Former FBI & DEA Agents Handling Internal Audits for Pharmaceutical Manufacturing Companies in the U.S.
Pharmaceutical Manufacturer Compliance Team Lead – Timothy E. Allen | Former Special Agent (U.S. Secret Service & DOJ-OIG)
Internal audits are critical for good quality systems in pharmaceutical manufacturing operations. They assess the presence and effectiveness of internal controls. Without internal audits, it would be impossible to improve or add value to an organization’s operations, establish/maintain control over pharmaceutical operations, achieve product realization, and foster growth.
For product realization to be achieved, quality raw materials must be bought. For the best raw materials to be acquired, they must be sourced from approved suppliers.
To establish and maintain near-perfect internal controls in your pharmaceutical manufacturing operation, internal audits are necessary. Audit results also need to be incorporated into continuous improvement programs.
Corporate Investigation Consulting handles all matters related to internal audits in pharmaceutical manufacturing facilities. We can assess existing controls and facilitate the required changes in internal policies and procedures. We also ensure internal controls are compliant with applicable laws and regulations.
Why Should Pharmaceutical Manufacturing Companies Conduct Internal Audits?
There are several reasons for internal audits in pharmaceutical manufacturing facilities. The most notable are:
- They are critical parts of process performance and monitoring product quality.
- Audit results inform management reviews concerning the quality of systems.
- They allow preventative and corrective actions.
- Feedback from audits is critical in making decisions that foster continuous improvement.
- They are also important for regulatory compliance.
Put our highly experienced team on your side
Roger Bach
Former Special Agent (OIG)
Timothy E. Allen
Former Senior Special Agent U.S. Secret Service
Chris J. Quick
Former Special Agent (FBI & IRS-CI)
Maura Kelley
Former Special Agent (FBI)
Ray Yuen
Former Supervisory Special Agent (FBI)
Michael S. Koslow
Former Supervisory Special Agent (DOD-OIG)
Marquis D. Pickett
Special Agent U.S. Secret Service (ret.)
Pharmaceutical Manufacturing Internal Audits: Regulatory Perspective
Current CGMP (Current Good Manufacturing Practice) regulations don’t make internal audits mandatory, however, most international Good Manufacturing Practices regarding medication require self-inspection. Doing audits is a regulatory expectation for all pharmaceutical manufacturers in the U.S.
Good Manufacturing Practices on active pharmaceutical ingredients also call internal auditing. The same applies to device quality system requirements (QRS 5) based on ISO certification standards and Good Laboratory Practice – GLP -6 – regulations requiring audits to be done by quality assurance units to guarantee integrity of nonclinical studies.
Internal audits are part of various pharmaceutical manufacturing regulations. However, they are mostly intended for internal use to boost operations as opposed to being used as weapons by regulators to uncover fault.
However, the FDA has the power to review the findings of internal audits. The FDA usually exercises this authority in times of litigation or when verifying compliance with audit provisions.
Pharmaceutical manufacturers need internal audit experts like us to ensure compliance and other benefits of internal audits, such as improved processes.
How are Internal Audits Done in Pharmaceutical Manufacturing?
Internal audits begin with the establishment of auditing programs – written procedures discussing the program. Procedures should be defined clearly with objectives for conducting audits. Potential objectives can include assessing quality system effectiveness, providing evidence of adequate systems/controls in place, and ensuring products meet specifications.
Internal audit procedures should define audit frequency and how audited operations are determined. Internal audits for pharmaceutical companies should also include past audit results in risk analysis.
Every aspect of quality systems in pharmaceutical manufacturing companies is audited annually (once or severally) and the responsibility of conducting audits must be stipulated in the procedures. Audit procedures must also identify management representatives charged with the responsibility of reviewing audit reports and implementing findings prudently.
Audit responsibilities should be well defined with audit teams in place. Audit leaders must be independent of the internal operations being audited. Most importantly, audit teams must be knowledgeable of pharmaceutical procedures or operations being audited. Audit teams and audit leaders can vary for different audits.
External experts i.e., consultants, can be used to do internal audits. Corporate Investigation Consulting has internal audit consultants that come with many benefits, including unbiased views and expertise in global pharmaceutical manufacture, among other related fields. Our consultants also allow internal audit teams to focus on core business activities.
Preparing for an Internal Audit
Pharmaceutical manufacturing companies preparing for an audit should begin by reviewing past results. Relevant internal procedures and policies should also be reviewed. Audit teams shouldn’t waste time reading procedures and policies that can be found and reviewed before the audit process begins.
An audit agenda is important for offering a timeframe for the audit team. A checklist will also come in handy to cover all aspects. An agenda and checklist will ensure every resource needed i.e., personnel, facilities, and documents are available when needed. Most importantly, agendas should allocate time for discussing observations and preventative or corrective actions.
Internal Audit Process
Audit teams are treated as guests in pharmaceutical manufacturing facilities. They are expected to follow applicable rules regarding the operation being audited. If the audit process is taking place in an area where safety equipment is needed, the audit team must comply with such requirements. Safety is of utmost importance. Audit teams must also be confidential. Records, including private data, must be audited in accordance with applicable privacy guidelines.
Logbooks and other records may include identification of other persons and should only be reviewed by the audit team after the materials have been reviewed and cleared by the outsourcing representatives. Audit teams should also audit without interfering with operations. If interruptions are inevitable, deliberate effort should be put to minimize such disruptions.
Audits also have documentation requirements. For instance, unique observations should be made. If materials are stored inappropriately, such instances should be documented in detail, including names or materials, lot numbers, and other material-specific information.
With external audit teams, pharmaceutical manufacturers have the right to ask questions about observations being made. An explanation should be given immediately in context to every observation. Auditors are also required to work diligently and avoid jumping to conclusions.
Given the above information, internal audits can be complicated processes whether they are done by internal teams, external teams, or regulators. However, there are rules to be followed.
Corporate Investigation Consulting exists to make internal audits less complicated, accurate and fair. We provide oversight into how pharmaceutical manufacturers can prepare and conduct internal audits. We also challenge audit results that are obtained without following due process. Our internal audit experts have extensive experience in legal matters, internal controls, and other related fields.
Talk to us if you wish to get help on anything regarding pharmaceutical manufacturing audits, from compliance to improving internal controls and the bottom-line. We have countless ways of meeting CGMP and quality system requirements.