Audits are a staple part of life sciences companies such as pharmaceutical companies, medical or biologic device manufacturers, and many more in the industry, and are key to success. While an audit gives a company valuable feedback on the quality of their processes and products, failing an audit can have a range of consequences from minor warning letters, to increased regulatory scrutiny, to fees and penalties, to bigger repercussions like the shutdown of production, etc.
Organizations should regularly run mock audits to familiarize their staff with the process and to stay prepared at all times in order to successfully avoid regulatory deficiencies. To do so, it is important for organizations to understand different kinds of audits to maximize inspection readiness.
1. Good Clinical Practice (GCP)
GCP’s focus is to ensure that clinical research trials of human subjects are conducted safely and according to industry standards. Public safety is a top priority to inspectors, who might show up announced or unannounced, to:
- Protect the rights, welfare, and safety of study participants (therefore a focus on communication and informed consent).
- Assure quality and validity of study data and results.
- Provide applicable protocols and standard operating procedures (SOPs) in conducting clinical research.
While audit frequency varies depending on study complexity, organizations should watch clinical trials closely, especially if the clinical trial involves potential for harm to study participants, or the trial develops a pattern of study participants starting to resign or require study-related medical care. Human subject safety is one of the highest priorities of the FDA. Consequently, GCP audits often focus on informed consent protocols and the processes that ensure the well-being of human subjects.
2. Good Laboratory Practice (GLP)
The focus of GLP is to ensure that nonclinical lab studies are conducted according to industry standards by investing test articles and testing materials. This audit is a requirement to get premarket approval of regulated products.
Formal FDA GLP audits occur at least twice a year and are mainly focused on avoiding contamination, documentation of the set-up, and cleanliness of the testing environment, chemical solutions, and equipment. With these in mind, organizations should either hire a third party company or have an internal team to regularly conduct mock audits to maximize preparedness.
3. Current Good Manufacturing Practice (cGMP)
The focus of cGMP is to ensure that procedures around manufacturing, packaging, and processing of pharmaceutical products are up to industry standards. Regulations are in place to assure that the drugs in the market have the appropriate formulas and strengths and that their packaging contains the necessary information and safety precautions. This audit is crucial for any drug to be brought to market.
There are four main cGMP audits:
- Pre-approval of product
- Post-approval of product
- Product surveillance
- For-cause/directed (due to drug contamination, complaint)
Failure in any of the audits mentioned above would lead to significant financial jeopardy and lead to the disruption of organizational stability, and public trust. Due to the importance of the audits, organizations may wish to collaborate and coordinate with their respective quality management teams in deciding when to conduct an audit. The quality systems approach to a cGMP audit requires the collaboration of Production, Materials, Facilities and Equipment, Packaging/labeling, and Laboratory Controls, and should be communicated clearly with everyone involved, and should be practiced regularly to remain up to date with FDA regulation.
The main difference between these three types of audits are the stages of the pharmaceutical, biologic, and medical device product manufacturing each audit emphasizes. The focus on GCP is the health, safety, and rights of the study participant, as well as documentation that the product creates more benefits than harms. GLP, on the other hand, does not involve human subjects and the focus is the regulation of nonclinical laboratory testing environments and materials and cGMP is focused on regulating the manufacturing process after successful clinical and nonclinical testing.
It is imperative that life sciences organizations familiarize themselves with the applicable auditing method and regularly audit their practices to always be prepared for a formal FDA audit.
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