GMP News - Validation

31.07.19

WHO publishes Draft Guideline on Production of WFI using Non-Distillation Methods

The WHO has reacted to the changes in the European Pharmacopoeia by issuing a draft guideline on the production of WFI (Water for Injection). The commentary phase is open to the public, comments can be submitted until 20 September 2019.

26.06.19

Deletion of Data: Does it have to be regulated in a SOP?

The data integrity topic raises a number of questions. Current questions are addressed in a loose sequence of News. Question 4: Does the deletion of data have to be regulated in a SOP?

05.06.19

cGMP Cleaning Validation - FDA's Current Requirements

What do authorities require regarding cleaning validation? Official GMP inspection reports deliver helpful answers to this question. Through the Freedom of Information Act, the FDA is required to publish inspection results. This is particularly the case with Warning Letters. Here, even details of deficiencies regarding cleaning validation are included in the Warning Letter.

22.05.19

Recent GMP defects in process validation

What are the authorities' requirements regarding process validation? Regulatory GMP inspection reports are useful in answering that question. The "Freedom of Information Act" obliges the US FDA to publish all inspection results. The FDA does that particularly when it comes to warning letters.

08.05.19

Ensuring the data integrity of cloud service providers

The topic data integrity generates a multitude of questions. Current questions are answered in a loose sequence of News. Question 3: What agreements need to be included in contracts with cloud service providers in order to ensure data integrity?

17.04.19

Critical Process Parameters and Process Validation

Regulations require that the critical process variables should be included in validation. This has been recently confirmed again by the FDA in a Warning Letter.

10.04.19

What does the FDA expect from Cleaning Validation today?

FDA's regulations regarding cleaning validation are now relatively old. A GUIDE TO INSPECTIONS VALIDATION OF CLEANING PROCESSES dates back to the early 90s. In this context, Warning Letters show the "current thinking" of the FDA.

04.04.19

Monitoring of Clinical Investigations: FDA´s Q&As on Data Integrity

The FDA provided additional guidance on risk-based monitoring for effective oversight, including Data Integrity. Read more on FDA`s draft Guidance for Industry A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers.

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?

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.

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.

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?

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?

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.

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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ICH Q7 Compliance for APIs Manufactured by Cell Culture/Fermentation

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GMP News - Validation

WHO publishes Draft Guideline on Production of WFI using Non-Distillation Methods

Deletion of Data: Does it have to be regulated in a SOP?

cGMP Cleaning Validation - FDA's Current Requirements

Recent GMP defects in process validation

Ensuring the data integrity of cloud service providers

Critical Process Parameters and Process Validation

What does the FDA expect from Cleaning Validation today?

Monitoring of Clinical Investigations: FDA´s Q&As on Data Integrity

Process Validation - FDA criticises Missing Lifecycle

Is the Sanitization Temperature for Water Systems too high?

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

Audit Trail Review required before Each Batch Release?

Cleaning Validation under the View of the FDA

Monographs on radiopharmaceutical preparations - Revised Guideline

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

Recommended Event

ICH Q7 Compliance for APIs Manufactured by Cell Culture/Fermentation Part of the ICH Q7 Training Courses 2022

GMP News - Validation

WHO publishes Draft Guideline on Production of WFI using Non-Distillation Methods

Deletion of Data: Does it have to be regulated in a SOP?

cGMP Cleaning Validation - FDA's Current Requirements

Recent GMP defects in process validation

Ensuring the data integrity of cloud service providers

Critical Process Parameters and Process Validation

What does the FDA expect from Cleaning Validation today?

Monitoring of Clinical Investigations: FDA´s Q&As on Data Integrity

Process Validation - FDA criticises Missing Lifecycle

Is the Sanitization Temperature for Water Systems too high?

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

Audit Trail Review required before Each Batch Release?

Cleaning Validation under the View of the FDA

Monographs on radiopharmaceutical preparations - Revised Guideline

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

Recommended Event

ICH Q7 Compliance for APIs Manufactured by Cell Culture/Fermentation Part of the ICH Q7 Training Courses 2022

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