Decree No. 130 / 2018 Coll.
Decree amending Decree No. 143 / 2008 Coll., on the establishment of closer requirements to ensure the quality and safety of human blood and its components (Ordinance on human blood), as amended
Valid
Effective from 13.07.2018
130
DECLARATION
of 19 June 2018
amending Decree No. 143 / 2008 Coll., laying down closer requirements to ensure the quality and safety of human blood and its components (Ordinance on human blood), as amended
According to Article 114 (1) of the Act No. 378 / 2007 Coll., on Medicines and on Changes to Certain Related Acts (the Law on Medicines), for the implementation of Section 67 (4) (a), as amended by Act No. 50 / 2013 Coll., Act No. 70 / 2013 Coll., Act No. 66 / 2017 Coll. and Act No. 36 / 2018 Coll.:
Decree No. 143 / 2008 Coll., on the establishment of closer requirements to ensure the quality and safety of human blood and its components (Human Blood Order), as amended by Decree No. 351 / 2010 Coll., Decree No. 96 / 2014 Coll. and Decree No. 304 / 2015 Coll., is amended as follows:
1. In footnote 1, the following sentence is added to the new line:
"Commission Directive (EU) 2016 / 1214 of 25 July 2016 amending Directive 2005 / 62 / EC as regards standards and specifications of the quality system for blood establishments. Commission Directive 2011 / 38 / EC of 11 April 2011 amending Annex V to Directive 2004 / 33 / EC as regards maximum pH values for platelet concentrates at the end of the shelf life. '
2. In Section 1 of the introductory part of the provisions and point (a), the words "European Communities' are replaced by the words" European Union '.
3. in Article 4 (3) (a) (4), the words "specific anti-treponem" shall be inserted after the words "determination."
4. in Article 5 (3) (e), the words "the date of issue of the transfusion preparation and" shall be deleted;
5. in Article 5 (3) (f):
"(f) the result of the compatibility assessment, the date and time of issue of the transfusion product and the name, surname and signature of the person issuing the transfusion product;"
6. in Article 5 (4) (a), "5.1.3." is replaced by "5.2.3."
7. in Article 11 (1) (i), the word "fax" shall be deleted and the word "on" shall be replaced by the words "and the identifier of the data box."
8. The title of Annex No 1 shall read: "QUALITY SYSTEM, CORRECT PRODUCTION PRACTICE."
9. In Annex 1, point 1.1 (1) reads as follows:
"1. The quality system and good manufacturing practice ensure the quality and safety of blood and blood components, the safety of donors and workers, the services of blood banks, the facilities of the blood service and the providers of health services to which blood products are issued on the basis of a request, and the operators used in the manufacture or preparation of medicinal products or exporting to third countries for the manufacture of medicinal products or for the distribution of human blood, its constituents or raw materials for further production (the" customer ') by establishing clear principles, objectives and responsibilities. The quality system shall include:
(a) planning, management, security, review and continuous improvement of quality;
(b) risk management;
(c) good manufacturing practice;
(d) the staff requirements referred to in point 2;
(e) requirements for premises, apparatus and equipment (including their qualification and validation), materials used in particular for the collection, processing and quality checks;
(f) documentation requirements;
(g) requirements for the collection, processing, storage, distribution, quality control, outsourced activities, blood withdrawal and its components, transfusion preparations and raw materials for further production from circulation;
(h) the management of contractual relations;
(i) the management of cases of disagreement; and
(j) the management of changes and internal control and audits. ';
10. In the second sentence of point 1.1 of Annex 1, the word "document 'shall be inserted after the words" quality system'.
11. in Annex 1, point 1.1, the following point 3 is added:
'3. Risk management shall ensure that process performance and quality monitoring systems and review systems are based on a risk assessment. Risk management shall include a systematic process for the analysis, control, communication and risk review of all activities, including equipment and processes. ';
12. In Annex 1, point 1.2, the sentence "Retrospective validation is not acceptable at the end of sub-point 2. 'is added.
13. In Annex 1, point 2 (4), the words "and the understanding of the tasks and specific activities defined by the description of the work of a particular staff member shall be inserted after the words" professional competence 'and the words "staff' shall be replaced by the words" staff '.
14. In Annex 1, point 2, the following point 7 is added:
'7. For the purposes of internal control, audit and control of authorised authorities, a list of signatures of staff members shall be available. ';
15. In Annex 1, point 3.3 (1), at the end of the second sentence, the words "or which have been rejected, discarded, withdrawn or returned shall be added. Where a system replacing physically separated storage is used, an equivalent level of safety shall be ensured 'and after the fourth sentence the sentence" Materials shall be stored under the conditions laid down by the manufacturer.'
