Workshop on Skip Testing

Transcription

1 12-13 June 2018, Bern, Switzerland Workshop on Skip Testing Rosmarie Neeser Swissmedic, Inspectorates and Licences, Inspector Swissmedic Schweizerisches Heilmittelinstitut Hallerstrasse Bern 9 Schweiz

2 Skip Testing: Quality versus Cost Saving - «Cost Saving» - «Skip testing proposal ( 1 batch in every 20/30 batches or 1 batch per year whichever is earlier)» less time before release, less resources (money and workload) 2

3 Terms Skip/ periodic testing Defined in ICH Q6A (Specifications: Test procedures and Acceptance Criteria for New Chemical Drug Substances and Products: Chemical Substances) (See slide 5) ICH Q6B (Test Procedures and Acceptance Criteria for Biotechnological/ Biological Products) does not address skip testing Reduced/ partial testing Addressed in EU-PIC/S GMP, chapter 5.35 Can be defined as «Partial repetition of tests for incoming materials» 3

4 Ph. Eur. : Skip Testing is possible Ph. Eur General Statements «Demonstration of compliance with the Pharmacopoeia: (1) An article is not of Pharmacopoeia quality unless it complies with all requirements stated in the monograph. This does not imply that performance of all tests in a monograph is necessarily a prerequisite for a manufacturer in assessing compliance with the Pharmacopoeia before release a product. The manufacturer may obtain assurance that a product is of Pharmacopoeia quality on the basis of ist design, together with ist control strategy and data derived, for example, from validation studies of the manufacturing process. 4

5 ICH Q6A 2.1. Periodic or skip testing Periodic or skip testing is the performance of specified tests at release on pre-selected batches and / or at predetermined intervals, rather than on a batch-to-batch basis with the understanding that those batches not being tested still must meet all acceptance criteria established for that product. This represents a less than full schedule of testing and should therefore be justified and presented to and approved by the regulatory authority prior to implementation. This concept may be applicable to, for example, residual solvents and microbiological testing, for solid oral dosage forms. It is recognized that only limited data may be available at the time of submission of an application (see section 2.5). This concept should therefore generally be implemented postapproval. 5

6 ICH Q6A: Skip Testing and out of specification results When tested, any failure to meet acceptance criteria established for the periodic test should be handled by proper notification of the appropriate regulatory authority(ies). If these data demonstrate a need to restore routine testing, then batch by batch release testing should be reinstated. Market surveillance and market authorization department have to be notified 6

7 ICH Q6A: Application / Approval of Skip Testing A request for a skip testing needs to be applied and justified by the Marketing Authorisation Applicant/Holder based on scientific considerations and supported by correspondig data Skip testing (including information on the testing frequency) is assessed and approved by the concerned regulatory authority (e.g. Swissmedic, section Quality Review, Division Marketing Authorisation). Test parameters with an approved skip testing (including information on the test frequency) are clearly defined with a corresponding footnote in CTD section 3.2.S.4.1 (Drug Substance Specifications) and/or 3.2.P.5.1 (Drug Product Specifications). Swissmedic (section Quality Review) can provide the approved specifications upon request to inspectors for inspection purposes. 7

8 Skip Testing: Market Authorization Switzerland Drug Substance Drug Product CTD 3.2.S.4.1 Specifications according to Swiss Market Authorization DMF (CEP) CoA Batch certificate API Manufacturer Europe or abroad CTD 3.2.P.5.1 Specifications according to Swiss Market Authorization CoA Batch certificate Specified tests at release on preselected batches GMP/GDP-inspection Inspector s tasks when Skip Testing is observed? GMP/GDP-inspection Inspector s tasks when Skip Testing is observed? 8

9 EDQM CEP (Certificate of Suitability) Current situation If an application for a CEP includes declaration related to skip testing, EDQM does not assess it (= does not accept or reject). Future EDQM is currently drafting a document to adress skip testing in the frame of CEP applications 9

10 Inspection in India: company (holder of CEP) requested to skip tests before blending PIC/S GMP part II Each batch incorporated into the blend should have been tested No blending of sub-batchs with OOS-results Switzerland: Only Skip Testing for finished products (APIs, dosage forms) is approved by Market Authorization department Inspectors have to verify Note: Inprocess parameters - are generally monitored with samples. - are not included in the definition of Skip Testing. 10