Residual Impurity (RI) Management. Crop Protection Quality Code of Practice. QCoP-005

Transcription

1 Residual Impurity (RI) Management Crop Protection Quality Code of Practice QCoP-005

2 Contents Residual Impurity (RI) Management Purpose Scope Definitions & Abbreviations Principles RI Management: Responsibilities of Functions P&S Management Global Product Integrity Quality Manager RI specialist RI Management: Contamination Prevention Requirements Separation rules RI limits / RIRA Cleaning of the production unit Site and Toller assessments RI audits RI incident management Generic RI change management process... 9 Summary sheet Last Revision: Version Date Reason for change Author 3 13-Nov-14 Entire review, update about new CropLife booklet, Standard Practice and RIRA 2.0 Christian Mueller Effective date: Classification: INTERNAL USE ONLY Page 2 of 11

3 Residual Impurity (RI) Management Crop Protection Quality Code of Practice QCoP Purpose Contamination of Crop Protection Products with Residual Impurities (RI) has been identified as one of Syngenta s highest business risks. Contamination with residual impurities is an area of risk for any (multi-purpose) chemical synthesis, formulation and packaging unit, storage facility and (bulk-) transportation operation. Residual impurities may cause adverse effects on sensitive treated crops or non-target species as well as regulatory issues. An incident may severely damage the image and brand of Syngenta and the reputation of the agrochemical industry itself. This CoP defines the requirements and responsibilities for the implementation and maintenance of a RI Management System and its performance review. 2. Scope This Code of Practice applies to all Syngenta Crop Protection sites, Tolling, Procurement and Bulk Distribution / Logistic Operations; it is applicable to line management responsible for the implementation, maintenance and resourcing of RI Management Systems and ensuring compliance to system requirements. 3. Definitions & Abbreviations AI Cleaning limit CropLife Facility FPP Manufacturing Unit Process Owner Residual Impurity RI RIRA 2.0 Active Ingredient Synonym for RI limit. The concentration (in ppm) of the previous active ingredient(s), or any other extraneous substance(s), below which it will not cause any adverse biological, toxicological, ecological effects or regulatory issues in the succeeding product. CropLife International A.I.S.B.L. A term used in RIRA 2.0 software; identical with a manufacturing unit/line and/or filling line Finished Product Production Combination of technical equipment used for the manufacturing of product(s) Individual that is responsible for design, implementation, ongoing monitoring and effectiveness, and relevant change management of a process Traces of active ingredients(s) of another product Residual Impurity Residual Impurity Risk Assessment software RI Limit Cleaning limit which must be calculated with RIRA 2.0 Effective date: Classification: INTERNAL USE ONLY Page 3 of 11

4 RI Specialist Senior management Shared manufacturing asset Significant change Toller / Toll Manufacturer A person trained on RI Management practices, RI auditing and / or the use of the RIRA software normally within the Quality Control or Quality Assurance functions Regional / Global Functional Head(s) in P&S Technical equipment (reactors, tanks, packaging lines, mills etc.) used for the manufacture and storage of different products (multi-purpose equipment) providing common wetted parts / surfaces with product contact Change of the manufacturing site and/or equipment design, separation, cleaning requirements and capabilities, manufacturing practices, new product class introduction A company synthesizing, formulating or packaging a product for Syngenta on a contractual basis. The term toller / toll manufacturer is synonymous with contract manufacturer or contractor. 4. Principles 4.1 RI Management: Responsibilities of Functions P&S Management Management of the following P&S functions is responsible for implementation, maintenance and resourcing of the RI Management System and must ensure compliance to the RI Management system requirements listed in chapter 4.2: Syngenta sites for AI synthesis and FPP Tolling Management for regional / supply chain managed FPP tollers Procurement for tolling and purchasing of AI s, intermediates, raw materials, formulation inerts, purchased finished goods (range enhancement) Distribution / Logistic Operations for bulk storage and bulk delivery Territory / Country Management for locally managed FPP tollers Resources to perform the required activities do not necessarily need to be part of P&S. Herewith the management has further specific responsibilities: Senior Management The requirements of this RI Management CoP are communicated to the relevant stakeholders (Functional Heads of Sites (Site Managers), Tolling Management, Procurement, Distribution / Logistic, Territory / Country Management). All key controls outlined in this CoP are implemented and their effectiveness verified on a regular basis. Functional Heads of Sites (Site Managers), Tolling Management, The requirements in this RI Management CoP are communicated to the relevant personnel. All key controls outlined in this CoP are implemented and their Effective date: Classification: INTERNAL USE ONLY Page 4 of 11