16. In Annex No 1, point 3.3, at the end of sub-point 4, the sentence "A system is in place to indicate that the storage conditions laid down are exceeded. 'is added.
17. In Annex No 1, point 4, the sentences "Records of calibration, qualification and validation shall be reviewed, dated of approval and validity and signed by an authorised staff member shall be added at the end of subpoint 1. In the event of non-compliant calibration, qualification or validation, their potential impact on quality shall be assessed and corrective actions taken if necessary. ';
18. In Annex 1, point 5, the following point 5.1 is inserted:
"5.1. General principles
1. A documentation management system is developed for review purposes, monitoring of copy distribution, history of revisions and archiving.
2. The documentation shall be kept in a manner that ensures its legibility throughout the storage period.
3. The documentation shall include qualification and validation procedures and the definition of their acceptance criteria (validation plan).
4. The documentation shall be protected against unauthorised interference. ';
Subpoints 5.1 to 5.3 shall be renumbered 5.2 to 5.4.
19. In Annex 1, point 5.2 (1), the words ", regularly reviewed by the authorised person 'shall be inserted after the word" kept' and the sentence "The documents shall have an effective date 'shall be added at the end of the text.
20. In Annex 1, point 5.2 (2), the text "5.1.1. 'is replaced by" 5.2.1.';
21. in Annex 1, point 5.2 (3) (c), the words "including the specification of the intermediate product" shall be inserted after the words "product characteristics."
22. In Annex 1, point 5.3 (2), the words "persons who have carried out, or verified, procedures and processes, shall be inserted after the words" processes, ";
23. In Annex 1, point 5.3, at the end of sub-point 2, the words "Any change to the entry made in the alert shall be dated and signed by the authorised staff member. The original information in the entry remains legible. If relevant, the reason for the change shall also be given. ';
24. In Annex 1, point 5.3 (5):
"5. The records shall include a report on the operation of the transfusion service facility for the previous calendar year in accordance with Annex 7 to this Regulation. ';
25. In Annex 1, point 6.2 (1), after the words "is so designed ', the word" to' is inserted.
26. In Annex No 1, point 6.2, at the end of sub-point 5, the sentence "With pre-printed labels bearing the sampling number shall be treated in such a way that they cannot be used to indicate another sampling."
27. In Annex 1, point 6.2 (7), the following sentence is inserted after the first sentence: "When a derogation is found, its impact on quality shall be assessed; the assessment decision shall be approved and the qualified person confirmed in writing. '
28. In Annex 1, point 6.3 (2), the words "Introduction 'are replaced by the words" They are introduced'.
29. In Annex 1, point 6.3, the following points 6 and 7 are added:
'6. Laboratory testing of donor samples shall be carried out separately from patient samples in order to avoid confusion or mutual influence of test results.
7. A process for transcription, completion and interpretation of the result of the examination is in place. '
30. In Annex 1, point 7, the following points 4 and 5 are added:
"4. Validated sterile tube welders are used to maintain a closed system for the processing of blood or its components. Each feud made shall be checked to ensure that it is correctly executed and intact.
5. To ensure processing, the function of the person responsible for his own production is created. The responsible person shall be involved in all matters relating to blood processing and its components. The person responsible for his own production shall be different from the person referred to in point 1.2.1. of this Annex. ';
31. in Annex 1, point 7.2, the sentence "When the blood or its components prepared during the validation process are released shall be added at the end of subpoint 1, mutatis mutandis, in accordance with the pre-determined acceptance criteria for validation."
32. In Annex No 1, point 8 (2), the words "and the return of transfusion products for subsequent dispensation or distribution 'are inserted after the word" transport'.
33. In Annex 1, point 9 (1) (b), "B 'is replaced by" A'.
34. In Annex 1, point 9, at the end of the text of the final part of the provisions of subpoint 1, the words "; for the checks referred to in point (f), samples shall be taken so that the disinfectant used does not affect the results of the examination 'are added.
35. In Annex 1, the following point 10 is inserted after point 9:
"10. AMENDMENT MANAGEMENT
1. Any change to any activity that may affect the quality and safety of blood and blood components as well as the safety of donors and workers and services to customers shall be made in accordance with a pre-approved procedure approved and signed by the authorised staff member. Changes which may affect the quality and safety of blood and blood components must be made known by a qualified person.
2. The assessment of planned changes shall, in accordance with risk management, assess the impact on the quality of blood, blood components, blood products and raw materials for further production, on the quality system of the blood services and blood banks equipment, documentation, validation, calibration, maintenance and, where appropriate, on other systems to avoid unintended consequences and to plan the necessary related activities (in particular validation, verification, training, training, documentation).
