copy and paste this google map to your website or blog!
Press copy button and paste into your blog or website.
(Please switch to 'HTML' mode when posting into your blog. Examples: WordPress Example, Blogger Example)
Input Form:Deal with this potential dealer,buyer,seller,supplier,manufacturer,exporter,importer
(Any information to deal,buy, sell, quote for products or service)
ICH Q7: API Guidelines | ISPE | International Society for . . . The ICH Q7 guideline provides details of Good Manufacturing Practice (GMP) for Active Pharmaceutical Ingredients (API) It is a guideline adopted globally for applying GMP to APIs (drug substances) and is crucial to ensure consistent quality and safety throughout the API manufacturing process
Regulatory Considerations for API Manufacturing in the EU: Ensuring . . . The legal framework for API manufacturing in the EU is based on several key regulations and directives These include Regulation No 1252 2014, which applies to active substances for human use; Directive 2001 83 EC and Directive (EU) 2017 1572, which apply to medicines for human use; and Directive 91 412 EEC and Regulation (EU) 2019 6, which
Stability Considerations for Liquid and Injectable Drugs . . . This article explores critical considerations and global best practices for conducting Stability Studies on liquid and injectable drugs, with an emphasis on reconstitution, sterility, container-closure integrity, in-use testing, and CTD-compliant documentation
GMP Regulations and Compliance for API and Excipients This webinar will review the areas that an inspector may examine when conducting an audit of a biopharmaceutical API supplier to ensure it complies with regulatory requirements
Considerations When Developing Formulations for Injectable Solutions The effect of pH on API solubility and stability is most important for solution formulation development of ionizable compounds It guides the CDMO when selecting the formulation pH in the solution dosage form (Figure 1)
Validating Injectable Manufacturing Process: Best Practices This process ensures that every injectable product meets its intended purpose and quality specifications Whether it’s sterile liquids, lyophilized powders, or complex biologics, validating the injectable manufacturing process minimizes risks, ensures compliance, and enhances patient safety
Injectable Manufacturing Process – Step by Step Guide In this blog post, I will explain the step-by-step process of injectable manufacturing, from formulation development to packaging and storage I will also provide some examples of injectable products and their applications
Risk Assessment for Injectable Formulations Development Below is a structured risk assessment approach: 1 Formulation Development Risks API Characteristics: Poor solubility, stability, or degradation under formulation conditions Mitigation: Conduct comprehensive pre-formulation studies, solubility enhancement techniques, and stability testing
What are the key elements of an injectable formulation development . . . The key elements of the injectable formulation development process include the following: 1 API Characterization and Selection The process begins with a thorough characterization of the active pharmaceutical ingredient (API), including its physical and chemical properties, solubility, stability, and compatibility with various excipients