Quality Assurance

TRIGGERING OF INSPECTIONS

ABHA

TRIGGERING OF INSPECTIONS

There are two types of events that trigger inspection: categories that will regularly prompt an inspection request,
and categories in which the district office may elect to perform an inspection at their discretion for elements of
applications — filed or otherwise.

The following categories will regularly prompt a pre-approval or cGMP:

1. New molecular entities (includes finished drug product and the active pharmaceutical ingredient)
2. Priority NDAs
3. First application filed by an applicant
4. For-Cause inspection
5. For original applications, if the current cGMP status is unacceptable or greater than 2 years
6. For certain preapproval supplements, such as site change or major construction, if the cGMP status is unacceptable
7. Treatment IND inspections (information is available to CDER indicating that an inspection of a clinical supplies manufacturer is warranted to protect the health of patients)

ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube