Analogous application of the GDP Guidelines 2013/C 343/01 for veterinary medicinal products

Transcription

1 Analogous application of the GDP Guidelines 2013/C 343/01 for veterinary medicinal products Document valid as of: Document number: I-SMI.TI.19e Version 01 Classification: public Replaces document: -- of: -- Assigned process: -- Primary QMI documents: -- Referenced QMI documents: -- Approval Date: Signature: Author: Anita Pfefferkorn Technical review: Christian Schärer Release VS-QMI: (formal review) Michelle Scheidegger Contents 1 Objective and scope Bases Definitions and abbreviations Description Background... 3 QMI-Ident: I-SMI.TI.19e / V01 / pan / scg / smi / /8

2 4.2 Implementation Interpretation Changes compared to the previous version Annexes... 8 QMI-Ident: I-SMI.TI.19e / V01 / pan / scg / smi / /8

3 1 Objective and scope This document defines the analogous application of the GDP Guidelines 2013/C 343/01 for veterinary medicinal products and their implementation in the context of inspections of distributors of veterinary medicinal products. This document applies to the Swiss inspectorates that conduct inspections under the jurisdiction of Swissmedic (i.e. the Swissmedic Inspectorate and the inspectorates of the cantons in the respective area according to art. 60 HMG), subsequently referred to as inspectorates. This interpretation is expected to remain valid for a limited 2-year implementation phase. 2 Bases Therapeutic Products Act (HMG; SR ) Ordinance on the Authorisation of Medicinal Products (AMBV; SR ) Ordinance on Medicinal Products (VAM; SR ) Guidelines of 5th November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01) 3 Definitions and abbreviations HMG Heilmittelgesetz (Therapeutic Products Act) AMBV Arzneimittel-Bewilligungsverordnung (Ordinance on the Authorisation of Medicinal Products) VAM Arzneimittelverordnung (Ordinance on Medicinal Products) GDP Good Distribution Practice 4 Description 4.1 Background With the aim of preventing the entry of falsified medicinal products into the legal supply chain, the European Union (EU) 2011 implemented a new directive on falsified medicinal products (Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011, also known as the "Falsified Medicines Directive"). The Guidelines on the Good Distribution Practice of medicinal products for human use (GDP Guidelines 94/C 63/03 of ) were subsequently revised. These modified Guidelines (2013/C 343/01) entered into force in the EU in September By way of amendments to Annex 2 of the Ordinance on the Authorisation of Medicinal Products (AMBV), Switzerland is adopting the new Guidelines. These entered into force on 1 st July 2015, with a specified implementation time limit of six months. Accordingly, as of 1 st January 2016, the Guidelines 2013/C 343/01 will be used as a basis for evaluating GDP compliance. This applies without restrictions for companies that distribute medicinal products for human use, while the Guidelines 2013/C 343/01 apply analogously to veterinary medicinal products and for nonready-to-use medicinal products. Taking into account the fact that, in the EU, the Guidelines 2013/C 343/1 apply only to medicinal products for human use, this makes use of the legal option to establish an "analogous" application for veterinary medicinal products and an adapted implementation of the guidelines for veterinary medicinal products. QMI-Ident: I-SMI.TI.19e / V01 / pan / scg / smi / /8

4 4.2 Implementation In the light of the amended Annex 2 of AMBV, a review of GDP compliance during an inspection and if necessary confirmation by means of a GDP certificate, will be undertaken as of 1 st January 2016 based on the Guidelines 2013/C 343/1. Between 2002 and the end of 2015, GDP inspections in Switzerland have been based on the GDP Guidelines 94/C 63/03. This has also applied to the distribution of veterinary medicinal products. The compliance with these old EU guidelines was also largely being implemented for veterinary medicinal products at the end of 2015, and the "old" guidelines were accepted as the minimum standard by the veterinary medicinal product sector. The following principles in particular apply to the specification and review of the analogous application for veterinary medicinal products: - As of 1 st January 2016, the assessment of GDP compliance during inspections will be based on the Guidelines 2013/C 343/1 (according to Annex 2 AMBV). - The same applies to GDP certificates: in particular, a reference to the Guidelines 2013/C 343/01 is included in the certificates. - During an implementation phase, distributors of veterinary medicinal products are to be given the opportunity to comply fully with the Guidelines 2013/C 343/01 in a staged process, but they should at least be able to continue demonstrating compliance with the existing GDP Guidelines 94/C 63/03. - Elements of the Guidelines 2013/C 343/01 that differ significantly from the requirements in the Guidelines 94/C 63/03 are listed in the table below. - Any deficiencies noted during inspections in respect of the points listed in the table will also be included in the inspection report by the inspector. - Provided there are no concerns about the quality of the products, a period up to 1 st January 2018 can be granted for correcting the noted deficiencies as described in the company's action plans, regardless of when the deficiencies were noted during an inspection. 4.3 Interpretation Elements of the Guidelines 2013/C 343/01 that differ significantly from the requirements in the Guidelines 94/C 63/03 are listed in the table below, which also defines the application of these individual chapters of the Guidelines 2013/C 343/1 to veterinary medicinal products. Further information is also provided about the minimum requirements/expectations relating to individual topics. Guidelines on Good Distribution Practice of medicinal products for human use 2013/C 343/01 (according to Annex 2 AMBV) Analogous application for veterinary medicinal products Chapter 1 Quality management Chapter 1 of the GDP Guidelines 2013/C 343/01 applies in principle to veterinary medicinal products, 1.3 Management of outsourced activities Qualification of the contract acceptor Regulation of responsibilities Control of the contract acceptor See also Chapter 7 It should be possible to submit a list of contract acceptors and a system should be introduced for the qualification of contract acceptors QMI-Ident: I-SMI.TI.19e / V01 / pan / scg / smi / /8

