Last week a federal jury convicted Stewart Parnell of fraud, conspiracy and several other charges stemming from the Salmonella outbreaks caused by Parnell’s Peanut Corporation of America in 2008. Parnell was sentenced to 28 years in federal prison. While Parnell got 28 Years, Mary Wilkerson, an employee who held titles of Office Manager, Quality Assurance Manager and Receptionist got 5 years.
In April 2016, the trial for New England Compounding Centers begins with charges including 25 counts of second degree murder for two pharmacists and significant charges for 12 others involved.
These are extreme cases with major misconduct, but in 2014, The FDA Issued over 700 Warning letters. Many of the organizations that received these warning letters do not have a validated quality management system (QMS) in place. Their paper-based processes are hard to manage, leading to compliance problems in areas that they don't even realize.
Whether you have a significant investment in a QMS already, or are planning to purchase one, the same methods apply. One of the core building blocks for your QMS is to follow the predicate rules. The predicate rules are any requirements set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act or any FDA Regulations (GxP: GLP, GMP, GCP, etc.) Think of the predicate rules as the rules for how you follow the rules. They offer the basics for building your QMS.
Summary of document predicate rules
- Approvals need date and signature
- Documents must be available at the point of use
- Obsolete documents must be prevented from unintended use
- Changes must be reviewed and approved with date and signature
- Approved changes must be communicated to the people who need them in a timely manner
- A change history of each document the includes a description of the change, a list of affected documents, signature and date of approval, and when the change becomes effective.
Summary of record predicate rules
- Records must be maintained at the location of use or be reasonably accessible during an inspection
- All records must me made readily available for review and copying by the FDA
- Records must be stored to minimize deterioration and prevent loss.
- Must be legible
- Must be retained for the appropriate period of time.
Whether you have a paper-based system, or an eQMS, keeping people informed of the basics is one critical building block to staying compliant. Get your record keeping rules under control, make sure your QMS is validated, and turn to consultants or other experts when you need help.