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.
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.
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?
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.
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.
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 Read more on FDA`s draft Guidance for Industry A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers.
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.
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.
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?
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?
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.
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?
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.
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.