Advanced Search

Enacting The Regulation, With The Detailed Regulations For The Operation And The Quality System Of Blood Establishments And Companies Solely For The Transfusion Given Blood Or Blood...

Original Language Title: Erlassung der Verordnung, mit der nähere Regelungen über den Betrieb und das Qualitätssystem von Blutspendeeinrichtungen und Betrieben, die ausschließlich zur Transfusion bestimmtes Blut oder Blut...

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$40 per month.

156. Regulation of the Federal Minister for Health, Family and Youth, with which the regulation, laying down detailed rules on the operation and quality system of blood establishments and establishments, the blood intended solely for transfusion, or blood components are to be processed, stored or distributed, (QS-VO-Blood), adopted, and the Regulation on medicinal products derived from human blood and the AMBO 2005 will be amended

Article 1

Regulation of the Federal Minister for Health, Family and Youth, laying down detailed rules on the operation and quality system of blood establishments and establishments that exclusively contain blood or blood components intended for transfusion. be processed, stored or distributed, (QS-VO-Blood)

Due to § 21 Blood Safety Act 1999, BGBl. I n ° 44, as last amended by the Federal Laws BGBl. I No 107/2005 and BGBl. 6/2007, and § § 62 and 62b of the German Medicines Act (BGBl). No. 185/1983, as last amended by the Federal Laws BGBl. I n ° 153/2005 and BGBl. I n ° 6/2007, shall be arranged:

Scope

§ 1. (1) This Regulation shall apply to the operation of blood establishments in accordance with Section 5 of the Blood Safety Act 1999, BGBl. I n ° 44, as last amended by the Federal Laws BGBl. I No 107/2005 and BGBl. I n ° 6/2007, including mobile blood donation facilities; further to establishments that process, store or distribute blood or blood components intended solely for transfusion. The term "establishment" in this Regulation refers to both of the institutions mentioned above.

(2) This Regulation shall not apply to blood depots pursuant to Section 8f of the Federal Law on Hospitals and Courses, Federal Law Gazette (BGBl). No. 1/1957, as last amended by the Federal Laws BGBl. I No 122/2006 and BGBl. I No 6/2007, or the country's statutory provisions on this subject.

(3) The General Workers ' Protection Regulation, BGBl. No 218/1983, as last amended by BGBl. II No 77/2007, and the Regulation on biological agents, BGBl. II No 237/1998, shall not be affected by this Regulation.

Quality system

§ 2. (1) The quality system of companies comprises the organisational structure, responsibilities, procedures, processes and resources for the implementation of quality management. Quality management means all coordinated activities for the management and control of the company in terms of quality at all levels.

(2) Quality shall be sought by all persons involved in the work processes, with the medical director or the responsible person and the management ensure a systematic quality claim and the introduction and maintenance of a quality system.

(3) The quality system shall ensure that all critical work processes are determined in appropriate written instructions and carried out in accordance with the standards and specifications set out in this Regulation. The medical director or the responsible person and the management have to check the system on a regular basis for efficiency and, where appropriate, to carry out appropriate corrective measures.

(4) The quality system must be in accordance with the state of the art of science and technology, in accordance with the guidelines adopted by the Commission for good practice in accordance with Article 29 lit. h of Directive 2002/98/EC.

Quality assurance

§ 3. (1) Quality assurance shall include all activities related to the collection of blood or blood components, including the necessary study of the donor and laboratory examination of the blood of donors and, where appropriate, the the necessary quality controls in relation to the processing, storage or distribution and the release to ensure that blood and blood components are used for the application in humans, the quality of the application in the context of its own blood donation.

(2) The quality system shall be guided by a person with the appropriate qualification, which is independent of the extraction, including, where appropriate, of the processing. This function can also be fulfilled by external quality assurance officers. This person must be involved in all issues relevant to quality, and shall review and approve all relevant quality-related documents.

(3) premises and equipment which have a direct influence on the quality and safety of blood and blood components must be qualified before they are introduced and regularly determined by the outcome of that qualification. Time slices are re-qualified.

(4) All procedures which have a direct impact on the quality and safety of blood and blood components must be validated before they are introduced and, in regular intervals determined by the result of such validation, will be validated.

(5) The establishments shall establish self-control or audit systems for all operations in order to verify conformity with the standards set out in this Regulation. The measures shall be carried out on a regular basis by trained and knowledgeable persons in accordance with the procedures laid down in advance.

(6) All the results of the checks referred to in paragraph 5 shall be documented and appropriate and effective corrective and preventive measures shall be taken in good time.

