The Pharmaceutical Industry
21 CFR Part 211.25(a)
Section 211.25 states that:
Education, Training, and Experience
(a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions.
Particular Operations
Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee’s functions.
Qualified Individuals
Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
FDA Expectation
As we can see, the FDA has an expectation that employees not only be trained and able to perform their assigned functions, but they must be trained in cGMP as it relates to these job functions. Next we’ll discuss qualifications for those supervising drug manufacturing operations.
The Medical Device Industry
21 CFR Part 820.25
It is important that the organization hire sufficient personnel with the necessary education, background, training, and experience.
This is partly defined by establishing written job descriptions which should be maintained as part of the employees training file.
A job description is required for each position and every level in the organization chart.
Education and Experience
The job description should be signed by both the employee and their manager, and should include specific education and experience requirements.
The persons resume, or Curriculum Vitae (CV) should be part of their training folder as well, as it provides evidence that the person has the correct education, experience and background for the position for which they’ve been hired.
Job Titles & Descriptions
Job titles, job descriptions and resumes must be aligned to ensure personnel have sufficient experience and education to perform their duties.
These items will be verified as part of an FDA audit typically with emphasis on the quality personnel.
Sufficient Personnel – Sec 820.25 (a)
As mentioned previously, “sufficient personnel” is quite subjective, and depends on the complexity and risk of the medical device.
The management review can aid in this determination, by reviewing the efficiencies of the various quality systems it can be seen when resources are not sufficient, but even this takes a certain level of experience to be able to determine.
Excessive Non-Conformances
If there are excessive non-conformances, deviations, manufacturing issues or other excursions, this is a typical indicator that quality and/or training are inadequate.
Another key metric is the length of time corrective actions, complaints and non-conformances are open.
If these are not being addressed in a timely manner, it’s likely due to there not being enough resources focused on these areas.