Key Benefits:
Minister of Social Affairs and Health and Minister of Agriculture, Agri-Food and Forestry,
Vu le Public Health Codeincluding articles L. 5145-1 and R. 5142-42;
On a proposal by the Director General of the National Food, Environment and Labour Safety Agency dated 11 December 2013,
Stop:
In application of thearticle R. 5142-42 of the Public Health Code, the pharmaceutical companies mentioned in theArticle L. 5142-1 of the Public Health Code establish each year a state of each of their veterinary pharmaceutical establishments. The state of the institution was arrested on 31 December for the past calendar year. The status content is specified for each activity category annexed to this Order.
This state is signed by the pharmacist or veterinarian responsible for the company on which the establishments or by the pharmacists or veterinarians bound by a convention for the establishments referred to in 11° to 14° of article R. 5142-1 of the public health code that benefit from the exemption provided for in the last paragraph of section L. 5142-1 of the Public Health Code.
The state is provided in paper format. It may also be provided electronically according to the characteristics specified by the Director General of the National Food, Environment and Labour Safety Agency.
It is sent, in two copies, to the National Veterinary Medicine Agency (ANMV).
For the establishments of categories 10° to 14° of article R. 5142-1 of the Public Health Code, a copy is forwarded to the ANMV, the other copy is forwarded directly to the departmental interdepartmental direction in charge of the protection of the population (DDPP or DDCSPP) of the department concerned.
For wholesale distributors of veterinary medicines and also human-use drugs, a copy is sent to the VAN, the other copy is sent directly to the Regional Health Agency (SRA) of the region concerned.
For establishments authorized for several activities as defined in section R. 5142-1 of the Public Health Code, the state includes information for each activity.
In the case of pharmaceutical establishments with both activities related to human drugs and veterinary medicines, the status model provided for inArticle R. 5124-46 of the Public Health Code may be used to carry out the condition of the establishment concerning the veterinary drug, provided that the points related to veterinary drugs are specifically and detailed.
Veterinary drug manufacturers provide an additional copy for their manufacturing, import or distribution of raw materials for pharmaceutical use if they opt for this reporting modality under the articles R. 5138-1 and R. 5138-2-1 Public Health Code.
The decision of May 4, 2005 taken under thearticle R. 5142-42 of the Public Health Code and the state of the veterinary pharmaceutical establishments referred to in section L. 5142-1 is repealed.
The Director General of the National Health Safety Agency for Food, Environment and Labour is responsible for the execution of this Order, which will be published in the Official Journal of the French Republic.
A N N E X E
This document is a state of pharmaceutical establishments as of December 31 of the year before its writing. An application for amendment shall not be made as required in accordance with the regulatory provisions relating to the conditions of authorization or declaration of amendments to the pharmaceutical establishments referred to in thearticle R. 5142-9 of the Public Health Code.
Corporate overview
Company information
General information: the name of the company, the name of the company and the trade name, if any, the legal form, the geographic and postal address, if any, the telephone and fax numbers of the head office, the e-mail address.
A brief description of the company, its operation by specifying the strength, belonging to a group and the links and pharmaceutical agreements with other companies with the exception of detailed subcontracting activities by institution.
General information on activities
Check the boxes from the tables that correspond to the activities of the company.
| Manufacturing | | | |
| Import | | | |
| Exploitation | | | |
| Depositary | | | |
| Wholesale distribution | | | |
| Wholesale export distribution | | | |
| Wholesale distribution EPA | | | |
| Wholesale drug premix distribution | | | |
| Wholesale distribution for premixed drug export | | | |
| Manufacturing of drug products | | | |
| Importation of drug foods | | | |
| Distribution of drug foods | | | |
| Export distribution of drug foods | | | |
| MVEC Distribution (Veterinary Drugs for Clinical Trials) | | | |
List of companies
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Medical or Veterinary Responsible, Interim
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STATE MODEL FOR FABRICAN STATION
OR IMPORTANT OF VETERICAL MEDIUMMENTS
MODEL DE PRESENTATION OF A STATE
Note. ― Annexes provided by this model whose summary record of the state of the institution must be provided.
1. General manufacturer/importer information
1.1. Manufacturer/importer contact information
Official name and address of the company's head office to which the manufacturer/importer establishment belongs.
Site name and physical address, buildings and production units located on the site.
Manufacturer/importer contact details including the telephone number of people who can be contacted 24/7 in the event of product defects or recalls.
Site identification number such as GPS data, DUNS number (Data Universal Numbering System) of the site (one-time identification number provided by Dun & Bradstreet) or any other geographic location system.
1.2. Product manufacturing activities
pharmaceuticals allowed on the site
Number and date of the establishment's opening authorization.
Brief description of manufacturing, import, export, distribution and other authorized activities.
Type of products currently manufactured on the site but not covered by the existing opening authorization (see Appendix 2).
List of inspections to verify compliance with good site manufacturing practices over the past five years with the dates and country of the competent authority having conducted the inspection, or a reference to the EudraGMP database is to be included, if available.
1.3. Other activities carried out on the site
Specific authorizations (stamps, micro-organisms and toxins, genetically modified organisms, pharmaceutical raw materials, customs warehouses...).
Description of non- Pharmaceutical activities carried out on the site, if applicable.
2. Quality Management System
manufacturer/importer
2.1. The quality management system
manufacturer/importer
Brief description of the quality management systems used by the company and reference to the standards used.
Responsible for maintaining the quality management system.
Information on activities for which the site is accredited and certified, including the date and content of accreditations, the name of accreditation bodies.