Staff

§ 4. (1) Holdings must have a sufficient number of qualified staff to carry out the activities relating to the production of blood and blood components, including the carrying out of laboratory tests, and, where appropriate, to those related to the production of blood and blood components. the processing, storage or distribution of related activities. The staff must be trained in such a way that they can carry out their duties properly before they start their duties. The staff of the staff must be regularly evaluated.

(2) The content of the training programmes shall be regularly reviewed and updated. The training measures must be documented.

(3) The tasks, responsibilities and responsibilities of the staff must be defined in functional descriptions which shall be regularly updated.

(4) The functional positions shall be defined in an organization scheme.

(5) Function descriptions and the organisation scheme shall be approved according to internal procedures.

(6) The medical director or the responsible person and all staff in a senior or responsible position shall be given sufficient powers to enable them to carry out their duties.

Person responsible

§ 5. (1) Any holding that processes, stores or distributes blood or blood components intended solely for transfusion shall have an uninterrupted possession of a responsible person responsible for ensuring that the processing, storage and distribution in accordance with the provisions of this Regulation and Annex B to the Regulation on medicinal products derived from human blood, BGBl. II No 187/2005, as last amended by BGBl. II No 156/2007, and the state of science and technology, and that blood and blood components comply with the specifications set out in Annex A to the Regulation on medicinal products derived from human blood.

(2) The responsible person shall also be responsible for the continuous training of the personnel, the establishment and maintenance of the quality system, the proper documentation, the traceability and the recall of blood, or Blood components responsible.

(3) The person responsible shall, in a Contracting Party to the Agreement on the European Economic Area or in Switzerland, be required to study human, dental or veterinary medicine or other studies in the field of life sciences or a study of the have completed, in the Contracting State concerned, an equivalent qualification and, after their successful completion, they have completed at least two years of professional activity in the European Economic Area or in Switzerland in one or more a number of holdings which have a permit for processing, storage and The distribution of blood or blood components during the period of this activity has been completed.

(4) The application for the grant of the authorization in accordance with § 63 of the German Medicines Act (Medicines Act) must be accompanied by the necessary documents on the person responsible The holder of the authorization shall inform the Federal Office for Health Safety of all changes in relation to the responsible person in advance. In the event of an unforeseen change, the notification shall be made without delay.

Premises

§ 6. (1) The premises, including mobile blood establishments, shall be set up and maintain that they are suitable for the activities to be carried out. They must offer the possibility of a logical sequence of work steps to minimize the risk of error, and allow effective cleaning and maintenance to reduce the risk of contamination of both the donor and the environment Minimum to be reduced.

(2) In order to protect privacy, it is necessary to establish in blood establishments an area for confidential personal conversations with donors and for the assessment of their health suitability. This area is available from all withdrawals and/or Separate separation and laboratory areas.

(3) The removal of blood or the separation of blood components shall be carried out in an area intended for the safe removal of blood or separation of blood components. It shall be fitted in such a way that it is suitable for the initial treatment of donors in the case of the removal or removal of such donors, respectively. In order to ensure that the safety of donors and personnel is guaranteed and that there is an error in the removal and/or removal of the product, the safety of donors and personnel should be ensured. Separation methods are avoided.

(4) To test the blood taken, or the separated blood components of the donor to the perfect condition of the blood or blood components obtained shall be established in a special laboratory area from the donor evaluation area and from the removal or removal of blood components to the blood components. Separation area is separated and only authorized to access.

(5) The safe disposal of medical waste, including the use of disposable material and blood or blood components used in the collection and testing of blood or blood components, shall be ensured.

Equipment

§ 7. (1) The equipment, such as machinery and instruments, as well as other operating and auxiliary equipment, must be suitable for the work to be carried out in each case and be present in sufficient numbers, so that a state of the art and technology is available. ensuring that all activities are carried out in operation. The equipment shall be selected in such a way as to reduce to a minimum a risk to donors, personnel and blood or blood components.

(2) The equipment intended for use in the work steps critical to the quality of the product shall be qualified according to its intended use.

(3) Waagen, weight pieces and other measuring devices are according to the measure and calibration law, BGBl. No. 152/1950, as last amended by the Federal Laws BGBl. I n ° 137/2004 and BGBl. I n ° 6/2007. According to the result of a risk analysis as critically defined measuring devices, which do not fall under the measure and calibration law, must be appropriately qualified and calibrated.

