New FDA guidance on Child-Resistant Packaging

The FDA published a new guidance on Child-Resistant Packaging (CRP). The guidance is intended to assist applicants, manufacturers, packagers, and distributors who include CRP statements in their drug product labeling.


No more FDA Inspections in the EU - really?

The Mutual Recognition Agreement (MRA) between the EU and the US is now in force as planned. But does this really mean the end of all FDA Inspections in the EU?


Warning Letter due to Cross Contamination

In August, the US FDA issued a Warning Letter due to cross-contamination with penicillin in areas for non-beta-lactam production.


New Ph. Eur. chapter on statistical process control (SPC) planned

Process controls have become customary in pharmaceutical processes. The aim is to monitor a process and improve it if possible. Statistical process control (SPC) is viewed as one option to implement Ongoing/Continued Process Verification. PharmEuropa has now published a new draft chapter in the topic.


GMP for Radiopharmaceuticals - WHO/IAEA Guideline open for comments

In July, the WHO and the IAEA published a draft guideline for the specific GMP requirements for the manufacture and control of radiopharmaceuticals, which can be commented until 20 September.


No Documentation in the Inspection? Not a good Idea!

A company in China has created GMP documents only for the purpose of inspection. With serious consequences.


Media Fill and Aseptic Behaviour in Focus of FDA Warning Letter

Significant deficiencies in the pharmaceutical quality management system led to a Warning Letter to the American company Akorn. What deviations in media fill and aseptic behavior were detected in the inspected company?


Track & Trace: Still ongoing issues

It has hardly worked out anywhere: the falsification protection project has not been properly adapted EU-wide and discontentment is spreading amongst pharmacists.


USP Packaging Standards

The USP´s General Chapters—Packaging and Distribution Expert Committee provided an overview of USP´s current packaging standards-strategy in the curent issue of Pharmacopeial Forum. The stimuli article covers USP general chapters related to the suitability for use for materials of construction including plastics and elastomers.


EMA publishes first two Guidances on Drug Shortages

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) published two guidance documents which can be seen as foundation for a long way to diminish shortages of medicinal products.


Fundamental GMP Deficiencies at US-American Pharmaceutical Manufacturer

During the inspection of a pharmaceutical manufacturer in the USA, the FDA discovered fundamental GMP deficiencies which concern - among other things - cleaning of equipment, cleaning validation, the water system and the stability programme.


What are suitable Cycles for Re-Qualification?

With the revision of Annex 15 in October 2015, the topic of requalification has become more important. Time intervals for the assessment of the equipment with regard to the qualification status and for the requalification itself should be justified. Criteria for the assessment should be defined. This is sometimes difficult. Chapter 9 of the revised ISPE Baseline No 5 Commissioning & Qualification of June 2019 on the periodic review can be helpful here.


Scale Calibration: Requirements of the FDA

The GMP regulations do not provide any concrete specifications for the calibration of weighing instruments. They refer to suitable measuring and weighing ranges and the required accuracy. Regular maintenance and calibration are also required.  So how can these general formulations be interpreted?


New Defect Evaluation List for Rubber Parts

The brand new and completely revised and enlarged 2019 edition of the Defect Evaluation List for Rubber Parts has been published.


Warning Letter for Indian Sterile Manufacturer

Indian sterile manufacturer Emcure Pharmaceuticals has once more received a warning letter from the FDA with concerns to the root cause analysis of deviations in sterility testing.


Analytical Quality by Design: MHRA´s Questions and Answers

In order to encourage stakeholders to take the opportunity to send comments on the application of AQbD to pharmacopoeial standards, the MHRA provides some Questions and Answers.


Medical Devices Warning Letters Statistics for the first half of Fiscal Year 2019

In both years 2017 and 2018 (period from October 1 to September 30), we reported a noticeably low number of Warning Letters. This seems to go on in 2019.


FDA's Answers to questions on GMP-compliant Chromatography in the Quality Control Laboratory

The FDA has clear expectations about cGMP compliance in an analytical laboratory. Read more about what the cGMP-compliant running of chromatographic systems in a quality control laboratory should look like.


What is a Combination Product?

The FDA released a final guidance on postmarketing safety reporting for combination products to further clarify what a combination product is and how applicants can comply with the rules on postmarketing safety reporting requirements (PMSR).


Warning Letter due to Deficiencies in the Purified Water System

In June, a US-American pharmaceutical manufacturer received a Warning Letter from the FDA due to deficiencies in the Purified Water System which concern - among other things - the design of the water system, monitoring, sampling and handling of CAPAs.


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