2.2. Procedure for release of finished products
Detailed description of the qualifications (training and professional experience) of authorized persons/qualified persons responsible for batch certification and release procedures.
General description of batch certification and release procedures.
Role of the authorized person/qualified person in the quarantine and release of finished products and in the assessment of compliance with the marketing authorization.
Claims between authorized/qualified persons when several authorized/qualified persons are involved.
Information on the conditions of release:
(a) Real-time release.
(b) Parametric release, if applicable.
(c) Analytical process technology (ATP).
2.3. Supplier and subcontract management
Brief description of the control of the supply chain and the knowledge of suppliers (from the external audit program).
Brief description of the subcontractor qualification system, manufacturers of active substances for pharmaceutical use (PMUP) and other critical component suppliers.
Measures taken to ensure conformity of products manufactured to the TSE Directives (Bunsmissible animal spongiform encephalopathy).
Measures adopted in the event of suspicion or identification of finished products, bulk (non-conditioning compounds), active principles or counterfeit/falsified excipients.
Use of scientific and analytical assistance or other external technical assistance related to manufacturing and analysis.
List of manufacturers and subcontracting laboratories with addresses, coordinates and diagrams of supply chains for subcontracted manufacturing and quality control activities (e.g. sterilization of primary packaging items for aseptic processes, raw materials control, etc.). This list is to be presented in Annex 4.
Brief description of the sharing of responsibilities between the order donor and the subcontractor with respect to the conformity of the product to the marketing authorization (if not included in paragraph 2.2).
2.4. Quality risk management
Brief description of quality risk management methods used by the manufacturer/importer.
Key areas of quality risk management including a brief description of all activities carried out at the Group level and those carried out locally. Brief description of the system put in place to ensure continuity of supply in order to avoid ruptures.
2.5. Quality reviews of products
Brief description of the methodologies used.
3. Staff
Organizational chart illustrating the provisions for posts/titles in quality management, manufacturing and quality control (see Appendix 5), including supervision and authorized persons/eligible persons, including the pharmaceutical manager and the interim pharmaceutical officer.
Number of establishment:
The facility's workforce includes people engaged in pharmaceutical operations.
Note. ― For establishments with both human-use and veterinary drug activities, specify the number of full-time equivalents specific to veterinary activity.
| Production | |
| Quality control | |
| Quality assurance | |
| Storage/distribution | |
| Maintenance | |
| Other non- Pharmaceutical Operations | |
4. Premises and equipment
4.1. Premises
Brief site description: size and list of buildings. If manufacturing for different markets, such as local, European, American, etc. is done in different buildings on the site, buildings are listed and the recipient markets identified (if not described in paragraph 1.1).
A simple plan or a description of the manufacturing areas by indicating the scale ( architectural or technical plans are not required).
Plans and diagrams of production areas (see annex 6) presenting the classification of premises and pressure differentials between adjacent areas and indicating production activities (mix, filling, storage, packaging, etc.) in the rooms. (use a color code distinguishing the claimed classes and pressure differentials with an arrow symbolizing the flow direction, and with encrypted data on pressures and renewal rates).
Stores and storage areas, with specific areas for handling highly toxic, hazardous and sensitivizing substances (if applicable).
Brief description of specific storage conditions (if applicable), but not indicated on plans.
4.1.1. Brief description of air treatment systems (HVAC).
Principles to define air supply, temperature, humidity, pressure differentials and air renewal rates (new air or recycled air operation [%]).
4.1.2. Brief description of water treatment systems.
Water qualities produced.
Schematic plans for production and distribution systems (see annex 7).
4.1.3. Brief description of other important utilities such as steam, compressed air, nitrogen, etc.
4.2. Equipment
4.2.1. The list of the main equipment of the testing and production laboratories with identification of critical equipment is to be provided in Annex 8.
4.2.2. Cleaning and disinfection.
Brief description of cleaning and disinfection methods of surfaces in contact with products (hand cleaning, automatic cleaning [CIP], etc.).
4.2.3. Critical computerized systems for GMPs.
Description of critical computerized systems for GMPs (excluding equipment-specific [PLCs] programmable automatons).
5. Documentation
Description of the documentary system (electronic, manual).
In case of storage or archiving of documents and records outside the site (including pharmacovigilance data, if applicable): list of documents/registration types; name and address of the storage site and estimate of the time required to recover archived documents off site.
6. Production
6.1. Types of products
Type of products made including:
- list of pharmaceutical forms of veterinary medicines manufactured on the site (see annex 2);
- list of pharmaceutical forms of medicines subject to clinical trials manufactured on the site and, in the event of a difference to commercial manufacturing, information on production areas and personnel.
Toxic or dangerous substances handled (e.g., with high pharmacological activity and/or sensitivizing properties).
Types of products manufactured in dedicated premises and/or dedicated equipment, manufacture by country, if applicable.
Process Analytical Technology Applications (ATPs), where applicable: general definition of technology and associated computerized systems.
6.2. Process validation
Brief description of the general process validation policy.
Principles on reprocessing or recovery.
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6.3. Component and product management and storage
Provisions concerning raw materials, packaging articles, bulk products and finished products, including sampling, quarantine, release and storage.
Provisions concerning the management of rejected components and products.
| Raw materials | | | | | |
| Packaging | | | | | |
| Semi-open products or bulk | | | | | |
| Finished products | | | | | |
7. Quality Control (QC)
Description of site quality control activities in terms of physical, chemical, microbiological and biological controls.
