Procurement Services Branch

Transcription

1 Procurement Services Branch Delivering supplies for reproductive health results WHO/UNFPA TCu380A IUD Technical Specification and Prequalification Guidance Nov 2015

2 Highlighted Modifications - 1 The lay-out of the Specification is amended to clearly indicate requirements for in-process and finished product; Some parts of the Technical Specification section are presented in a tabular format; additional packaging and labelling requirements are specified; more advice is given on the requirements and methods for sterility assurance; (page 9-3 Revision of WHO/UNFPA TCu380A IUD Specification, Prequalification and Guidelines for Procurement, 2010, Introduction. See also page 83 - section 15 Discussion Relating to the Revision of the 2010 WHO/UNFPA of TCu380A IUD Specification Annex I Technical Basis Paper).

3 Highlighted Modifications - 2 Clearer differentiation between the testing and sample requirements for prequalification testing and the testing of continuing lots in production and/or for pre-shipment testing; the prequalification information is placed in a single chapter and product dossier and site master requirements revised; and the layout and content of the document is harmonized with the WHO/UNFPA documents for female and male condoms. (page 9-3 Revision of WHO/UNFPA TCu380A IUD Specification, Prequalification and Guidelines for Procurement, 2010, Introduction)

4 Status and Transition This revised version supersedes all previous publications since it includes important changes to the TCu380A IUD Technical Specification and the prequalification process (page 9-3 Revision of WHO/UNFPA TCu380A IUD Specification, Prequalification and Guidelines for Procurement, 2010, Introduction) Transitions within the specification Sealed pouch integrity (page 49-5 Packaging, labelling and information requirements, in Chapter 3 TCu380A Intrauterine Device Technical Specification)

5 Capacity Building through Standards and Specifications Development of specifications and standards Developments in medical device regulations Developments in our own device areas Achievements through joint working It is a journey with challenges still ahead.

6 Other key changes Lot definition Flange displacement force Film film packaging Growth of importance in process capability and control Emphasis on non-contact measurement Seal strength test Biocompatibility evaluation Shelf-life evidence based permission to extend to 7 years (2.4 pages 41 and 42)

7 Background to two key changes Product Bioburden and Product Sterility Product bioburden process control Product sterility validation Sampling plans and process capability

8 Sterility Assurance Sterility validation and process control Product bioburden validation and process control: Validation Process control Steriliser validation and process control Steriliser validation Steriliser process control Sterility dose validation Product sterility process control Where now with post sterilisation sterility testing? How does this relate to package integrity?

9 Sampling Plans and Process Capability - 1 There is a need to optimise consumer and producer risk Simple statement of AQL and lot or batch size does not achieve this. Utilising the manufacturing product characteristic of uniformity and specifying sample size and accept numbers does achieve this. Which is why AQLs have been dropped in favour of sample size and accept numbers; BUT:

10 Effect of Inspection on a Sampling A truncated histogram ends abruptly at one end, which indicates possible sorting or inspection of nonconforming parts. This may also mean that part of the distribution has been removed by screening, 100 % inspection or review. Figure 4. Truncated, or cliff-like, Histogram. Source:

11 OC Curve o OC Curve was Developed along with SQC in 1930 s and 40 s. o Graph used in quality control to determine the probability of accepting production lots. o Used in Discrimination of Sampling Plan Between Good And Bad Lots. o Measures Performance of Acceptance Sampling Plans. Source

12 Shape Of OC Curve o Ideal OC Curve: o o When percentage of Non-Conforming items are Below prescribed level Pa is 100%. And more than it makes Pa 0%. Ideal OC Curve Can be Obtained By 100% Inspection. Dividing line of Probability of acceptance Between 0 to 100% is AQL Source

13 Ideal OC Curve Source

14 oy axis Gives the probability that the lot will be accepted (Pa). ox axis = p Percentage Defective. oshows percentagedefectives along the horizontal ('X'), axis and probability of acceptance along the vertical ('Y') axis. Source

15 Sample Size brings discrimination Sample Size Nonconforming products Equivale nt AQL Pa at the AQL Pa at CRQ

16 Effect of sample size and process average AQL 0.65, manufacturer s process average 0.325% AQL 0.65, manufacturer s process average 0.65% Sample Size Accept Number Probability of a Lot Being Accepted (%) Sample Size Accept Number Probability of a Lot Being Accepted (%) AQL 0.65, manufacturer s process average 1.95% Sample Size Accept Number Probability of a Lot Being Accepted (%) Source

17 Sampling Plans and Process Capability - 2 To maximize successful independent testing and final verification success you need to operate at well below the process average of the corresponding AQL. Application of tables Impact of switching rules

18 Sampling Plans and Process Capability - 3 Capacity and competence established in process capability Confidence in measurement established with capacity and competence in management of measurement uncertainty. Remember that measurement is a sampling exercise Put process management into practice!

19 A footnote Copper surface area

20 Procurement Services Branch Delivering supplies for reproductive health results