Healthcare Good Distribution Practice (GDP)

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Healthcare Good Distribution Practice (GDP) 10 March 2018 Copyright

2 The role of the MHRA Ensuring that medicines and medical devices work, and are acceptably safe. They aim to make as much information as possible publicly available. No product is risk-free. Underpinning all their work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. Enable greater access to products, and the timely introduction of innovative treatments and technologies that benefit patients and the public. To keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. Encourage everyone - the public and healthcare professionals as well as the industry - to tell them about any problems with a medicine or medical device, so that we can investigate and take any necessary action 10 March 2018 Copyright silverbacklogistics.com. All rights reserved The place to go for free supply chain advice 2

3 The powers of the MHRA Enter premises & inspect goods Request records and take copies Seize and/or detain suspect records and/or goods which may be required as evidence in proceedings for an offence Test purchases Prohibit the supply of goods considered to be unsafe Recall Notices (DMRC) Suspend or revoke authorisations Remove an RP from the register! Keeping updated: sign up for MHRA alerts Revoked authorisations New authorisations and register of medicines manufacturers, importers and suppliers Devices and medicines alerts Newly granted Marketing Authorisations (MA) News Help & advice 10 March 2018 Copyright silverbacklogistics.com. All rights reserved The place to go for free supply chain advice 3

4 FMD February 9, 2016, the Delegated Act on safety features was published. EU FMD specifically outlines how the EU FMD contains three major government requirements: SERIALIZATION (Must happen at the secondary or saleable-unit level in Europe) VERIFICATION AND SAFETY FEATURES (2D barcode, Anti-tampering technologies) COMPLIANCE REPORTING EMVO European Medicines Verification Organization (EMVO) oversees the following: The European hub (Connect and exchange data with multiple national systems, maintain master data and pack status as product moves through the supply chain) A blueprint system offered by EMVO-approved vendors (available to reduce time, risk, and cost) Service providers Service-level agreements with national authorities Launched an online portal for pharmaceutical companies, offers guidance documents for on boarders to ensure that their systems are compliant 10 March 2018 Copyright silverbacklogistics.com. All rights reserved The place to go for free supply chain advice 4

Directive 2013/C 343/01 GDP Guidelines 10 March 2018 Copyright

5 Good Distribution Practice of Medicinal Products For Human Use 2001/83/EC Medicines Directive 2011/62/EU Falsified Medicines Directive 2013/C 343/01 GDP Guidelines 10 March 2018 Copyright silverbacklogistics.com. All rights reserved The place to go for free supply chain advice 5

Complaints, Returns, Suspected Falsified Medicinal Products and Medicinal Product Recalls 7: Outsourced

6 What is in the Guidelines? 2013/C 343/01 1: Quality Management 2: Personnel 3: Premises & Equipment 4: Documentation 5: Operations 6: Complaints, Returns, Suspected Falsified Medicinal Products and Medicinal Product Recalls 7: Outsourced Activity 8: Self-Inspections 9: Transportation 10: Specific Provisions for Brokers 10 March 2018 Copyright silverbacklogistics.com. All rights reserved The place to go for free supply chain advice 6

7 Quality Management /C 343/01 Chapter 1 1.1: Principal Wholesale distributors must maintain a quality system setting out responsibilities, processes and risk management principles in relation to their activities. 10 March 2018 Copyright silverbacklogistics.com. All rights reserved The place to go for free supply chain advice 7

8 Quality Management 2013/C 343/01 All distribution activities should be clearly defined and systematically reviewed All critical steps of distribution processes and significant changes should be justified and where relevant validated The quality system is the responsibility of the organisation s management and requires their leadership and active participation and should be supported by staff commitment 10 March 2018 Copyright silverbacklogistics.com. All rights reserved The place to go for free supply chain advice 8

9 Process Approach To Quality System M.A.R.I.O. Management Input Activity Output Resources 10 March 2018 Copyright silverbacklogistics.com. All rights reserved The place to go for free supply chain advice 9

10 Quality System: Sample of Contents QUALITY MANUAL (MASTER FILE) WHAT YOU DO! Company Details Scope of Quality System Exclusions *Quality Objectives (must be Specific, Measurable, Achievable, Relevant, Timely + Evaluated, Reviewed) Process Flowchart An Organisational Chart 10 March 2018 Copyright silverbacklogistics.com. All rights reserved The place to go for free supply chain advice 10

Quality System: Contents Management Responsibility Management of outsourced activities Management Review & Monitoring Quality Risk Management PROCEDURE MANUAL

11 Quality System: Contents Management Responsibility Management of outsourced activities Management Review & Monitoring Quality Risk Management PROCEDURE MANUAL (SOPS) HOW YOU DO IT! Standard Operating Procedures 10 March 2018 Copyright silverbacklogistics.com. All rights reserved The place to go for free supply chain advice 11