8. Distribution, claims,
non-compliant products and recalls
8.1. Distribution
(for the part under the responsibility of the manufacturer)
Types (depositary, wholesale distributor, wholesale export distributor [...], manufacturer, etc.) and addresses (country) (EU/EEA, USA, etc.) of the companies to which the products are shipped from the site.
Description of the system used to verify that each customer/recipient is legally authorized to receive veterinary drugs from the manufacturer.
Brief description of the system guaranteeing appropriate environmental conditions during transit, for example: temperature monitoring/control.
Provisions for the distribution of products and means to ensure traceability of products.
Measures taken to prevent the distribution of goods operated in France by an illegal supply chain.
8.2. Claims, non-compliant products and recalls
Brief description of the claims management system, non-compliant products and recalls.
9. Self-inspections
Brief description of the self-inspection system based on the criteria used to select areas to be covered in the planned audits, the practical organization and the monitoring activities of the deviations and corrective actions implemented.
Annexes
(The numbering of the annexes as it appears
in the European model is retained)
Annex 2. ― List of manufactured/imported pharmaceutical forms, with the international common name (DCI) or common name (on availability) of used pharmaceutical active substances (MPUP)
Annex 4. ― List of manufacturers and subcontracting laboratories with addresses, coordinates and diagrams of supply chains for subcontracted activities (see Appendix model below)
Annex 5. ― Organizational chart(s)
Annex 6. ― Plans of production areas including flow of components and personnel, diagrams of principles of manufacturing processes of each type of product (pharmaceutical form). Use a color code to differentiate different streams (personal, raw materials, packaging, semi-open products, finished products and waste)
Annex 7. ― Schematic plans of water treatment systems
Annex 8. ― List of major laboratory equipment and production areas with their start-up date and requalification rate
Annex 9. ― List of raw materials implemented in the year (see model below)
Annex 2
List of manufactured/imported pharmaceutical forms, with the international common name (DCI) or common name (subject to availability) of used pharmaceutical active substances (MPUP)
This annex concerns only those categories that manufacture/importe veterinary medicines and veterinary medicines subjected to clinical trials.
Part 2
Veterinary drugs
| 1.1. | Sterile medicine |
| | 1.1.1. Aseptic preparation (list of pharmaceutical forms) 1.1.1.1. Large-volume liquids 1.1.1.2. Lyophilisats 1.1.1.3. Semi-solids 1.1.1.4. Small liquids 1.1.1.5. Solids and implants 1.1.1.6. Other products prepared aseptically (free text) |
| | 1.1.2. Preparation with final sterilization (list of pharmaceutical forms) 1.1.2.1. Large-volume liquids 1.1.2.2. Semi-solids 1.1.2.3. Small liquids 1.1.2.4. Solids and implants 1.1.2.5. Other sterilized products in their final container (free text) |
| | 1.1.3. Release of lots |
| 1.2. | Non-sterile drugs |
| | 1.2.1. Non-sterile products (list of pharmaceutical forms) 1.2.1.1. capsules 1.2.1.2. Soft capsules 1.2.1.3. Drug chewing gums 1.2.1.4. Matrices impregnated 1.2.1.5. Liquids for external use 1.2.1.6. Liquids for internal use 1.2.1.7. Medical gases 1.2.1.8. Other solid pharmaceutical forms 1.2.1.9. Pressurized preparations 1.2.1.10. Radiopharmaceutical generators 1.2.1.11. Semi-solids 1.2.1.12. Suppositories 1.2.1.13. Depressed 1.2.1.14. Transdermal devices 1.2.1.15. Intra-ruminal devices 1.2.1.16. Drug premixes 1.2.1.17. Other non-sterile products (free text) |
| | 1.2.2. Release of lots |
| 1.3. | Biological drugs |
| | 1.3.1. Biologic Pharmaceuticals 1.3.1.1. Blood products 1.3.1.2. Immunological products 1.3.1.3. Cell therapy products 1.3.1.4. Gene therapy products 1.3.1.5. Biotechnology products 1.3.1.6. Products of human or veterinary origin 1.3.1.7. Products from tissue engineering 1.3.1.8. Other biological drugs (free text) |
| | 1.3.2. Release of lots (product list) 1.3.2.1 Blood products 1.3.2.2. Immunological products 1.3.2.3. Cell therapy products 1.3.2.4. Gene therapy products 1.3.2.5. Biotechnology products 1.3.2.6. Products of human or veterinary origin 1.3.2.7. Products from tissue engineering 1.3.2.8. Other biological drugs (free text) |
| 1.4. | Other products or manufacturing activity |
| | 1.4.1. Manufacture of: 1.4.1.1. Herbal medicines 1.4.1.2 Homeopathic medicine 1.4.1.3. Other (free text) 1.4.2. Sterilization of active/excipient/finished products: 1.4.2.1. Filtration 1.4.2.2. Dry heat 1.4.2.3. Wet heat 1.4.2.4. Chemicals 1.4.2.5. Irradiation gamma 1.4.2.6. Irradiation beta 1.4.3. Other (free text) |
| 1.5. | Packaging |
| | 1.5.1. Primary 1.5.1.1. capsules 1.5.1.2. Soft capsules 1.5.1.3. Drug chewing gums 1.5.1.4. Matrices impregnated 1.5.1.5. Liquids for external use 1.5.1.6. Liquids for internal use 1.5.1.7. Medical gases 1.5.1.8. Other solid pharmaceutical forms 1.5.1.9. Pressurized preparations 1.5.1.10. Radiopharmaceutical generators 1.5.1.11. Semi-solids 1.5.1.12. Suppositories 1.5.1.13. Depressed 1.5.1.14. Transdermal device 1.5.1.15. Intra-ruminal devices 1.5.1.16. Drug premixes 1.5.1.17. Other non-sterile products (free text) |
| | 1.5.2. Secondary packaging |
| 1.6. | Quality control |
| | 1.6.1. Sterility tests 1.6.2. Microbilology: out of sterility tests 1.6.3. Physico-chemicals 1.6.4. Biology |
| 2.1. | Quality control of imported drugs |
| | 2.1.1. Sterility tests 2.1.2. Microbiology: out of sterility tests 2.1.3. Physico-chemicals 2.1.4. Biology |
| 2.2. | Release of lots of imported drugs |
| | 2.2.1. Sterile products 2.2.1.1. Aseptic preparation 2.2.1.2. Sterilized in their final receptacle 2.2.2. Non-sterile products |
| | 2.2.3. Biological products 2.2.3.1. Blood products 2.2.3.2. Immunological products 2.2.3.3. Cell therapy products 2.2.3.4. Gene therapy products 2.2.3.5. Biotechnology products 2.2.3.6. Products of human or veterinary origin 2.2.3.7. Products from tissue engineering 2.2.3.8. Other biological drugs (free text) |
| 2.3. | Other import activities (any other import activity not covered above) |
| | 2.3.1. Physical import establishment 2.3.2. Import of bulk products for manufacturing operations 2.3.3. Biological active substances 2.3.4. Other (to be specified) |
Annex 4
List of manufacturers and subcontracting laboratories with addresses, contact information and supply chain diagrams for outsourced activities
This chapter deals with the modalities of subcontracting between the pharmaceutical establishment of the company concerned and any other enterprise, including those in the same group.
