Annex 14 to the Current Edition of the Good Manufacturing Practices Guidelines - Schedule D Drugs, Human Blood and Blood Components (GUI-0032)

Introduction
This document is to provide guidance for the application of Good Manufacturing Practices (GMP) to blood establishments for human blood and blood components. Formatting changes were made to this document on 2012-11-09. No changes were made to document content.

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Supersedes: 1999-12-01

Date issued: 2012-11-09

Date of implementation: 2012-11-09

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.

Table of Contents:

• Preface
• Regulation
  • Premises
  • Equipment
  • Personnel
  • Sanitation
  • Raw Material Testing
  • Manufacturing Control
  • Quality Control Department
  • Packaging Material Testing
  • Finished Product Testing
  • Records
  • Samples
  • Stability
  • Sterile Products
• Appendix A: GMP requirements for blood manufacturing activities
• Appendix B: Glossary of terms

Preface

The purpose to this document is to provide specific guidance for the application of good manufacturing practices to blood establishments.

Regulation

Premises

C.02.004

1. See section C.02.007 (Sanitation) for additional explanation on premises.

2. Premises must be located, designed, constructed and adapted to suit the operations to be carried out. Their design and furnishing must be chosen to minimise the risk of errors. Premises should, if possible, be designed so that operations can proceed in an orderly manner. Buildings should be maintained so as to protect against the effects of weather or ground seepage and the entry of vermin, pests and birds.

3. The facility should be designed to align with the process flow but shall include:

• 3.1 An area set aside for donor screening which maintains confidentiality for questioning and examination of individuals to determine their suitability as blood donors. If the Confidential Unit Exclusion (CUE) is used, a private area must be provided.
• 3.2 An area set aside for the safe withdrawal of blood from donors and equipped with appropriate supplies for the treatment of donors experiencing adverse reactions or injuries from events associated with blood donation.
• 3.3 A means of communication (e.g. telephone, cellular phone) whenever donors are being bled to ensure that emergency help is available, if required.
• 3.4 A separate controlled area for the quarantine storage of blood or blood components prior to completion of processing, and for reagents and test kits prior to acceptance testing and approval at the processing facility.
• 3.5 A separate secure area for the quarantine storage, handling and disposition of blood components and reagents not suitable for use or recalled.
• 3.6 A secure area in both quarantine and released storage for units collected under special criteria (e.g., Autologous/Directed Donation)
• 3.7 Separate dedicated areas for component preparation and laboratory testing. Entry to these areas shall be restricted to authorized personnel.
• 3.8 Separate controlled storage areas for released components available for distribution.
• 3.9 A designated area for safe storage of waste and items used during the collection, processing and testing of blood and blood components, or rejected blood or blood components, prior to disposal.
• 3.10 A dedicated area for the labelling and release of components into inventory.
• 3.11 A designated alternate storage site for blood components in the event of equipment or power failure in the main storage facility.
• 3.12 Adequate storage space for the dry, clean and orderly placement of stored material under monitored temperature conditions compatible with conditions specified on label. Storage areas shall provide for suitable and effective separation of quarantined and released material.

4. When blood collection clinics are conducted by mobile teams, a realistic attitude towards environmental standards is necessary. The premises should satisfy common sense requirements for the health and safety of both the mobile teams, and the donors concerned, with due regard for relevant legislation or regulation. Points to check should include adequate heating, lighting and ventilation, general cleanliness, provision of a secure supply of water and electricity, adequate sanitation, compliance with fire regulations, satisfactory access for unloading and loading of equipment, adequate space to allow free access to the bleed and rest beds. An area shall be provided for a confidential interview with a donor.

Equipment

C.02.005

1. See section C.02.015 (Quality Control Department) for Laboratory Testing Equipment information and water purification systems.

2. Schedules and procedures for equipment validation, maintenance and calibration must be maintained and followed. This requirement applies to all instruments, equipment and measuring devices critical to ensure that the provision of blood and blood components conform to applicable regulations, requirements and standards.

3. Manufacturing equipment used, or intended to be used, in whole blood collection, apheresis procedures, and component production should be designed and maintained to suit its intended purpose and shall not present any hazard to donors, components or operators. All equipment shall be maintained, standardized and calibrated on a regularly scheduled basis according to established procedures described in operating procedures (OPs) and/or the equipment manual. If the instrument has been disturbed or is suspected of malfunctioning, these tests shall be carried out before further use.