(4) The equipment must be kept hygienically correct and must be cleaned at appropriate intervals and waiting. For the purposes of cleaning and maintenance, written instructions must be drawn up which must be kept in the institution for five years from the date of the last signed signature.

(5) Only reagents and materials that comply with the documented requirements and specifications may be used. Critical materials must be released by a person who is technically suitable for the performance of this task. If necessary, the materials, reagents and devices must comply with the requirements of the Medical Devices Act, BGBl. No. 657/1996, as last amended by the Federal Laws BGBl. I n ° 153/2005 and BGBl. I n ° 6/2007, the requirements of Council Directive 93 /42/EEC on medical devices and Directive 98 /79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices, or-in the case of procurement in third countries-equivalent standards .

(6) Documents on the stock of equipment as well as on the qualification, cleaning and maintenance (device-specific data) shall be kept for at least five years from the last date of the signature.

(7) If computer-assisted systems are used, software, hardware and data protection procedures shall be validated prior to use and regularly checked. Hardware and software shall be protected from unauthorised use or unauthorized modification. The data backup must prevent loss or damage to the data in case of expected and unexpected downtime or malfunction.

Documentation

§ 8. (1) A documentation shall be established on specifications, procedures and records relating to each work step carried out by the holding. These documents must be clear, clear, error-free and up-to-date.

(2) If data are not recorded in writing but with electronic, photographic or other data processing systems, the operation shall validate the system in advance by demonstrating that the data during the foreseeable future shall be Retention period is saved correctly. These data stored with such systems must be made available at any time in a legible form and must be submitted to the Federal Office for Health and Safety in the Health Care Sector on request. Electronically stored data must be protected against data loss or damage by appropriate measures such as duplication or back-up and transfer to another storage system. These measures must be comprehensible.

(3) Any substantial modification of documents shall be reviewed, dated and signed without delay by a person authorized to do so.

Recovery of blood and blood components

§ 9. (1) The method of obtaining blood or blood components shall ensure that the identity of the donor is verified and documented safely, and that the link between donor and blood, blood components and blood samples is clearly established is fixed.

(2) The sterile collection and processing systems used in the collection of blood and blood components shall bear the CE mark or, in the case of procurement from third countries, comply with equivalent standards. The batch number of the container must be traceable for each blood component.

(3) The method of obtaining blood or blood components must reduce the risk of microbial contamination to a minimum.

(4) Blood of the donor, which shall be subjected to a laboratory examination for the purpose of testing the flawless nature of the blood or blood components obtained, shall be taken out at the time of donation and shall be stored properly prior to the examination.

(5) The procedure for the identification of documents, collection systems and laboratory samples with donor numbers shall be designed in such a way as to avoid any risk of an identification error or confusion.

(6) After extraction, the blood bags are to be handled in such a way that the quality of the blood is not impaired and a storage and transport temperature suitable for the further processing is ensured.

(7) It is necessary to provide for a system which ensures that at each donation a reference to the collection and processing system with which it has been obtained and/or processed can be made.

Operating hygiene

§ 10. (1) It is necessary to ensure that blood and blood components are not adversely affected by external influences.

(2) This shall be carried out in accordance with a hygiene programme which must be in operation. The instructions shall be designed to prevent contamination of equipment, collection and processing systems and blood and blood components.

(3) The hygiene programme shall at least contain:

1.

Instructions for the hygienic behaviour in the production of blood and blood components, including the carrying out of laboratory tests, where appropriate during processing and storage, as well as information on the work clothes to be used,

2.

Instructions on the cleaning and disinfection measures to be carried out, their frequency and the equipment and tools to be used,

3.

particulars of persons responsible for cleaning or disinfection and those responsible for the proper conduct of those activities; and

4.

Instructions for the disposal of waste, including information on the authorising officers responsible for disposal and responsible for the proper conduct of those activities.

(4) The hygiene programme shall, where appropriate, be the person responsible for the collection of blood and blood components, including the carrying out of laboratory tests, and, where appropriate, the person responsible for processing and storing them and persons referred to in paragraph 3 (3) (3) and (4) prior to the start of their duties, after each modification of the hygiene programme and subsequently, at least once a year, to be brought to the attention of the persons concerned.

(5) Waste water, waste and other residues in and out of the working spaces and their immediate environment shall be disposed of in a safe and hygienic manner.

Laboratory tests

§ 11. (1) All laboratory examination procedures shall be validated prior to use.

(2) Each donation is in accordance with § 12 of the Blood Dispenser Ordinance, BGBl. II No 100/1999, in the BGBl version. II No 188/2005.

