339/2012 Sb.
DECREE
from day 4. October 2012,
amending Decree No 422/2008 Coll., laying down detailed requirements
in order to ensure the quality and safety of human tissues and cells intended for
human applications
The Ministry of health determined in accordance with section 29 of Act No. 297/2008 Coll. on
ensure the quality and safety of human tissues and cells intended for
human applications and amending related laws (Act on human
tissues and cells), as amended by Act No. 77/2012 Coll. (hereinafter the "Act")
for the implementation of § 5 para. 1 (b). k) and section 20a para. 2 of the Act:
Article. (I)
Decree No 422/2008 Coll., laying down detailed requirements to ensure
the quality and safety of human tissues and cells intended for use in
man, is amended as follows:
1. In paragraph 1, at the end of the text of the letter h), the words "and permission to
distribution of tissues and cells ".
2. In paragraph 1, at the end of the letter h) dot is replaced by a comma and the following
the letter i), which read as follows:
"i) rules of good distribution practice for distribution of tissues and cells.".
3. in paragraph 6, the following new section 6a, which including the title reads as follows:
"§ 6a
Requirements to procedures for distribution of tissues and cells
[To section 5, paragraph 1 (b)) and section 20a para. 4 of law]
The rules of good distribution practice for distribution of tissues and cells are
laid down in annex 9 to this Ordinance. ".
4. in section 12 paragraph 1. 1 and 2, the words "Annex 8" the words
"parts".
5. under section 12, the following new section 12a, which including the title reads as follows:
"§ 12a
Application for authorisation to distribution of tissues and cells
(To section 20a, paragraph 2, of the Act)
Application for authorisation to distribution of tissues and cells contains data and documents
referred to in annex 8, part B, to this Ordinance. ".
6. in annex No. 1 in the final part of point 5.5 and section 5.7, the words
"Annex 8" the words "parts".
7. In annex 4, paragraph 1.2, the word "incidence" is replaced by
"prevalence".
8. in annex 5, point 2.4, the word "incidence" is replaced by
"prevalence".
9. in annex 5 section 4.2:
"4.2. Blood samples shall be taken
and) in case of partner donation within 3 months prior to the first
giving it away, unless it is of direct use. For other donation partners
from the same donor is another blood samples shall be taken no later than 24 months
from the previous collection of blood samples,
(b)) in the case of another donation than between the partners in the time of each donation,
and in the case of oocyte donation, blood samples shall be taken at the latest at
begin stimulation. ".
10. In annex 5, point 4.3, the words "or ova" are deleted.
11. in annex No. 8 (2). (c)), the words "§ 10 para. 2 and 3 of the law "
replaced by the words "§ 10 para. 2 and 4 of the law ".
12. In Annex 8, the text referred to as part A and the following
(B) to read as follows:
"(B)
Application for authorisation to distribution of tissues and cells
1. Application for a permit activity-distribution of human tissues and cells
contains a summary of the basic data, which includes
and) name, surname, place of business and identification number, if
granted, a natural person applying for a permit; If the authorization
calls for a legal entity, its business name, or the name, address of the registered office,
address for service and the identification number or similar information,
(b)) the required range of distribution, which is to be implemented, depending on the type
tissues and cells, and a list of the procedures provided in the distribution,
c) types of tissues and cells that are to be the subject of a distribution,
(d) the addresses of all places) activities and bringing the procedures provided under the
distribution in a given location,
2. Furthermore, the request contains
and support for business permission) of the person of the applicant related to the
the activities to be carried out, for example, the proof of the statement from the
commercial register, not the older 3 months valid trade
permission or a valid incorporation of the Charter,
(b) a basic document on the site), which contains in particular information on
1. your organization including the integration of all activities and the sites where the activities
carried out, to the overall structure of the Organization,
2. persons providing activities, including their number, qualification
system requirements, training, education, health and hygiene
requirements for the persons involved; lists the organizational scheme involving
the function of leading people and their hierarchy, including links to the highest
level of management of the Organization,
3. premises and equipment, which may influence the quality and safety of
tissues and cells, including facilities for the cleaning, disinfection and
sanitation of critical equipment,
4. cleaning, maintenance, inspection, repair, calibration and validation,
5. the internal regulations and the management system of records; submit a list
internal regulations, forms and templates developed for records
the procedures that are to be provided,
6. critical procedures, including their technical and material
ensure quality control, to be carried out and the specifications
the conditions and implementation of procedures,
7. validacích and calibrations performed and
8. the system of its own review of the quality system for traceability
and monitoring system of serious adverse events and their
notification.
