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2013/c 343/01

(2)  Articles 166 to 181 of Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code (OJ L 302, 19.10.1992, p. 1).Non-opposition to a notified concentration (Case COMP/M.7031 — Eurenco/Maxamchem/Manuco) ( 1 )Where transportation is performed by a third party, the contract in place should encompass the requirements of Chapter 7. Transportation providers should be made aware by the wholesale distributor of the relevant transport conditions applicable to the consignment. Where the transportation route includes unloading and reloading or transit storage at a transportation hub, particular attention should be paid to temperature monitoring, cleanliness and the security of any intermediate storage facilities.

Medicinal Products for Human Use (2013/C 68/01). These guidelines, published by the European Commission, became effective on 8 September 2013. Due to some typographical errors in the guidelines, an updated version was published, Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01) Self-inspections should be conducted in order to monitor implementation and compliance with GDP principles and to propose necessary corrective measures.Wholesale distributors receiving medicinal products from third countries for the purpose of importation, i.e. for the purpose of placing these products on the EU market, must hold a manufacturing authorisation (14).assessing the suitability and competence of the contract acceptor to carry out the activity and checking authorisation status, if required;

Good Manufacturing and Distribution Practices Public Healt

On 29 October 2013, the Commission decided not to oppose the above notified concentration and to declare it compatible with the common market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004. The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available: BMMI Djibouti first to achieve international certification in EU Commission Guidelines on GDP September 13, 2018. BMMI Djibouti is now officially certified in the EU Commission Guidelines on Good Distribution of Medicinal Products for Human Use (2013/C 343/01), becoming the first organisation in the Group and across the Horn of Africa to attain this certification Wholesale distributors must immediately inform the competent authority and the marketing authorisation holder of any medicinal products they identify as falsified or suspect to be falsified (19). A procedure should be in place to this effect. It should be recorded with all the original details and investigated. the link 2013/C 343/01 TechFact: PrimeLINE® Unit P6-5 Test In conjunction with our December 2013 TechLINE article (pre-trip P6-5), Carrier Transicold has introduced the following procedures to assist the technician in troubleshooting a P6-5 occurrence. PrimeLINE® unit pre-trip P6-5 ensures that th

Free zones and free warehouses are parts of the customs territory of the Community or premises situated in that territory and separated from the rest of it in which:its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; orThe contract acceptor must forward any information that can influence the quality of the product(s) to the contract giver in accordance with the requirement of the contract. medicinal products for human use (2013/C 343/01) Issue November 5th 2013. The GDP compliance audit covered the following scopes and found no critical nonconformities: Warehousing and transport of pharmaceutical products - temperature range 2-8°C or 15-25°C Date of audit Date of Revision Certificate expiry date Certificate Registration No

medicinal products are procured, held, supplied or exported in a way that is compliant with the requirements of GDP; LOGIFARMA ensures its customers the national distribution of pharmaceutical products in bi-temperature (2° C to 8° C, 15° C to 25° C), in strict compliance with the guidelines for good Distribution practices, published by the Community policy 2013/C 343/01. We have our own fleet composed of 30 vans and 3 trucks, which guarantee a market coverage [ The rules for wholesale distribution apply in their entirety in the case of export of medicinal products. However, where medicinal products are exported, they do not need to be covered by a marketing authorisation of the Union or a Member State (18). Wholesalers should take the appropriate measures in order to prevent these medicinal products reaching the Union market. Where wholesale distributors supply medicinal products to persons in third countries, they shall ensure that such supplies are only made to persons who are authorised or entitled to receive medicinal products for wholesale distribution or supply to the public in accordance with the applicable legal and administrative provisions of the country concerned.