(3) The suitability of the non-CE-labelled laboratory reagents used in the laboratory testing of donor samples shall be validated and re-validated in the time intervals established by this validation.

(4) The quality of the laboratory tests shall be regularly assessed by taking part in a formal performance test system, for example by taking part in ring trials.

Marking

§ 12. (1) During all stages of manufacture, all containers shall be marked with relevant information on their identity. If there is no validated computer-aided condition control system, unreleased and unreleased units of blood and blood components must be clearly distinguished from the label.

(2) The labelling system for the blood obtained, as well as the semi-finished and finished blood components and samples, must clearly identify the respective contents and the requirements for re-enforcability in accordance with § 11 (2) of the Blood Safety Act and comply with the labelling requirements laid down in Article 9 of the Regulation on medicinal products derived from human blood.

Processing and storage

§ 13. (1) Processing shall be carried out in accordance with appropriate validated procedures, including measures to avoid the risk of contamination and of microbial infestation in the blood components obtained.

(2) The procedures for the storage and distribution of blood or blood components shall be validated in order to ensure the quality throughout the storage period and to exclude the confusion of blood components. All transport and storage operations, including receipt and distribution, shall be determined by written procedures and specifications.

(3) Own blood and blood components and blood components obtained and processed for specific purposes shall be stored separately.

(4) Inventory and distribution shall be accompanied by appropriate documentation, including the type and quantity of blood components, the date of extraction and processing, as well as the delivery and the receiving position. This documentation shall be kept for at least 30 years in the establishment, if it is necessary for traceability.

(5) Blood or blood components taken back may only be allocated to the levy for the levy if it is ensured that all the quality requirements and procedures laid down in order to ensure the integrity of the blood or blood components.

(6) The premises for storage must ensure the proper, safe and separate storage of different categories of blood and blood components. Provision should be made for the failure of the equipment or the energy supply in the storage area.

Release of blood and blood components

§ 14. (1) Through a safe and reliable system, it is necessary to prevent individual blood units and blood components from being released before all the specified requirements are met.

(2) Any holding that processes, stores or distributes blood or blood components intended solely for transfusion must be able to demonstrate that each blood unit or blood component is obtained by a validated computer-based system, or a responsible person has been released by signature. Prior to release, appropriate records shall demonstrate that the blood components comply with the specifications set out in Annex A to the Regulation on medicinal products derived from human blood.

(3) Prior to release, blood and blood components must be kept separate administratively and physically from released blood and released blood components. A system is to be set up to visually identify the release status of the products.

(4) If the finished blood component cannot be released due to an examination result pursuant to Section 12 (3) of the Blood Spender Regulation, it shall be ensured by means of a check that the remaining components are from the same donation and from previous Donations made by the same donor are identified. The donor documentation must be updated immediately.

Contract management

§ 15. (1) Tasks which are carried out externally shall be defined in a written agreement between the establishment and the contractor. In this Agreement, the tasks and responsibilities of each page shall be clearly defined in terms of the duration and scope of the tasks. The agreement must be permanently in operation in the original or in the form of a copy. Upon request, the Federal Office for Health Security must prove the existence of the agreement. The contractor shall not pass on to third parties without the written consent of the company the contract which is contractually transferred to him.

(2) Depending on the nature of the activity, the contractor must, where necessary, be granted a blood donation facility or an authorization pursuant to § 63 of the German Medicines Act or a corresponding authorization by a competent authority of a competent authority. other Contracting Parties to the Agreement on the European Economic Area.

Traceability

§ 16. Within the framework of the documentation to be carried out for the complete traceability of the transfusion chain, each donor, blood unit or blood component unit obtained, including the date of production and each of the resulting units, shall be The blood component and all the devices to which a specific blood component has been supplied must be clearly identifiable.

Non-compliance

§ 17. (1) All information, including serious adverse reactions and incidents, which suggest that defective blood components have been made available, should be documented and carefully examined for the causes of the defect. If necessary, corrective measures shall be taken to prevent the recurrence of the error. The procedure in these cases shall be laid down in written instructions which must be in operation.

(2) procedures should be laid down to ensure that the Federal Ministry of Health, Family and Youth, or a body designated by that authority properly on serious incidents in accordance with Section 75d of the German Medicines Act and the Regulation on Hemovigilance in 2007, BGBl. II No 155/2007.

