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Microbiological contamination of non-sterile medicinal products is an infrequent, but longstanding and recurring issue. But there is no ‘one size fits all’ approach towards objectionable organisms, says David Elder...
A thorough understanding and control of extractables and leachables in liquid and semi-solid products has long been a regulatory requirement.1,2 Regulatory guidelines require that product contact surfaces are “not reactive, additive or absorptive”.3
References Fujiwara M, Nagy ZK, Chew JW, Braatz RD. First-principles and direct design approaches for the control of pharmaceutical crystallization. J. Proc. Control. 2005;15:493-504. ICH M7, 2014. Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk. Current Step 4 version. 23 June 2014. Teasdale…
Biologically-derived drugs, such as proteins, peptides and monoclonal antibodies (mABs), are playing an increasingly important role in global healthcare. It was recently reported that mAB therapeutics sell for over $50 billion globally. However, one of the major downsides of biological therapeutics is their significantly greater costs compared with small molecule…
Globalisation has facilitated greater international harmonisation and standardisation of quality standards, which in turn has impacted on pharmacopoeias1. Historically, general chapters were developed based on input from local regions with little concern for global consequences. This often led to the development of similar, but unidentical tests, for example, Residue on…
Historically, dissolution testing has been used primarily as a quality control (QC) test for solid oral drug products1. Indeed, it is the only QC test which provides a measure of the quantitative release rate of the drug from the pharmaceutical product. More recently, the test has been proposed in lieu…
One of the principle objectives of the Internal Conference on Harmonisation (ICH) initiatives was to introduce harmonised approaches, prevent duplication and eliminate wasteful and unnecessary testing. Although good progress was made initially, there was evidence that certain countries, regions and trans-national organisations were unhappy with some of the proposed harmonised…
Historically, the regulation and control of medicinal products has relied on national and supranational guidelines covering good manufacturing practice (GMP). However, the quality of these medicinal products can be adversely affected by a lack of adequate control over the myriad activities that occur during the distribution process. In addition, the…
Maintaining the security of the supply chain for drug products is a significant responsibility to ensure the sustained availability of safe medicines...
The World Health Organisation (WHO) in 2010 described counterfeit medicines as those which are “Deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active…
Cocrystals can help to address the manufacturability (flow, compaction, processability) as well as solubility/dissolution,hygroscopicity and stability properties of an active pharmaceutical ingredient (API).
Crystallography is the science underpinning crystallisation, as well as a basic understanding of atomic arrangement within solids and their resulting structures. The United Nations announced that 2014 would be the International Year of Crystallography (IYCr2014). IYCr2014 commemorates the 100th anniversary of X-ray diffraction according to Bragg’s Law (celebrated by the…
Analytical method specificity is assessed using ICH (International Conference on Harmonisation) Q2 (2005). Although, certain methods are not specific enough for their intended purposes, they may have other advantages. Both titrimetric and UV (Ultra-violet spectroscopy) assays are non-specific, but have superior precision (ca. 0.1-0.5% RSD (Residual Standard Deviation)) compared with…
An effective quality risk management (QRM) process ensures proactive identification and control of potential issues that may arise during development and commercialisation. Where quality is defined as the degree to which a set of intrinsic properties of a drug product, its underpinning manufacturing process, and any supporting processes fulfils the…
An effective quality risk management (QRM) process provides a key mechanism for the proactive identification and control of potential issues that may arise during product development and subsequent commercialisation1. In this context, risk is defined as the combination of the probability of occurrence of harm (or unwanted outcome) and the…
