Overview of HPRA Sampling and Analysis (S&A) Programme

Transcription

1 Overview of HPRA Sampling and Analysis (S&A) Programme Considerations for Wholesalers Patrick Saunders & Kevin O Donnell Wholesale Distribution Conference 11 th November 2014

2 Objective & Scope This is a risk-based surveillance programme focussed on patient and animal health protection Objective: To independently monitor the quality of medicinal products in the Irish marketplace and those manufactured in Ireland for export. It involves the independent laboratory testing of medicinal products (H&V) and APIs, as well as the examination of packaging and labelling Scope: All MA types National, MRP/DCP, Centrally Authorised Products Active Substances & Excipients Unauthorised & Borderline products (e.g. Enforcement samples) 11th November

3 Key Features of the Programme Approx. 400 samples per year are tested or examined Products are prioritised for surveillance using a risk ranking tool Wide ranging types of analysis and checks are performed Physico-chemical testing (e.g. identity, assay, related subs, dissolution) Microbiological testing (e.g. Yeasts and Moulds, as per PhEur) Biological tests (e.g. biological assays) Product usability tests & checks (e.g. eye drop products) Packaging & Labelling checks Presence of correct safety information in Package Leaflets Presence of correct and legible Braille Indications of falsification 11th November

4 Key Features of the Programme An annual S&A plan is developed Most samples are tested using company test methods Product compliance is assessed against Registered specifications & other Marketing Authorisation Requirements Compendial monograph requirements Braille and other requirements Strongly aligned with EU surveillance programmes Cost effective and helps avoid duplication of effort Co-ordinated workplans, Sample Exchange, sharing of results occur Best practices and problem issues shared 11th November

5 Test types Safety warnings Braille checks Parallel imported/distributed products checks General Packaging & Leaflet checks, e.g. presence of PLs in packs Packaging & Labelling Checks Lab Analysis Physico-chemical Microbiology Biological Tests e.g. Can product be used as per leaflet instructions? Product Usability Checks Dealing with Sample-only Requests From other HPRA staff 11th November

6 Looking for signs of falsification All samples are checked for signs of falsification Presence of seal and whether it is tamper proof Any evidence of tampering? Characteristics of the Outer Carton, Package Leaflet and Labels: Are they of the expected quality? Anything unusual - e.g. poor quality paper for package leaflet? Characteristics of the Batch Number Anything unusual e.g. very short batch numbers, poorly printed details, etc. Checks of the packaging against HPRA records do they match? 11th November

7 Testing Laboratories HPRA uses labs in Ireland and in other EEA countries for testing work Public Analyst s Laboratory, Galway State Laboratory, Co. Kildare Various labs in other countries, e.g. UK, Czech Republic, Finland, Sweden & Denmark 11th November

8 Sampling and Analysis Work Key interactions with Wholesalers

9 The Lifecycle of a Sample S&A Request Log-in and Validation Risk Assessment and Planning Sample Collection Sample Dispatch to Lab Receipt of COA and Follow-up actions 11th November

10 When might we contact you Risk Assessment and Planning To obtain info on product stock availability To arrange a date for the sampling* Note: We try not to visit the same wholesaler too many times in any one year. We usually spread our sampling across the country. 11th November

11 What happens during sampling Sample collection Note: samples are collected by an authorised officer of the HPRA for independence We often sample multiple packs from the same batch We normally require packs with at least 6 months left to their expiry date We won t sample if the sampling will leave the wholesaler in an outof-stock or short stocked situation. 11th November

12 What happens during sampling Sample collection We will collect the products by ourselves directly from the shelves. This is done to assure impartiality. The HPRA is legally entitled to take samples without payment (Section 32B(3)(F) of the Irish Medicines Board (Miscellaneous Provisions) Act, No. 3 of 2006.). NOTE: the MAHs are usually aware of the planned sampling activity. HPRA authorised officers will provide the wholesaler with an official receipt for the samples this may enable the wholesaler to get reimbursed by the MAHs *In exceptional or unavoidable circumstances, we may request the wholesaler to send us in the sample 11th November

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14 Sampling of Cold Chain Products Sample collection For samples requiring cold chain (2-8 C) or frozen (-18 C) storage conditions, we will make arrangements with the Wholesaler to send the samples under appropriate conditions directly to the testing laboratory Where possible, we will witness the packing of the products HPRA will cover the cost of cold chain shipment 11th November

15 Sampling of Centrally Authorised Products These are known as CAP products Every year we take part in a CAP EU surveillance programme (run by the EDQM in Strasbourg, France) During CAP sampling, we perform labelling checks on the sample, at the wholesaler If the product is cold chain, we will organise the shipment directly at your site and we will bring a validated cold chain box with us Quantities of product collected are usually bigger than the normal sampling, because more labs are involved in the testing We will provide you an official EDQM voucher which will enable you to obtain replacements for the sampled packs at no cost 11th November

16 Example of an EDQM Voucher 11th November

17 Key S&A Findings in 2013

18 Key S&A Findings in samples were taken for lab testing or other examinations Several Out-of-Specification results were obtained, e.g. 11 products OOS for assay (of active substance) 8 products failed the Ph. Eur. subdivision of tablets test 1 product OOS for alcohol content excipient in a paediatric product Problems with the company analytical test methods were seen when testing 21 samples The Packaging and Labelling of 19 samples were non-compliant e.g. incorrect safety information in package leaflets e.g. Various Braille non-compliances 11th November

19 Key Messages

20 Key Messages for Wholesalers The Importance of GDP Compliance: Wholesale activities can affect the quality of medicines but continued compliance with GDP provides assurance that any OOSs identified with a sample were not related to inadequate storage or handling at the wholesaler We consider stock availability when sampling and we do not leave the wholesaler short stocked or out-of-stock Sampling Costs: We spread sample collection across the country to reduce the number of visits to your sites. This is not always possible. MAHs may reimburse the cost of samples we obtain useful to include this in any technical agreements with MAHs We do sample very expensive products but we apply riskbased approaches and we sample only when necessary 11th November

21 Questions / Discussion 11th November