Decree No. 339 / 2012 Coll.
Decree amending Decree No. 422 / 2008 Coll., on establishing closer requirements to ensure the quality and safety of human tissues and cells intended for human use
Valid
Order
Effective from 16.11.2012
Text versions:
16.11.2012
17.10.2012
339
DECLARATION
of 4 October 2012
amending Decree No. 422 / 2008 Coll., laying down closer requirements for the quality and safety of human tissues and cells intended for human use
According to Article 29 of Act No. 296 / 2008 Coll., on the quality and safety of human tissues and cells intended for human use and on the amendment of related laws (Act on Human Tissue and Cells), as amended by Act No. 77 / 2012 Coll., ("the Act ') for the implementation of Sections 5 (1) (k) and 20a (2) of the Act:
Decree No. 422 / 2008 Coll., establishing closer requirements to ensure the quality and safety of human tissues and cells intended for human use, is amended as follows:
1. In Section 1, at the end of the text in point (h), the words "and permission to distribute tissues and cells' are added.
2. In Article 1, at the end of point (h), the dot is replaced by a comma and the following point (i) is added:
"(i) rules of good distribution practice for the distribution of tissues and cells."
3. The following Section 6a is inserted after Section 6:
Requirements for tissue and cell distribution procedures
[Articles 5 (1) (k) and 20a (4) of the Act]
The rules of good distribution practice for the distribution of tissues and cells are set out in Annex 9 to this Decree. '.
4. In Article 12 (1) and (2), the words "Part A 'shall be inserted after the words" Annex No 8'.
5. The following Section 12a is inserted after Section 12:
Application for authorisation to distribute tissues and cells
(Paragraph 20a (2) of the Act)
The application for authorisation for the distribution of tissues and cells shall contain the particulars and documents set out in Annex 8, Part B, to this Order. ';
6. In Annex 1, in the final part of point 5.5 and in point 5.7, the words "Part A 'shall be inserted after the words" Annex No 8'.
7. In Annex 4, point 1.2, "incidence 'is replaced by" prevalence'.
8. In Annex 5, point 2.4, "incidence 'is replaced by" prevalence'.
9. In Annex 5, point 4.2:
"4.2. Blood samples shall be taken
(a) in the case of donation between partners within 3 months of the first donation, if not for direct use. For further donation between partners from the same donor, further blood samples shall be taken no later than 24 months after the previous blood sample collection,
(b) in the case of donation other than between partners at the time of each donation, and in the case of oocyte donation, blood samples shall be taken no later than the start of stimulation. "
10. In Annex 5, point 4.3, the words "or eggs' are deleted.
11. In Annex 8, point 2 (c), "Paragraph 10 (2) and (3) of the Act 'is replaced by" Paragraph 10 (2) and (4) of the Act'.
12. In Annex No 8, the current text becomes Part A and the following Part B is added:
Application for authorisation to distribute tissues and cells
1. The application for authorisation of activity - distribution of human tissues and cells contains, a summary of the basic data, which includes:
(a) the name, surname, place of business and identification number, if any, of the natural person requesting authorisation; where the authorisation is sought by a legal person, its trading firm or its name, address of the registered office, address for service and identification number or equivalent,
(b) the required extent of distribution to be carried out by type of tissues and cells and a list of the procedures provided for in the distribution;
(c) the types of tissues and cells to be distributed;
(d) address of all sites of activity and indication of the distribution procedures at the site;
2. The application shall also contain:
(a) evidence of an authorisation for the business of the applicant's person related to the activity to be carried out, such as proof of an extract from the commercial register, not more than 3 months old, a valid business licence or a valid instrument of incorporation;
(b) a basic document on the location containing in particular information on:
1. organisation, including the integration of all activities and sites where activities are carried out, into the organisation's overall structure;
2. persons carrying out activities, including their number, qualification requirements, training system, education, health and hygiene requirements for persons involved; an organisational chart covering the functions of managers and their hierarchy, including links to the highest level of management;
3. premises and equipment which may affect the quality and safety of tissues and cells, including areas for cleaning, disinfection and sanitation of critical equipment;
4. cleaning, maintenance, inspection, repair, calibration and validation systems;
5. internal rules and records management system; a list of internal rules, forms and models of records drawn up for the procedures to be carried out shall be submitted,
6. critical procedures, including technical and material collateral, quality checks to be carried out and specifications of the conditions and implementation of the procedures;
7. validation and calibration performed; and
8. the system of self-examination, traceability and monitoring and notification of serious adverse events. ';
13. the following Annex 9 is inserted after Annex 8:
"Annex No 9 to Decree No 422 / 2008 Coll.