5 Procurement, Distribution / Logistic, Territory / Country Management Line Managers effectiveness verified on a regular basis. An implementation plan for this CoP is developed and progress closely monitored to address any gaps. Develop and implement an implementation plan of the key controls outlined in this document. Verify the effectiveness of the key controls on a regular basis. Procurement Personnel Ensure that any purchased active ingredient complies with this CoP and CropLife requirements. The management will ensure the following requirements are covered and implemented [2, Chapter 4.3]: Nominate a company contact who is able to speak authoritatively on behalf of the company on all aspects of Contamination Prevention (Global Product Integrity Quality Manager) Protect the confidentiality of exchanged information Provide sufficient qualified resources for all aspects of Contamination Prevention Apply requirements and best practices as demonstrated in the CropLife Contamination Prevention in the Manufacture of Crop Protection Products Guidelines and Best Practices booklet Written approval if separation of herbicides from non-herbicides is not fulfilled (see chapter 4.2.1) Continuous training and awareness Good housekeeping Exceptions to any of the general requirements have documented approval from senior management Global Product Integrity Quality Manager Update of global RI Management System documentation Own and administer RIRA 2.0 (Residual Impurity Risk Assessment) Software [1] Maintain and update, if necessary, the RIRA 2.0 software Act as the Syngenta contact person for CropLife member companies able to speak authoritatively on behalf of the company on all aspects of RI Management Coordinate biological trials for NOEL determination Act as a trainer and consultant on RI Management RI specialist Create and maintain RIRA 2.0 matrices Perform RI audits Perform RI Standard Practice assessment [6] Effective date: Classification: INTERNAL USE ONLY Page 5 of 11

6 4.2 RI Management: Contamination Prevention Requirements Syngenta Crop Protection will ensure that their products on the market do not contain residual impurities in the form of active ingredients not defined in the product specification, at levels which will prejudice safety and efficacy, or which do not meet regulatory requirements. Syngenta Crop Protection will set the limits for their products, following an appropriate written risk assessment. Legal requirements such as US EPA Pesticide Regulation (PR) Notice 96-8 as well as any local legislation must be followed [2, Appendix C]. Syngenta manufacturing sites, third party toll manufacturers, suppliers and Distribution / Logistic Operations for bulk storage and transportation must implement an RI Management System which includes at a minimum: Separation rules Non-herbicides must not be produced in the same equipment as herbicides, i.e. separation between manufacturing units must be guaranteed. This applies to all synthesis, formulation, filling and packaging operations (chapter 4.2 Contamination Prevention in the Manufacture of Crop Protection Products Guidelines and Best Practices ) [2]. An exception to this rule can only be permitted with written approval from senior management. The approval could be issued with regional and/or global validity [2]. In any case stringent cleanliness of the equipment must be confirmed by achievement of the applied RI limit [4]. Seed treatment products must be separated from herbicides (normal rate and low rate herbicides) for any formulation, fill and pack procedure. No exception to this rule is allowed because multiplication steps from relatively small volumes of product to large volumes of treated seeds and eventually hectares of crops, significantly increases the financial risk to Syngenta. The use of any industrial chemical (non-agrochemical) must comply with the requirements of the CropLife Contamination Prevention guidelines [2]. Any kind of pesticide including active ingredients must not be manufactured and/or transported together with: Human and Veterinary pharmaceutical products Personal Care and other health care products Food and feed stuffs (including vitamins) RI limits / RIRA 2.0 RI limits must be defined and up to date for any agrochemical product (pesticide, fertilizer, micronutrient, bactericide and adjuvant) manufactured or packaged in shared manufacturing and/or packaging assets. The RI limits must be provided by an RI matrix calculated with the Residual Impurity Risk Assessment (RIRA) 2.0 software [4]. An RI matrix must be created, updated or recalculated at a minimum in following cases: New production / packaging line (facility) Product mix change of existing facility (additional product or residual impurity, relocation of existing product to another facility) After 3 years for registration information (application rates, crops, region, seed treatment) of all facility products After major update of the RIRA database (admin version change to next integer number, e.g. from 2.14 to 3.0) Effective date: Classification: INTERNAL USE ONLY Page 6 of 11