4. Computers, which maintain data used to identify donors, to make decisions regarding the suitability of blood components for transfusion or further manufacture, and/or to maintain data used to trace a unit of blood or a blood component from collection to its final disposition, must be validated in accordance with current Health Canada guidelines (Validation of Computerised Systems in Blood Establishments) prior to implementation and must be maintained in a validated state.

Personnel

C.02.006

1. There shall be an organization chart showing the hierarchical structure with clear delineation of lines of responsibility and the relationship of individuals responsible for key functions.

2. A blood establishment shall be under the direction of designated, qualified personnel who shall exercise control of the establishment in all matters relating to good manufacturing practices (GMP) for blood component manufacturing. Designated staff shall have an understanding of the scientific principles and techniques involved in the manufacture of blood components. Training and competency evaluations must be documented.

3. The fabricator shall ensure the employment of adequate personnel qualified by education and/or experience, as specified in their job descriptions. The tasks and responsibilities of all individuals must be clearly understood and documented. All personnel shall be trained in the principles of GMP relevant to their work. Records of the qualifications, training, and continuing competence of individuals shall be maintained.

4. Personnel shall receive initial and continued training appropriate to their duties. Training programs shall be available for this purpose; the effectiveness of the programs shall be assessed by regular competency evaluation.

5. Key personnel shall include at least a Production Manager, a Quality Assurance (QC/QA) Manager and a Medical Officer. An individual may have more than one function but the Production Manager and Quality Assurance Manager must be independent of each other.

6. The Medical Officer, who is a licensed physician and qualified by training or experience, shall have responsibility and
authority for all medical and technical procedures, including those that affect laboratory personnel and test performance, and for the consultative and support services that relate to the care and safety of donors. The acceptability of donors must be determined by trained qualified staff under the supervision of a qualified licensed physician.

7. Individuals in charge of production should hold a post secondary qualification (e.g., in management, medical laboratory science, general science or nursing) and have had practical experience under professional guidance in the manufacture and control of therapeutic products made under GMP. Individuals with equivalent combination of education, training and experience may be qualified.

8. QC/QA staff must hold a university degree in science or equivalent experience/knowledge directly related to Immunohematology or nursing.

Sanitation 

C.02.007

1. Blood establishments routinely fabricate blood components in a closed system so that there is no possibility of microbial contamination from outside after collection of blood from the donor.

2. The blood establishment should be maintained in a clean and sanitary condition. A written sanitation program should be available that addresses good housekeeping issues. An accidental spill clean up procedure must be available and include instructions to dispose of blood spills as biohazardous material.

3. Blood and its components must be handled and discarded with precautions that recognize the potential for exposure to infectious agents.

4. There must be procedures for biological, chemical and radiation safety, where applicable.

5. Adequate hand washing facilities must be available for staff collecting and handling blood units. At mobile sites where hand washing facilities are not available, an alternate method to clean hands, i.e. bactericidal hand wipes, is acceptable.

C.02.008

1. Persons whose presence can adversely affect the safety or quality of the product shall be excluded from areas where the collection, processing, testing, storage or distribution of blood or blood components is conducted.

2. Personnel shall be aware that microbial contamination of themselves, the donors, the blood components and the environment must be prevented.

3. Hygiene instructions, including clothing and behaviour requirements, must be present in each department. These instructions should be understood and followed by all personnel.

Raw Material Testing 

C.02.009

1. Because whole blood is the source material for blood components, special considerations are given to the procedures for donor screening and vendor audit (C.02.010).

2. Donor Screening

• 2.1 All blood donors must be found acceptable each time they donate based on the approved health screening criteria. A document shall be available at each blood collection site that details the approved health screening criteria for acceptance/deferral of donors.
• 2.2 Potential donors who do not meet all the applicable acceptance criteria for donating must be informed of the reason they cannot donate and the circumstances under which they have been deferred.
• 2.3 A comprehensive list of donors who are temporarily or permanently deferred must be maintained. If a blood manufacturer has multiple collection and processing facilities, a composite donor deferral registry, including the names and/or unique identifiers of all donors deferred at each facility, must be made available to each site and updated on a regular basis.

