GMP News - Validation

08.02.23

Cloud Computing: Are SaaS closed systems per 21 CFR Part 11?

Financial and organizational advantages also speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas: Question 4: Are SaaS closed systems per 21 CFR Part 11?

01.02.23

ICH Q9 Quality Risk Management published as Revision 1

In December 2020, you could already read about the ICH announcement to revise the ICH Q9 Quality Risk Management Guidelines. The final version has now been published.

01.02.23

Cloud Computing: Reasons for choosing the particular Cloud Model?

Financial and organizational advantages also speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 3: What are the reasons for choosing the particular cloud model (private cloud, community cloud, public cloud)?

25.01.23

Risk Analyses do not always help - Example of Cross-Contamination

With ICH Q9 Quality Risk Management becoming effective, risk analyses have become the "magic word" in the GMP environment. But risk analyses do not always help. An example of this can be found in an FDA Warning Letter on the subject of cross-contamination.

18.01.23

USP-NF Stimuli Article on Quality by Design (QbD) Principles in Method Development

In the Pharmacopeial Forum, PF 49(1), a stimuli article entitled "A Novel Approach Using Quality by Design to Develop and Implement Flexible Methods in Non-Application Over-the-Counter Monographs" was published.

18.01.23

Cloud Computing: Cloud Models in the GxP environment

Financial and organizational advantages also speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 2: What cloud models are there and where do they have applications in the GxP environment?

07.12.22

Cleaning in 6th Place in the FDA Warning Letter Statistics

The ECA regularly provides evaluations of the FDA Warning Letters per fiscal year. In 6th place in the fiscal year 2022 (Oct. 2021 - Sept. 2022) are deficiencies regarding the topic of cleaning/cleaning validation. What was found?

30.11.22

Revision of the EU GMP Guide Annex 11 "Computerised Systems" - Presentation of Concept Paper

The current EU GMP Annex 11 "Computerised Systems" was published in 2011. Due to new technological and regulatory developments, a forthcoming revision of Annex 11 has been discussed for some time. On 16 November 2022, the EMA published a concept paper for public comment. Which points are to be revised?

15.11.22

Temperature Mapping for the Qualification of Storage Areas

In the Pharmacopeial Forum, PF 48(5), a stimuli article entitled "The Use of Temperature Mapping for the Qualification of Storage Areas for the Proper Temperature Storage of Drug Products" was published.

09.11.22

Cloud Computing: What is the meaning of Iaas / PaaS / SaaS / XaaS?

Financial and organizational advantages also speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 1: What is the meaning of IaaS / PaaS / SaaS / XaaS?

02.11.22

FDA Warning Letter for Chinese OTC Hand Sanitizer Drug Products Manufacturer

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Chinese manufacturer. The FDA blames the company in question for a whole series of GMP violations, including to identity testing, cleaning and maintenance of equipment, microbial testing and QU oversight.

19.10.22

How to react to Deficiencies after an FDA Inspection?

GMP deficiencies are often identified during FDA inspections. Responding to an FDA deficiency report is important, otherwise a Warning Letter may be issued. But how should one respond?

12.10.22

Manufacturing medicinal and non-pharmaceutical Products on the same Equipment - is that possible?

Is it possible to manufacture medicinal and non-pharmaceutical products on the same equipment? The FDA objects to this manufacturing practice.

14.09.22

FDA Requirements for the "Worst Case" Product during Cleaning Validation

Bracketing approaches are certainly allowed in the context of cleaning validation. First, for the products themselves, so that a "worst case" substance can be used for validation, second, for devices of the same design, the effort can be reduced by bracketing. In this way, a device can be selected. So how to define these "worst cases"? Read more here about FDA's view on this.

07.09.22

Guidance for Industry on the Topic of Cross-Contamination

The topic cross-contamination is very important in the GMP environment. For example, Chapter 5 of the EU GMP Guide was adapted in this regard a few years ago. Annex 15 also paid more attention to the topic with the 2015 revision. However, the topic is also an issue in the USA.

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