Public Cord Blood Bank
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1 The The Public Cord Blood Bank Page 1 of 21
2 TABLE OF CONTENTS INTRODUCTION... 3 WHAT ARE GOOD MANUFACTURING PRACTICES? TOTAL QUALITY PREMISES EQUIPMENT AND MATERIAL PERSONNEL RAW MATERIAL TESTING MANUFACTURING CONTROL NON-CONFORMITIES AUDITS RECORDS CONCLUSION Page 2 of 21
3 INTRODUCTION This manual describes the Good Manufacturing Practices (GMPs) taken from Health Canada regulations and adapted for the reality in hospitals. You will see how these Good Practices apply to everything you do at work as well as in your daily life since GMPs are just plain common sense. The objective is to make you aware of and familiar with Good Practices in order to standardize the work methods used by the hospitals and Héma-Québec. The following regulations, which apply to facilities that handle blood and blood derivatives, are described in two main documents published by Health Canada: Annex to the GMP Guidelines: Part 2 of Good Manufacturing Practices for Schedule D Drugs, which is entitled Human Blood and Blood Components The Good Manufacturing Practices Guidelines. Specific sections of these regulations are included in this document. The Public Cord Blood Bank must also meet CSA Standard Z , Cells, tissues, and organs for transplantation and assisted reproduction: General Requirements and Z , Lymphohematopoietic cells for transplantation. Health Canada (HC) has divided the GMPs in keeping with the chronological order in which they are completed. Before marketing a product, the manufacturer needs premises, equipment and personnel. This is followed by the procurement of raw materials, manufacturing, etc. An overview of the standards applicable specifically to hematopoietic stem cells originating from cord blood will help you understand the role of hospitals as collection centers and link them to GMPs. The diagram on the following page shows how Héma-Québec meets Health Canada and CSA requirements and where you stand as hospital personnel. Page 3 of 21
4 Health Canada Standards regulation applicable to blood guide lines GMPs and Schedule D Canadian Standards Association (CSA) Standards Standards Institutions handling blood and blood products Hematopoietic stem cells from cord blood Hospital. Page 4 of 21
5 WHAT ARE GOOD MANUFACTURING PRACTICES? The Good Manufacturing Practices that concern the entire pharmaceutical field are basically requirements issued by Health Canada to ensure the marketing of safe and of optimum quality products. The Guidelines set out minimal practices that the manufacturer must follow in order to maintain its licence: The holder of an establishment licence, or any operation to which the requirements of Division 2 are applicable, must ensure that the fabrication, packaging, labelling, distribution, testing, and wholesaling of drugs comply with the requirements of the marketing authorization and do not place consumers at risk due to inadequate safety and quality. The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment of personnel in many different departments and at all levels within the establishment and its suppliers. To achieve the objective reliably, there must be a comprehensively designed and correctly implemented system of quality assurance that incorporates Good Manufacturing Practices and thus quality control. The system should be fully documented and its effectiveness monitored. All parts of the quality assurance systems should be adequately resourced with qualified personnel, suitable premises, equipment, and facilities. Health Canada, Good Manufacturing Practices Guidelines, 2002 Edition, p. 6. More specifically, the standards applicable to lymphohematopoietic stem cells regulate : The Institutions (or their services) who transplant lymphohematopoietic stem cells as well as the people who participate in: the evaluation and acceptance of the donors, the collection process, the labeling, packaging and recording of files. The treatment, quarantine, conservation and storage, the declaration of an adverse events, the distribution import-export and the recall of products as well as the transplantation of lymphohematopoietic stem cells, and particularly to: the clinical transplantation programs the lymphohematopoietic stem cells collection services the lymphohematopoietic stem cells treatment services Note : The institutions (or their services) as described in points a) to c) may be situated in the same geographic area, or in a separate institutions and may be exploited independently. (Z Lymphohematopoietic cells for transplantation) Page 5 of 21