3. The changes made shall be documented.
4. The impact of the amendment shall be assessed. ';
Points 10 to 12 shall become points 11 to 13.
36. Point 1.3 of Part A of Annex 3 reads as follows:
'1.3. Protein values in donor blood
| Bílkovina | ≥ 60 g/l | u odběrů plazmy aferézou se nejméně jednou ročně stanoví celková koncentrace bílkovin v séru |
| IgG | ≥ 6 g/l | u odběrů plazmy aferézou se provádí nejméně jednou ročně |
| “. | ||
37. In Annex 3, Part B, point 1, in the row "Transmissible spongiform encephalopathy disease (TSE) ', the words" for more than 6 months'; transfusions before 1996 abroad 'are replaced by' for more than 12 months; transfusions between 1980 and 1996 abroad '.
38. In Annex No 3, Part C, point 1, last sentence, the words "or the results with boundary values' shall be inserted after the words" reactive result '.
39. Point 2 of Part C of Annex 3 reads as follows:
'2. In the case of an "initially reactive 'result, the sample shall be tested twice. If the two results of the repeated examination are negative, the total result shall be interpreted as" negative' and the blood or its component shall be released for further use. If the result of the initial examination and at least one result of the repeated examination are reactive or borderline, the sample shall be referred to as "repeatedly reactive." '
40. In Annex No 4, Part A, in the table in the column "Acceptable results of quality measurements', in the row" Erythrocytes from apheresis, meaning erythrocytes from apheresis', the word "specifications' is deleted.
41. In Annex No 4, Part A, in the table in the row "pH 'in the column" Acceptable quality measurement results', the number "- 7,4 'is replaced by" or more'.
42. In Annex 5, Part A, in the first row of Tables 1 and 2, in Annex 5, Part B, in the first row of Tables 1 and 2, and in Annex 6, in the first row of Tables 1.1 and 2, the words "this Order 'are replaced by the words" Decree No. 143 / 2008 Coll., on the establishment of closer requirements for ensuring the quality and safety of human blood and its components (the Ordinance on Human Blood), as amended'.
43. In Annex 6, the text "2.1 'is replaced by" 1.2' in the table.
44. In Annex 6, in the first row of Table 1.2, after the text "Section 9 (4) ', the words" Decree No. 143 / 2008 Coll., on the establishment of closer requirements to ensure the quality and safety of human blood and its components (the Ordinance on Human Blood), as amended', are added.
45. In Annex 6, in the fifth row of Table 2, after the text "Paragraph 4 (3) ', the words" Decree No. 143 / 2008 Coll., on the establishment of closer requirements to ensure the quality and safety of human blood and its components (Human Blood Order), as amended', are added.
46. The following Annex 7 is added:
"Annex No 7 to Decree No 143 / 2008 Coll.
Activity Report of Transfusion Services and Blood Bank
The report on the operation of the blood service and blood bank facilities shall include:
(a) information on the number of donors,
1. the total number of donors, provided that the preponderants who have repeatedly donated blood in the reference period, are only listed once in the total number of donors,
2. the total number of multiple donors,
3. the total number of primary producers,
(b) the total number of individual types of sampling and the sum of all samples;
(c) an updated list of blood banks supplied by the blood services facility during the reference period;
(d) the total number of whole withdrawals not used;
(e) number of processed individual types of sampling;
(f) the quantities of transfusible preparations and raw materials produced and distributed for further production, the name of which is given in Annex 4, Part A;
(g) incidence and prevalence of indicators for individual transfusions communicable infections and the total number of repeat donors or primary donors tested;
(h) the number of packages of withdrawn transfusions or raw materials for further production;
(i) the number of serious adverse reactions and events reported.
The data in points (b), (d) and (e) shall be reported separately for each type of sampling, in particular full blood or plasmapheresis or cytaferesis. The data in point (f) shall be presented separately in the appropriate units for whole blood, erythrocytes, platelets, plasma and any other product types to be given. The activity report for the previous year in electronic form shall be transmitted to the Ministry of Health by 31 January of the following year. ';
Efficacy
This decree shall take effect on the 15th day following its publication.
Minister for Health:
Mgr. et Mgr. Vojtěch v. r.
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Regulation Information
| Citation | Decree No. 130 / 2018 Coll., amending Decree No. 143 / 2008 Coll., on the establishment of closer requirements to ensure the quality and safety of human blood and its components (Human Blood Ordinance), as amended |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 28.06.2018 |
|---|---|
| Effective from | 13.07.2018 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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