A Basic GMP Audit Guide
The Food and Drug administration sets strict industry standards to protect and advance public health by helping to safely and effectively speed innovations and ensuring the safety, efficacy, and security of medication, biological products and medical devices. Organizations are responsible for meeting these standards and passing the Good Manufacturing Practice (GMP) audit process, which is crucial to identifying potential operational flaws and other legal violations. Government bodies conduct these audits. Or third-party company provides a big picture look at an organization’s GMP audit regulations’ compliance by evaluating the coordination of production, materials, facilities and equipment, packaging/labeling, and laboratory controls.
Tips to Ensure A Smooth GMP Audit
1. Preparation is key
The first step to preparing for an audit is reviewing standard operating practices(SOPs) and the results of past audits and FDA inspections. Once strengths and weaknesses from past experiences are effectively identified, teams should perform pre-audit checks to ensure that every member knows what to expect the day of the audit and is prepared to effectively carry out their responsibilities.
2. Have checklists for audit requirements
It is crucial to create checklists for all necessary documents and everything needed for GMP compliance in your facility. Keep these documents as up-to-date as possible and accessible at all times to avoid any confusions or delays during the audit as you must have all official documents in order and ready to immediately present on request.
3. Timely communication with team members
Inform employees of plans for audit as soon as possible to allow sufficient time for teams to prepare and practice their roles. While employees should be regularly training for quality assurance evaluations, it is in the organization’s best interest to keep a timely and transparent line of communication with staff members. This would also allow for teams to identify their best members to represent them during the audit.
4. Be on high alert the day of the audit; Nothing is over until the auditor leaves
Designate a command center and make sure that it’s fully stocked and there’s always someone available to tend to audit related comments, questions and concerns. Whether it’s extra copies of all necessary documents, organizational charts, facility layouts, Quality System Manuals, SOPs, or more, operate a functional command center until the last second. The smoothness and success of a GMP audit depends on the organization’s functionality on the day of the GMP audit.
GMP audits are extremely valuable in assuring stakeholders that an organization meets the quality and safety standards and regulations set by the FDA whether they are producing a consumable product or device. Like all formal evaluation processes, GMP audits can be quite intimidating, but an organization can ensure a smooth auditing process by following best practices, preparing effectively and in a timely manner, and working with industry professionals and experts when needed. Reach out to Precision Life Sciences or Precision Talent Group if you would like more information about a GMP audit.