Good Distribution Practice: update from 5 November 2013. The corrected version of the Guidelines on the wholesale Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01) was published in the Official Journal of the European Union on 5 November 2013. The new guidelines replace those from 7 March 2013 and are applicable the. The quality system should include an emergency plan which ensures effective recall of medicinal products from the market ordered by the manufacturer or the competent authorities or carried out in cooperation with the manufacturer or marketing authorisation holder for the medicinal product concerned (23). The competent authorities must be immediately informed of any suspected falsified medicines offered in the supply chain (24).Rest, wash and refreshment rooms for employees should be adequately separated from the storage areas. The presence of food, drink, smoking material or medicinal products for personal use should be prohibited in the storage areas.On 18 November 2013, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which Bulgarian Airways Group EAD (‘BAG’, Bulgaria) and Swissport International AG (‘Swissport’, Switzerland) acquire within the meaning of Article 3(1)(b) of the Merger Regulation joint control of Swissport Bulgaria AD (‘Swissport Bulgaria’, Bulgaria) by way of purchase of shares.For emergency deliveries outside normal business hours, persons should be designated and written procedures should be available.

Following an audit, UPS's existing GDP-compliant procedures across its entire German network were certified to meet the specific requirements of the European Commission guideline 2013/C 343/01 for the non-temperature controlled transport of pharmaceutical products Equipment and processes should be respectively qualified and/or validated before commencing use and after any significant changes, e.g. repair or maintenance.Procedure should be approved signed and dated by the responsible person. Documentation should be approved, signed and dated by appropriate authorised persons, as required. It should not be hand-written; although, where it is necessary, sufficient space should be provided for such entries. With adoption of Good Distribution Practices 2013/C 343/01, documentation requirements for transportation and storage conditions are more stringent than ever for medicines. To capture the data needed and protect up to 150 shipments per day, The Coghlan Group , an expert in clinical trials, relies on data loggers and temperature-controlled.

Premises should be designed and equipped so as to afford protection against the entry of insects, rodents or other animals. A preventive pest control programme should be in place. On February 2, 2019, the Hellenic Ministry of Health and the National Organization for Medicines extended the validity of Cosmofarm's license for the wholesale of pharmaceutical products for human use for a period of five years and pursuant to the EU directive of (2013/C 343/01) Self-inspections should be conducted in an impartial and detailed way by designated competent company personnel. Audits by independent external experts may also be useful but may not be used as a substitute for self-inspection. GDP <2013/C 343/01>: Frequently Asked Questions Click on the link below to view the PDF Staying Current in Cold Chain Management: Changes to USP, EU GDPs and Storage and Shipping Practices for Drugs 4.04 M

EUR-Lex - 52013XC1123(01) - EN - EUR-Le

GP Nord pride themselves on being compliant with EU Good Distribution Practice for medicines for human use, 2013/C 343/01.Our warehouse facility operates ambient storage between 15-25 degrees Celsius, and refrigerated storage of 2-8 degrees Celsius. A permanent monitoring solution provided and installed by Testo.Climate control runs 24/7 to ensure that any products stored are kept well withi (2013/C 343/01) INDLEDNING Retsgrundlaget for denne vejledning er artikel 84 og artikel 85b, stk. 3, i Europa-Parlamentets og Rådets direktiv 2001/83/EF (1). Kommissionen offentliggjorde i 1994 vejledningen i god distri­ butionspraksis (GDP) (2). En revideret vejledning blev offentlig Good documentation constitutes an essential part of the quality system. Written documentation should prevent errors from spoken communication and permits the tracking of relevant operations during the distribution of medicinal products.A self-inspection programme should be implemented covering all aspects of GDP and compliance with the regulations, guidelines and procedures within a defined time frame. Self-inspections may be divided into several individual self-inspections of limited scope. The course covers the Good Distribution Practice Guidelines (2013/C 343/01) in detail from the Responsible Person's perspective. Emphasis is placed on interaction of delegates, team activities and encouragement to ask questions and share experiences