6 The Public Cord Blood Bank applies Canadian regulations in order to be able to supply cord blood that is both safe and of optimum quality. The hospital staff involved in the collection of cord blood therefore becomes an important link in a process where the goal is to supply to the recipient a secure product that represents total quality. HOSPITALS + HÉMA-QUÉBEC Donor Recipient These regulations must be applied to all levels throughout the process. Enrollment Preparation and and mailing mailing of of documents Preparation of of material Verification of of documents Reception and and filing filing documents at at the the hospital hospital Collection Labelling Packaging Release to to inventory Quarantine Cryopreservation Treatment Reception Shipping Page 6 of 21
7 1 TOTAL QUALITY The Good Practices are part of a process referred to as total quality. Total quality is the quality of the product (cord blood), the quality of the service provided to internal clients (at Héma-Québec) and external clients (hospitals and future parents) and respect for the donor (the child). Total quality means surpassing the client s expectations and exceeding their satisfaction. Quality starts with needs to be met; it results from a desire that is made concrete by means of a policy implemented by general management; it is created by designers, purchased by the procurement department, manufactured by the operators in the production department who are hired and trained by the human resources department. It is stored, shipped, distributed, used and maintained by various stakeholders, each of whom has a direct impact on quality. Manufacturing is just one link and the quality specialists can only observe what is produced and offer their technical support to those who create it, purchase it, make it, sell it, store it, ship it, install it, use it. (Unofficial translation Pour une Qualité Totale, Joseph Kélada, p. ii. Here are the principal guidelines established by the Canadian Standards Association (CSA) for hematopoietic stem cells : A quality assurance program must be initiated and maintained in order to ensure that all procedures, rules and regulations are respected and applied. The Operating procedures manual must describe the elements which are submitted to Quality control, which should include the following ; without limiting itself to it: The competency evaluations to which the employee s have been submitted to, in order for them to be able to carry out their functions while respecting procedures. And any corrective measures which have been applied to correct inefficiency. Periodic calibration of equipment (for example : the scale which is used to weigh the cord blood bags). (Z Cells,Tissues, and Organs for Transplantation and Assisted Reproduction, General Requirements.) It is up to each of the links in the large chain that connects the hospitals to Héma-Québec to ensure that their work is done according to standards so as to avoid errors, prevent non-conformities and ensure that the product is of optimum quality for the recipient. Page 7 of 21
8 2 PREMISES REGULATION Guidelines C The premises in which a lot or batch of a drug is fabricated or packaged/labelled shall be designed, constructed and maintained in a manner that: permits the operations therein to be performed under clean, sanitary and orderly conditions; permits the effective cleaning of all surfaces therein; prevents the contamination of the drug and the addition of extraneous material to the drug. CSA standards applicable to hematopoietic stem cells state that: Each establishment (or their service) must have suitable premises, as described in the Operating procedures manual, in order to operate with a optimum degree of precision, efficiency, sterility, speed and security established by this standard. The Premises must be appropriate to carry out the activities intended and satisfy the fundamental standards of asepsis, offer sufficient space with restricted access for file recordings and storage ( for example: collection devices must be stored in a restricted area in the maternity ward ). (Z Cells, Tissues, and Organs for Transplantation and Assisted Reproduction, General Requirements.) Page 8 of 21
9 3 EQUIPMENT AND MATERIAL The regulations applicable to hematopoietic stem cells are as follows : Establishments (or their services) must have in their possession the necessary materials to accomplish their activities with efficiency and optimal precision. (Z Cells,Tissues, and Organs for Transplantation and Assisted Reproduction, General Requirements.) In respect to the cord blood collection, the hospital staff should use material designed specifically for this purpose (i.e., collection devices). Standards of asepsis must be rigorously met so as to prevent any contamination of the blood product. Throughout the collection process it is rigour that will enable us to avoid errors and contamination. In order to prevent direct or cross contamination, all materials, instruments and reusable surgical devises used for collection or treatment purposes must be cleaned, disinfected and sterilized after each use; as stipulated in the Operating procedures manual. These procedures are already established and in effect in hospital centres. Page 9 of 21