3. The collection bags, which are approved Medical Devices, do not require further testing. The certificate of analysis for each lot of collection bags must be reviewed and approved prior releasing for clinic use. Each collection bag must be visually examined prior to its use for blood collection, again at the time of product release into available inventory, and finally before the released product is distributed.

C.02.010 

1. Vendor Audits

• 1.1 All vendors which supply critical materials that are used in blood collection (eg. blood collection bags, apheresis harness sets and apheresis collection bags) should be audited periodically by the manufacturer of blood/components to ensure that the vendor operates in compliance with GMPs and that the products they supply consistently meet pre established specifications.
• 1.2 There must be a system in place to ensure the timely reporting of complaints or product defects to the vendor and prompt effective remedial action by the vendor.

Manufacturing Control

C.02.011

1. Written Operating Procedures (OPs)

• 1.1 Every manufacturer shall maintain and control all documents (policies, processes, procedures and forms) relating to the requirements for each activity in the manufacturing process.
• 1.2 OPs must be clear, concise, current and approved, and be available in the area where the activity is performed.
• 1.3 The issue of OPs and any changes made shall be controlled by a documented system which ensures that all OPs in use are current and authorised, and that obsolete documents are archived and protected.
• 1.4 The OPs must describe the significant steps of the operation:
  • 1.4.1 The determination of donor acceptability and deferral status, including the process for donor identification.
  • 1.4.2 Method of accurately and uniquely relating the blood components or product(s) to the donor, donor samples, and all associated records, for each donation.
  • 1.4.3 The procedure(s) used for blood collection, including methods used to prepare the site of phlebotomy, and to link critical materials (e.g., the collection pack lot number) to the clinic and donor.
  • 1.4.4 Specific manufacturing procedure(s) for the preparation of all components, including labelling steps (i.e., type of labels and method of labelling).
  • 1.4.5 All tests and repeat tests performed on blood and blood components including testing for infectious disease markers. Procedure(s) shall address the shipment of samples to off-site and contract facilities, as required.
  • 1.4.6 Procedure(s) for the capturing, assessing, investigating and monitoring of adverse donor and recipient reactions.
  • 1.4.7 Procedure(s) for determining the suitability of blood components for transfer to available inventory, i.e., formally approving the blood component for release. There must be a suitable means of identification to ensure that blood components which cannot be released for issue can be distinguished from those which conform to specification and are ready for release.
  • 1.4.8 Procedure(s) for the voluntary return of issued blood and blood components, specifying the conditions under which the returned blood may be suitable for re issue.
  • 1.4.9 Procedure(s) used for tracking a unit of blood or any blood component from the donor to its final disposition.
  • 1.4.10 Procedure(s) for the quality control of blood components, processing methods and laboratory testing.
  • 1.4.11 Procedure(s) for plasmapheresis, plateletpheresis and leukapheresis, including precautions to be taken to ensure reinfusion of a donor's own cells, if applicable.
  • 1.4.12 Procedure(s) for the operation, maintenance and validation of all computerized systems that contribute to decisions regarding the suitability and/or traceability of blood and blood components.
  • 1.4.13 Procedure(s) for capturing, assessing, investigating, and monitoring errors and accidents (i.e., manufacturing discrepancies). Defined methods for identification, data collection, analysis, and follow-up of corrective and preventive action shall be used for process improvement.
  • 1.4.14 Procedure(s) and criteria for performance of lookback and traceback investigations.
  • 1.4.15 Procedure(s) which detail the requirements for units collected under special criteria (such as Autologous and Directed Donations).
  • 1.4.16 Procedure(s) which details recall procedures including the identification of the person or persons responsible for initiating and co-ordinating the recall activities as well as the process for notifying the regulatory authorities.
  • 1.4.17 Procedure(s) to detail the receipt, inspection, and storage of material and products within the premises.
  • 1.4.18 Procedure(s) to describe the calibration of equipment. It shall include the method to be used, frequency of calibration and action to be taken when results deviate from defined acceptance limits. Parameters being tested should approximate operating conditions for that equipment.
  • 1.4.19 Procedure(s) for the packaging and transport of blood components, to ensure they remain within specifications.

2. A system shall be established and maintained to identify, document, review, approve and control all process and product changes.

