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Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorisation and licensing for manufacture and sale of drug products and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.
Tecan’s range of advanced liquid handling solutions will soon be enhanced with the introduction of the new Fluent® Gx Automation Workstation*, designed specifically to meet the stringent needs of clinical and regulated laboratories...
New from Watson-Marlow Fluid Technology Group (WMFTG) is the Flexicon PF7 peristaltic tabletop aseptic liquid filling machine optimised for operation in GMP regulated industries such as biotechnology, pharmaceutical and diagnostics...
In this in-depth focus: Non-contact single cell adhesion and micromechanical property characterisation with ultrasound. Is high resolution mass spectrometry the missing piece in continuous bioproduction? Regulatory, clinical and logistics challenges of ATMPs in clinical research...
Scale-up and manufacturing strategy for insect cell culture (ICC) should be assessed at the earliest stages of process development. Your final goals will shape the process and determine at what stage to implement steps that can make the process more reliable and robust at manufacturing scale. Sharyn Farnsworth, Associate Principal…
New ISPE guidance provides a scientific, risk-based approach for managing cross-contamination risk within shared facilities ...
In Issue #3 2017: In-Depth Focuses covering Raman Spectroscopy, Separations & Purifications, Formulation Development & Delivery; Guide To Testing Services; GMP and mutual recognition; Regulatory Insight; RMMs; Microbiology Series; and much more...
19 January 2017 | By Particle Measuring Systems
ISO 14644-2:2015 is not only a new standard with which to be compliant, but is also a beneficial tool to use in achieving mature cleanroom environmental control. This webinar provides a review of the changes and how they affect your environment monitoring...
3 November 2016 | By Wickham Laboratories Limited
Wickham Laboratories will be on Stand 8 at the 24th Annual Pharmig Conference in the Nottingham Belfry Hotel, November 16th & 17th...
20 October 2016 | By Wickham Laboratories
Wickham Laboratories reports a successful completion of the FDA auditing process with renewal of GMP accreditation....
The manufacture of sterile medicinal and therapeutic products increasingly calls for aseptic processing using barrier separation technology comprising isolators and restricted access barrier systems (RABS) that have glove-sleeve systems.
23 September 2016 | By CI Precision
Global consumer goods group RB (formerly known as Reckitt Benckiser) is implementing CI Precision’s MES solution (Ci-DMS) in the dispensing area at their manufacturing plant in Pakistan...
16 December 2015 | By Quotient Clinical
Quotient Clinical, the Translational Pharmaceutics® company, has announced that it has acquired formulation development specialist Co-Formulate Limited...
16 October 2015 | By David Shore, Pfizer
Counterfeit medicines pose a serious risk to public health around the world. The trade in fake drugs is considerable; according to Pfizer’s own company records, more than 200 million counterfeit doses of Pfizer product have been intercepted since 2004. Meanwhile, the issue of counterfeits has no single or simple solution…
Maintaining the security of the supply chain for drug products is a significant responsibility to ensure the sustained availability of safe medicines...
28 October 2014 | By James L. Drinkwater, F Ziel Head of Aseptic Processing Technology/GMP & Chairman of Pharmaceutical and Healthcare Sciences Society
Control strategies are often implemented when developing drugs and manufacturing biological and therapeutic products, however, increasingly they are considered important in the manufacture of sterile medicines. A control strategy for manufacturing sterile pharmaceutical products and substances sets out a documented approach and rationale taken to control product quality, efficacy and…