10 4 PERSONNEL We have clean, adequate premises and the required materials; all we need is qualified personnel to implement the collection procedure. REGULATION Guidelines C RATIONAL People are the most important element in any pharmaceutical operation, without the proper personnel with the right attitude and the right training, it is almost impossible to fabricate, package/label, test, or store good quality drugs. It is essential that qualified personnel be employed to supervise the fabrication of drugs. The operations involved in the fabrication of drugs are highly technical in nature and require constant vigilance, attention to details and a high degree of competence on the part of employees. Inadequate training of personnel or the absence of an appreciation of the importance of production control, often accounts for the failure of a product to meet the required standards. Health Canada, Good Manufacturing Practices Guidelines, Edition 2002, p. 23. REGULATION Schedule D C 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 GMPs relevant to their work. Records of the qualifications, training, and continuing competence of individuals shall be maintained. Moreover the Canadian Standards Association also requests the following: Qualified and experienced personnel, as outlined in the SOP manual, shall be available to carry out required procedures. They shall have the skills, experience, educational background, training, and Page 10 of 21
11 necessary authority to perform their duties properly and safely, and shall ensure that quality assurance (QA) measures are carried out. Documentation of personnel qualifications shall be maintained as part of the personnel record. There shall be a documented orientation and training program for new personnel to ensure that they understand, and can properly and safely perform, their assigned duties. Ongoing training shall be provided to all technical staff. Employees shall maintain competency in the activities they perform ( example: packaging, labelling ). (Z Cells,Tissues, and Organs for Transplantation and Assisted Reproduction, General Requirements.) Why must we offer GMPs training to hospital personnel? We already know that the hospital staff has the expertise required in the delivery room. The purpose of the GMPs training is to certify their ability to take part in the cord blood collection procedure, while respecting the standards to which Héma-Québec is submitted to, as well as to ensure traceability. Page 11 of 21
12 5 RAW MATERIAL TESTING Before starting the manufacturing phase, we must make sure that we have the raw materials, including packaging, and suppliers who satisfy the standards. REGULATION Schedule D C Because whole blood is the source material for blood components, special considerations are given to the procedures for donor screening and vendor audit (C ). Donor Screening: All blood donors must be found acceptable each time they donate based on the approved health screening criteria. 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. Health Canada, Good Manufacturing Practices for Schedule D Drugs, Part 2, Human Blood and Blood Components, 1999, p. 10. According to CSA regulations, here are certain requirements that specifically apply to cord blood donations destined to allogenic transplantations: Laboratory testing must be carried out ( ex: HLA, ABO Group, Rh factor) as well as infectious disease tracking ( ex: anti-hiv Antibodies, syphilis ). Must correspond to requirements in regards to quality indicators (ex: cell numeration, volume ). The future donors must be evaluated by using their past medical history which must comply to the qualification criteria as stated in the Selection criteria manual for cord blood donations. (Z Cells,Tissues, and Organs for Transplantation and Assisted Reproduction, General Requirements.) Page 12 of 21
13 Héma-Québec will select the future donors (mothers) who will donate their child s cord blood. A medical qualification questionnaire ensures quality control of the product by reducing the risk of passing on family illnesses, genetic disorders or transmittable diseases. The hospital staff takes over and ensures product quality during the collection process by accurately following procedures. Raw material quality is essential to the quality of the finished product. 5.1 SUPPLIERS Who are the suppliers and what do they do? In the case of cord blood donations, we are working with more than one supplier. The initial supplier provides the crucial material (i.e., the collection device). This supplier must be able to guarantee that it has a quality control system in place (GMPs, ISO, etc.) and that it follows the procedures of that system. Obviously, the donor (the mother who donates her baby s cord blood) is the second yet equally important supplier since she must satisfy the qualification criteria established by Héma-Québec. 5.2 OUR SHARED RESPONSIBILITY Once Héma-Québec s Public Cord Blood Bank personnel has qualified the medical fitness of the future mother, it is up to the hospital staff to make sure that the standards are respected and applied when the cord blood is collected. Not only does the mother have to qualify, but the procedure continues with the qualification of the cord blood itself (namely the baby s blood) after which the product will be placed into inventory and used for transplant. Unless all procedures are rigorously respected, the entire process is rendered impossible. Page 13 of 21