Good distribution practice for tissue and cell distribution
1. Quality system requirements
1. Quality system, organisation and management
The implementation of the quality system shall include a written functional organisational structure, a structure of responsibilities and reporting obligations, a written obligation for involved persons, and a written procedure, procedures and resources for quality management; quality management means coordinated activities that manage and control the organisation from a quality perspective. The quality system shall include all activities which contribute directly or indirectly to the quality. The documented quality system and quality management shall apply to all distribution-related activities.
2. Engaged persons
2.1. The execution of individual distribution-related activities shall be ensured in such a way that a sufficient number of persons qualified for the operations to be carried out are available. Their eligibility shall be assessed at appropriate intervals, as specified in the quality system documentation.
2.2. A clear, documented description of the work shall be developed and updated for each person involved. It is ensured that responsibilities and responsibilities are clearly documented and understood.
2.3. Before carrying out activities, each involved person shall be provided with adequate preparation and up-to-date preparation in case of changes in procedures. The preparation programme shall be documented. Ensuring that each individual
(a) be eligible for the tasks entrusted to him;
(b) have adequate knowledge and understanding of the process and principles relating to the tasks entrusted to it;
(c) understand the organisation, quality system and internal rules of the establishment in which it operates; and
(d) has been informed of the broader ethical, legal and regulatory context of his work.
3. Equipment and premises
3.1. The equipment used in the distribution shall be designed and maintained in a manner suitable for its intended purpose and in a way that presents a minimum risk to the quality and safety of tissues and cells and to the persons involved handling them.
3.2. Critical equipment shall be identified, validated, regularly checked and maintained in accordance with its manufacturer's instructions. Equipment that may affect critical parameters of tissue and cell distribution (e.g. temperature) shall be subject to monitoring, warning systems, alarms and corrective measures, as appropriate, in order to detect defects and defects in time and to ensure that critical parameters are continuously maintained within acceptable limits. The equipment to measure critical parameters shall be calibrated, using appropriate observable etalon, suitable for calibration, if available.
3.3. New and repaired equipment shall be tested during installation and validated before use. Test results shall be documented.
3.4. Maintenance, service, cleaning, disinfection and sanitation are performed regularly for critical equipment and recorded.
3.5. Procedures are available for the operation of each critical equipment component, detailing the measures to be taken in the event of failure or failure.
3.6. Installations and premises suitable for distribution-related activities shall be provided, including areas for cleaning, disinfection and sanitation of critical equipment.
4. Documentation
4.1. A system shall be established to ensure clearly defined and effective documentation, both internal rules and records. The documentation system shall be established in such a way as to ensure that all quality distribution and quality assurance activities are carried out in a standard manner and that all steps of such activities can be monitored. In order to establish and maintain the documentation system, appropriate rules shall be drawn up for the management of internal rules and records.
4.2. In particular, the procedure for the management of internal rules shall ensure that internal rules are approved and reviewed regularly, that their current versions are used and that the history of changes in individual internal rules is traceable.
4.3. The internal rules shall include, in particular, standard working procedures, training and methodological manuals, record forms and a basic location document.
4.4. The basic document on the site summarises the organizational, technical and personnel assumptions created for compliance with the requirements of the law and the decree, in particular the requirements for the quality system. An up-to-date basic document on the site shall be submitted to the Institute before checking at least to the extent developed for the authorisation of the activity referred to in Annex 8 (B) (2) (d).
4.5. Equipment and persons involved who participate shall be identified and documented for the distribution activity.
4.6. Amendments to internal rules and records shall be reviewed, approved, dated and properly implemented by the authorised persons.
