2. Standard Operating Procedures & Instructions (Levels 2-3)
: A formal statement of the company’s commitment to meeting quality standards and regulatory requirements. Site Master File (SMF) list of qa documents in pharmaceutical industry
These records provide evidence that a specific batch was made according to the approved formula. Master Formula Record (MFR) : The master "recipe" for each drug product. Batch Manufacturing Record (BMR) organized by functional cluster.
Below is the master list of QA documents, organized by functional cluster. list of qa documents in pharmaceutical industry