3. Supplies and Reagents

• 3.1 Each blood collecting container and its satellite container(s), if present, must be examined visually for damage or evidence of contamination prior to its use (before blood collection) and before the product is distributed. Where any defect, improFer labelling or abnormal appearance is observed, the container shall not be used, or, if detected after filling, the component shall be properly discarded.
• 3.2 Representative samples of each lot of reagents or solutions shall be inspected and/or tested on each day of use as described in the Operating Procedure(s) to determine their suitability for use.

4. Labelling of blood components

• 4.1 See labelling requirements described in Division 4 of the Regulations.
• 4.2 Blood component labelling occurs at various stages in the manufacturing process. Each critical labelling procedure must include effective in process controls, appropriate to the system and equipment, to ensure correct labels have been applied. Component labelling must be reviewed prior to final product release
• 4.3 Each donation shall be identified in a unique manner and shall allow for the traceability of each blood component back to the donor and forward to final disposition.
• 4.4 If coloured labels are used to identify products for transfusion, the colours must follow the conventions outlined in the Guidelines for Blood Collection and Component Manufacturing (Part IV section 2.4.2) .
• 4.5 Each successful donation must be classified as to ABO and Rh group. Whole blood (WB), red cell concentrate (RCC), platelets (PLT), and granulocytes (GRAN) must be labelled with both ABO and Rh (D) groups, based on test of record. The label shall specify: "Rh positive" if D or weak D positive, or "Rh negative" if D and weak D negative.
• 4.6 The label shall state the composition and volume of anticoagulant/additive, the Establishment Licence Number and address of the component fabricator, and date of expiry. Expiry labels for products with a shelf-life of 72 hours or less must include the time of expiry.
• 4.7 Information and cautionary statements specific to blood component fabricating are outlined in the Guidelines for Blood Collection and Component manufacturing (Part IV).

5. Circular of Information

• 5.1 An information circular (package insert) is an extension of the blood component labelling and shall be available for distribution if the component or blood product is intended for transfusion. The information circular shall provide adequate directions for storage and use, including information on the composition and properties of the product, the indications for use, contraindications, and possible adverse events.
• 5.2 Packaging differs from pharmaceutical manufacturing, in that, the initial whole blood container with satellites is also the final packaging material.

C.02.012

1. Whole Blood and Blood Component Recall

• 1.1 All complaints and other information that may suggest that defective blood components have been issued must be carefully investigated. Written procedures must exist for recalling defective blood components or blood components suspected of being defective. All complaints about delivered blood components shall be dealt with and investigated as quickly as possible.
• 1.2 Blood establishments shall maintain a system of control that permits complete and rapid recall of any component to the consignee level (e.g., hospitals or fractionator). Distribution records shall be readily available and easy to follow so as to expedite the recall of any blood component or material whenever necessary.
• 1.3 Post Donation Information reports may lead to recall of all in date components.
• 1.4 The guidance on recalls in the document entitled "Product Recall Procedures" published by the Health Protection Branch does not apply in its entirety to Blood Components.

2. Internal audit

• 2.1 Internal audits are required to ensure that all procedures and the associated quality control are performed according to GMP, and applicable regulations and legislation. Internal audits should be comprehensive and performed according to an established program. The findings shall be documented.
• 2.2 The internal audit personnel shall be knowledgeable in the subject matter and process being audited, and shall have defined responsibilities and authority.

Quality Control Department 

C.02.013

1. Quality Control/Quality Assurance department shall be a distinct organizational unit that is not linked to fabricating of blood components.

2. For sub-centres and mobile clinic sites, which are technically multiple sites of a single licence, it must be demonstrated that the overall supervision of quality and production is adequately controlled by the blood centre.

C.02.014

1. Sections C.02.014 (1), (3), and (4) do not apply to blood fabricators due to their nature, the fact that each component is a separate lot and that they are not reprocessed (as per definition of reprocessing for pharmaceuticals).

 2. Within a blood component fabricating operation, the requirements of this section may be fulfilled by positions or departments other than the Quality Control Department as specified in the operating procedures.

 3. Because of their intended use, good quality is crucial to blood components. Therefore, the collection of blood and the processing, storage and distribution of blood components must be organised in a way to ensure a high component quality. This can only be achieved if the fabricator has a system of quality management. Quality management is an integrated system of quality assurance covering all matters which individually or collectively influence the components in order to guarantee their quality.