13. After annex No. 8 the following Annex No 9, to read as follows:
"Annex 9 to Decree No 422/2008 Sb.
Good distribution practices for the distribution of tissues and cells
1. quality system requirements
1. Quality system organization and management
The introduction of the quality system includes fixed in writing functional
the organisational structure, responsibilities and reporting structure
obligations, the obligations laid down in writing by the persons involved, and in writing
set out the processes, procedures and resources for quality control; quality management
means the coordinated activities that the organization is managed and
checked in terms of quality. Part of the quality system are all
activities that directly or indirectly contribute to quality. A documented
quality and quality management system applies to all activities
related to the distribution.
2. the persons involved
2.1. Carrying out the various activities related to the distribution of the
to ensure that there is a sufficient number of involved people
qualified for the tasks that have to be provided. Their
eligibility shall be assessed at appropriate intervals, specified in
the quality system documentation.
2.2. For each connected person shall establish and keep clear,
a documented description of the work. Ensures that the duties and responsibilities
they have been clearly documented and understood.
2.3. Prior to the execution of the activities of each involved person provides
adequate preparation and timely preparation in the event of changes in procedures.
The program of preparation of the documents. Ensures that each individual
and) was qualified to carry out the tasks which it is authorised by the
(b)) had appropriate knowledge and understand the process and principles, which
are related to the tasks for which it is authorized,
(c) understand the organising arrangements) of the quality system and the internal
the legislation, in which the device works, and
(d)) has been informed of the wider ethical, legal and regulatory
the context of their work.
3. Equipment and facilities
3.1. the equipment used when the distribution is proposed and maintains the way
suitable for its intended purpose and in a way that represents the minimum
the risk for affecting the quality and safety of tissues and cells and for involved
persons handling.
3.2. Identifies the critical equipment, validate, regularly
inspects and maintains a preventive measure in accordance with the instructions of the manufacturer.
The equipment, which can adversely affect the critical parameters of the distribution of tissues and
cells (such as temperature), is subject to monitoring as necessary, systems
warning alarms and corrective measures, in order to be detected in a timely manner
faults and defects and to ensure that the critical parameters are continuously
kept within acceptable limits. Equipment which measures critical
the parameters are calibrated, and applies the appropriate monitor
Etalon, suitable for calibration, if available.
3.3. New and repaired equipment to try and Setup before using
shall be validated. The test results shall be documented.
3.4. maintenance, servicing, cleaning, disinfection and sanitation in
critical facilities shall be carried out on a regular basis and shall be recorded.
3.5. Are there procedures for the operation of each component of the critical
equipment, detailing the measures to be taken in case of
disturbances or failures.
3.6. Provide establishments and premises suitable for activities related
with the distribution, including facilities for the cleaning, disinfection and
sanitation of critical equipment.
4. Documentation
4.1. Establish a system to ensure a clear and effective
documentation, both in the internal rules and records. System documentation
is created to guarantee that all activities related to
distribution and quality assurance will be carried out normally, and that the
all the steps of these activities will be traceable. For the implementation and
maintain system documentation shall draw up the relevant regulations
providing for the management of the internal rules, and records management.
4.2. The management procedure of the internal rules will ensure in particular that the
internal regulations approved and regularly reviewed in order to
use their current version and change history to individual
internal regulations was traceable.
4.3. the internal regulations shall in particular include standard operating procedures,
training and methodological manuals, forms and basic document
about the place.
4.4. the basic document of the place summarizes the organizational, technical and
personnel assumptions made for fulfilling the requirements of the law and
the Ordinance, in particular the requirements of the quality system. The current base
the document shall be submitted to the Institute's before checking in at least
range established for enabling activities referred to in annex 8, part B
point 2 (a). (d)).