5 1.4 Management review and monitoring Documentation of the review by management 1.5 Quality risk management Assessment of risks to the quality of medicinal products Active involvement of the company management is already required by art. 7 para. 1a. The specific implementation should be described in the processes A comprehensive quality risk management process should be introduced Chapter 2 Personnel Individual preconditions stated in this chapter shall in any case apply based on the provisions of AMBV and shall also apply to veterinary medicinal products. Chapter 2 of the GDP Guidelines 2013/C 343/01 applies in principle to veterinary medicinal products, 2.2 Responsible person Requirements and responsibilities of the responsible person 2.4 Training The training for personnel should also include aspects of product identification and the avoidance of falsified medicinal products entering the supply chain The relevant provisions of HMG and AMBV apply Where applicable, the training for personnel should be expanded to include the stated aspects Chapter 3 Premises and equipment Individual preconditions stated in this chapter apply anyway on the basis of the provisions of AMBV and thus also apply to veterinary medicinal products. Chapter 3 of the GDP Guidelines 2013/C 343/01 applies in principle to veterinary medicinal products, 3.2 Premises Separate wholesale distribution authorisation required for the premises of third parties Computerised warehouse systems should provide equivalent security and should be validated Computerised systems Up-to-date written description of the system Physical or electronic securing of data, incl. access protection should be checked at regular intervals Strategy for system failure or breakdown and restoration of data Qualification and validation Risk-based assessment to identify what equipment and processes need to be qualified/validated Qualification before first use and after relevant changes Written validation and qualification reports The licensing requirements pertaining to the storage of medicinal products by logistics companies apply according to I-SMI.TI.11. see Particularly if computerised storage management systems are used, the system should be described, and it should be possible to check and guarantee the access protection and securing of data. Consequently it should not be possible, as a result of inadequate system validations, for incorrect deliveries to occur or for distribution data to be incorrect and therefore for traceability no longer to be guaranteed The company should be able to demonstrate that it has thought about what equipment and processes are important for product quality and should initiate risk-based activities in order to be able to prove that this equipment is functioning correctly. Traceable Planning and documentation of these checks must also be ensured QMI-Ident: I-SMI.TI.19e / V01 / pan / scg / smi / /8

6 Chapter 4 Documentation Chapter 4 of the GDP Guidelines 2013/C 343/01 applies in principle to veterinary medicinal products, 4.2 General With regard to personal data, the right to privacy must be taken into account (Directive 95/46/EC) The data protection laws apply, even though these are not covered by therapeutic products legislation Personal data should be deleted/anonymised Chapter 5 Operations Chapter 5 of the GDP Guidelines 2013/C 343/01 applies in principle to veterinary medicinal products, 5.1 Principle Marketing authorisation for distributed medicinal products 5.2 Qualification of suppliers Importation of medicinal products from third countries only with valid manufacturing authorisation 5.3 Qualification of customers Unusual sales patterns should be investigated and reported to the authorities Art. 9 HMG applies The licensing provisions of HMG and AMBV apply to the import of veterinary medicinal products Refer to the reporting obligation stated in art. 59 HMG and to the due diligence obligations in the handling of narcotics and the corresponding legal requirements (e.g. art. 10 Narcotics Control Ordinance, BetmKV; SR ) The provisions stated in art. 9 HMG and art. 7 para. 3 AMBV apply As regards the establishment licences, the provisions of art HMG apply in particular. The due diligence obligations apply analogously 5.4 Receipt of medicinal products Proof of marketing authorisation of batches before inclusion in the saleable stock. 5.9 Export to third countries Wholesale distribution authorisation must exist Medicinal products do not need to be authorised in the EU The customer in the third country must be authorised Guarantee that medicinal products do not enter the EU market Chapter 6 Complaints, returns, suspected falsified medicinal products, medicinal product recalls Chapter 6 of the GDP Guidelines 2013/C 343/01 applies in principle to veterinary medicinal products, 6.2 Complaints Complaints about the quality of the medicinal product must be reported immediately to the manufacturer or marketing authorisation holder The reporting obligations stated in art. 59 HMG and VAM apply Chapter 7 - Outsourced activities Chapter 7 of the GDP Guidelines 2013/C 343/01 applies in principle to veterinary medicinal products, QMI-Ident: I-SMI.TI.19e / V01 / pan / scg / smi / /8

