For information on cGMPs, please visit: www.fda.gov.
Part
IV: Staffing Quality Control Personnel
Getting the right Quality Control staff is another of the major
components of cGMP Demystified. Manufacturers must take into
account an employee’s education and experience in their
field when beginning to work on any manufacturing process for
a dietary supplement. In turn, supervisors must be able to know
employee’s standard operating procedures, assist when needed
and have the proper mix of education, on-the-job training and
experience to direct other employees. To ensure cGMP compliance,
the FDA requires all those who manufacturer
dietary supplements to staff their Quality Control Personnel
accordingly to these guidelines and rules.
The final rule requires manufacturers of dietary supplements
to:
Staff qualified employees to be part of the Quality Control
Personnel who manufacture, package, label or hold dietary supplements
Staff qualified Quality Control Personnel to be supervise employees
and oversee the manufacturing, packaging, labeling or holding
of dietary supplements
Guidelines for staffing Quality Control
Employees:
Requires each employee involved in performing quality control
operations to have pertinent education, training or experience
to do assigned functions
Companies are expected to provide training for employees
and additional training if needed through videos, texts, internet
courses or seminars as they see fit for the job function
As a standard, manufacturers have a minimum of two persons,
one to do the work and the other to verify work completion and
accuracy
Guidelines for staffing Quality Control
Supervisors:
Requires each employee involved in performing quality control
operations to have pertinent education, training, experience
to do assigned functions
Possess on-the-job training or experience from knowledge gained
over time from growing familiar with manufacturing actions or
equipment
Companies are to determine the appropriate balance of education,
training and experience to promote or designate
a supervisor
Staff qualified employees to be part of the Quality Control
Personnel who manufacture, package, label or hold dietary supplements