Inspection Strategy for Blood and Source Plasma Establishments (POL-0039)

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Our Mandate:
To promote good nutrition and informed use of drugs, food, medical devices and natural health products, and to maximize the safety and efficacy of drugs, food, natural health products, medical devices, biologics and related biotechnology products in the Canadian marketplace and health system.

Supersedes: December 20, 2007

Date issued: July 23, 2010

Date of implementation: July 23, 2010

Disclaimer

This document does not constitute part of the Food and Drugs Act (Act) or its associated Regulations and in the event of any inconsistency or conflict between that Act or Regulations and this document, the Act or the Regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the Regulations and the applicable administrative policies. This document is not intended to provide legal advice regarding the interpretation of the Act or Regulations. If a regulated party has questions about their legal obligations or responsibilities under the Act or Regulations, they should seek the advice of legal counsel.

Table of Contents:

• 1.0 Purpose
• 2.0 Background
• 3.0 Scope
• 4.0 Definitions
• 5.0 Policy Statement
  • 5.1 Inspection
    • 5.1.1 Inspection cycle
    • 5.1.2 Duration of Inspections
    • 5.1.3 Inspection Rating and Reporting
  • 5.2 Responses to Non-Compliance
• References

1.0 Purpose

The purpose of this document is to describe the strategy for the fair, effective and uniform application of the national inspection program to assess compliance of blood and source plasma establishments (establishments) with the requirements of the Food and Drugs Act (FDA) and Regulations (FDR).

This policy also describes the Health Products and Food Branch Inspectorate approach to planning the cycles of Good Manufacturing Practices (GMP) inspections in relation to issuance of the Blood Establishment Licences (EL).

The main objective of this inspection strategy is to maintain consistency of inspections nationally.

2.0 Background

Blood is defined as a drug under Schedule D of the FDA. Blood and blood components for transfusion are regulated primarily by Division 1A (i.e. Establishment Licences) and Division 2 (Good Manufacturing Practices) of Part C of the FDR. Source plasma used for further manufacturing is also subject to Division 4 of the FDR. The annex to the GMP Guidelines, entitled "Good Manufacturing Practices for Schedule D Drugs, Part 2, Human Blood and Blood Components (GUI-0032)" provides specific guidance to inspectors and stakeholders for the application of GMP to establishments.

Health Canada is the federal authority which regulates the safety, efficacy and quality of drugs in Canada deriving its statutory authority over these products from the FDA and FDR.

3.0 Scope

This inspection strategy applies to all known Canadian establishments that manufacture blood and blood components used for transfusion and plasma used for further manufacturing for which an establishment licence is required.

4.0 Definitions

Blood Component: A therapeutic agent produced by physical or mechanical separation of the constituents of whole blood. Components include, but are not limited to, red blood cells, platelets, plasma and cryoprecipitated anti-hemophiliac factor (AHF).

Contact Centre: A site where calls and/or inquiries from donors are received and decisions regarding donor suitability are made.

Fixed Site: Permanent site where blood is collected but no component production is initiated. Equipment and supplies remain on site in a secured environment. Fixed sites are under the responsibility of a main centre.

GMP: The requirements of Part C, Division 2 (Good Manufacturing Practices) of the Food and Drugs Regulations and the interpretive guidelines on the subject published by Health Canada.

Main Centre: Permanent site that collects blood for transfusion, manufactures and distributes components.

Mobile clinic site: A blood collection site that is held at a non-permanent location. Mobile clinics are under the responsibility of a main centre.

Source Plasma: Means human plasma collected by plasmapheresis that is intended for use in producing a drug for human use.

Sub-Centre: Permanent site where blood is collected and some limited steps of component manufacturing take place. Equipment and supplies remain on site in a secured environment. Sub-centres are under the responsibility of a main centre.

For additional definitions, consult the documents listed as references at the end of this strategy.

5.0 Policy Statement

Any Canadian Blood Establishment involved in the fabrication, packaging/labelling, testing, distribution of blood and blood components must comply with the requirements of Division 2 (GMP) of the FDR. Establishments involved in the collection of source plasma must also comply with the requirements of the Division 4 of the FDR (C.04.400 to C.04.423).

Compliance will be assessed through inspections conducted by inspectors of the Inspectorate of Health Canada, designated under Section 22(1) of the FDA. Inspections for compliance with the FDA and the FDR are conducted under the authority of Section 23 of the FDA, with reference to relevant policies and guidance documents.

5.1 Inspection

5.1.1 Inspection cycle

The inspection cycle is determined according to a priority ranking scale, based on the complexity of activities performed in each centres.

The following inspection cycle targets have been established:

1. Main Centres will be inspected every fiscal year (April 1 to March 31)
2. Sub-Centres: every 2 years
3. Fixed Sites: every 3 years

Mobile clinics, existing in conjunction with a centre / fixed site, may be randomly selected for inspection and documented on the inspection plan, as applicable. Contact Centres will be inspected at the minimum every 3 years.

These inspections are the basis for the issuance of EL to domestic sites according to the requirements described in Division 1A of the Food and Drugs Regulations. For new establishments applying for an EL, they must be ready for an inspection when submitting their application since the Inspectorate expects that all proper information and systems are in place at the time of inspection. The Inspectorate is committed to perform an initial inspection prior to the start of their operation. This initial inspection will be followed by the appropriate inspection cycle.

Regardless of the inspection cycle targets above, all establishments may be inspected for cause, if necessary.

5.1.2 Duration of Inspections

The average time for a regular inspection will vary depending on the type of activities, history of compliance and the size of the establishment. Regular inspections will be conducted as announced inspections and the schedule will be provided annually to the establishment. Inspections may also be conducted at the discretion of Health Canada and may be unannounced.

5.1.3 Inspection Rating and Reporting

Rating

Two ratings will be used:

• compliant (C): at the time of the inspection, the regulated party has demonstrated that the activities it conducts are in compliance with the Food and Drugs Act and its associated Regulations. A C rating does not mean that there are no observations or corrective actions required; and
• non-compliant (NC): at the time of the inspection, the regulated party has not demonstrated that the activities it conducts are in compliance with the Food and Drugs Act and its associated Regulations.

Reporting

All inspection activities are recorded in the Inspection Reporting System (IRS). All observations are limited to the current Annex to the GMP guidelines and a risk is assigned to each observation according to the "Risk Classification of Observations made during inspections of blood establishments (GUI-0061)". All observations are discussed with the establishment during the inspection and confirmed to the establishment in the Exit Notice.

5.2 Responses to Non-Compliance

Where a non-conformity to the Act and/or Regulation is identified, the establishment will have the opportunity to correct the identified deficiency. Where necessary, the Inspectorate will consider enforcement actions in accordance with its "Compliance and Enforcement Policy (POL-0001)".

References

1. Food and Drugs Act
2. Food and Drug Regulations
3. Compliance and Enforcement Policy (POL-0001)
4. Good Manufacturing Practices (GMP) and Establishment Licensing Enforcement Directive (POL-0004)
5. Recall policy (POL-0016)
6. GMP Annex for Biologicals, Part II, Human Blood and Blood Components (GUI-0032)
7. Risk Classification of Observations Made During Inspection of Blood Establishments (GUI-0061)