1. Manufacturing in subcontracting
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| .../... | | | | |
2. Manufactures accepted in subcontracting
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3. Subcontracted analysis
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| .../... | | | | | |
4. Accepted subcontracting analysis
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Annex 9
List of materials implemented in the year
1. Raw materials implemented
in the past year
For manufacturers mentioned in 1° of Article R. 5142-1 that import raw materials for their own use, the mention of this activity in this state is a declaration for import, as mentioned in theArticle R. 5138-1 of the Public Health Code.
For the manufacturers mentioned in the 1st of Article R. 5142-1 the mention in this document of the purchase of raw materials for pharmaceutical use (MPUP) in France and their storage for their own use, is a declaration under the distribution activities of MPUP.
2. List of active chemical substances implemented in the past year
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| (1) If yes, specify whether subcontracting is total (T) or partial (P) and its justification | |||||||
3. List of excipients and fitness elements implemented in the past year
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| .../... | | | | | |
| (1) If so, specify whether subcontracting is total (T) or partial (P) and its justification. | |||||
4. List of organic raw materials implemented in the past year
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| .../... | | | | | | |
| (1) Please specify whether this is a raw material of animal or human origin, extractive or biotechnology. (2) If so, specify whether subcontracting is total (T) or partial (P) and its justification. | ||||||
STATE MODEL FOR EXPLISHING TO 3°
DE L'ARTICLE R. 5142-1 DU PUBLIC HEALTH CODE
Introduction
The status of a veterinary drug establishment is a document that contains, among other things, specific information about wholesale sales or sale operations, free of charge, advertising, information, pharmacovigilance, batch tracking, withdrawal and storage that are conducted on the site.
A state is dated and does not exceed 10 to 15 pages A4.
MODEL DE PRESENTATION OF A STATE
1. Presentation
1.1. Establishment information.
The name, the exact address with telephone, fax, telephone number in case of emergency and email.
A brief description: site location and environment, size and type of buildings.
An establishment's plan specifying the location of storage sites where appropriate, the recalled product areas.
Site identification number such as GPS data, DUNS number (Data Universal Numbering System) of the site (one-time identification number provided by Dun & Bradstreet) or any other geographic location system.
1.2. Activities of the establishment as specified in the third paragraph of section R. 5142-1 of the Public Health Code and Pharmaceutical Forms: (this part is not applicable if this annex is used as a supplement to another activity).
Number and date of opening authorization.
Specific authorizations (stamps, customs warehouses...).
Other activities related to veterinary pharmacy (drug foods, wholesale distribution, manufacturing, export...).
Other activities not related to veterinary pharmacy (human use medications, medical devices, animal feeds, dietary or hygiene products, phytopharmaceuticals, biocides, biological reagents, consumables...).
List of veterinary drugs used.
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2. Quality management
Presentation of the quality management system (less than 750 words or 3 pages A4).
Define the responsibilities of the quality assurance department and the architecture of the quality assurance system. If applicable, specify the ISO standards used (9000: 2000 or later).
3. Staff
3.1. Organization chart.
Preferably a single flow chart summarizing the positions of the various services and revealing the responsible pharmacists or veterinarians and the pharmacovigilance manager as well as their relationship with commercial and advertising officials.
3.2. Pharmaceutical key positions.
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| (*) Pharmaceutical or veterinary responsible, delegated, acting and deputy. Precise the pharmaceuticals. | ||||
| Quality assurance | |
| Storage and Wholesale Sales Operations | |
| Advertising/information | |
| Pharmacovigilance | |
| Monitoring of lots, reminders and withdrawals | |
| Other non- Pharmaceutical Operations | |
| Depositary | |
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4. Premises and equipment
4.1. Storage activity.
Situation plans (plans must be readable and if necessary in A3 format).
4.1.1. Plans (plans must be rated, readable and if necessary in A3 format).
Provide a site map showing the different activities.
