Over the last 20 to 30 years, there has been a big cultural change in blood establishments: Scientific focus (Testing)

Transcription

1

2 Over the last 20 to 30 years, there has been a big cultural change in blood establishments: Scientific focus (Testing) Therapeutic focus (Manufacturing) Quality & Regulatory Consultant 2

3 This change has been driven by: 1. Evolution of Quality Control (QC) to Quality Assurance (QA) to Quality Management Systems (QMS) 2. Recognition of blood components as therapeutic goods 3. Introduction of regulation of fresh blood & blood components in many countries, together with 4. Introduction of good manufacturing practice (GMP) Quality & Regulatory Consultant 3

4 What is a QMS? QC & QA activities pulled together into an integrated system, including some additional support activities: Management Commitment Quality Objectives Monitoring & management of resources (personnel, equipment, material, facilities etc) Quality & Regulatory Consultant 4

5 What are therapeutic goods? goods for therapeutic use directly eg red cells, platelets, FFP plasma products such as FVIII concentrate BUT ALSO goods for therapeutic use indirectly eg: anticoagulant, additive solution, blood bags, TTI screening assays, ABO & Rh(D) antisera devices used as part of the manufacturing process (rapid freezers) Quality & Regulatory Consultant 5

6 The Pharmaceutical industry has been regulated for many years Regulation of blood manufacture has been driven by acknowledgement that blood is also a therapeutic product Much more recent eg Australia introduced regulation in 1992, some countries are still unregulated or moving towards regulation Quality & Regulatory Consultant 6

7 We manufacture therapeutic products They are transfused into patients who are sick and who need them as part of their medical treatment Our manufacturing processes need to be very strict & controlled GMP provides that strictness & level of control Quality & Regulatory Consultant 7

8 GMP makes sure that: manufacture of blood components is consistent manufacture is controlled manufacture & components meet appropriate therapeutic standards GMP is focussed on reducing risk by preventing: errors & mix-ups disease transmission contamination Quality & Regulatory Consultant 8

9 QMS = framework for managing quality GMP = manufacturing principles BUT GMP does not provide detailed specifications or instructions, therefore need: Blood Standard = detailed minimum accepted specifications for: performance of processes characteristics of components Quality & Regulatory Consultant 9

10 How do we know what to do? Quality & Regulatory Consultant 10

11 With the change in culture to a manufacturing focus, Blood Centres have looked for guidelines & Standards to help them introduce QMS & GMP The more common ones that have been used are: ISO 9001 ISO Codes of GMP Standards AABB & Council of Europe Quality & Regulatory Consultant 11

12 Let s look at these in more detail: 1. ISO 9001:2015 Quality management systems - Requirements 2. ISO 15189: 2012 Medical laboratories - requirements for quality & competence 3. Codes of GMP 4. Blood Standards (minimum performance requirements) Quality & Regulatory Consultant 12

13 Many different kinds of industries have implemented a QMS They have used ISO 9001 as the Standard to guide them ISO 9001 sets out the requirements for a general QMS The QMS ensures that processes, procedures, policies related to quality activities are followed Quality & Regulatory Consultant 13

14 ISO 9001 can be used by any organisation that provides goods or services to customers & wants to: show it can consistently provide products that meet requirements (customer, regulatory) give good customer satisfaction through using the QMS effectively and continually improving it be certified to the Standard Quality & Regulatory Consultant 14

15 ISO can be used by any Medical Laboratory that performs diagnostic testing for customers & wants to: Control the quality of testing show it can consistently provide results that are accurate & meet requirements (customer, regulatory) be certified to the Standard Quality & Regulatory Consultant 15

16 Requirements for GMP are defined in documents that are called Codes of GMP (cgmps) These are relevant for the type of therapeutic goods (blood is biological) Codes of GMP focus heavily on controlling blood manufacturing processes to: manage risks assure safety, purity & effectiveness Quality & Regulatory Consultant 16

17 There are cgmps specifically written for manufacture of blood components: WHO Australian EUD US FDA Quality & Regulatory Consultant 17

