MHRA GDP Symposium. Novotel London West, London 8 & 10 December #GMDPevents

Transcription

1 MHRA GDP Symposium Novotel London West, London 8 & 10 December 2015

2 Deficiencies in GDP Phil Neale, GDP Operations Manager Tony Orme, GDP Senior Inspector.

3 Finding deficiencies in GDP is not only for those with magic powers. Deficiencies are just observations of non compliances with GDP and should not be a surprise. Deviations from GDP put patients at risk of poor quality medication 4

4 Major Deficiencies - most commonly reported Temperature control - Environment/Equipment 2. Personnel -Responsible Person duties, training 3. Transportation 4. QMS management documentation 5. Qualification checks Temperature control and monitoring - general 2. Documentation/Procedures 3. Temperature control and monitoring - cold chain 4. Premises and equipment 5. Quality system and duties of RP 5

5 Quality Management System most common deficiency (2015) 1.4 Management review and monitoring Failure to adequately review and incorporate changes driven by regulatory changes or business objectives Failure to assess performance indicators e.g. CAPA, customer complaints. 12

6 QMS Interactive session On your tables with the i-pad spend 10 minutes considering management review and monitoring of the QMS: What makes an effective management review? Who should be included and attend meetings? How frequently should they occur? What topics might be discussed? Are they effective in your own organisation? 14

7 Summary feedback top management be involved, including RP. The agenda should include a review of: internal and external audit findings and reports customer feedback negative and positive supplier performance CAPAs raised or resolved to look for trends in the data process performance is the process reaching/maintaining performance targets? any changes to standards, regulations, technology, competition, staffing, and other business activities that could affect the quality system. Meetings held more frequent than annually 16

8 General QMS deficiencies QMS doesn t reflect the business activities Parts of operation not documented or monitored QMS doesn t reflect GDP or Human Medicines Regulations obligations Deviations / CAPA / Change control poorly managed Management of outsourced activities not controlled 17

9 Quality Management - summary HMR Regulation 43(12) The licence holder must maintain a quality system setting out responsibilities, processes and risk management measures in relation to their activities. Get trained in how to implement a QMS Review the QMS from start to finish against GDP and HMR Ensure all aspects of your operation are controlled Make your QMS work for you and use it effectively Empower staff to report deviations and contribute to CAPAs Regular effective management review of the QMS 18

10 Personnel most common deficiency (2015) Responsible person failing to ensure a quality system is implemented and maintained EU Guidance 2.2 The responsible person should carry out their duties in such a way as to ensure that the wholesale distributor can demonstrate GDP compliance and that public service obligations are met. 21

11 Responsible person Interaction session What can the MHRA and industry do to ensure that this type of deficiency is markedly reduced? On you tables, please discuss and provide some feedback of your ideas on the i-pads (10 minutes) 23

12 The Responsible Person Responsible Persons are appointed based on their knowledge and experience Named on a WDA Is this as far as it goes? Good application of knowledge, experience and common sense to how the Quality System is managed Good communication of knowledge and training Staff involved in operations Take Responsibility for keeping everything up to date and in full compliance 25

13 Premises and Equipment Most common deficiencies Chapter 3 (2015) 3.2 Premises The main deficiencies observed related to the following: Inadequate segregation of medicines of different status Inadequate measures to mitigate against pest infestation. 26

14 Most common deficiencies (2015) Temperature and environment control The main deficiency refers to inadequate temperature mapping: Temperature mapping not adequately recorded (who, what, when, why, how) Temperature mapping not carried out (ambient storage, transport vehicles) Temperature mapping carried out incorrectly, e.g. using a single roaming thermometer to map. 27

15 Equipment Interactive session Domestic refrigerator. Thermometer calibrated at 0, 20 and 40ºC On your tables with the i-pad spend 10 minutes identifying what steps should be taken to demonstrate that the refrigerator is fit for purpose. 29

16 Equipment Validation and qualification reports Risk assessment Design, installation, operation and process qualification Training / SOPs/ maintenance / change control 31

17 Premises and equipment - summary GDP 3.1 Wholesale distributors must have suitable and adequate premises, installations and equipment, so as to ensure proper storage and distribution of medicinal products. In particular, the premises should be clean, dry and maintained within acceptable temperature limits. Equipment calibration Temperature mapping Qualification and validation of key equipment Management of temperature excursions Controlled segregation of medicines of different status A preventative pest control programme 32

18 Documentation Most common deficiencies Chapter 4 (2015) 4.2 Documentation Lack of availability of records Records of purchase and sales are required to be retained for five years (unless longer predicate rules apply). Retention of records applies equally to electronic records even when entered on a spreadsheet. Version control and traceability should be assured and maintained when required by GDP. 33

19 Documentation traceability summary Records must be kept either in the form of purchase/sales invoices, delivery slips, or on computer or any other form, for any transaction in medicinal products received, supplied or brokered. Records should be made at the time each operation is undertaken. 34

20 Qualification checks on Customers -Most common deficiencies (2015) Failure to demonstrate that customer status was re-assessed routinely Failure to obtain notarised translations of authorisations for non UK customers Failure to demonstrate that customers in third countries were authorised to import into that country the specific medicines supplied. 35

21 Qualification checks Chapter 5 - some real examples 1. Botox supplied to an unlicensed dentist and then sold to physicians in USA 2. GSL Products purchased by large wholesaler from unlicensed company 3. POM products sold to Hong Kong doctors. No documentation available authenticating customers 4. Purchases from a Turkish company with no evidence that the company was authorised in Turkey 36

22 Qualification checks more real examples 1. No notarised translation process in place for authorisation documents for non-english suppliers and customers 2. Obtained a copy of the licence but did not accurately check the authorised activities matched the trade e.g. buying cold chain from someone who is not licensed to do it etc. 3. Not checking that both the physical location of supply and the payee are both authorised 4. Large company unable to buy a product directly from manufacturer, decided to purchase from a sole trader, who was unlicensed and the product had been stolen 37

23 Qualification checks Interaction session Qualification checks on suppliers and customers requirements described in EU Guidance are a cornerstone in the protection of public health Why is it difficult for companies to meet requirements on Qualification checks? What can be done to reduce deficiencies? On your tables, please discuss and provide ideas as feedback on the i-pads. ( 10 minutes) 39

24 Transportation the hidden and sometimes unknown process 41

25 Most common Transport Deficiencies Transportation is outsourced and little is known about it Lack of appropriate oversight of transportation and knowledge of specific journeys. EU Guidance Transport (Chapter 9) Transportation providers should be made aware by the wholesale distributor of the relevant transport conditions applicable to the consignment Risk assessment of delivery routes should be used to determine where temperature controls are required. 42

26 Most common deficiencies (2) Transport storage space temperature variations not known Inadequate monitoring or assessment of temperature during transport EU Guidance ( Chapter 9) It is the responsibility of the wholesale distributor to ensure that vehicles and equipment used to distribute, store or handle medicinal products are suitable for their use and appropriately equipped to prevent exposure of products to conditions that could affect their quality and packaging integrity. The required storage conditions for medicinal products should be maintained during transportation within the defined limits as described by the manufacturers or on the outer packaging. 43

27 Transport risk assessment Credit: Maersk Line 44

28 Transport Risk assessment 45

29 Transportation - summary Transportation is outsourced and little is known about it Reliance on the customer who collects Lack of appropriate oversight of transportation and knowledge of specific journeys. Inadequate monitoring or assessment of temperature during transport Transport storage space temperature variations not understood Absent or poor risk management of processes and journeys made in getting product to the customer 46

30 Transportation-Interaction session Why are these transportation deficiencies so common and frequent, when EU Guidance is very clear as to what the responsibilities are? What can industry and the MHRA do to reduce the number of transportation deficiencies? On your tables, please discuss and provide ideas as feedback on the ipads. (10 minutes) 48

31 How can we all improve? MHRA On- site discussions and inspection follow up GDP Symposium Green Guide Gov.uk website Inspector Blogs E-Learning packages Pharmaceutical Wholesalers RP Given time and authority Improved attention to details Harmonise processes for checks Use temperature control approved hauliers All agreements in place and understood 51

32 Questions and contact 52

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