12 Quality System: Contents SOP NUMBER VERSION DOCUMENT TITLE PAGE NUMBER DATE PROCEDURE FLOWCHART* SCOPE PURPOSE (WHY) RESPONSIBILITIES DEFINITIONS PROCEDURE SAY WHAT YOU DO, DO WHAT YOU SAY! ASSOCIATED DOCUMENTS PROCESS OWNER AND RP APPROVALS 10 March 2018 Copyright silverbacklogistics.com. All rights reserved The place to go for free supply chain advice 12

13 Sample of an Organisation s Process Flowchart Customer Enquiry Customer places order Marketing Dept: Quotation Purchasing Dept: Place Purchase Order with Supplier Warehouse: Goods received, checked and entered onto stock Customer Service: Process Customer Order Warehouse: Pick, sort, pack & despatch goods Post Market Activity Complaints, Investigations Customer Feedback Finance Dept Raise & send invoice to Customer 10 March 2018 Copyright silverbacklogistics.com. All rights reserved The place to go for free supply chain advice 13

14 Quality Systems Document & Record Control: Clause 4.2 Documents: Quality Manual, SOPs, uncompleted Registers and Forms Records: Entries into Forms & Records, collected data Example: The form used to create a purchase order is a document, once purchase order has been completed and sent to the supplier, it becomes a record. Documents and records can be review or check by staff but can only be approved by the RP! 10 March 2018 Copyright silverbacklogistics.com. All rights reserved The place to go for free supply chain advice 14

Review Re-assess risks Measure Monitor effectiveness 10 March 2018 Copyright

16 PDCA: Plan-Do-Check-Act Change Management Objective Deploy as per plan Activities Resources Risks Documentation Control Analyse review Change Maintain effectiveness Review Re-assess risks Measure Monitor effectiveness 10 March 2018 Copyright silverbacklogistics.com. All rights reserved The place to go for free supply chain advice 16

17 Quality Risk Management: Clause 1.5 A systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle Analyse Risk Assess Risk The word risk is mentioned 27 times in the Guidelines. Control Risk Review Risk 26/07/2017 info@pharmacyconsulting.co.uk 17

18 Risk Management Risk Rating Low or Broadly Acceptable Risk The probability and/or severity of the risk are so low that the risk is negligible. Medium Risk The risks within this region should be reduced as far as possible High or Not acceptable risk The probability and/severity of these hazards should be reduced to Low or broadly Acceptable (for patient health, these risks must be reduced 26/07/

19 Risk Management Example A Medicine Distributor s Warehouse Management System software is no longer able to cope with the increase of stock and stock movements so new software will need to be sourced and installed. What risks could be considered? Hazard Cause Harm Risk Rating Risk Control Residual Risk Incorrect or incomplete data transferred from existing system to new one Systems incompatible Or Errors in manual entry of legacy data Historical data could be lost or incorrect High Ensure compatibility between systems and validated prior to implantation. Check and test manually transferred data and test Low The new system does not do everything that the old system does Not obtaining user interface specifications (UIS) prior to installation Software does not enable key functions i.e.: Unable to track & trace stock, process sale & purchase orders High Included all key personnel when deciding specifications and functionality of new software Medium 26/07/2017 info@pharmacyconsulting.co.uk 19

20 Responsibilities of the RP: Clause 2.2 of Guidelines Should fulfil their responsibilities personally and should be continuously contactable Duties may be delegated but not the responsibility A written job description or Technical Agreement defining authority Defined authority, resources and responsibility Carry out duties in a way that the wholesale distributor can demonstrate GDP compliance Ensure the quality management system is implemented and maintained Managing authorised activities and the accuracy of records Ensure that training programmes are implemented and maintained Recalls Ensure relevant complaints are handled effectively Supplier/Customer approvals Subcontracted activity approval Self-inspections and CAPAs Records of delegated activities Disposition of non-conforming/returned product Approval of returned products National Law updates are implemented 10 March 2018 Copyright silverbacklogistics.com. All rights reserved The place to go for free supply chain advice 20

21 Personnel: Clauses 2.3, 2.4 & 2.5 Adequate personnel dependant on volume & scope of activities Roles, responsibilities, and inter-relationships defined Written job descriptions Trained COMPETENT! Appropriate Hygiene measures 10 March 2018 Copyright silverbacklogistics.com. All rights reserved The place to go for free supply chain advice 21

22 Premises: Clause 3 Suitable & adequate Secure security & cameras Structurally sound 10 March 2018 Copyright silverbacklogistics.com. All rights reserved The place to go for free supply chain advice 22

Essential standards for a warehouse Medicines stored in segregated, clearly marked areas Authorised personnel only/access control Clearly defined quarantine locations Protection from prevailing

23 Essential standards for a warehouse Medicines stored in segregated, clearly marked areas Authorised personnel only/access control Clearly defined quarantine locations Protection from prevailing weather conditions Goods-In/Out separation logic workflows Pest Control (preventive) House Keeping programme & records No food, drinks, tobacco, personal medicinal products 10 March 2018 Copyright silverbacklogistics.com. All rights reserved The place to go for free supply chain advice 23

Essential standards for a warehouse: temperature and environmental control Clause 3.2.1 What is wrong with this fridge?