18 Some Blood Establishments in countries that are not regulated have used ISO 9001 as a driver for improvement: They have been certified to ISO 9001 by a third party This is GOOD because they now have a QMS in place BUT ISO 9001 only sets out requirements for a QMS ISO 9001 does NOT say anything about the principles of manufacturing of therapeutic goods, blood or blood components Quality & Regulatory Consultant 18

19 The definitions for a Quality System in ISO 9001 & in the Code of GMP are very similar The Code of GMP also sets out very similar requirements for a QMS But the Code of GMP includes requirements that focus on: consistency & reliability safety & risk management avoiding errors & disease transmission manufacture of blood & blood components Quality & Regulatory Consultant 19

20 GMP emphasis is on activities that reduce risks: Preventing contamination, cross-contamination, disease transmission or other adverse events Reliability of staff (training), processes, materials, equipment (validation & qualification) Minimising errors (SOPs, workflows, training) Appropriate facilities design, construction, cleaning, hygiene, waste management, environmental control, security RECORDS - full traceability of all activities, materials, equipment etc (recall) Quality & Regulatory Consultant 20

21 Most Codes of GMP for Blood have the following contents: Quality Management Personnel & Training Buildings & Facilities Equipment Documentation & Records Control of Materials General QS requirements (also in ISO) Donor Selection / Donation TTI Screening ABO Rh(D) Testing Process Control Storage, Packaging and Transport Blood manufacture Quality & Regulatory Consultant 21

22 Blood is a biological material: Biological materials behave very differently to nonbiological materials Example whole blood donations have different Hbs, red cell counts, platelet counts, IG levels The raw material (source material) is a human being: Human beings are very variable Example height, weight, health, lifestyle factors Quality & Regulatory Consultant 22

23 Some Blood Centres in countries that are not regulated have used ISO as a driver for improvement in the TTI laboratories They have been certified to ISO by a third party This is GOOD because they now have a wellcontrolled TTI screening laboratory in place Quality & Regulatory Consultant 23

24 BUT ISO is designed mainly for diagnostic medical laboratories It has only been applied to TTI in Blood Centres Blood grouping & RC antibody screening are also mandatory tests & therefore equally important ISO has not been applied to these areas ISO does NOT say anything about the GMP principles of performing mandatory tests on therapeutic goods, blood or blood components Quality & Regulatory Consultant 24

25 Most Codes of GMP for Blood have the following contents: Quality Management Personnel & Training Buildings & Facilities Equipment Documentation & Records Control of Materials General QS requirements (also in ISO) Donor Selection / Donation TTI Screening ABO Rh(D) Testing Process Control Storage, Packaging and Transport ISO Blood manufacture Quality & Regulatory Consultant 25

26 Manufacturing Principles: Safety Reliability Consistency Error reduction Prevention of contamination, disease transmission Therapeutic Standards GMP Quality Management System Donation screening for TTI ISO 9001 Quality Management System ISO Medical Laboratory Testing Quality & Regulatory Consultant 26

27 GMP Manufacturing Principles: Safety Reliability Consistency Error reduction Prevention of contamination, disease transmission Therapeutic Standards ISO 9001 Quality Management System ISO Donation screening for TTI Quality & Regulatory Consultant 27

28 GMP provides principles of manufacturing, not the detailed requirements Need a suitable Blood Standard to set out minimum accepted specifications for: performance of processes characteristics of components Quality & Regulatory Consultant 28

29 EXAMPLE: Donor selection GMP requirement: The selection of donors and relevant screening tests including those for infectious agents should ensure that the manufactured products are suitable for their intended purpose. Donors should be selected according to documented procedures defining the selection criteria, infectious disease screening tests and any other relevant tests. Ref: Australian cgmp 2013 Quality & Regulatory Consultant 29

30 EXAMPLE: Donor selection Blood Standard requirement: Donors must meet the following: Acceptable age range 18 to 65 years old Weight 50 kg Hb 125 g/l (females) 135 g/l (males) No health, travel or lifestyle risk factors Not be on certain medications Ref: Council of Europe 16 Ed Quality & Regulatory Consultant 30

31 Blood Standards may be selected by: Blood Service Regulator and/or Government Authority Options: Locally specific Standards Established industry Standards: AABB, Council of Europe Quality & Regulatory Consultant 31

32 Thank You Quality & Regulatory Consultant 32