 4. The person or group of persons who coordinate, monitor and facilitate all QA activities is the QC/QA unit.

5. The quality requirements involve the following topics:

• premises, equipment and materials
• personnel and organisation
• donor screening and blood collection
• blood processing
• documentation
• quality control and proficiency testing
• complaints and component recall
• internal and external audits

6. In the case of C.02.014 (2), if blood components are returned to the manufacturer they are only acceptable for re-issue if the manufacturer can document that the product, while out of their hands, was continuously stored under the appropriate storage conditions.

C.02.015 

1. The donor screening criteria (see Raw Material Testing) and donor sample testing (Quality Control Department) are factors in determining the acceptable quality and safety of blood and blood components. In process controls, as specified in approved OPs, provide specific GMP for Blood Component fabrication.

2. A quality control program for assessing the quality and performance of all reagents and test kits used in the processing of blood components, must be in place.

3. Test kit procedures, acceptable to Health Canada, must follow the strict protocol of their applicable package inserts.

4. Detailed specifications for purchase of critical reagents and materials are required. Only reagents and materials that meet the documented requirements shall be used. Manufacturers shall provide a certificate of compliance for these reagents and materials.

5. Serological and Transmissible Disease Testing

• 5.1 Testing is performed on blood samples (pilot samples) collected at the time of donation. The samples are marked with an identifier which links the sample to the donor and the corresponding unit of blood. Pilot samples must be collected by a technique that prevents external contamination of the blood product.
  
  
• 5.2 Responsibilities between contract laboratories and the blood establishment shall be defined by written agreement.
  
  
• 5.3 All donors of whole blood must be tested for the following serological tests at the time of each donation:
  • ABO group, including forward and reverse grouping
  • Rh group (D and weak D testing)
  • Antibody screen
    
    
• 5.4 All donors must be screened for the following transmissible disease markers at the time of each donation:
  • Syphilis
  • Hepatitis B surface antigen (HBsAg)
  • Antibody to Hepatitis C virus (HCV)
  • Antibody to HIV type 1 and 2
  • Antibody to HTLV-I/II (except plasma for further manufacturing use only)
  • HIV-1 p24 Ag
  • Any disease marker(s) specifically required by the Minister
    
    
• 5.5 Units that are repeat reactive for a transmissible disease marker listed above must not be issued for allogeneic transfusion.
  
  
• 5.6 All donors that are found repeat reactive for a transmissible disease marker listed above must be deferred.

6. A quality control program which assesses the quality of all manufactured blood components must be followed by every fabricator. The frequency of quality control testing, expressed as a percent of overall production, as well as the minimum number specified over a period of time, and the acceptable criteria for quality control testing of each type of component must be established by each fabricator.

7. The results of quality control testing must be analysed on an ongoing basis and appropriate corrective action taken when values fall outside the acceptable limits.

8. Although blood is not a sterile drug, sterility testing should be performed as part of Quality Control testing. Sterility testing must be done with a methodology specific to aerobic and anaerobic pathogens in blood. Sterility testing serves as a monitor of the effectiveness of the protocol for phlebotomy site preparation.

9. Blood establishments must participate in a proficiency testing program. Proficiency testing is an aspect of Quality Assurance which monitors the ability to perform laboratory procedures within acceptable limits of accuracy through the analysis of unknown specimens.

Packaging Material Testing

C.02.016 and C.02.017

1. Packaging Material testing does not apply to blood component manufacturing as original collection bags and satellite bags must be approved Medical Devices. Additional routine testing is not required for use of approved collection bags. However, testing may be required during the investigation of a complaint or an adverse reaction.

Finished Product Testing

C.02.018 and C.02.019

1. The requirements for finished product testing cannot be applied to the manufacture of blood components since each unit of blood collected represents a separate lot. The safety of each component depends on the selection of donors, blood collection, and serological and transmissible disease testing. The quality of components is established by quality control testing as a method of the fabricating process eg. Factor VIII level in cryoprecipitate.

Records

C.02.020

1. Records shall be maintained concurrently with the performance of each significant step in the collection, processing, testing, storage and distribution of each unit of blood and blood components so that all steps can be clearly traced.

