Good Distribution Practices Toolkit. Quality Management System 08 March 2016

Transcription

1 Good Distribution Practices Toolkit Quality Management System 08 March

2 Quality Policy GDP, Legal, Environmental, H&S Processes & Systems Resources Risk Assessments 2

3 Quality Policy & Objectives Principles Standard Operating Procedures 3

4 Quality Policy & Objectives Quality Policy Statement, is an organization s general statement of its beliefs about quality, how quality will come about and its expected result. The Quality Policy Statement is the first layer of documentation in a Quality Management System (QMS) Statement of quality Senior Management commitment to quality Consistent Quality Patient centric How quality will be achieved = objectives 4

5 Example of Quality Policy 5

6 Principles Organization and administration Regulatory compliance and/or engagement Approved Suppliers IT systems Product Integrity Self Inspections Non conformances Corrective Action and Preventative Action Validation Calibration Change Control Risk Assessments 6

7 Organization and Administration Resources Approved Suppliers 7

8 Organization and Administration CEO/MD Marketing/Sales Head QA Head Operations Head Regulatory Head 8

9 Roles and Responsibilities Relevant training, education and/or experience (GDP). Signed Job Descriptions (Employee & Management) Relevant HR policies Documented & Available. 9

10 Regulatory Compliance and/or Engagement Regulatory Compliance GDP, Legal, Environment al, H&S Self Inspections GDP/ Health & Safety/ Environmental Health Authority Engagement 10

11 Regulatory Compliance and/or Engagement Registration with relevant Regulatory bodies (MOH, Pharmacy Board, Health Authority) Communication with Regulatory bodies (recalls, counterfeits) Formally recorded and reported Audits, Inspections Contact Details of relevant Regulatory Personnel must be recorded and maintained 11

12 Approved Suppliers (min. requirements) Contracts must with exist between Distributors and Suppliers of Product. Contracts must stipulate obligations of each party with regards to Good Distribution Practice. Distributors must ensure that Suppliers comply with the relevant Regulations and Products supplied are legitimate. Procurement and Receiving Processes must be documented in written SOPs to achieve this objective. 12

13 Non Conformances (NCs) Corrective Action Preventative Action Change Control Calibration Processes & Systems Validation IT Systems Customer Complaints 13

14 IT Systems (min. requirements) Computer system security: Access controlled Unique user passwords Timed auto-log-off Audit trail capability Computer System Validation relating to quality documentation 14

15 Product Integrity Factors Impacting Product Integrity Lot Traceability Inventory Control Receiving Pick/Pack/Ship Returns Recall Storage Complaints Change Control Non Conformances Self Inspections and CAPA Validation/Calibration/Temperature Mapping Operations 15

16 Self Inspections Inspections should be in line with principles of GDP and if necessary, to trigger corrective and preventative measures The Responsible Person (QA Head) is to ensure that selfinspections are performed and any deviations (non conformances) are followed up and concluded. NB Deadlines Must Be Set Written procedures for self- inspections should be established to provide minimum and uniform standards. Should at least be annually Follow up programmes should verify the effectiveness of the corrective measures taken 16

17 Non Conformances Any deviation to the requirements of GDP is recorded as a non conformance for e.g. temperature excursion out of required range in warehouse. Non conformances must be documented and investigated Corrective actions must be implemented. Responsibility for implementation must be allocated. It must be determined whether the nonconformity is an isolated or a repetitive problem Repetitive NCs should result in a CAPA 17

18 Corrective and Preventative Action Corrective action is taken after nonconformities are identified. Preventive action is taken to prevent the reoccurrence of the event. Preventive action should be considered if there are opportunities to improve the quality management system. Effectiveness check to be done after closure of CAPA 18

19 Change Control Changes in : Processes; Products; Structures; Systems. Formalised Documentation: Assessment; Evaluation and Approval/Rejection; Implementation Plan; Handle as Project with timelines etc. 19

20 Validation The following should be validated as a minimum: Warehouse premises: ambient and cold-chain storage conditions including temperature mapping; Lagged containers; Cold-chain processes; and Computerised systems. Validation should be conducted in accordance with a validation protocol. A written Validation Report should be available after completion of the validation 20

21 Calibration All measuring equipment must be calibrated Calibration Programme It is the Responsible Person s (QA Head) responsibility to approve the calibration programme 21

22 Temperature Mapping Temperature mapping should be conducted across the storage facility (ambient and cold room). Calibrated temperature monitors (thermometers, templates, I buttons) should be located in areas that are most likely to show fluctuations. Records should be available for review. There should be defined intervals for checking the temperature over a period of 72 hours (seasonal change, structural change, cooling system change) 22

23 Risk Assessments 23

24 Risk Assessments Risk can be defined as the measure of the probability and consequence of not achieving a specific goal Assessing a system such as pest control, temperature/ humidity control and evaluating risks Worst case scenario Mitigation Implementation 24

25 Questions and Answers 25