Complaints should be recorded with all the original details. A distinction should be made between complaints related to the quality of a medicinal product and those related to distribution. In the event of a complaint about the quality of a medicinal product and a potential product defect, the manufacturer and/or marketing authorisation holder should be informed without delay. Any product distribution complaint should be thoroughly investigated to identify the origin of or reason for the complaint.Medicinal products intended for destruction should be appropriately identified, held separately and handled in accordance with a written procedure.Voorafgaande aanmelding van een concentratie (Zaak COMP/M.7107 — Cordes & Graefe/Pompac/Comafranc) (1)

Richtsnoeren van 5 november 2013 inzake goede distributiepraktijken voor geneesmiddelen voor menselijk gebruik (1)Procedures to be followed if the system fails or breaks down should be defined. This should include systems for the restoration of data. Commission Guideline 2013/C 343/01 on Good Distribution Practice of medicinal products for human use, Chapter 9 - Transportation) ATHENS, 05/09/2019 GENERAL MANAGER BQC | Certification Body | 96, D. Gounari str. & Kifissias Av., GR 15125, Μaroussi, Athens | Τ +302112213726 | info@ bqc.gr | www.bqc.gr AN AUDIT TOOK PLACE WITH REPORT NUMBE

Personnel dealing with any products which require more stringent handling conditions should receive specific training. Examples of such products include hazardous products, radioactive materials, products presenting special risks of abuse (including narcotic and psychotropic substances), and temperature-sensitive products. For more information on Vaisala's Environmental Mapping Qualification solutions, please see our brochure, or contact your local service center. Resources. EU GDP (2013/C 343/01) Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human us There should be a system in place to control the re-use of cool-packs to ensure that incompletely cooled packs are not used in error. There should be adequate physical segregation between frozen and chilled ice packs.

EUR-Lex - C:2013:343:TOC - EN - EUR-Le

  1. In September 2013, the EU introduced its revised Good Distribution Practice (GDP) Guidelines (2013/C 343/01) aimed at maintaining the quality and integrity of medicinal products for human use right along the supply chain from manufacturer to patient
  2. The recently introduced EU Guidelines on the Good Distribution Practice of Medicinal Products for Human Use, (first published on March 8th 2013 as 2013/C 68/01 and updated on November 5th 2013 as 2013/C 343/01) places significant new demands on the manufacturers and distributors of pharmaceutical products
  3. Dec 20, 2018: In September 2018, German audit company DQS GmbH has awarded cargo handler Cargogate with GDP (Good Distribution Practice of Medicinal Products for Human Use - 2013/C 343/01.
  4. The current EU-GDP guidelines of 5 November 2013 ref.: 2013/C 343/01 outline the requirements for holders of a WDA on Good Distribution Practice of medicinal products for human use. In Ireland, the licensing authority for the wholesaling of medicinal products for human use is the Health Products Regulatory Authority (HPRA)
  5. for TPG Group: private investment firm investing in a broad range of industries including inter alia: consumer, retail, technology, internet, healthcare, energy, clean-tech and renewables, transportation, industrials, and business services,
  6. Equipment used to control or to monitor the environment where the medicinal products are stored should be calibrated at defined intervals based on a risk and reliability assessment.
  7. (2013/C 68/01). Section 6.3, (iii), states another of the conditions to be satisfied, that: it has been demonstrated by the customer that the medicinal products have been transported, stored and handled in compliance with the products specific storage requirements. The publication of the Guidelines (2013/C 68/01) shoul

Containers should bear labels providing sufficient information on handling and storage requirements and precautions to ensure that the products are properly handled and secured at all times. The containers should enable identification of the contents of the containers and the source.The Commission has published EU Guidelines on Good Distribution Practice (GDP) in 1994 (2). Revised guidelines were published in March 2013 (3) in order to take into account recent advances in practices for appropriate storage and distribution of medicinal products in the European Union, as well as new requirements introduced by Directive 2011/62/EU (4). Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01). The aim of self-inspection is ensuring of maintaining the level of quality determined by throughout th Having worked in seniors posts for some of Ireland's largest wholesalers, Bernard was personally responsible for ensuring full, ongoing compliance with Good Distribution Practice and for advising all relevant Boards of Directors, Senior Management, Heads of Departments of their roles, duties and responsibilities and for identifying and.