2. All records shall be legible and indelible, and shall identify the person performing the work, include dates of the various entries, show test results, the interpretation of the results, any retests or invalidation of test results.

3. All manual transcription of test results shall be independently verified.

C.02.021

1. Section C.02.021 does not apply to blood establishments as blood component records must be kept indefinitely. Blood establishments may decide to use microfiche, microfilm or other means of retaining permanent records. Records must be accessible at all times.

2. Records that substantiate the safety of blood and blood components and the traceability of the components from donor to final disposition shall be retained indefinitely. The records must enable the fabricator to trace blood or blood components to donors in the case of a traceback investigation, and to the point of end use in case of lookbacks.

C.02.022

1. Section C.02.022 applies directly to blood establishments in that procedures must clearly determine the distribution of all whole blood and blood components which will ensure an effective recall, if necessary. Records shall demonstrate that a blood component can be readily located during transportation to another site.

C.02.023

1. Records of complaints regarding blood components issued to consignees must be completely investigated.

2. Records of adverse transfusion reaction reports must be maintained.

3. Section C.02.023 (2) does not apply in that records are maintained indefinitely.

C.02.024

1. Records of self audits performed within the blood establishment must be available for review. C.02.024 (1)(b) does not apply as records are maintained indefinitely.

2. Records of sanitation need not to be retained.

Samples

C.02.025 and C.02.026

1. The provisions of this section do not apply to blood component manufacturing due to the fact that each unit is a lot. When a transfused blood component is associated with a post transfusion infection or serious adverse reaction, a thorough investigation is undertaken.

2. Blood components intended for transfusion which are stored long term in a frozen state (eg. frozen red cell units) must have a serum or plasma sample kept for future testing purposes.

Stability

C.02.027 and C.02.028

1. Blood components must be stored at all times under appropriate monitored storage conditions.

2. During shipment, blood components must be placed in appropriate shipping containers that ensure the maintenance of appropriate storage temperature during shipment as well as the security of the contents.

3. Shipment documentation must specify the shipping conditions of the blood components.

Sterile Products

C.02.029

1. Blood components are injectable but are generally not considered to be sterile products.

2. Using an appropriate sampling plan, blood components should periodically have sterility testing performed as part of routine quality control testing to evaluate the overall effectiveness of the arm scrub.

3. If a sterile connecting device is used to produce sterile welds (i.e. maintaining closed system) it must be an approved medical device. The weld made must be inspected for completeness.

4. A sample taken from every final product processed in an open system (e.g., red blood cells, deglycerolized) shall be tested retrospectively for sterility.

Appendix A: GMP requirements for blood manufacturing activities

Note: X = Yes

GMP requirements for blood manufacturing activities

Section	Regulation	Applies Directly	*Applies in part	**Does Not Apply
Footnotes *  applies in part = applies as described in annex. **  does not apply = does not apply as described in the guidelines, only applies as described in the annex.
Premises	C.02.004		X
Equipment	C.02.005		X
Personnel	C.02.006		X
Sanitation	C.02.007			X
	C.02.008			X
Raw Material Testing	C.02.009			X
	C.02.010			X
Manufacturing Control	C.02.011		X
	C.02.012	X
Quality Control	C.02.013		X
	C.02.014			X
	C.02.015		X
Packaging Material Testing	C.02.016			X
	C.02.017			X
Finished Product Testing	C.02.018			X
	C.02.019			X
Records	C.02.020		X
	C.02.021			X
	C.02.022	X
	C.02.023		X
	C.02.024		X
Samples	C.02.025			X
	C.02.026			X
Stability	C.02.027			X
	C.02.028			X
Sterile Products	C.02.029			X

Appendix B: Glossary of Terms

Autologous Donation

Blood collected from an individual for the purpose of transfusion back to the same individual.

Allogeneic Donation

Blood collected from an individual and placed in the general blood supply for the purpose of transfusion to another person.

Antibody Screen

Serological test by which donor serum/plasma is tested with reagent red cells of known antigenic profile to determine if unexpected clinically significant antibodies are present. "Clinically significant" refers to antibodies that may cause adverse reactions in the recipient due to incompatibility.

Blood

Whole blood collected from a single donor and processed either for transfusion or further manufacturing. The term is often used to describe blood components in general.

