The updating of two important documents by the EDQM reflects the current practice of the CEP procedure. Read more about the competencies and responsibilities of the various bodies in the CEP application procedure and about the code of practice for assessors and inspectors.
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.
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 on the topic.
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?
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.
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.
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.
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.
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?