14 6 MANUFACTURING CONTROL REGULATION Guidelines C Every fabricator, packager/labeller, distributor referred to in paragraph C.01A.003(b) and importer of a drug shall have written procedures prepared by qualified personnel in respect of the drug to ensure that the drug meets the specifications for that drug. RATIONAL This Regulation requires that a number of measures be taken to maintain the integrity of a drug product from the moment the various raw materials enter the plant to the time the finished dosage form is released for sale. These measures seek to ensure that all manufacturing processes are clearly defined, systematically reviewed in light of experience, and shown to be capable of consistently manufacturing pharmaceutical products of the required quality that comply with their established specifications. Health Canada, Good Manufacturing Practices Guidelines, 2002 Edition, p. 33. REGULATION Schedule D (the points listed here apply to hospitals) C Written Standard Operating Procedures (SOPs) Every manufacturer shall maintain and control all documents (policies, processes, procedures and forms) relating to the requirements for each activity in the manufacturing process. SOPs must be clear, concise, current and approved, and be available in the area where the activity is performed. The SOPs must describe the significant steps of the operation: Method of accurately and uniquely relating the blood components or product(s) to the donor, donor samples, and all associated records, for each donation. 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. Page 14 of 21
15 Specific manufacturing procedure(s) for the preparation of all components, including labelling steps (i.e., type of labels and method of labelling). Each institution (or their service) must keep an Operating procedures manual which describes all the aspects of the following: evaluation and donor qualification, collection, treatment, conservation, labelling, packaging, storing, quarantine, evaluation, record files, declaration of adverse effects, distribution, importexport, product recall for cells, tissues and organs. The standard operating procedures (SOPs) are the key element in any quality system. The procedures describe the steps leading to a result/product that satisfies predetermined quality criteria. These quality criteria are determined by government organizations through regulations, customer requirements in the specifications, standards set by professional organizations, etc. The procedures describe the steps that must be followed for manufacturing, testing, storing and distributing products. The procedures must be followed if the organization is to function properly, maintain the quality of the product or service offered and satisfy the fundamental requirements of Good Manufacturing Practices. There is a specific SOP for each step in the cord blood bank procedure. If a step in the procedure is defective, the product is not compliant and must, in certain cases, be destroyed. For example, labelling is a very important step in a quality system. Labelling errors may result in the loss of human life through: Incorrect use of the product The inability to track the product The loss of the product history To sum up, procedures are essential if the organization or group is to function properly. Procedures are ways of doing things to ensure standardization and prevent errors that could harm the effectiveness or the quality of the product or service. Hospital staff may draw connections between the protocols that have already been established and the SOP s. Page 15 of 21
16 7 NON-CONFORMITIES A procedural defect, a step in a procedure that is forgotten or a failure to respect a procedure: Results in non-conformities Has an impact on the product May results in the rejection of the product (lost donation) These defects, omissions or failures to respect procedures are called non-conformities. They are documented in writing in order to ensure: Follow-up Modifications (as required) That training is updated (as required) More rigorous compliance Héma-Québec manages non-conformities with a five-step procedure: Non-conformities are detected using the following tools: Internal audit reports External audit reports (prepared by external agencies) Verification of files Internal system for declaring non-conformities. Investigation of non-conformities The purpose of the investigation is to document all of the facts concerning the incident in order to determine the primary cause of the non-conformity. The investigation covers all of the people involved or affected as well as procedure experts and, as needed, witnesses. In order to evaluate the procedure or the system involved in the non-conformity, we must determine if the related elements of the system are adequate: SOPs, training, personnel assignment, equipment, etc. Assessment of non-conformities Page 16 of 21
