Change Search. Of Human Tissues And Cells For Human Application

Original Language Title: změna vyhl. o lidských tkáních a buňkách pro použití u člověka

Read the untranslated law here: https://portal.gov.cz/app/zakony/download?idBiblio=78354&nr=339~2F2012~20Sb.&ft=txt

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.