Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient. Extractables and leachables (E&L) studies therefore play an important role in verifying the safety of a drug product over its lifetime.
Regulatory organisations such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are taking an increased interest in the interactions of various drug delivery devices, pharmaceutical product containers and medical devices with drug product and/or patient and this field is therefore growing in importance.
Regulatory guidelines indicate that an extractables profile should be determined for all materials that contact the drug product. Once established, this profile can be used to determine whether any of these extractables are present as leachables within the product. If a leachable is detected, amounts can be determined using validated analytical methods, after which a biological risk can be established based on the exposure.
This white paper will provide an overview of the processes used to determine extractables and leachables from plastics.
Cross contamination must be avoided in the Pharmaceutical industry at all costs and successful cleaning validation ensures that patients are not put at risk due to cross contamination.
The process can be divided into a number of sections each of which must be fully understood and areas of concern addressed to ensure a successful outcome across the entire process. This spans both the manufacturing and subsequent analytical and microbological support.
The data used to confirm a positive/successful cleaning validation is underpinned by the results of validated analytical methods. It is essential that these results are truly representative as patient safety is based upon the absence of equipment residues.
So what are those areas of concern, what affects your ability to get a successful outcome and what do you need to consider when carrying out a Cleaning Validation exercise?
The development and validation of suitable analytical methods is a critical part of the overall drug-development life-cycle. For the majority of products, particularly those that are clinically successful, the transfer of the analytical method between laboratories will be required. This process is designed to verify that a given laboratory is capable of performing a test method for its intended purpose. This can be performed either internally (at the same company), or, with the on-going increasing trend in outsourcing, to an external Contract Research or Development organisation (CRO or CDO).
With upcoming changes, including the implementation of the International Conference on Harmonisation (ICH) E2B(R3) Electronic Transmission of Individual Case Safety Report and Identification of Medicinal Products (IDMP) standards, the current state of safety reporting can be confusing. Your existing safety system may not be flexible enough to accommodate these changing regulations, which are still moving targets regarding the details needed for a comprehensive solution with the right level of processes, company-to-company integrations and finalized regional rules.
Because a key step towards database lock is obtaining clean data for all patients, the ability to verify that data are clean early accelerates the ability to lock the clinical database. This ultimately shortens the overall study timeline while ensuring the quality of your data. However, this can be challenging when manually reviewing study data, particularly with larger studies.
Process characterization is an essential step in the commercialization of a new (biological) drug. For drug product commercialization, manufacturers must validate the drug’s manufacturing process. This ensures that the manufacturing process delivers consistently a quality product and that the patient is not at risk.
This paper presents highlights from a thermal performance study conducted by Modality Solutions LLC. The study examined the performance of five shipping technologies commonly used by specialty pharmacies to transport high-value refrigerated specialty medicines against an industry accepted temperature profile standard.
The specialty pharmacy industry could reduce costs by $27.5 million annually (product and call center staff costs only) if visual temperature indicators were used as decision-making tools to determine if medicine should be used or returned when patients suspect heat damage. In addition, 97% of patients surveyed, who received medicine from specialty pharmacies with a visual temperature indicator included in the package, agree that they would want an indicator in all shipments and 95% agree the indicator increased their confidence in the medicines received.
Cheshire Business Awards 2018: Technoprint Cheshire Ltd. wins Corporate Social Responsibility Award
Technoprint has prided itself on being a socially responsible organisation since it was founded in 1988. Winning the Corporate Social Responsibility award is a real testament to their ethos and shows that hard work and making a difference to the local area really does make an impact in the long term, internally and externally. More info >>
Modifying MDI Canister Surfaces to Improve Drug Stability & Drug Delivery
Presspart Manufacturing Ltd
Hydrofluoroalkane (HFA)-based propellants are widely used in modern metered-dose inhalers (MDIs), due to their lack hazardous and environmentally-damaging effects. However, an HFA's active pharmaceutical ingredient can interact with the canister substrate, causing deposition of the drug to the canister walls, or interact with the solution, causing degradation and resulting in increased impurity levels. Over the past few years, a number of surface coatings have been developed that can be applied to MDI canisters and valve components, to protect the contents from deposition and degradation. More recently, plasma processes have been developed to modify and improve the surface energy performance of a MDI canister. This approach has a number of advantages to alternative coatings but requires careful optimisation to ensure the highest quality finish and MDI performance. Richard Turner, Business Development Director, Presspart Manufacturing Ltd, explains. More info >>
Cell Therapy Manufacturing & Gene Therapy Congress
4-6 December 2018, RAI, Amsterdam
Bringing together 300+ leaders and key influencers from
pharma and biotech companies on 4 - 6 December 2018 in Amsterdam, Cell Therapy
Manufacturing & Gene Therapy will provide you with the latest advice for
transforming innovative research to prosperous cell & gene therapy
manufacturing. More info >>