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-Haemophiliac Factor (AHF).

Closed System

A system for collecting and/or processing blood in containers that have been connected together before sterilization, so that there is no possibility of microbial contamination from outside after collection of blood from the donor.

Confidential Unit Exclusion (CUE)

A system that allows the donor, in private, to indicate that his/her collected blood should, or should not, be used for transfusion to another individual.

Contract Facility

Organisation performing work associated with the manufacturing process for the manufacturer.

Critical Labelling

Labelling which identifies a product or status, such as a quarantine label or blood group label, if it is used to control release for inventory.

Directed Donation

Blood collected from an individual for the purpose of transfusion to a different individual, named by the donor, who has been identified in advance to be compatible.

Facilities

Any area, including mobile clinic sites, used for the collection, testing, component production, storage (including records) or distribution of blood and blood components.

Leukapheresis

Separation of leukocytes by removing whole blood from the donor, separating the leukocytes, and returning the formed elements and plasma back to the donor.

Leuko Reduced Components

Component units that have been treated by centrifugation, filtration or other methods to reduce the amount of leukocytes per unit to a level below a standard acceptable value.

Lookback

The process of identifying current or previous donations from a donor subsequently confirmed positive for a transfusion-transmitted agent in order to identify and notify consignees and recipients of suspect blood components from that donor, and retrieve available components. A lookback may be initiated through a traceback investigation or by a report of seroconversion or infection in a donor.

Medical Officer

A person registered and licensed under the laws of a province to practice the profession of medicine.

Mobile Clinic Site

Blood collection location, not under the control of the fabricator, to which equipment and supplies must be brought prior to the donor clinic and from which they are removed at the conclusion of the clinic.

Open System

A blood collection and/or processing system which has been breached but where every effort is made to prevent external contamination by using sterilised materials and aseptic handling techniques in a clean environment.

Plasma

The fluid portion of whole blood collected, stabilized against clotting and separated from the red blood cells.

Plasmapheresis

Separation of plasma from whole blood and the continuous or intermittent return of red blood cells and formed elements to the donor. Plasma collected by plasmapheresis may be used either as source plasma for further manufacturing or fresh frozen plasma for transfusion.

Plateletpheresis

Separation of platelets from whole blood and the continuous or intermittent return of red blood cells, with or without platelet-reduced plasma, to the donor. If plasma is collected as a final product during plateletpheresis, the regulations for plasmapheresis apply.

Post Donation Information (PDI)

Information related to a donor or a donation made available to the collection facility following a donation. The information can be provided by the donor or other source. It may adversely affect the safety and/or quality of the donated blood/component. PDI does not include errors, accidents or anomalies that occur during screening or later during collection, processing or testing but are discovered at some point after the donation is made.

Processing

Any fabricating step performed between the collection of blood and the issuing of a component.

Quality Assurance (QA)

The actions, planned and performed, to provide confidence that all systems and elements that influence the quality of the product are working as expected individually and collectively.

Quality Assurance Program

Comprehensive system of an establishment for manufacturing safe, effective, and quality products according to regulatory requirements. This program includes preventing, detecting, and correcting deficiencies that may compromise product quality.

Quality Control (QC)

A component of a QA program that includes the activities and controls used to determine the accuracy and reliability of the establishment's personnel, equipment, reagents, and operations in the fabricating of blood components including testing and product release.

Quality Control/Assurance Unit

One or more individuals designated by, and reporting directly to, management with defined authority and responsibility to assure that all quality assurance policies are carried out in the organization.

Recovered Plasma

The liquid portion of a single donation of whole blood separated from cellular components and intended for further manufacture.

Serum

The liquid portion of clotted blood.

Source Plasma

Plasma collected by plasmapheresis and used for further manufacture.

Sub-Centre

Permanent site under the control of a Blood Centre, which is licensed for limited fabrication activities.

Traceback

The process of investigating a report of a suspected transfusion-associated infection in order to identify a potential implicated donor. The purpose of the investigation is to determine whether any donor who contributed to the transfusion is infected with, or positive for, serologic markers of the same infectious agent, and to retrieve available blood components from that donor, and to notify consignees and recipients of components collected from the same donor.

Unit

A specific volume of blood or one of its components obtained from a single collection of blood from one donor.