4.5. For the activity of distribution shall be determined and documented and the connected equipment
persons who participate in the activity.
4.6. Changes of the internal rules and records will be reviewed, approved,
the date and properly implement the authorized persons.
4.7. the records shall be kept so that they are reliable and true view
the facts and results.
4.8. the records shall be legible and indelible manner, can be
handwritten or other validated the procedure, for example,
electronically. If the signature is used, the date and what is
the signature is confirmed.
4.9. all records related to the distribution are kept as records
to ensure traceability and maintained so that to them was
secured access for at least 30 years from the date of the distribution.
4.10. the security measures against illegal refill
data erasure or changes in the records. Introducing procedures for the
resolve data discrepancies.
5. Review of the quality of
5.1. A system of self checking. Carrying out checks,
entrust the staff or external natural or legal persons,
that are trained and competent and are independent in relation to
activities that control refers to. A custom control is carried out at least
once every 2 years, in order to verify compliance with the internal rules and with
requirements of the Act and this order. The findings and the measures shall be documented.
5.2. All deviations from the applicable provisions related to
quality and safety are examined and documented. Document is also
a decision on corrective and preventive measures.
5.3. the remedial measures shall be initiated and completed in a timely and effective manner. After
the implementation of preventive and corrective measures to assess their
efficiency. The progress of the measures and their effectiveness should be documented.
5.4. There shall be the procedures for review of the performance management system
quality, in order to ensure systematic improvement.
2. the movement of tissues and cells of the sampler to the tissue establishment
2.1. Part of the internal rules, the procedure is for the transportation of the tissues and cells of
sampler in the tissue establishment, including related
records.
2.2. Tissues and cells, including samples from the donor intended for examination, the
be transported in a container that is suitable for the transport of biological
material and that ensures the quality and safety of tissues and carried
cells. Container and packaging of tissues and cells be selected so as to ensure that
tissues and cells are kept securely and under specified conditions.
2.3. the shipping container is equipped with continuous emission monitoring
temperature. The system must not allow outside interference with the values recorded before the
reading and evaluating the status values for conditions of carriage.
2.4. Transport the only tissues and cells labeled in accordance with Annex No.
2 point 7.
2.5. Identification of each shipping container containing at least the information
referred to in annex 2, point 8.
3. the Distribution of tissues and cells for human applications released
3.1. When you follow the distribution of critical transport conditions laid down
tissue establishment, such as temperature and time period that they are
preserved the required properties of tissues and cells.
3.2. Container and packaging of tissues and cells shall be selected so as to ensure that they are
tissues and cells are kept securely and under specified conditions.
3.3. the shipping container is equipped with continuous emission monitoring
temperature. The system must not allow outside interference with the values recorded before the
reading and evaluating the status of the values of the distribution terms.
3.4. the requisition for the supply of tissue and cell preparation for treatment
use in the recipient will provide the data that uniquely identifies a request
including data identifying the medical equipment, the workplace and the
physician requesting the delivery of the product and the date of the requisition.
3.5. The tissue and cellular medicine supplied medical equipment for
the treatment of the recipient is accompanied by the proof of delivery that allows you to verify
compliance with the requirement requisitions for the supply of tissue and cell preparation.
3.6. When you download a tissues and cells from circulation, it adheres to the guidelines and procedure
the tissue establishment that tissues and cells withdraws from circulation.
3.7. Transport the only tissues and cells labeled in accordance with Annex No.
6 section 5, including the accompanying documentation.
3.8. the outer shipping container containing at least the information
referred to in annex 6, point 6.
4. Notification requirement
4.1. The adverse events in the course of distribution shall be notified to tissue
devices that pass the tissues and cells for human applications.
4.2. adverse events during transportation of procured tissues and cells from the
sampler in the tissue establishment shall be notified to tissue
the device to which the tissues and cells are transported. ".
Article. (II)
The effectiveness of the
This Decree shall enter into force on the thirtieth day after the date of its publication.
Minister:
doc. MUDr. Heger, CSc., r.