We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The responsibilities and procedures applicable to the quality control unit are not in writing.
Specifically, SOP 011-35, General Responsibilities of Quality Assurance and Quality Control, fails to include the quality unit's authority to approve and reject batches manufactured.' Further, individuals reviewing and approving product release are also responsible for reviewing and approving quality control and manufacturing records. For example, we observed Batch 5994, Lidocaine 3.0% Cream was released by personnel not within the quality unit; this individual also reviewed and approved the associated manufacturing and quality control records.