The DPT library of white papers focus on topics related to drug development, pharmaceutical manufacturing and packaging for semi-solid and liquid dosage forms.
Effective Controlled Substances Supply Chain Management: What You Need to Know to Ensure Compliance and Optimize Efficiency
Controlled substances are highly regulated and must be vigilantly monitored from the laboratory to the marketplace to prevent theft and illicit sale in the black market, a growing trend. In 2011 there were 36 cases of pharmaceutical cargo theft in the United States at an average value of more than $500,000 per incident. Abundant federal and state regulations, plus increased globalization – with its stringent import and export restrictions, permits and declarations required for controlled substances – has made compliance even more challenging. Partnering with a contract development and manufacturing organization (CDMO) experienced in supply chain management of controlled substances, from Schedule II and III through to V, can prevent costly delays, steep penalties for regulatory noncompliance, and the potential postponement of a clinical trial.
Ensuring Quality & Regulatory Compliance when Collaborating with a Service Provider
With the FDA’s heightened focus on safety, regulatory agencies are increasing their presence in the manufacturing arena to ensure current Good Manufacturing Practices (cGMP) are top of mind, and sponsors are placing greater responsibility for meeting cGMP requirements onto their outsourcing partners. Regulatory compliance starts with choosing the right contract pharmaceutical manufacturing partner but the real work begins once a deal is in place. A quality agreement between a CDMO and sponsor is the starting point for cGMP compliance, after which a transparent, metrics-driven focus on continual improvement is needed.
Ensuring a Streamlined Approach for Nasal Spray Product Development & Manufacturing
Because the efficacy of the drug product depends on the ability of the spray device to deliver reproducible plumes and uniform dose content, some aspects of nasal spray development are unique such as formulation, container closure system, plume characterization, manufacturing and stability testing. Therefore, these aspects need to be carefully considered during the drug development program. Working with a CDMO that understands FDA guidance on nasal spray testing can help accelerate the CMC aspect of regulatory submissions.
Key Steps to Consider When Working with a CDMO to Identify Optimal Packaging Options
There are many factors to take into consideration when selecting or designing a pharmaceutical packaging and drug delivery component. Steps involved during the initial stage of the process are extremely important in ensuring that the most optimal packaging is identified. Working with a CDMO early in the process helps eliminate costly packaging problems that may arise after the drug development stage.
CDMO Best Practices
Industry reports identify a growing competitive landscape internationally, which has created a greater demand for outsourced services; but how does one find a CDMO with the appropriate capabilities, expertise, readiness and proven ability to transition from concept to commercialization? This white paper provides key elements to consider when selecting a CDMO partner for contract drug development and manufacturing. By understanding these elements companies can save time and money when outsourcing to a contract pharmaceutical services provider.
Inhalation Drug Delivery – Understanding Basic Steps Involved in pMDI Development
Drug delivery via the inhalation route is an efficient, safe and efficacious method for local and systemic administration of certain therapeutic agents.This white paper provides insight into the aspects of formulation development, packaging development and analytical development associated with inhaled drug delivery as it relates to pressurized metered dose inhalers (pMDI).
Analytical Method Development and Validation – A CDMO Perspective
A CDMO that understands customer needs, regulatory requirements and has a proven track record for developing and validating analytical methods can minimize developmental costs and reduce the time to market. Properly validated drug product characterization methods are necessary for CMC regulatory filings, but can also reduce overall turnaround time during scale-up, clinical release and commercial-scale pharmaceutical cGMP manufacturing. To achieve these time savings sponsors must choose a CDMO partner that understands the characterization and stability of excipients, APIs and finished dosage forms.
Partnering with Your CDMO for CMC Preparation
Collaborative partnering between CDMOs and the drug product submission applicants is becoming increasingly important with the emphasis on product design by regulatory agencies. The CDMO can provide the appropriate resources to build the scientific knowledge base for the product and the depth of science-based information for the drug design and development that are required in the CMC sections, Modules 2 and 3, of the application.
Effective ICH Q8 Pharmaceutical Development Reports
The International Conference on Harmonization (ICH) Common Technical Document (CTD) format is the submission standard for new and abbreviated drug product applications (NDA, ANDA) in the United States, the European Union and Japan. One of the significant sections of the CTD is the Pharmaceutical Development Report (PDR). A complete PDR is essential to provide a comprehensive understanding of the product and process for the FDA application reviewers and inspectors. The information in the PDR is based upon the documentation generated during the formulation and process development phase of drug development. Efficient completion of this process is reliant on working with a CDMO that understands Quality-by-Design (QbD) elements such as critical quality attributes (CQAs), critical process parameters (CPPs) and design space.