Why is Pharmaceutical Validation Important?
Pharmaceutical quality assurance requires validation to provide documented evidence that systems, facilities, and processes perform their intended functions established by current specifications. FDA 21 CFR Part 11 Guidelines for Pharmaceuticals require appropriate testing of Electronic Records and Electronic Signatures. In pharmaceutical regulatory compliance, 21 CFR Part 11 requires that Electronic Signatures are reliable and equivalent and that the associated Electronic Records are trustworthy and secure. Additionally, compliance must be observed related to the manufacture of pharmaceuticals governed by related guidelines. Validation in a regulated industry is further challenged to adapt to market needs while managing evolving and intricate supply chains.
How Do You Validate the Pharmaceutical Industry?
Arbour Group assists with Good Practice (GxP) compliance in the pharmaceutical industry by supporting a culture of compliance that raises quality levels, reduces risk and costs, and increases shareholder value. The pharmaceutical software validation process consists of testing regulated processes and developing the associated documentation that demonstrates the software system works as intended. Current Good Manufacturing Practices (CGMP) address FDA regulations and other requirements for the process and workflows used in the manufacturing, processing, and packing of a product in the pharmaceutical industry. CGMP enables an understanding of pharmaceutical compliance requirements like 21 CFR Part 210, Current Good Manufacturing Practice in Manufacturing Processing, Packing, or Holding of Drugs and 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals.
What are the Types of Software Validation in Pharmaceuticals?
Prospective validation is the testing of a software system before its introduction into production. Retrospective validation is the testing of a software system after it has been placed into production use. Revalidation ensures that the product’s quality is unaffected by process changes.
What is Validation in Industrial Pharmaceutical Manufacturing?
The validation process of manufacturing and commercialization is critical to pharmaceutical quality assurance. Manufacturers must confirm that products meet quality standards required by governing agencies, and manufacturing procedures must address safety and efficacy mandates. Written documentation of production and process procedures ensures that the quality and identity of pharmaceuticals are accurately represented.
Arbour Group Validation and Compliance Services
We utilize proven methodologies and best practices to deliver in-depth regulatory expertise globally in the following areas: