INGREDIENTS, FOOD SUPPLEMENTS AND NUTRITIONAL

Transcription

1 INGREDIENTS, FOOD SUPPLEMENTS AND NUTRITIONAL COMPOUNDS SAFETY: THE QUALITY CONTROL OF RAW MATERIALS IN NUTRACEUTICALS, TO PREVENT CONSUMER HEALTH RISK GRF Supplier qualification of nutraceutical raw material using a Quality Risk Managment approach

2 Supply Chain Challenges WHAT WE SPEAK ABOUT? QMS GRF Raw materials Storage Manufacturing Quality control Distribution

3 Supply Chain Challenges World demand for nutraceutical is increasing continuosly Import of ingredients will continue to grow as a result of cost concern (need for lower cost and higher productivity), availability, consumer demand and scarsity of natural resoucers. The continued growth of this market is creating complexity for regulators because supply chain become more complex. Traceability Quality Counterfeit

4 Goal of supplier qualification Guarantee the consumer safety and mantain the good reputation of the Company from the risk associated to the quality of the raw materials KNOW YOUR SUPPLIER!

5 Supply Chain Challenges What is needed? Ensure traceability Ensure safety and quality Satisfy Regulation requirements Increase the level of GMP compliance

6 What we are doing in order to qualify our suppliers? Supplier qualification team Harmonizing procedure to develop a global approach to supplier management Many companies struggle to develop a rigorous supplier qualification programme What is the difference between a good or rigorous supplier qualification programme in a complex supply chain? A way that allows to limit resources is using a supplier risk managment approach

7 SUPPLIER RISK MANAGMENT RISK MANAGEMENT: using managerial resources to integrate risk identification, risk assessment, risk prioritization, development of risk handling strategies, and mitigation of risk to acceptable levels. For supplier qualification, risk can be defined in the following ways: Risk of a quality event (e.g., out-of-specification resulting in a falsification of the finished product) Safety risk to the component user or consumer Risk of disruption of service or supply IPR: is the priority risk index and is the combination of different risk factors

8 SUPPLIER RISK MANAGMENT Supplier risk management advantages apply limited resources to those components and suppliers that represent the greatest risk flexibility to shift resources to prevent a significant quality event reduce costs and risk for safety

9 SUPPLIER QUALIFICATION FLOW CHART YES Audit is required: High risk Evaluation technical documentation of supplier Analysis of the component in order to confirm test results from those reported on the supplier s COA Assessment supplier and component risk profile Audit is needed? NO Audit is not required: low risk Determine the criteria for periodic riqualifications Periodic reevaluation of supplier risk assessment Determine the frequency of full testing Final risk supplier/ component profile YES Purchase raw material NO Qualify altenative supplier

10 SUPPLIER RISK MANAGMENT The evaluation of the supplier documentation is the first approach to qualify it. THE DOCUMENTATION OF THE SUPPLIER IS THE MIRROR OF ITS QUALITY SYSTEM Pre qualification documentation: Raw material information: specifications, declarations Evaluate if meet quality requirements Evaluate if meet regulatory requirements Evaluate if meet development needs Facility information: Supplier Questionnaire/Self-Audit Assessment, Third-Party Certifications, regulatory enforcement history

11 PRE QUALIFICATION DOCUMENTATION CERTIFICATE OF ANALYSIS The evaluation of the certificate of analysis is the first step of the supplier qualification. General information The name and address of the supplier and contact information of the supplier. The name and address of the manufacturer and manufacturing site of the component if different from the supplier. Specifications for identity, purity, strength, composition and appropriate limits for pertinent contaminants. The trade name, grade of the material (if any) and applicable compendial designations (if any). A lot/batch number of uniquely identifying the material. The date of manufacture. The date of testing. The expiration date or retest date.

12 PRE QUALIFICATION DOCUMENTATION CERTIFICATE OF ANALYSIS Analysis Test Name Test Results Acceptance Criteria (i.e., Specifications) Reference to the Test Method Reference to Skip-lot Testing Other Microbiological information Physical Tests Tests (if applicable) Type Total of Chemical Plate Extract/Solvent Count Appearance Tests System Country Yeast Identification & of Mold Origin Color for the botanical if different from Salmonella the Assay manufacturing Texture (if location appropriate) Statements E. coli Water (Aflatoxins, Aroma content(if appropriate) Allergens) Storage Total Sulphated Count Recommendations Taste Enterobacteriacea Ash (if appropriate) Total Heavy Particle Metals Size (ifapplicable) appropriate) Related Total substances Solids (if applicable) OVI/Residual Refractive Solvents Index (if applicable) Pesticides Viscosity (if applicable, (if applicable) e.g., botanicals) Solubility (state solvent) Density loose/tapped Product Characteristics (if applicable, e.g., botanicals) Plant Part used Carrier used Plant: Extract ratio

13 PRE QUALIFICATION DOCUMENTATION ADHERENCE TO SPECIFICATIONS The component user should evaluate the supplier s specifications and methods to ensure that they are appropriate and acceptable for the quality control needed for the manufacturing process of its dietary supplement product. COMPENDIAL COMPLIANCE The supplier that has to claim a compendial grade on the COA has to guarantee two requirements: the component has to meets all of the specifications contained in the identified compendial monograph the methods used for each test are the same prescribed by the monograph.

14 PRE QUALIFICATION DOCUMENTATION TECHNICAL DOCUMENTATION Product Information Manufacturing Information: information about where and how the product is manufactured, description of manufacturing process (blend, reaction, etc.) and/or flowchart, brief description of known or potential sources of impurities and/or contaminants. Physical/Chemical Information: synthetic, animal sourced, vegetable sourced, mineral based, product of fermentation. Labelling Information Stability information Package information

15 SUPPLIER RISK MANAGMENT RISK FACTORS Supplier considerations Country of origin Supplier regulatory history Supplier experience Supplier audit results Component considerations Origin of material Characteristic of material Intended use of material Process complexity Documentation considerations Compendial status of material Supplier specifications Technical documentation

16 Examples of risk analysis application Risk factors related raw material A Risk level High Medium Low Origin Animal origin Plant origin Chemical synthesis B Risk level High Medium Low Compendial grade No compendial grade No compendial monograph, but identity, strength, purity, and composition well characterized and consistent with material complexity Compendial grade (EP. USP)

17 Examples of risk analysis application Risk factor related raw material C Risk level Characteristic of raw material High Low shelf life: photosensitive, hygroscopic, oxidable, termolable Medium Medium shelf life: partial combination of above risk factors Low Very stable: no Photosensitive, no hygroscopic, no oxidable, no termolable

18 Examples of risk analysis application Risk factors related supplier E Risk level High Medium Low Suppier quality system Scarse level of documentation: no technical dossier, no declarations No technical service support Technical dossier with gaps in some information Some technical services support, but lacking in experience for the component and process knowledge Good level of quality documents: strong technical dossier, strong technical services support personnel with good knowledge of component and process F Risk level High Medium Low Suppier certifications No Third party Certifications Third party certifications (e.g. ISO certifications) National Regulatory Authorities Certification (e.g. GMP certifications)

19 Examples of risk analysis application Risk factors related supplier G Risk level High Medium Country and region of supplier Company manufactures in country with a developing government regulatory system Company manufactures in country with moderately robust government regulatory system Low Company manufactures in well-developed country with mature government regulatory system

20 Examples of risk analysis application IPR= ( raw material risk factor x supplierriskfactor)=(a+b+ C)x(E+F+G) Supplier and its system (degree of risk) Low Medium High Component (degree of risk) High Medium Low Red: no/limited opportunity for risk mitigation. Orange: some opportunities for risk mitigation to a lower risk level. Yellow: good opportunities for risk mitigation to a lower risk level. Green: very low risk component and supplier combination.

21 Examples of risk analysis application Supplier/Component Low Risk Assessment: Full analysis on first 3 incoming batches and, if acceptable, will proceed with reduced testing. Reduced testing will include an identity test only. CoA reconformation 1 per year. The users will not perform an audit on the manufacturing site because the supplier receives periodically national regulatory inspections. Supplier/Component Medium Risk Assessment: Full analysis on first 5 incoming batches and, if acceptable, will proceed with reduced testing. Reduced testing will include some test e.g. identification, assay, water content, impurities. CoA reconformation 2 per year. Supplier may be reassessed as low-risk if the user will choose to audit the supplier and the if the audit results with minor deviations.

22 Examples of risk analysis application Supplier/Component High Risk Assessment: a lack of facility-specific audit information, incomplete technical documentation The user decides to proceed with the qualification of this supplier and implement audit on manufacturing site before purchasing full testing for each incoming batch for 1 year or 20 individual batches Supplier may be reassessed as medium -risk if the audit corrective actions are promptly completed and if all test results are conforms for each batch tested.

23 Conclusion A proper supply chain provides quality and safe product to the end user and is reached by companies with a good supply chain managment integrate with a good quality system managment.

24 Thank you for your attention.