FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacture of Biological Products | Guideline Explorer

Description

The Food and Drug Administration (FDA) is announcing the availability of a guidance document concerning the use of pilot facilities for the development and manufacture of biological products.The guidance document, entitled ``Center for Biologics Evaluation and Research; Use of Pilot Manufacturing Facilities for the Development and Manufacture of Biological Products; Guidance,'' provides guidance by the Center for Biologics Evaluation and Research (CBER) to manufacturers of biological products to clarify the licensing requirements for the use of small scale and pilot facilities for thedevelopment and manufacture of biological products. These facilities are sometimes collectively referred to by industry as pilot facilities.This guidance document is intended to provide increased flexibility for industry without diminishing public health protection.

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

1

Biological Products

Requires analytical comparability per ICH Q5E

Regulatory Context

Regulatory Activities

3

Investigational New Drug Application

IND for treatment use; Regulatory submission required for clinical trials and expanded access.

Product License Application

CBER submission type used in cost calculation

Establishment License Application

CBER submission type used in cost calculation

Technical Details

Processes

1

Process Validation

General principles and practices for manufacturing validation; Summary of batch data for new synthetic procedures

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Quality control unit failed to exercise its responsibility

101

Failure to conduct at least one test to verify the identity of each component

95

Failure to establish adequate written procedures for production and process control

88

Failure to thoroughly investigate any unexplained discrepancy or failure of a batch

56

Failure to have appropriate laboratory determination of satisfactory conformance to final specifications

56

Failure to establish an adequate quality control unit

49

Failure to test samples of each component for identity and conformity

47

Failure to establish laboratory controls

35

Failure to thoroughly investigate any unexplained discrepancy

28

Failure to test samples of each component for identity

25

Recent Cases

Related Warning Letters (10)

Related MFDS Guidelines

Korean regulatory guidelines covering similar topics