation. There are systems in which the pharmaceutical water is stored hot and systems that are heated cyclically to an elevated, germicidal temperature. However, excessive temperatures not only increase costs, they can also damage the materials. Read more here.

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27.03.19

Does Purified Water (PW) have to be tested for Endotoxins?

Within the framework of risk analysis, qualification and preparation of sampling plans for new purified water (PW) systems, the question arises as to whether PW should be tested for endotoxins. Read more here.

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13.03.19

Audit Trail Review required before Each Batch Release?

The topic data integrity generates a multitude of questions. Current questions are answered in a loose sequence of News. Question 2: Is the Audit Trail review required by the authorities before each batch release, or is it only recommended?

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27.02.19

Cleaning Validation under the View of the FDA

With the publication EMA's guideline on Shared and Dedicated Facilities and the revision of Annex 15, the topic of cleaning validation has gained new attention. The PDE concept is now the determining factor. But what about the FDA?

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27.02.19

Monographs on radiopharmaceutical preparations - Revised Guideline

At the beginning of the year, the EDQM published a revised version of its guidelines for the preparation of monographs on radiopharmaceutical preparations. It now includes a new section on method validation.

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09.01.19

Cleaning Validation: What can a Quality Risk Management Approach Look Like?

With the implementation of the ICH Q9 document, risk management has become mandatory in virtually all GMP areas. This also applies to cleaning validation. But what can such a quality risk management approach look like for cleaning validation? The American Society of Testing and Material (ASTM) has recently issued a guideline on a Science-Based and Risk-Based Cleaning Processes Development and Validation. What does the Guide suggest?

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09.01.19

Process Validation: The Impact of Equipment Change

In a previous News you could already read about the cleaning issues at a US-American pharmaceutical company. Now, the Warning Letter issued provides much more information - also with regard to process validation.

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19.12.18

British Regulatory Authority MHRA criticises Cross Contamination Issue

The publication of EMA's "Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities" and the related Q&A documents have given the topic cross contamination a greater importance.

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19.12.18

Cross Contamination: One of FDA's Current Issues

In a current Warning Letter from November 2018, the FDA criticised insufficient cleaning validation and verification at a pharmaceutical manufacturer. They referred to 21 CFR 211.67 (a). What was the reason for this?

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03.12.18

PIC/S gives ECA the Opportunity to comment on PI 041-1 (Draft 3) - Data Integrity

The Pharmaceutical Inspection Co-operation Scheme as international association of pharmaceutical inspectors is currently elaborating a document on data integrity. This document was published for comment on 30 November 2018. Among others, the ECA Foundation has been given the opportunity by the PICS to comment on this third draft by 28 February 2019. Read more about the new draft 3 of PI 041-1 "Good Practices for Data Management and Data Integrity in regulated GMP/GDP Environments".

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03.12.18

British Authority MHRA provides Interpretation on Cleaning Validation

With the introduction of the Permitted Daily Exposure (PDE) values in conjunction with questions on cross contamination and on cleaning validation, the EMA began a new chapter a few years ago. This is a complex issue and it caused uncertainty within the industry. Insofar, the EMA brought a subsequent Q&A document. This is being interpreted by the British Regulatory Authority MHRA with regard to inspection results.

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28.11.18

Qualification of Identical Pieces of Equipment: is a Bracketing Approach acceptable?

Again and again, the question arises as to whether a bracketing approach - i.e. selective skipping of individuals tests - may be used for the qualification of identical pieces of equipment. Can the answer to the question whether or not to skip individual tests be found in Part IV of the EU GMP Guide?

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14.11.18

USP article on pharmaceutical continuous manufacturing

In the latest edition of the Pharmacopoeial Forum 44(6), the US pharmacopoeia USP has published a so-called Stimuli Article on pharmaceutical continuous manufacturing. Apart from important definitions, the document contains further information on material properties and characteristics as well as risk management approaches for continuous manufacturing.

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07.11.18

Current Questions on Validation of Blend Uniformity - Stratified Sampling

Validating blend uniformity is a decisive factor for the validation of solid dosage forms. In Europe, there are no regulatory provisions for this. This is different in the USA: the 21 Code of Federal Regulation (CFR) 211.110 requires the regular assessment of the adequacy of mixing.

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