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in this new edition of the Quality Assurance of Aseptic Preparation Services. The NHS Pharmaceutical Quality Assurance Committee works closely with MHRA to maintain equity of standards between licensed and unlicensed units. Patients treated with products made in the NHS in either of these types of unit are entitled to
For aseptic production, the principal equipment is the cleanroom and the laminar airflow hoods (or isolators) installed inside. Initial qualifications of the cleanroom design and filtration system are mandatory. The cleaning and sanitisation of the controlled environment and the validation of its efficiency have become major GMP topics. Routine monitoring of viable and nonviable particle ...
A holistic approach to validation and quality assurance is essential. Understanding the Impact of Annex 1 on Isolator Design. November 03, 2020. An optimal engineering design is crucial for aseptic operation and cleaning. Understanding the Critical Role o ...
As we enter the new year, this is the perfect time to make the 2021 ISPE Aseptic Conference part of your personal professional development plans. The virtual conference will allow participation from across the globe with no risk to pandemic exposure. The three-day format with shorter sessions will...
Automated Systems of Tacoma (AST) is a U.S.-based pharmaceutical machine manufacturer specializing in advanced aseptic filling equipment and packaging machines, and a pioneer in the use of robotics in the fill/finish industry. Its relationship with Stäubli goes back more than two decades. In 2010 ...
Editorial note: This article was written prior to the new FDA Guidance for Aseptic Processing being published. The second part of this article to be published in the near future will reflect the new Guidance recommendations. Article Overview Provide an overview of the critical manufacturing process, aseptic fill/finish production of sterile products. This article is […]
Several new areas are covered in this Guide’s appendices, including knowledge management and instrument devices, and there is an appendix on Computer Software Assurance (CSA) that details CSA key concepts and provides illustrative case studies. “Computer Software Assurance was born from US FDA CDRH’s Case for Quality, which treats compliance attainment as the baseline and promotes the ...
Job Description: The Quality Operations Manager assures compliant manufacturing procedures, equipment, and facilities in the new aseptic manufacturing plant in adherence with cGMP requirements, Quality Standards, and other regulatory requirements. This position is part of the project team designing and building the new aseptic facility. Job Responsibilities: Design of facility, equipment, and ...
In its root causes investigation, the company has indicated issues with the bottle within the filling process—e.g. when the bottle isn’t correctly placed in the filling machine. Several manual interventions in the aseptic process were necessary, whereby defects haven’t always been detected, particularly when cracks occur in the glass bottle under the cap. Moreover, such cracks may ...
During this training course, you will learn about environmental monitoring systems, facility cleaning and disinfection, aseptic cleanroom operations, filtration, sterilization, aseptic process simulation (media fill), and regulatory requirements. Hands-on activities will include gowning qualification, facility cleaning and disinfection, performing aseptic processes in ISO 5 conditions and ...