7 7.1 Principle A written contract between the contract giver and contract acceptor regulates the obligations of both parties It must be possible to submit a list of all the contract acceptors for outsourced activities and this serves as the basis for a risk assessment for the implementation of any required precautions (incl. written contracts) Chapter 8 Self-inspections Chapter 8 of the GDP Guidelines 2013/C 343/01 applies in principle to veterinary medicinal products. Chapter 9 Transportation Chapter 9 of the GDP Guidelines 2013/C 343/01 applies in principle to veterinary medicinal products, 9.1 Principle Traceability of the transportation conditions guaranteed Risk-based approach for planning transportation 9.2 Transportation Written procedures must be in place for the operation and maintenance of vehicles, including cleaning and safety precautions Risk assessment of the delivery routes as a basis for assessing whether temperature controls are required during transport Temperature-monitoring instruments must be maintained and calibrated at least once a year There is no requirement for veterinary medicinal product deliveries to be temperature-controlled in all cases. The delivery routes and modes of transport should be analysed and evaluated in a risk assessment (see 9.2). If the risk assessment indicates that deliveries require temperature controls, the temperature records kept by the company for the deliveries should be checked for compliance with the required transportation conditions A procedure should be drafted The delivery routes and modes of transport should be analysed and evaluated in a risk assessment (see 9.1). The specific type of transport and transport monitoring required for particular medicinal products in order to minimise the risks of quality impairment as far as possible and necessary is decided on the basis of this assessment. The risk of an impairment in the quality of veterinary medicinal products and the measures for preventing the entry of falsified medicinal products takes priority in this assessment. In addition to the delivery routes, the choice of transport container and transport packaging play an important role in ensuring appropriate transportation conditions (see 9.3). The better the submitted proof of validation of the selected shipping container, the less the need for temperature-monitored transportation. The precautions should be supplemented by appropriate information or training for the transportation personnel so that they are able to deliver the goods in accordance with the requirements. If the risk assessment indicates that deliveries require temperature controls, the temperature records kept by the company for the deliveries should be checked for compliance with the required transportation conditions For veterinary medicinal products this applies particularly to those deliveries for which the need for temperature controls has been shown in the risk assessment of the delivery routes QMI-Ident: I-SMI.TI.19e / V01 / pan / scg / smi / /8

8 Vehicles should, if possible, be used exclusively for the transportation of medicinal products. If other materials are transported, procedures should be in place to ensure that the quality of the medicinal products is not compromised Transportation by a third party must be regulated contractually Critical situations during transportation (reloading, transit storage, unloading) should be monitored with particular care Transit storages should be kept to a minimum 9.4 Products requiring special conditions Traceability of the transport temperatures must be ensured at all times As regards veterinary medicinal products, particular attention should be paid to checking the avoidance of any negative effect on the veterinary medicinal products as a result of joint transportation with other materials See 7.1 and 9.1./9.2. The third party should at least provide the information required for guaranteeing the correct handling of the transported veterinary medicinal products For veterinary medicinal products this applies particularly to those deliveries for which the need for temperature controls has been shown in the risk assessment of the delivery routes Chapter 10 Specific provisions for brokers Chapter 10 of the GDP Guidelines 2013/C 343/01 does not apply to veterinary medicinal products. According to HMG, in Switzerland brokers who perform the activities described in the EU Guidelines are considered to be wholesalers and require an establishment licence according to art. 28 HMG. As regards GDP, these companies therefore need to comply with the provisions of chapters 1 to 9 (taking account of this TI). If the brokerage activity takes place in another country, but is originating in Switzerland, without the goods entering Switzerland, the companies must possess a licence for trading abroad and comply with the associated due diligence obligations stated in art. 21 HMG and art AMBV Chapter 11 Final provisions Chapter 11 of the GDP Guidelines 2013/C 343/01 does not apply to veterinary medicinal products 5 Changes compared to the previous version None (new) 6 Annexes None QMI-Ident: I-SMI.TI.19e / V01 / pan / scg / smi / /8