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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.
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…
15 December 2013 | By Christos Georgakis, Department of Chemical and Biological Engineering and Systems Research Institute for Chemical and Biological Processes, Tufts University and Gregory M. Troup, Merck Research Laboratories, Merck & Co., Inc
Process Systems Engineering (PSE) has had a profound impact in the chemical, petroleum and petrochemical industry in the last 30 - 40 years. Even though PSE has already started to make a significant impact on the pharmaceutical industry, there are substantial additional benefits that can be derived. The purpose of…
The International Conference on Harmonisation (ICH) guideline for the Validation of Analytical Procedures (ICHQ2(R1)) currently covers validation procedures for the four most common analytical tests: identification tests, quantitative tests for impurities, limit tests for the control of impurities and quantitative tests for the active moiety(ies) in APIs (active pharmaceutical ingredients)…
10 January 2009 | By Martin Warman, Director, MWC Ltd
As the industry approaches the five year anniversary of the ground breaking regulator initiatives (the ‘PAT framework' and ‘cGMPs for the 21st Century'1,2), it is time to assess the impact they have had on the industry and to look forward to what the industry may look like in another five…
23 November 2007 | By Steve Simmons, Head of Process Knowledge QbD, Wyeth Pharmaceuticals
ASTM Committee E55 formed in April of 2003 as a result of FDA’s GMPs for the 21st Century Initiative and the subsequent Guidance, “PAT – a framework for innovative pharmaceutical manufacturing and quality assurance.” Focusing on process understanding and flexible manufacturing, FDA encouraged the pharmaceutical industry to utilise the consensus…