4.7. The records shall be conducted in such a way as to be a reliable and true display of reality and results.
4.8. The records shall be kept in a legible and indelible manner, may be written by hand or by another validated procedure, for example electronically. If the signature is used, the date and what is signed shall be added.
4.9. All distribution-related records shall be kept as traceability records and shall be kept in such a way that they can be accessed for at least 30 years from the date of distribution.
4.10. Security measures shall be taken against the unauthorised addition of data, erasure or alteration of records. Procedures shall be established to address irregularities in the data.
5. Quality examination
5.1. A self-control system is created. The inspection shall be carried out by staff or, where appropriate, external natural or legal persons who are trained and competent to do so and who are independent in relation to the activity covered by the inspection. Self-control shall be carried out at least every 2 years in order to verify compliance with internal rules and with the requirements of the law and this decree. The findings and measures shall be documented.
5.2. Any derogation from the provisions in force relating to quality and safety shall be investigated and documented. Decisions on corrective and preventive measures shall also be documented.
5.3. Corrective measures shall be initiated and completed in a timely and effective manner. After implementing preventive and corrective measures, their effectiveness shall be assessed. The progress of the measures and their effectiveness shall be documented.
5.4. Procedures for reviewing the performance of the quality management system shall be established to ensure systematic improvement.
2. Transport of tissues and cells from the sampling facility to the tissue facility
2.1. The internal rules include the procedure for transporting tissues and cells from the sampling facility to the tissue establishment, including related records.
2.2. The tissues and cells, including samples from the donor to be tested, are transported in a container suitable for transporting biological material and which ensures the quality and safety of the tissues and cells transported. The container and the packaging of tissues and cells shall be selected to ensure that the tissues and cells are kept safely and under specified conditions.
2.3. The transport container is equipped with a continuous temperature monitoring system. The system shall not allow external intervention in the recorded values before reading and evaluating the status values of the transport conditions.
2.4. Only tissues and cells marked in accordance with Annex 2, point 7 shall be transported.
2.5. The marking of each container shall contain at least the particulars listed in Annex 2, point 8.
3. Distribution of tissues and cells released for human use
3.1. The distribution shall comply with critical transport conditions established by the tissue establishment, such as temperature and time period, in order to maintain the required characteristics of tissues and cells.
3.2. The container and the packaging of tissues and cells are selected to ensure that the tissues and cells are kept safely and under specified conditions.
3.3. The transport container is equipped with a continuous temperature monitoring system. The system shall not allow external intervention in the recorded values before reading and evaluating the status values of distribution conditions.
3.4. In the request for delivery of the tissue and cellular product for therapeutic use to the recipient, data shall be provided clearly identifying the requirement, including data identifying the medical establishment, the workplace and the physician requesting delivery of the product and the date of issue of the request.
3.5. The tissue and cell product delivered to the health care establishment for the treatment of the recipient is accompanied by a proof of delivery which allows verification of compliance with the request for delivery of the tissue and cell product.
3.6. When the tissues and cells are withdrawn from the circulation, the procedure and instructions of the tissue establishment which removes the tissues and cells shall be followed.
3.7. Only tissues and cells marked in accordance with Annex 6, point 5, including accompanying documentation, shall be transported.
3.8. The indication of the external transport container shall contain at least the particulars listed in Annex 6 (6).
4. Notification obligations
4.1. Adverse events during distribution shall be reported to the tissue establishment which released tissues and cells for human use.
4.2. Adverse events in the transport of tissues and cells from the sampling facility to the tissue establishment shall be reported to the tissue establishment to which the tissues and cells are transported. ';
Efficacy
This Decree shall take effect on the 30th day following its publication.
Minister:
Doc. MUDr. Heger, CSc., v. r.
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Regulation Information
| Citation | Decree No. 339 / 2012 Coll., amending Decree No. 422 / 2008 Coll., on establishing closer requirements to ensure the quality and safety of human tissues and cells intended for human use |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 17.10.2012 |
|---|---|
| Effective from | 16.11.2012 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
The regulation text is for informational purposes only.
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