Establishing Stability Programs
Increased Investment in Stability Programs are Imperative in the BioPharma Workplace
Creating efficient Stability Programs in the BioPharma workplace has never been more important. Drug Substance/Drug Product efficacy and shelf-life are fundamental attributes for establishing successful development pipelines and necessary for commercialization of any product.
Why Are Stability Programs So Important?
Stability Programs are designed to determine the intended storage condition, orientation of containers/packaging and shelf-life by testing at accelerated, intended and long-term storage conditions over a predetermined time interval. The medicinal components are assessed over the course of the study to determine how the quality of product is influenced by various environmental factors including temperature, humidity, and light. The results provide insight for establishing suitable handing instructions and efficient storage conditions, eliminating adverse effects to patients when the product is administered accordingly.
Establishing Comprehensive and Efficient Stability Programs Is Essential.
Stability Plans are designed to identify potential degradation pathways, determine shelf life, and generate data to support regulatory filings. The goal is to maintain the quality of products from date of manufacture to the date of expiry.
Determining product stability offers necessary control over storage conditions for raw materials, intermediates, formulations and finished pharmaceuticals, as well as rigorous testing throughout their lifecycle. By creating clear policies, procedures, training & education, and being proactive to changes within the industry delivers confidence in the health and safety of patients.
Choosing BCG to Implement and Support Stability Studies.
When choosing the expertise of BioPharma Consulting Group for implementing Stability Programs, we guarantee your company will produce high-quality products which conform to all applicable regulatory guidelines for efficacy and patient safety.
Biotech & Pharmaceutical Consulting Services
Our Quality Assurance services focus on improving quality, integrity and compliance by providing certainty of the product and data. Guaranteeing effectiveness and efficiency as per client expectations and regulatory requirements with regard to patient safety.
BCG will manage client projects with technical competencies focused on quality design efficiency through customized strategies to meet all company goals and produce completed projects compliant to objectives and timelines.