CPG Sec. 280.110- Microbiological Control Requirements-Licensed Anti-Human Globulin and Blood Grouping Reagents

Description

The purpose of this Compliance Policy Guide (CPG) is to provide guidance to FDA staff on the microbiological control requirements for Anti-Human Globulin (AHG) and Blood Grouping Reagents (BGR) licensed by the Center for Biologics Evaluation and Research (CBER).In general, FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the FDA’s current thinking on a topic and should be viewed only as recommendations unless specific regulatory or statutory requirements are cited. The use of the word “should” in FDA’s guidances means that something is suggested or recommended but not required.

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

3

In Vitro Diagnostic Products

Licensed IVDs subject to stability requirements

Blood Grouping Reagents

Licensed biological reagent subject to microbiological control

Anti-Human Globulin

Licensed biological reagent subject to microbiological control

Stakeholders

2

Investigators

Guidance for Sponsors, Investigators, and Institutional Review Boards

Manufacturer

Entity responsible for submitting NDINs

Regulatory Context

Regulatory Activities

1

License Application

Review process where sterility requirements are evaluated

Document Types

1

Standard Operating Procedures

IRB's documented procedures for reviewing documents.

Attributes

1

Microbial Level

Should not adversely impact product performance

Technical Details

Substances

1

Preservatives

personnel adding lower amounts than needed to ensure uniform distribution

Processes

2

Process Validation

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

Aseptic Processing

implied manufacturing process under QS regulation

Standards & References

Specifications

1

Acceptance Criteria

limits for solid state form and particle size; Tightening acceptance criteria; Numerical limits or ranges for tests

Related CFR Sections (5)

21CFR606.65§ 606.65 Supplies and reagents.
All supplies and reagents used in the collection, processing, compatibility testing, storage and distribution of blood and blood components shall be stored in a safe, sanitary and orderly manner.Read full regulation →
21CFR660.50§ 660.50 Anti-Human Globulin.
(a) Proper name and definition. The proper name of this product shall be Anti-Human Globulin which shall consist of one or more antiglobulin antibodies identified in § 660.55(a)(4) .Read full regulation →
21CFR660.20§ 660.20 Blood Grouping Reagent.
(a) Proper name and definition. The proper name of this product shall be Blood Grouping Reagent and it shall consist of an antibody-containing fluid containing one or more of the blood grouping antibodies listed in § 660.28(a)(4) .Read full regulation →
21CFR610.12§ 610.12 Sterility.
(a) The test. Except as provided in paragraph (h) of this section, manufacturers of biological products must perform sterility testing of each lot of each biological product's final container material or other material, as appropriate and as approved in the biologics license application or supplemenRead full regulation →
21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Adulterated under section 501(f)(1)(B)

21

Misbranded under section 502(o)

19

Failure to adequately develop, maintain, and implement written MDR procedures

10

Failure to establish and maintain procedures to control the design of the device

10

Failure to establish and maintain procedures for implementing corrective and preventive action

10

Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints

8

Failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints

8

Failure to establish and maintain procedures for implementing corrective and preventive actions

8

Unapproved Device Violations

8

Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures

7