GMP News - Validation


Interpretation of 21 CFR 211.67 Cleaning of Equipment

The US-American GMP regulations for medicinal products are laid down in 21 CFR 211. Section 21 CFR 211.67 requires the establishment of and adherence to written instructions regarding the cleaning and maintenance of equipment. What is exactly meant by this?



Validation of Mixing Uniformity also required for Active Ingredients

The issue of mixing uniformity has been a validation-required topic in the field of solids for years. This is even explicitly required in the US regulations (21 CFR 211.110). In a recent Warning Letter, requirements for the mixing uniformity of an active ingredient were also addressed. What did the FDA criticise?



Accuracy, Specificity and Reproducibility of Analytical Test Methods in the Focus of a FDA Warning Letter

The U.S. Food and Drug Administration (FDA) has issued a warning letter to an American manufacturer of OTC drug products. Among others, the analytical test methods had not been validated for accuracy, specificity, and reproducibility. Further violations concern the process validation and OOS investigations.



FDA Warning Letter: Deviation from USP Compendial Methods

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to an American manufacturer. The firm produces a United States Pharmacopeia (USP) article. The core problem was that the company deviated from the USP for analytical testing, but could not adequately demonstrate that the method is equivalent or better than the current USP compendial method.



New FDA Draft Guidance "Cybersecurity in Medical Devices"

On 8 April 2022, the FDA published a new draft guidance "Cybersecurity in Medical Devices..." to replace the previous guidance from 2014. Why did the FDA publish this draft?



FDA Warning Letter: Testing into Compliance using Unvalidated Test Methods

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to an American drug manufacturer. The company retested failing lots with unvalidated test methods until passing results were obtained. Other deficiencies concern the cleaning validation, the stability program and HPLC data integrity.



Product Transfer: Is a Transfer Plan a required GMP Document?

A frequently asked question in courses on product / technology transfer is: Is a transfer plan a required GMP document?



Process Validation Deficiencies from the FDA's Perspective - Statistics for Fiscal Year 2021

In our News on FDA Warning Letter Statistics for the fiscal year 2021 (October 2020 - September 2021) you could read that deficiencies for process validation are on place 5. But what deficiencies did the FDA find in process validation?



Remote Data Acquisition in Clinical Trials

The FDA provides recommendations for sponsors, investigators, and other interested parties on the use of digital health technology for remote data acquisition in clinical trials. What is required regarding software validation and electronic documents?



Turning Nasal Drops into Eye Drops - not a good Idea from the FDA's Point of View

In a Warning Letter, the FDA criticises eye drops from a Chinese manufacturer for not being manufactured under sterile conditions. The manufacturer argues that it made the eye drops under non-sterile conditions as nasal drops. Of course, the FDA did not accept this argumentation. Citing the FDA Aseptic Guide, the Warning Letter shows what the FDA considers to be the state of the art in aseptic manufacturing.



Draft revision of ICH Q9 Quality Risk Management Guideline published

Since 2005 at the latest, the topic of quality risk management has dominated almost the entire GMP sector. At that time, the corresponding ICH Q9 guideline was published as "Step 4". Now the draft of a planned revision has been published. What could be in store?



Cleaning Validation from the FDA's Point of View

The requirements for cleaning validation are not very clearly defined in the US GMP regulations 21 CFR 210/211. Even a Guide to Inspection on this topic dating back to the 1990s does not represent the FDA's current interpretation. Current Warning Letters on the subject of cleaning validation are helpful here.



FDA Warning Letter: Combination of Returned Capsules from Various Lots into New Batches

The U.S. Food and Drug Administration (FDA) has published a Warning Letter to a Californian drug manufacturer. During an inspection, it was observed that the firm combined returned capsules from various lots into new batches, resulting in new lots with no uniform character and quality. The FDA also criticizes the firm’s stability programme and validation activities.



Results Survey Remote Factory Acceptance Tests (Remote FATs)

Due to the Covid-19 pandemic personal presence of pharmaceutical customers at the supplier site has generally been reduced or even become impossible - especially for FAT. So “remote-FATs” came up more and more in the last year and are still used. But how successful are such remote FATs? What are the problems showing up? This was something we wanted to find out from you, to get an overview - and therefore a survey was set up. Find out what the survey results were.



IT Infrastructure in GMP Inspections

The validation of computer-based systems is a regular part in GMP inspections. In this context, the IT infrastructure has also become an important topic. Read more about the regulatory requirements and deficiencies in inspection practice.


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