Recall

§ 18. (1) establishments shall establish an effective recall procedure, including a description of the responsibilities and the measures to be taken. This also includes the notification in accordance with § 75d of the German Medicines Act and the Ordinance on Hemovigilance in 2007.

(2) Holdings must have professional staff with the power to assess the need to recall blood and blood components and to initiate and coordinate the necessary measures.

(3) The measures shall be carried out within a reasonable time limit laid down in advance. In this case, all the affected blood components must be determined and, if necessary, traced back in order to identify all donors who may have caused the transfusion reaction. Blood components from this donor must be identified and supplied to the equipment (and recipients of the blood components obtained from the same donor) to inform them of the potential risk.

Corrective and preventive measures

§ 19. (1) In the context of quality assurance, a system is to be set up to ensure corrective and preventive measures in the case of non-compliant blood components and quality problems.

(2) A routine data evaluation shall be carried out in order to identify quality problems requiring corrective action, or adverse developments which may require preventive measures.

(3) All errors and incidents shall be documented and investigated in order to identify problems of the quality system with a view to a necessary correction.

References to acts of the European Community

§ 20. This Regulation shall

1.

Directive 2005 /62/EC on the implementation of Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications for a quality system for blood establishments, OJ L 327, 30.4.2005, p. No. OJ L 256, 1.10.2005 p. 41,

2.

Directive 2005 /61/EC on the implementation of Directive 2002/98/EC of the European Parliament and of the Council as regards requirements for traceability and reporting of serious incidents and serious adverse reactions, OJ L 327, 30.12.2005, p. OJ No 256, 1.10.2005, p. 32,

.

Article 2

Regulation of the Federal Minister for Health, Family and Youth, amending the Regulation on medicinal products derived from human blood

According to § § 5, 20 and 62b of the Medicines Act, BGBl. No. 185/1983, as last amended by the Federal Laws BGBl. I n ° 153/2005 and BGBl. I n ° 6/2007, and § 7 of the Drug Import Act 2002, Federal Law Gazette (BGBl). I n ° 28, as last amended by the Federal Laws BGBl. I No 41/2006 and BGBl. I n ° 6/2007, shall be arranged:

The Federal Minister for Health and Women's Regulation on medicinal products derived from human blood, BGBl. II No 187/2005, shall be amended as follows:

1. The Word "and" at the end of Section 4 (1) (1) (1), the point at the end of Section 4 (1) (2) shall be replaced by "and" replaced and the following Z 3 added:

" 3.

and in the blood establishments, a traceability system established in accordance with the procedure referred to in Article 2 (2) to (5) of Directive 2005 /61/EC on the implementation of Directive 2002/98/EC of the European Parliament and of the Council as regards the Requirements for traceability and reporting of serious adverse events and serious adverse reactions, OJ C 327, 30.4.2002, p. 32., is equivalent to the system laid down in paragraph 2. '

2. § 8 is deleted.

3. The point at the end of § 10 Z 2 shall be replaced by a stroke, the following Z 3 shall be added:

" 3.

Commission Directive 2005 /61/EC of 30 September 2005 (OJ L 327, 28.12.2005, p. No. L 256 of 1 10. 2005, S 0032-00400). "

Article 3

Regulation of the Federal Minister for Health, Family and Youth, which amended the Medicines Operating Regulations 2005

According to § § 48, 62 (1), 62b and 69a (2) of the Medicines Act, BGBl. No. 185/1983, as last amended by the Federal Laws BGBl. I n ° 153/2005 and BGBl. I n ° 6/2007, shall be arranged:

The Pharmaceutical Operating Regulations 2005, BGBl. II No 479/2004, shall be amended as follows:

1. The Word "and" at the end of Section 1 (3) (2) (2), the point at the end of Section 1 (3) (3) (3) shall be replaced by a letter and the word "and" replaced and the following Z 4 shall be added:

" 4.

Establishments which process, store or distribute blood or blood components intended solely for transfusion. "

2. According to Article 26 (1), the following paragraph 1a is inserted:

" (1a) By way of derogation from paragraph 1, any establishment which processes, stores or distributes human blood or blood components without having to carry out any further manufacturing activities without producing proprietary medicinal products shall not have to be carried out by means of a competent person, but uninterrupted by a responsible person according to § 5 of the Ordination of the Federal Minister of Health, Family and Youth, with the detailed regulations on the operation and quality system of blood donation facilities and establishments which are solely responsible for transfusion, or Process blood components, store or distribute blood components (QS-VO-Blood), BGBl. II No 156/2007. "

Kdolsky