The document provides a checklist of requirements for premises and personnel to comply with current Good Manufacturing Practices (cGMP) as regulated by the FDA. The checklist includes requirements for the building premises such as protection from weather/floods, adequate lighting/ventilation, and segregation of production areas. It also lists personnel requirements such as medical examinations for employees, training documentation, and independent quality assurance operations. Adhering to the specifications in the checklist can help pharmaceutical manufacturers avoid penalties and brand damage from being found noncompliant with FDA cGMP regulations.

1. For Your Premises: For Your Personnel:
〇〇 Building must be protected against weather,
flood and animal infestation.
〇〇 Area surrounding the building must
be free of sources of pollution, industrial
or otherwise.
〇〇 Lighting and ventilation must be adequate.
〇〇 Toilets must be well ventilated and
segregated from production areas.
〇〇 Floors, walls and ceilings must be
constructed of materials that are easy
to clean and disinfected.
〇〇 A full schematic of the building’s
plumbing system, including sanitation, must
be available.
〇〇 Full schematics of the building’s
ventilation system must be available.
〇〇 Each production area must be suitably laid out
and provide adequate working space.
〇〇 Hazardous and toxic products must
be properly stored and segregated
from production areas.
〇〇 Documentation and procedures for
preventative maintenance must be
made available.
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〇〇 All areas must be adequately staffed.
〇〇 Every unit must have proper supervision.
〇〇 An up-to-date organizational chart detailing
quality assurance must be available.
〇〇 An up-to-date technical staff list detailing
staff’s qualifications and experience must
be provided.
〇〇 Production and quality assurance
operations must be demonstrably
independent of one another.
〇〇 All new employees must undergo
medical examinations.
〇〇 All employees must have
periodic medical examinations
during their employment.
〇〇 Employees who are ill must be removed
from the production area immediately and
remain away until they have recovered.
〇〇 Suitable washing, changing and rest
areas must be provided for employees.
〇〇 Clear instructions on the use of
protective clothing must be provided.
〇〇 All personnel must have received GMP
training, and a training manual must be
made available.
〇〇 Records of training details must be
made available.
cGMP Compliance Checklist
For a pharmaceutical manufacturer, being found to be noncompliant with the FDA’s
current Good Manufacturing Practices (cGMP) can be devastating. Not only can
noncompliant manufacturers face stiff penalties from the federal government,
but they also can lose the trust of consumers and face irreparable damage to
their brand. This checklist covers many of the most prominent areas of cGMP
compliance. Review it to determine whether your operations are compliant —
before an audit tells you they are not.