Specify specific storage facilities (direct temperature storage equipment, anti-deflagration premises...).
Locate different product categories (marketable veterinary drugs, quarantine products, returned, recalled, to be destroyed and other products).
Provide simple plans of stores with streams of people, products and waste (use a color code).
4.1.2. Storage space.
Present the surfaces and total capacity, and then those of the different areas identified on the plan.
Existence of a system of protection against intrusions and harmful animals.
4.2. No storage activity.
Situation plans (plans must be readable and if necessary in A3 format).
4.3. Computerized systems.
Computer systems diagram (architect, software in place, data backup mode, disaster recovery plan, maintenance...).
Please specify which computer-assisted operations are.
Method of validation of computerized systems, systems validated in the year.
5. Documentation
5.1. Documentary management.
Indicate briefly how documents are drafted, disseminated, archived and destroyed.
5.2. Product quality documents:
| Staff training | |
| Staff hygiene | |
| Cleaning premises | |
| Storage and security | |
| Claims, reminders | |
| Control capture and preparation | |
| Liability control | |
| Monitoring of batches | |
| Emergency plan (retirement and batch recall) | |
| Claims processing | |
| Advertising and information | |
| Pharmacovigilance | |
| Management and distribution of free samples | |
| Audit of subcontractors | |
| Self-inspections | |
| Reception | Receipt check | | | |
| Storage | Premises | | | |
| Preparation | Colisage | | | |
| Shipping | Transport Delivery | | | |
6. Wholesale sales operations
6.1. Reception.
Specify the controls at the reception.
6.2. Storage.
Describe the inventory management modes (management of expiry dates, locations and batch numbers).
Information on toxic products, cytotoxic products, (cytotoxic products, phytopharmaceuticals, biocides...) or dangerous (inflammable or explosive) held by indicating the principles retained for their storage and handling (dedicated areas, anti-deflagration buildings...).
Information on regulated products: products subject to the regulation of narcotic drugs, hormones, psychotropics, indicating the principles used to secure storage.
7. Preparation and delivery of orders
7.1. Right.
Describe the quality control procedure to be entitled.
Provide an assessment of the distribution to the different recipients.
7.2. Distribution.
| entitled | Veterinary professional staff | | | |
| | Officine products | | | |
| | Approved groups (CSP article L. 5143-6) | | | |
| | Distributors or depositaries | | | |
| | Heads of Pharmacology and Toxicology Services of National Veterinary Schools | | | |
| | Drug food manufacturers | | | |
| Derogation | Certified breeders for extemporary preparation of medicinal foods on the farm | | | |
| | Persons with an authorization to experiment on the animal | | | |
| | Other (to be specified) | | | |
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8. Lot monitoring, pharmacovigilance and quality
8.1. General plan for the receipt, registration and processing of claims of all kinds.
Describe the procedures for receiving, recording and processing claims (regarding quality defects, adverse effects and claims of any kind).
8.2. Quality of veterinary drugs.
8.2.1. Claims.
Name of the Veterinary Drug Quality Claim Recorder.
Specify the recording modes and planned actions.
8.2.2. Reminders.
List of lots of medicines recalled in the year.
8.3. Releases and batch reminders.
Describe how to manage a recall of veterinary drugs and the planned emergency plan (customer information, stock management...).
List veterinary medicines with lot numbers that have been recalled during the year.
8.4. Pharmacovigilance.
8.4.1. If the system is homogeneous for the company, describe the pharmacovigilance system.
- Organization.
B. - Description of activities.
B.1. ― Managers:
Persons who are responsible for the pharmacovigilance.
B.2. ― Other people.
C. - Training, qualification.
D. - Quality management.
Organization.
Documentation.
E. Databases.
F. - Reporting of adverse effects.
8.4.2. If the system is different depending on the veterinary drugs used.
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9. Advertising and information
9.1. Management of advertising documents.
Guidelines for the drafting, approval and control of regulatory compliance of any type of advertising material.
9.2. Dissemination of advertising documents.
Supports used for advertising messages:
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10. Self-inspections, audits
10.1. Description of the self-inspection system.
10.2. Self-inspections and audits and self-inspections and audits.
Self-inspections.
Audits of subcontracting institutions.
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11. Product counterfeiting
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| ... | | |
Introduction
The status of a distribution or depositary establishment is a document that contains specific information on the procurement, storage, preparation and delivery of orders conducted on the site.
A state is dated and does not exceed 15 to 20 pages A4.
MODEL DE PRESENTATION OF A STATE
1. Overview of the facility
1.1. Establishment information.
The name of the establishment, the trade name where applicable, the geographic and mailing address, email, telephone, fax numbers, telephone number in the event of an emergency.
A brief description: site location and environment, size and type of buildings.
Site identification number such as GPS data, DUNS number (Data Universal Numbering System) of the site (one-time identification number provided by Dun & Bradstreet) or any other geographic location system.
1.2. Activities of the establishment.
Number and date of opening authorization.
Specific authorizations (stamps, customs warehouses...).
Other activities related to veterinary pharmacy (drug foods, manufacture, operation, export...).
Other activities not related to veterinary pharmacy (human use medications, medical devices, dietary or hygiene products, phytopharmaceuticals, biocides, biological reagents, consumables, material, animal feeds...).
1.3. Activity volume.
Specify the geographic area covered.
For depositaries, specify the parties to the contract and its date of signature as well as in a table, the number of veterinary units distributed.
| .../... | | | |
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2. Quality management
Presentation of the quality management system (less than 750 words or 3 pages A4) and in particular the device to comply with the provisions of article R. 5142-52 relating to the emergency batch removal plan.
