LABORATORY SAMPLES AND CONTRACT MANAGEMENT

1. LABORATORY SAMPLES AND CONTRACTMANAGEMENT IFUDU COLETTE.N QUALITY ASSURANCE MANAGER NAFDAC CENTRAL DRUG CONTROL LABORATORY,YABA.

2. Learning Objective • To understand the management of samples and contracts in Quality control laboratory.

3. OUTLINE • Samples • Sampling • Sample handling • Sample receipt • Documentation- Sample register/log • Retained sample • Environmental monitoring of storage location • Contract

4. Samples Sample type includes; • Starting materials • Packaging materials • Intermediates • Bulk products • Finished products • Water Sample

5. Sampling • Written procedure for sampling which include the person(s) authorized to take samples, the method and equipment to be used, the amounts to be taken and any preparations to be observed to avoid contamination of the material or any deterioration in it’s quality. • Representative samples of each shipment of each batch should be collected for testing. • Sampling methods should specify the number of containers to be samples which part of the container to sample and the amount of material to be taken from each container.

6. Sample handling • Each sample container should bear a label indicating; • The name of the sampled material • The batch or lot number • The number of the container from which the sample has been taken • The number of the sample • The signature of the person who has taken the sample • The date of sampling

7. Sample Handling • Retention samples should be representative of batch materials or products from which they are taken. • Retention sample from each batch of finished products should be retained till one year after the expiry date • .Retention samples of materials • Finished products should be kept in their final packaging and stored under the recommended conditions. • If exceptionally large packages are produced, smaller samples might be stored in appropriate containers. • Retention samples of materials and products should be of the size sufficient to permit at least two full re-examination

8. Sample handling-1 • Samples to be taken in accordance with approved written procedures that describe: • The method of sampling • The equipment to be used • The amount of sample to be taken • Instructions for any required sub-division of the sample • The storage conditions • Instructions for the cleaning and storage of sampling equipment.

9. Sampling handling-2 • The type and condition of the sample container to be used • The identification of containers sampled • Any special precaution to be observed, especially with respect to sampling of sterile or noxious materials

10. Sample Receipt Area • Organized to accommodate incoming and outgoing samples. • Provision of sampling tools (spatulas, containers) . • Appropriate storage conditions e.g. refrigeration where necessary. • Secure storage of samples, retained samples. • Environmental monitoring and control • Organized to accommodate incoming and outgoing samples. • Appropriate storage conditions. • Segregation ( dosage,source,purpose of analysis).

11. Samples Incoming samples • Sample size sufficient for: • the tests to be performed • replicate tests • retained / retention sample

12. Registration and labelling • All samples should be assigned a registration number -The numbering format should be as stated in the sample receipt procedure • Separate registration numbers - different batches • A label with appropriate information on each container of the sample

13. Registration and labelling • Separate registration numbers should be assigned to requests referring to two or more medicines, different dosage forms, or different batches of the same medicine or different sources of the same batch.

14. Test Request form-1 Test request can be filled out during sampling - accompany each sample submitted to the laboratory, and should contain the following information e.g.: • source of the material • full description including its International Non proprietary Name, concentration or strength, manufacturer(for starting materials) and batch number (if available), size of the sample • reason for requesting the analysis • date on which the sample was collected

15. Test Request form-2 • size of the consignment from which it was taken, when appropriate • expiry date (pharmaceutical product) retest date, (starting material, pharmaceutical excipients) • pharmacopoeia specifications or other official specifications to be used for testing • record of further comments (e.g. discrepancies found) • required storage conditions

16. Contract Analysis • Contract analysis must be correctly defined, agreed and controlled in order to avoid misunderstandings which could result in unsatisfactory analysis report. • A written agreement covering the analysis arranged under the contract and any technical arrangements made in connection with it. • The contract should permit the contract giver to audit the facilities and activities of the contract acceptor or mutually agreed subcontractors • The final approval for release must be given by the authourized person in accordance with GMP and marketing authourization as specified in the contract.

17. The Contract-1 • A written contract between the contract giver and the contract acceptor which clearly establishes the responsibilities of each party • Covers the outsourced activities, communication processes relating to the outsourced activities and any technical arrangements made in connection with kit. • Technical aspects of the contract should be drawn up by competent persons suitably knowledgeable in pharmaceutical technology and analysis.

18. The Contract-2 • All arrangements for analysis must be in accordance with the marketing authourization and agreed by both parties. • The contract should clearly describe who is responsible for contracted activities,e.g. who has responsibility for sampling and analysis, whether or not the contract acceptor should take samples at the premises of the manufacturer.

19. The contract-3 • Analytical records and retention samples should be available to the contract giver. • Any records relevant to assessing the quality of a product in the event of complaints or suspected defect must be accessible and specified in the recall procedures of the contract giver. • The contract agreement must state that the contract giver and NAFDAC have the right to visit the facilities of the contract giver. • The contract acceptor should accept that he is subject to inspection by NAFDAC.

20. The Responsibilities of the contract giver-1 • Responsible for assessing the legality, suitability and competence of the contract acceptor to successfully carry out the tests required for approval for contract activities and for ensuring by means of the contract . • Provide the contract acceptor with all the information necessary to carry out the contracted operations correctly in accordance with the marketing authourization and any other legal requirements. • Ensure that the contract acceptor is fully aware of any harzards to his premises,equipment,personnel and other materials or products.

21. The Responsibilities of the contract giver-2 • Review and assess the records and results related to the outsourced activities • Monitor and review the performance of the contract acceptor including the implementation of any needed improvements and their effectiveness. • Ensure that the contract acceptor understands that his activities may be subject inspection by NAFDAC.

22. Responsibilities of the Contract acceptor-1 • Have adequate premises and equipment, knowledge and experience and competent personnel to carry out satisfactorily, the work ordered by the contract giver. • Must not pass to a third party any work any work entrusted to him under the contract without the contract giver’s prior evaluation and approval of the arrangements

23. Responsibilities of the Contract acceptor-2 • Arrangements made between the contract acceptor and any third party should ensure that information and knowledge including that from assessment suitability of the third party are made available in the same way as between the original contract giver and contract acceptor. • The contract acceptor should refrain from any activity including Unauthourized changes outside the terms of the contract which may adversely affect the quality of the product analyzed for the contract giver.

24. Summary • The management of laboratory samples and efficient handling of contract analysis are key performance indicators for laboratory QMS as the accuracy and reliability of tests results are influenced by sample handling and integrity and the requirements of second and third party agreements/contracts for analysis.

25. Group exercise • Global Investment company procured medicines worth two hundred and fifty million naira for the guinea worm eradication program in Taraba state, to be delivered within two months. • The company contracted Sophia pharmaceuticals to analyze the products and verify the quality . • What measures will Sophia pharmaceuticals implement to execute this contract, ensure product integrity ,assure accuracy of test results and guarantee customer satisfaction.