17 During the assessment, we must identify the primary cause of the non-conformity, determine the scope of the problem, determine whether other factors contributed to the non-conformity and, finally, assess the gravity of the non-conformity. Correction of non-conformities Short-term: Take corrective measures (actions taken to eliminate the causes of a nonconformity). Long-term: Correct the cause of the problem so that it does not recur (was it an isolated incident or a systemic problem?) Communication of non-conformities In order to be of use, the data collected must be analyzed and communicated to the various departments, namely the nurse responsible for the non-conformity and the head nurse of the unit concerned. In the case of repeated non-conformities, the required corrective measures will be applied To sum up, an effective quality improvement system requires the full and complete involvement of all employees. It is not a matter of casting doubt on the competence of the hospital staff but of making these employees aware of the importance of respecting procedures and of the impact of non-conformities on the product (for example: the recall of the product). Page 17 of 21
18 8 AUDITS Per definition, an audit is an independent process which is documented. It allows to determine in an objective way if the activities (ex: installations, transformation, and qualification of products) are in conformity with: Health Canada s requirements and regulations Procedures or Company policies According to CSA regulations: Internal audits must take place once a year by a quality assurance service which assumes no direct responsibility relatively to the service concerned with this particular process (all services are audited at Héma-Quebec). Page 18 of 21
19 9 RECORDS REGULATION Guidelines C RATIONAL Good documentation is an essential part of the quality assurance system and should therefore be related to all aspects of GMPs. Its aims are to: Define the specifications for all materials and methods of fabrication, packaging/labelling, and control. Guarantee that the Quality Control department has all the information necessary to decide whether or not to release a lot of a drug for sale. Provide an audit trail that will permit investigation of the history of any lot that is suspected to be defective. The fact that drugs have been manufactured, packaged and labelled in keeping with the requirements can only be proven if adequate record systems have been prepared for this purpose. These records should provide assurance that imported drugs are manufactured, packaged and labelled in a manner similar to those manufactured in Canada. Therefore: The form must be completed in a legible, clear and indelible manner. Do not use lines or quotation marks to indicate repetition. Identify those who completed the steps in the procedure. Do not hide information. Complete the documentation immediately after completing the work (not in advance and not from memory). Repositionable notes (Post-Its) and liquid corrector must NEVER be used on forms since all entries must be legible, indelible and permanent. Corrections are made by drawing a horizontal line through the inaccurate information so that the original text remains legible and by entering the corrected information as close as possible to the initial entry. All corrections made by staff must be initialled and dated. Page 19 of 21
20 Cells, tissues, and organs must be labelled in order to be identifiable and traceable during all the stages from the collection, treatment, conservation, storage, distribution. In order to facilitate the follow-through from donors to recipients. The unique identification number must be present on the label which identifies the cells, tissues and organs. (Z Cells,Tissues, and Organs for Transplantation and Assisted Reproduction, General Requirements.) Records in regards to the public cord blood bank must be kept indefinitely and must be accessible at all times. To sum up, inscriptions to files and conservation of all documents related to the collection of cord blood are of primary importance. They ensure traceability, namely who did what, when and where. Any action must be noted in a file immediately after it is taken, thereby reducing the risk of error. Page 20 of 21
21 10 CONCLUSION In conclusion, GMPs are based on regulations issued by Health Canada. They provide a way of performing daily tasks. By respecting and applying these Good Practices, we ensure a safe product of optimum quality for the recipient. When you hear about a cord blood transplant, you know for certain that the product is of high quality since you ensured that quality. Page 21 of 21
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