Define the responsibilities of the quality assurance department and the architecture of the quality assurance system. If applicable, specify the ISO standards used (9000: 2000 or later).
3. Staff
3.1 Organizational chart.
Preferably a single flow chart summarizing the positions of the various services and revealing the responsible pharmacists or veterinarians and their relationship with the commercial managers.
3.2. Pharmaceutical key positions.
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| (*) Pharmaceutical or veterinary responsible, delegated, acting and deputy specifying pharmaceuticals. | ||||
| Quality assurance | |
| Reception/stocking | |
| Control capture and preparation | |
| Delivery | |
| Claims processing | |
| Products withdrawals and returns | |
| Other non- Pharmaceutical Operations | |
| | | | | |
4. Premises and equipment
4.1. Plans (plans must be readable and if necessary in A3 format).
Provide a site map showing the different activities.
Specify specific storage facilities (direct temperature storage equipment, anti-deflagration premises...).
Locate the different product categories (marketable veterinary drugs, returned products, recalled, to be destroyed and other products).
Provide simple plans of stores with streams of people, products and waste (use a color code).
4.2. Storage space.
Present the surfaces and total capacity, then those of the different areas identified on the plan.
Existence of a system of protection against intrusions and harmful animals.
4.3. Control of conservation conditions.
Record the monitoring of conservation conditions (temperature, humidity). Please specify the points where the different parameters are identified and the corrective measures implemented in the event of non-compliance with the defined threshold values.
If applicable, specify whether there is a heating and/or air conditioning system and coupled alarms.
4.4. Equipment.
Describe the main equipment (direct temperature storage equipment, barcode reading systems) with their start date and the date of the last validation.
Record the monitoring of conservation conditions (temperature, humidity). Please specify the points where the different parameters are identified and the corrective measures implemented in the event of non-compliance with the defined threshold values.
| Reception | Receipt check | | | |
| Storage | Premises | | | |
| Preparation | Colisage | | | |
| Shipping | Transport Delivery | | | |
5. Supply, reception and storage operations
and Handling of Veterinary Drugs
5.1. Reception.
Specify the controls at the reception.
5.2. Storage.
Describe the inventory management modes (management of expiry dates, locations and batch numbers).
Information on toxic products (cytotoxic products, phytopharmaceuticals, biocides...) or dangerous (inflammable or explosive) held by indicating the principles retained for their storage and handling (dedicated areas, anti-deflagration buildings...)
Information on regulated products: products subject to the regulation of narcotic drugs, hormones, psychotropics, indicating the principles used to secure storage.
6. Preparation and delivery of orders
6.1. Right.
Describe the quality control procedure to be entitled.
Provide an assessment of the distribution to the various recipients:
| entitled | Veterinary professional staff | | | |
| | Officine products | | | |
| | Approved groups (CSP article L. 5143-6) | | | |
| | Distributors or depositaries | | | |
| | Heads of Pharmacology and Toxicology Services of National Veterinary Schools | | | |
| | Drug food manufacturers | | | |
| Derogation | Certified breeders for extemporary preparation of medicinal foods on the farm | | | |
| | Persons with an authorization to experiment on the animal | | | |
| | Other (to be specified) | | | |
| | | |
7. Non-defect drug returns,
claims, recalls or withdrawals, destruction
7.1. Back.
Describe the procedure for the disposal of non-defective veterinary drugs.
7.2. Reminders.
Describe how to manage a batch recall of veterinary drugs and the planned emergency plan (customer information, stock management...).
List of reminders.
Method of destruction of defective products.
8. Documentation
8.1. Documentary management.
Indicate briefly how documents are drafted, disseminated, archived and destroyed.
8.2. Product quality documents.
| Staff training | |
| Staff hygiene | |
| Cleaning premises | |
| Storage and security | |
| Supply and reception | |
| Management of drugs subject to special storage conditions | |
| Inventory management | |
| Order preparation | |
| Control of recipients | |
| Validation and qualification of major equipment | |
| Maintenance, metrology | |
| Claims, reminders | |
| Return management | |
| Self-inspections | |
| Record keeping for products subject to specific regulations, inventory monitoring to manage potential flights | |
9. Self-inspections
9.1. Description of the self-inspection system.
9.2. Programme and self-inspection assessment.
9.3. List of audits by external companies and foreign inspections over the past three years.
10. Product counterfeiting
| | | |
| ... | | |
Introduction
The state of a manufacturing, import, distribution of drug products is a document that contains, among other things, specific information regarding free manufacturing, sale or disposal operations, import, quality control and storage.
A state is dated and it is informed for all entries.
Note. ― The summary record of the state of the institution must be provided.
MODEL DE PRESENTATION OF A STATE
1. Overview of the facility
1.1. Establishment information.
The name, the exact address with telephone, fax, telephone number in case of emergency and email.
A brief description: site location and environment, size and type of buildings.
Site identification number such as GPS data, DUNS number (Data Universal Numbering System) of the site (one-time identification number provided by Dun & Bradstreet) or any other geographic location system.
1.2. Activities of the establishment.
Number and date of administrative authorization.
Other administrative authorizations or approvals (regulation on classified facilities, animal feed, genetically modified organisms or animal experimentation...).
Other activities not related to veterinary pharmacy: animal feeds, nutritional supplements, dietary or hygiene products, phytopharmaceuticals, biocides...
