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Pharmaceutical Manufacturing and Packing Sourcer

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Few would argue with the need for pharmaceutical businesses to follow safe and proven quality assurance procedures. To this end, companies have been operating traceability systems and keeping records founded on good manufacturing practice (GMP) and good distribution practice (GDP) for a number of years. More recently, as automated monitoring and recording systems have become more commonplace, 21 CFR Part 11 has been introduced and provides appropriate guidelines for the application of electronic record keeping and signatures. Effectively, 21 CFR Part 11 defines the criteria under which electronic records and electronic signatures are considered to be trustworthy and reliable. MHRA guidelines share many of the safeguards.

Temperature and humidity have always been important factors in the pharmaceutical industry, but never more so than now. Levels in key areas, such as laboratories, cold stores, chill rooms, incubators, test chambers, production processes and storage areas need to be regularly monitored and procedures put in place to establish corrective actions if they move outside pre-set limits. Documents, together with complete and comprehensive records, need to be kept and electronic systems need to comply with necessary guidelines.


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Andy Wallace was educated at Staffordshire University and has a degree in Electrical and Electronic Engineering. He worked for British Aerospace before joining Comark and has over 15 years’ experience working in the test and measurement industry. He has progressed within Comark from Service Engineer through to Technical Services, before being appointed Product Manager and taking responsibility for the complete product range eight years ago. His current role involves identifying market requirements and liaising with development engineers to provide cutting-edge technical solutions for temperature and humidity monitoring.
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