24 Essential standards for a warehouse: temperature and environmental control Clause What is wrong with this fridge?! No air circulation Goods blocking fan Goods in Goods out mixed What is wrong with this picture? Is this a medicines fridge or meat fridge? Which temperature is correct? What to look for in an ideal fridge: External temperature reading/alarm Lockable Wire shelving enables air flow Ensure that there is ample space around the fridge to allow good ambient air flow. 10 March 2018 Copyright silverbacklogistics.com. All rights reserved The place to go for free supply chain advice 24

25 Essential Standards for a Warehouse Temperature & Environmental Control: Fridge Mapping 26/07/2017 info@pharmacyconsulting.co.uk 25

26 Essential Standards for a Warehouse Equipment: Clause 3.3 Validated/ Verified Maintained Calibrated Alarmed Repaired Maintenance is planned & recorded 26/07/2017 info@pharmacyconsulting.co.uk 26

27 Computerised Systems: Clause Validated or Verified Written detailed description of the system Up to date, principles, objectives, security measures, system scope & main features Diagrams where appropriate Data security Repaired Procedures for system failure 26/07/

28 Essential Standards for a Warehouse Storage: Clause 5.5 Protect medicines Stock rotation (FEFO) Handled/Stored carefully Removal of short shelf life stock Regular inventory Investigation of stock irregularities 26/07/2017 info@pharmacyconsulting.co.uk 28

29 Qualification of Suppliers/Customers: Clauses 5.2 & 5.3 Are the customers/suppliers who they say they are? How can we ensure this? GPs, WDA(H), Marketing Authorisation full copy with notarised translation (where required) EudraGMP GDP Compliance Certificate (specifically for suppliers) Appropriate qualification (questionnaire/audit) Due diligence checks websites/references/additional certification Compliance with Good Distribution Practice (Suppliers only): A certificate of Good Distribution Practice (GDP) is issued to a wholesale distributor by the national competent authority that carried out an inspection if the outcome of the inspection confirms that the wholesale distributor complies with Good Distribution Practice, as provided by European Union legislation. If the outcome of the inspection is that the wholesale Distributor does not comply a statement of non-compliance may be entered into EudraGMDP. GDP certificates and statements of non-compliance may be issued to wholesale distributors of medicinal products and distributors of active substances. 10 March 2018 Copyright silverbacklogistics.com. All rights reserved The place to go for free supply chain advice 29

30 Complaints: Clause 6.2 Distinction between product and distribution issues Inform manufacturer or marketing authorisation holder Investigate distribution issues Appoint a member of staff and allocate sufficient personnel Follow up actions including CAPA RP review and sign off 26/07/2017 info@pharmacyconsulting.co.uk 30

31 Returns: Clause 6.3 Written Procedure Is it damaged? How long has it been out of your control? Where has it been? How has it been stored? What temperature has it been stored/transported at? Can you prove it? RP approval & signature 26/07/

32 Falsified Medicinal Products: Clause 6.4 Any part of a medicine, packaging or paperwork not just counterfeit Written procedure Inform MA holder/rp/mhra Segregate immediately Document and retain records Reports can be made for all medicines including vaccines, blood factors and immunoglobulins, herbal medicines and homeopathic remedies, and all medical devices 26/07/2017 info@pharmacyconsulting.co.uk 32

33 Medicinal product recall: Clause 6.5 Capable of being initiated at any time Follow the instructions of the recall Record recall operation at the time & available to the competent authority Records of distribution readily accessible (traceability) Recall progress recorded for final report Evaluate effectiveness of recall procedure (dummy recalls) Negative recall records 26/07/

34 Outsourced activity: Chapter 7 WRITE IT DOWN! Whom did you talk to? When did you talk to them? Where were they? What process were they doing? What documents & records did you review (both paper & electronic) What did you see & hear (observe) What were your findings? Your notes should be legible and are retained for future reference 26/07/2017 info@pharmacyconsulting.co.uk 34