1.3. Drug products manufactured, imported or distributed in the year.
List of drug premixes used:
| | | |
| | | |
| BOVINS | Dairy | | | |
| | Other cattle | | | |
| OVINS | | | | |
| CAPRINS | | | | |
| PORCINS | Porcelets 1st age | | | |
| | Porcelets 2nd age | | | |
| | Truies | | | |
| | Livestock and fattening | | | |
| VOLAILLES | Bottles of flesh | | | |
| | Chickens, egg weights | | | |
| | Chickens, reproductive weights | | | |
| | Dindons: breeders | | | |
| | Dindons: fertilizer | | | |
| | Pintades | | | |
| | Fat palms | | | |
| | Roasting palms | | | |
| | Cailles | | | |
| LAPINS | | | | |
| EQUINS | | | | |
| GIBIERS | | | | |
| POISSONS | | | | |
| OTHER ANIMAL | | | | |
| TOTAL | | | | |
| (*) Drugs. | ||||
| BOVINS | Dairy | | | |
| | Other cattle | | | |
| OVINS | | | | |
| CAPRINS | | | | |
| PORCINS | Porcelets 1st age | | | |
| | Porcelets 2nd age | | | |
| | Truies | | | |
| | Livestock and fattening | | | |
| VOLAILLES | Bottles of flesh | | | |
| | Chickens, egg weights | | | |
| | Chickens, reproductive weights | | | |
| | Dindons: breeders | | | |
| | Dindons: fertilizer | | | |
| | Pintades | | | |
| | Fat palms | | | |
| | Roasting palms | | | |
| | Cailles | | | |
| LAPINS | | | | |
| EQUINS | | | | |
| GIBIERS | | | | |
| POISSONS | | | | |
| OTHER ANIMAL | | | | |
| TOTAL | | | | |
| (*) Drugs. | ||||
| BOVINS | Dairy | | | | |
| | Other cattle | | | | |
| OVINS | | | | | |
| CAPRINS | | | | | |
| PORCINS | Porcelets 1st age | | | | |
| | Porcelets 2nd age | | | | |
| | Truies | | | | |
| | Livestock and fattening | | | | |
| VOLAILLES | Bottles of flesh | | | | |
| | Chickens, egg weights | | | | |
| | Chickens, reproductive weights | | | | |
| | Dindons: breeders | | | | |
| | Dindons: fertilizer | | | | |
| | Pintades | | | | |
| | Fat palms | | | | |
| | Roasting palms | | | | |
| | Cailles | | | | |
| LAPINS | | | | | |
| EQUINS | | | | | |
| GIBIERS | | | | | |
| POISSONS | | | | | |
| OTHER ANIMAL | | | | | |
| TOTAL | | | | | |
| (*) Drugs. | |||||
| BOVINS | Dairy | | | | |
| | Other cattle | | | | |
| OVINS | | | | | |
| CAPRINS | | | | | |
| PORCINS | Porcelets 1st age | | | | |
| | Porcelets 2nd age | | | | |
| | Truies | | | | |
| | Livestock and fattening | | | | |
| VOLAILLES | Bottles of flesh | | | | |
| | Chickens, egg weights | | | | |
| | Chickens, reproductive weights | | | | |
| | Dindons: breeders | | | | |
| | Dindons: fertilizer | | | | |
| | Pintades | | | | |
| | Fat palms | | | | |
| | Roasting palms | | | | |
| | Cailles | | | | |
| LAPINS | | | | | |
| EQUINS | | | | | |
| GIBIERS | | | | | |
| POISSONS | | | | | |
| OTHER ANIMAL | | | | | |
| TOTAL | | | | | |
| (*) Drugs. | |||||
| BOVINS | Dairy | | | | |
| | Other cattle | | | | |
| OVINS | | | | | |
| CAPRINS | | | | | |
| PORCINS | Porcelets 1st age | | | | |
| | Porcelets 2nd age | | | | |
| | Truies | | | | |
| | Livestock and fattening | | | | |
| VOLAILLES | Bottles of flesh | | | | |
| | Chickens, egg weights | | | | |
| | Chickens, reproductive weights | | | | |
| | Dindons: breeders | | | | |
| | Dindons: fertilizer | | | | |
| | Pintades | | | | |
| | Fat palms | | | | |
| | Roasting palms | | | | |
| | Cailles | | | | |
| LAPINS | | | | | |
| EQUINS | | | | | |
| GIBIERS | | | | | |
| POISSONS | | | | | |
| OTHER ANIMAL | | | | | |
| TOTAL | | | | | |
| (*) Drugs. | |||||
| | | |
| | | |
2. Quality management
Presentation of the quality management system, and in particular procedures relating to the establishment of batch files of drug feeds and the emergency plan for batch removal.
Define the architecture of the quality assurance system. If applicable, specify the ISO standards used (9000: 2000 or later).
Details on the qualification of subcontractors (if applicable).
Brief description of the subcontractor qualification, including details on joint audits, qualification programs and risk analysis approach.
3. Staff
3.1. Organization chart.
Preferably a single flow chart summarizing the positions of the different services and showing the key positions, including the management of drug premixes, production, quality control and distribution.
3.2. Pharmaceutical key positions.
| | | | |
| Quality assurance | |
| Quality control | |
| Drug premix management | |
| Production | |
| Storage/distribution | |
| Control capture and preparation | |
| Claims | |
| Returns or recalls of medications | |
| Other non- Pharmaceutical Operations | |
| | | | | |
4. Premises and equipment
4.1. Premises.
Plans (the plans requested are comprehensive plans in A3 or A4 format to highlight the manufacturing areas as well as the storage areas of the medicinal premixes and drug foods accompanied by a synoptic or manufacturing diagram. For distribution activities, plans refer to staff, drug feed and waste streams. These plans must be readable.
