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A new regulatory guidance in the US has clarified expectations for pharmaceutical companies wishing to transition from an existing pharmaceutical component wash process to another, such as the Westar® Ready-to-Sterilize (RS) process.
The FDA has recently published the following guidance for post-approval manufacturing changes:
Guidance for Industry: CMC (Chemistry, Manufacturing and Controls) Postapproval Manufacturing Changes To Be Documented in Annual Reports (March 2014)
This supplements existing FDA guidances covering post-approval CMC changes and should be used in conjunction with those guidances when evaluating planned changes to a pharmaceutical manufacturing process.
In line with FDA’s Pharmaceutical Quality Initiative, the Agency has moved toward a risk-based approach for assessing pharmaceutical manufacturing process changes. Evaluation of post-approval CMC submissions has led FDA to identify a number of additional post-approval changes that represent a low risk to drug product quality and safety.
This final guidance outlines examples of changes that the Agency would now consider Annual Reportable. Of particular interest to customers contemplating a move to Westar RS products, the guideline clarified Agency thinking on changing contract manufacturing organizations (CMOs) for washing, drying or siliconization processes.
Transferring to a new CMO for washing, drying or siliconization of a primary container closure component is considered to be a minor change under the guidance. The application holder must certify that the CMO’s processes are validated, and that the CMO’s site has been audited and found cGMP compliant (by the application holder or a representative).
Validation of, and quality standards for, the Westar RS wash process are designed to meet regulatory standards. Please contact West’s Technical Customer Support for additional information regarding Westar RS products.
<p><strong>J. Riter, A. Janssen, D. Engels</strong></p><p>Cracking of elastomeric needle shields and tip caps is a costly problem for pharmaceutical manufacturers. Cracked components can cause leaks that can result in loss of drug potency and sterility and may lead to a safety risk for the person administering the drug and the patient. This cracking has been attributed to ozone degradation of the elastomer formulations.</p>
When faced with drug shortages or supply chain issues affecting a branded drug product, generic drug manufacturers need to move quickly to help ensure that needed therapies reach the market safely and efficiently. Access to high-quality packaging and delivery components can make a huge difference in ensuring patients receive life-saving medications on schedule.
Particulates in injectable drug products continue to be an area of great interest in the industry. The main reason is the potential clinical effects on patients, which can range from emboli to inflammations to infections. There are a series of clinical risk factors that should be considered in evaluating and mitigating these challenges. These factors are route of administration, patient population, and particulate composition (i.e., number, size, and shape). All are critical inputs to understanding risk and determining corrective and preventative actions.
The FDA has approved over twenty (20) cell and gene therapy drugs, and with the rapid growth of the cell and gene therapy market, there is greater demand than ever to demonstrate container-closure integrity (CCI) at ultra-low temperatures. To preserve the product’s efficacy, most cell and gene therapy drugs are stored at temperatures below -60ºC. Many of these products are packaged in either vial systems or cryogenic freezing bags. While each of these container-closure systems poses a unique challenge for the evaluation of CCI at ultra-low temperatures, the discussion in this blog focuses specifically on vial systems.
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