35 Non-conformity What is a non-conformity? Not meeting the specific requirements of a standard, directive or guidelines Or Not following the approved written procedures Minor Non-conformities: A one off incident Human error Minimal or no risk to product or service Example: The housekeeping records were found not to have been completed for one day, all the other records were found to be complete (procedure **/Clause 3.2) Major Non-conformities: Systemic, repeated minor incidents relating to the same clause of the standard, directive or guidelines A break-down in the effectiveness of the Quality System i.e.: not following the approved written procedures A single or multiple non-conformities that could have detrimental effect on products or service (patient safety) Example: Following a report that a product had failed during use, the written procedure and the requirement for reporting product failure was not applied (procedure ***/Clause 6.2) 26/07/2017 info@pharmacyconsulting.co.uk 35

36 Follow-up Capable of being initiated at any time Follow the instructions of the recall Record recall operation at the time & available to the competent authority Records of distribution readily accessible (traceability) Recall progress recorded for final report Evaluate effectiveness of recall procedure (dummy recalls) Negative recall records 26/07/

Transportation: Chapter 9 STORAGE CONDITIONS MUST BE MAINTAINED DURING TRANSPORTATION WDA(H) holder must protect products from adulteration Transport within the temperature range indicated on the

37 Transportation: Chapter 9 STORAGE CONDITIONS MUST BE MAINTAINED DURING TRANSPORTATION WDA(H) holder must protect products from adulteration Transport within the temperature range indicated on the packaging Report excursions Inform contract providers of storage requirements Use dedicated vehicles where possible Risk assess the delivery routes Validate the route/methods to be used 26/07/2017 info@pharmacyconsulting.co.uk 37

38 Introducing for Export What do you need on your license: 1.3 Without Marketing Authorisation in EEA not for use in EEA 2.4 Export 4.7 Importing from outside EEA to send outside the EEA If the origin is outside the EEA but bought from an EEA provider it s still a special. If buying specials in EEA and exporting you don t need 4.7 on your license. 26/07/2017 info@pharmacyconsulting.co.uk 38

Brokers: Chapter 10 Specific provisions for brokers A broker is a person involved in activities in relation to the sale or purchase of medicinal products, except for wholesale

39 Brokers: Chapter 10 Specific provisions for brokers A broker is a person involved in activities in relation to the sale or purchase of medicinal products, except for wholesale distribution, that do not include physical handling and that consist of negotiating independently and on behalf of another legal or natural person 26/07/2017 info@pharmacyconsulting.co.uk 39

40 Self Inspection: Clause 8.2 Self-inspection: objectives To assess conformity to statutory, regulatory and contractual requirements Evaluate the effectiveness of the Quality System Identification of areas of improvement Self Inspections focus on the RP not the Director Scope and Plan for self-audits to cover compliance with all aspects of Good Distribution Practice Culture RP dispute with directors Lack of details on the Qualification of Suppliers/Customers No detailed bona fides checked on Export Customers No reassurance that licence suspensions and revocations would be captured and acted on in a timely manner. RP what activities are conducted by the RP procurement process CPD for RP GDP Training- Competence check of Directors 10 March 2018 Copyright silverbacklogistics.com. All rights reserved The place to go for free supply chain advice 40

41 Audit Audit Evidence (objective evidence) Review related documents and records and record document references and Issue/Review numbers Review documents Plan audit Audit Audit sequence Keep the audit fact/evidence based Summary Report Nonconformity Report(s) Corrective Action(s) Review of Corrective Actions 10 March 2018 Copyright silverbacklogistics.com. All rights reserved The place to go for free supply chain advice 41

42 The Inspection: What to Expect Application + fee Standard operating procedures Technical agreements On-site or contract warehouse Site for administration Internal or contract RP 90 days for inspection 1 9 months for inspection 2 Future inspections are based on your compliance at the time of your 9 month inspection The more compliant you are, the longer between inspections. BE PREPARED FOR A CANCELLATION! Future inspections are based on your compliance at the time of your 9 month inspection The more compliant you are, the longer between inspections. Compliancy leads to a positive GDP Compliance report Up to 4 years before your next inspection 26/07/2017 info@pharmacyconsulting.co.uk 42

43 The Inspection: What to Expect Quality of product and service to ensure public safety Risk assessment, both proactive and reactive (including Change Management) Validation relating to the introduction of the Falsified Medicines Directive Calibration Records keeping, maintaining & archive retrieval (Records are to be retained for a minimum of 5 years including personnel records) Evidence of compliance If it hasn t been recorded it hasn t happened! Inspectors like written records Inspectors do not to look for deviations they will jump out while trying to find evidence of compliance 26/07/2017 info@pharmacyconsulting.co.uk 43

44 Feedback from MHRA inspections Review all your QTAs even if ongoing, follow through/review TAs not signed by both parties and often expired No formal assessment of the arrangements for the safe and secure transport of products to customers Risk assessment of transport did not cover all arrangements No process in place for controlling outsourced activities Regularly evaluating the effectiveness of the arrangements for product recall 26/07/