Storage space.
Present the total capacity then that of the different areas identified on the plan.
Existence of a system of protection against intrusions and harmful animals.
4.2. Equipment.
4.2.1. Description of the main production equipment (premix and mixing system...).
Describe the implantation and incorporation of drug premixes.
Describe the mixing system, in particular the draining modalities.
Please specify the general policy for the qualification and validation of these devices.
4.2.2. Description of the ventilation system in areas that are at risk of cross-contamination, including the premix incorporation area.
4.2.3. Computerized systems.
Computer systems diagram (architect, software in place, data backup mode, disaster recovery plan, maintenance...)
Provide the validation principle of computerized systems.
Identify what computer-assisted operations are in production and quality control and access restrictions
5. Documentation
5.1. Documentary management.
Indicate briefly how documents are drafted, disseminated, archived and destroyed.
5.2. Product quality documents.
| Staff training | |
| Staff hygiene | |
| Cleaning of premises and equipment | |
| Drug premix management | |
| Manufacturing and storage of drug food | |
| Cross-contamination management | |
| Homogeneity test | |
| Products refused, returned: storage and reprocessing | |
| Quality control: sampling, sampling, specifications | |
| Validation and qualification of major equipment | |
| Maintenance | |
| Control of recipients | |
| Order control | |
| Traceability of drug distribution | |
| Claims and reminders | |
| Pharmacovigilance | |
| Self-inspections | |
6. Production
6.1. Description of manufacturing processes.
Present, in diagrams, production flows.
6.2. Prevention of cross-contamination.
Please describe the technical or organizational measures taken to limit the risk of cross-contamination.
6.3. Management of refused, returned and recovered products.
| Drug premixes | | | |
| Packaging | | | |
| Products bulk | | | |
| Finished products | | | |
7. Quality control
7.1. Description of activities.
Present the monitoring plan implemented as well as the number of analyses carried out.
7.2. Controls.
Describe the controls made prior to the implementation of raw materials as well as periodic controls of homogeneity and cross-contamination, specifying those responsible for these operations.
8. Distribution
8.1. Control.
Describe the ordering procedure: empowerment of persons, validation of the order, control of authorizations and orders.
8.2. Delivery.
Describe the means of transport used and the measures taken to control cross-contamination and delivery errors.
9. Manufacturing in subcontracting, analysis and transport
9.1. Manufacturing.
| | | | |
| | | | |
| | | | |
| | |
10. Claims, reminders
10.1. Emergency plan, batch reminders of drug food.
Brief description of how to manage drug recalls, in particular the person responsible, their storage and the balance sheet distributed and returned.
11. Pharmacovigilance
Name of the manager.
Date of transmission of severe adverse effects.
12. Self-inspections
12.1. Description of the self-inspection system.
12.2. Self-inspections and audits and self-inspections and audits.
12.3. List of audits by external companies and foreign inspections over the past three years.
RECAPITULATIVE FICHE DE L'ÉTAT
DE L'ÉTABLISSEMENT
The document "Recapitulative Records of the State of the Institution" is an indispensable tool for ANES agents, especially for the Inspection and Market Surveillance Department (DIS), hence the importance of the quality of the information provided. This document reproduces qualitative and quantitative information on pharmaceutical operations carried out in the pharmaceutical establishment, which was arrested as at 31 December for the past year.
Name of establishment:
City (+ address if several establishments in the same city), department :
Opening authorization:
Establishment parameters:
Type of establishment: put a cross in the box(s) concerned.
Name of establishment:
City (+ address if necessary), department :
Opening authorization:
Establishment parameters:
Type of establishment: put a cross in the box(s) concerned.
| | | | | | | |
| (*) Example: external packaging, batch release, quality control or any other specific activity. | ||||||
| | | | | | | |
| (**) Specify whether the activity concerns only export. | ||||||
| Non-sterile | | | | | |
| Sterile with final sterilization | | | | | |
| Sterile distribution | | | | | |
| Biological products | | | | | |
| | | | | |
| No. | Yes |
| | |
Reporting table for antibiotic-based medicines or medicines
Distributed medicines (drug foods manufactured and distributed or purchased and distributed in France directly to breeders, or groupings, veterinarians or pharmacists of officin):
| BOVINS | LAITIÈRE VACHES | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | OTHER BOVINS | | | | | | |
| | | | | | | | |
| | | | | | | | |
| OVINS | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| CAPRINS | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| PORCINS | PORCELETS 1 | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | PORCELETS 2nd ÂGE | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | TRUIES | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | LEVELING AND FERTILING | | | | | | |
| | | | | | | | |
| | | | | | | | |
| VOLAILLES | CHAIR POULETS | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | POULETTES, PONDEUSES OF CONSOMMATION | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | POULETTES, PONDEUSES REPRODUCTRICES | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | DINDONS REPRODUCTEURS | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | DINDONS: | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | PINTADES | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | PALMIPÈDES GRAS | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | ROUND PALMIPES | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | CAILLES | | | | | | |
| | | | | | | | |
| | | | | | | | |
| LAPINS | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| EQUINS | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| GIBIERS | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| POISSONS | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| OTHER ANIMAL | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| TOTAL | | | | | | | |
| Drug premixes | | | | | | | | | | | | | | |
| Other drugs | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
Done on 17 February 2014.
Minister of Social Affairs
and Health,
For the Minister and by delegation:
Director General
health,
B. Vallet
Minister of Agriculture,
agri-food and forest,
For the Minister and by delegation:
Director General
food,
P. Dehaumont
