pharmaceuticals
18
Issue 6 2019
Metrohm’s NIR software exceeds data integrity requirements
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ata integrity in the context of laboratory analytics is a must, particularly in regulated environments. However, how is data integrity exactly defined, and what are the software features required to achieve it? A new Metrohm white paper answers these questions based on examples from modern NearInfrared Spectroscopy (NIRS) Software. Data integrity is commonly defined by a number of properties, which are summarised by the acronyms ALCOA and ALCOA+, respectively. Hence, ALCOA stands for ‘attributable’, ‘legible’, ‘contemporaneous’, ‘original’ and ‘accurate’, while ALCOA+ extends these attributes by the properties ‘complete’, ‘consistent’, ‘enduring’ and ‘available’. The present white paper explains these properties in detail and gives examples for each of them based on Metrohm’s NIRS software Vision Air. From the present white paper, a clear picture emerges of the functionalities that state-of-the-art laboratory software should provide in order for laboratories to safeguard the integrity of their data and comply with, for example, the requirements of FDA 21 CFR Part 11. At the same time, the present white paper emphasises that compliant-ready software such as Vision Air can only provide a solid base to achieve data integrity and does not spare companies from establishing a solid framework of standard operating procedures.
Waters data integrity solutions for your lab D ata integrity is a key element in the pharmaceutical industry and companies have to ensure that end products meet the required quality standards. Data integrity refers to the overall completeness, accuracy and consistency of data and processes during their entire life cycle. Though this seems simple, the whole process of generating, maintaining and transforming data with completeness and accuracy is a challenging task for any organisation. Data integrity addresses the ‘life cycle of data’. This includes the steps involved in setting up and running the analyses, as well as managing the data that is collected, both raw chromatographic data, but more importantly through the cycle of processing, interpreting, reviewing, reporting and managing that data. So, it is not only a concern about how to store data, as the generation through analytical experiments is equally as important. Laboratories need to have confidence in the quality of their results and the methods used to generate those results. Many customers use Waters’ consumables, instruments, software, and services in regulated environments. Waters
experts have years of experience supporting these customers to ensure their laboratories meet regulatory expectations, such as Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs) and Good Clinical Practices (GCPs) from health authorities across the globe. Specifically, informatics specialists have developed
expertise in the expectations regarding management of electronic data to meet those regulations, for example 21 CFR Part 11, EU Annex 11 and PIC/s Annex 11, plus regulatory and industry guidelines. Electronic data and computerised systems introduce new challenges to maintaining data integrity. Waters chromatography systems and informatics software address these specific concerns and challenges when demonstrating data integrity to an auditor or regulator. Audit trails are considered the key to the security of a system since they track changes to data and metadata. Waters’ Empower chromatography data software (CDS) platform assists with audit trails and logs, which are important to reviewers. Waters Compliance Services can simplify the process of qualification, validation and record-keeping so that your business can focus on delivering products to market. MICROSEP (PTY) LTD Louis van Huyssteen Tel: (011) 553 2300 Fax: (011) 553 2400 louis.vanhuyssteen@microsep.co.za www.microsep.co.za
Humidity validation and compliance in food and pharmaceutical manufacturing
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ecause the control of humidity is vital for many processes in pharmaceutical manufacturing, there are a large number of probes in use at any time - all of which will need to be regularly calibrated to ensure accuracy. Sending RH probes away for calibration is a time-consuming exercise for both food and pharmaceutical companies, but is often seen as necessary, because creation, modification, archival, retrieval and transmission of electronic records is an essential business practice. Simple on-site validations While many companies opt to set up their own in-house humidity calibration laboratories, this is not an option for all
manufacturers because of the capital expense and resources needed to manage it. However, there are affordable alternatives. Instrotech offers Michell Instruments, a cost-effective humidity validator that gives food and pharmaceutical companies the option to save time and money on recalibrations, paying back the cost of the instrument in a few months. The HygroCal100 is unique in its class. As well as being completely portable, it has data-logging and documenting capabilities. It is extremely easy to use and inexpensive to maintain. For full, traceable calibrations, it can be used in combination with a chilled mirror reference hygrometer. Although any hygrometer can be used, Michell offer the HygroCal100 and Optidew
Vision as a complete package for fully documented, traceable calibrations. The HygroCal100 is compatible with any analogue probe with mA or voltage outputs: this includes most brands on the market today. Up to seven probes can be validated at a time, and users can choose to operate manually or use an automated programme.
INSTROTECH Tel: (101) 1595 1831 sales@instrotech.co.za www.instrotech.co.za
METROHM SA (PTY) LTD Tel: (011) 656 1918 CPT: (021) 852 0213 DBN: (031) 265 0067 Fax: (011) 656 2698 078 643 7113 info@metrohm.co.za www.metrohm.co.za
Procarta awarded £7.4m for microbial treatment
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iotechnology company Procarta Biosystems will receive up to £7.4 million to develop a new class of antibiotics in the fight against antimicrobial resistance. The company, which has discovered a new type of antimicrobial that kills bacteria by blocking their gene expression, was awarded the funding by CARB-X, a global partnership dedicated to accelerating early antimicrobial R&D. Procarta Biosystems CEO, Dr Andrew Lightfoot, says, “This new award from CARB-X recognises the value of the novel modalities in our pipeline and their potential to precipitate a paradigm shift in antimicrobial treatments.”
The company’s new antibiotics are founded on its oligonucleotide-based antimicrobial platform and will target potentially life-threatening infections caused by the five ESKAPE pathogens that are commonly associated with AMR. Its PRO-202 drug is in preclinical development to treat complicated urinary tract infections (cUTI) and complicated intra-
abdominal infections (cIAI), which are both caused by the ESKAPE pathogens. Specifically, PRO-202 targets Enterobacteriaceae (CRE) strains of bacteria that are resistant to carbapenem, a class of antibiotic used to treat severe infections. Procarta Biosystems - which is based across Norwich Research Park and Stevenage Bioscience Catalyst - will be funded partly by the UK government’s Global AMR Innovation Fund. Its other existing investors include UKI2S, Wren Capital, Meltwind and Morningside. Boston University-led CARB-X is investing up to $500m from 2016 to 2021 to support development of innovative antibiotics. https://www.labnews.co.uk/ article/2030063/procarta-awarded-7-4mfor-microbial-treatment