7 4.2.3 Cleaning of the production unit Cleaning of the production unit is essential for effective contamination prevention; the cleaning limit required for a product-changeover is the primary indication of the risk involved in the changeover [2]. Written cleaning procedures must be in place, at a minimum they must take into account: RI limit, product mix and sequence Type of operation (synthesis, formulation or packaging of liquids or solids) Physical/chemical properties of products Design of the production unit A cleaning operation must take place as soon as possible after the production has stopped, not only when changing from one product to the next but also if the equipment will be left idle Site and Toller assessments Regular site and toller assessments must be in place and take into account at a minimum: RI Assessment based on Syngenta Standard Practice maturity model [6] An improvement plan to address any gap or non-conformity Contractual agreement on RI Management requirements with toll manufacturers and suppliers based on CropLife requirements [2] RI audits RI audits must be performed regularly according to QCoP 6.1 [5] by an RI specialist whose competence has been approved by the Global Product Integrity Quality Manager. Audits must consider the following: Compliance assessment of contamination prevention processes, technical and analytical equipment and the competency of staff against the CropLife Contamination Prevention criteria and best practices (CropLife self-assessment checklist) [2, 10] An RI Standard Practice assessment followed by a full RI audit must be performed at any new toller or third party supplier performing synthesis and formulation operations before first commercial supply [6]. Third parties limited to packaging operations must be audited if the assessment indicates an RI risk [6]. Note: A toller is not qualified to start commercial supply as long as product compliance cannot be achieved (e.g. if major non-conformities have been identified which include a serious risk of cross contamination due to equipment design issues etc.) Audits should not take place during downtime of manufacturing site (e.g. maintenance) Performance assessment of the RI Management System based on historical data / incidents Additional audits may be required according to QCoP-6.1 [5] (all CP sites are classified as high risk sites) and/or after o o o Major non-conformity related to RI (follow up audit in subsequent year) Significant change RI incidents Effective date: Classification: INTERNAL USE ONLY Page 7 of 11

8 o Non-conformities / complaints with significant RI impact (financial, reputational or systematic issue) RI incident management Report external RI incidents immediately to the Emergency Management Syngenta if the RI incident is a serious business risk which might trigger regulatory action and product recall or attract media interest [7] Report external RI incidents to authorities if requested by legislation [9] Investigate all RI incidents to determine root causes in order to implement effective corrective actions and to improve and share learning within the organization [8] Effective date: Classification: INTERNAL USE ONLY Page 8 of 11

9 5. Generic RI change management process Implementation of new tollers and changes to any existing facilities (toller and Syngenta) with respect to RI Management will follow the process flow on fig 1: Fig.1 Effective date: Classification: INTERNAL USE ONLY Page 9 of 11

10 Summary sheet Title Purpose Scope Personal Scope Geographic Scope Target audience Contamination of Crop Protection Products with Residual Impurities (RI) has been identified as one of Syngenta s highest business risks. Contamination with residual impurities is an area of risk for any (multipurpose) chemical synthesis, formulation and packaging unit, storage facility and (bulk-) transportation operation. Residual impurities may cause adverse effects on sensitive treated crops or non-target species as well as regulatory issues. An incident may severely damage the image and brand of Syngenta and the reputation of the agrochemical industry itself. This CoP defines the requirements and responsibilities for the implementation and maintenance of a RI Management System and its performance review. This Code of Practice applies to all Syngenta Crop Protection sites, Tolling, Procurement and Bulk Distribution / Logistic Operations; it is applicable to line management responsible for the implementation, maintenance and resourcing of RI Management Systems and ensuring compliance to system requirements. [x] General Policy / CoP [_] Functional Policy / CoP [x] Group Policy / CoP [_] Country Policy / CoP Syngenta Managers and Process owners Version no. 3 Effective date of current version Effective date of original version Revision history Approved by Issued by Owner / Contact information Entire review of CoP-005 ed.2 Fernando Ospina, Moray Weir Christian Mueller Richard French Further References [1] QPR RIRA 2.0 Administration [2] CropLife "Contamination Prevention in the Manufacture of Crop Protection Products - Guidelines and Best Practices" English edition [3] HSE CoP 620 Supplier HSEQ Assessments [4] QPR Residual Impurity (RI) matrix creation [5] QCoP-6.1 Quality Auditing [6] RI Standard Practice assessment model 4.0

11 [7] HSES CoP 801 Emergency Management Syngenta [8] [9] [10] Reliance No QPR QFR QFR RI Incident Management RI Incident Definition RI Self-assessment checklist Syngenta Crop Protection AG Global Quality Schwarzwaldallee Basel Switzerland