Official Journal C 343/2013 - EUR-Le

  1. Retail Transport Services Ltd is a team of freight forwarding experts with over 250 years of combined logistics experience. Established in 1999, we celebrate our 20 th year in the freight forwarding business and we are proud to have kept our core beliefs of quality and service at the forefront of today's growing team.. We provide a knowledgeable approach to transport, giving our customers a.
  2. Medicinal Products for Human Use (2013/C 343/01). The EU Guidelines have been adapted by the Expert Circle on GDP for PIC/S purposes. However, the EU specific references have been deleted in this Guide. This Guide has been adopted by PIC/S as a guidance document. It is up to each PIC/
  3. Technoparkstrasse 1, CH - 8005 Zurich info@modum.io 1 • The modum system ensures compliance with Chapter 9 of the new EU GDP regulations (2013/C 343/01). • The modum system uses a per shipment service model. • The modum system consists of 3 key components: the app for all standard devices, a dashboard fo
  4. (4)  Directive 2011/62/EU of the European Parliament and of the Council amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of falsified medicinal products, OJ L 174, 1.7.2011, p. 74.
  5. These Guidelines replace the Guidelines on Good Distribution Practice of medicinal products for human use, published on 1 March 1994 (25) and the Guidelines of 7 March 2013 on Good Distribution Practice of medicinal products for human use (26).
  6. Voorafgaande aanmelding van een concentratie (Zaak COMP/M.7079 — Bulgaria Airways Group/Swissport International/Swissport Bulgaria) — Voor een vereenvoudigde procedure in aanmerking komende zaak (1)
  7. Deliveries should be made to the address stated on the delivery note and into the care or the premises of the consignee. Medicinal products should not be left on alternative premises.

Prior notification of a concentration (Case COMP/M.7079 — Bulgaria Airways Group/Swissport International/Swissport Bulgaria) — Candidate case for simplified procedure ( 1 ) In 2014, the Pharmaceutical Inspection Co-operation Scheme PIC/S published a PIC/S Guide to Good Distribution Practice for Medicinal Products (PE 011-1). This Guide is based on the EU GDP-Guidelines (2013/C 343/01) and quotes the EU Guide almost completely 2013/C 343/01. Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (1) 1. 2013/C 343/02. Non-opposition to a notified concentration (Case COMP/M.6922 — Triton/Logstor) (1) 15. 2013/C 343/03 Obtaining, acquiring, purchasing or buying medicinal products from manufacturers, importers or other wholesale distributorsDocumentation comprises all written procedures, instructions, contracts, records and data, in paper or in electronic form. Documentation should be readily available/retrievable.

Guideline 2013/C 343/01 states that 'all personnel involved in wholesale distribution activities should be trained in the requirements of GDP' Do you have drivers in different locations and find it difficult to get them al The contract acceptor should not pass to a third party any of the work entrusted to him under the contract without the contract giver’s prior evaluation and approval of the arrangements and an audit of the third party by the contract giver or the contract acceptor. Arrangements made between the contract acceptor and any third party should ensure that the wholesale distribution information is made available in the same way as between the original contract giver and contract acceptor. 2013/C 343/01. Richtsnoeren van 5 november 2013 inzake goede distributiepraktijken voor geneesmiddelen voor menselijk gebruik 1. 2013/C 343/02. Besluit om geen bezwaar aan te tekenen tegen een aangemelde concentratie (Zaak COMP/M.6922 — Triton/Logstor) 15. 2013/C 343/0

  1. The process for delivery of sensitive products and control of seasonal temperature variations should be described in a written procedure.
  2. Dedicated vehicles and equipment should be used, where possible, when handling medicinal products. Where non-dedicated vehicles and equipment are used, procedures should be in place to ensure that the quality of the medicinal product will not be compromised.
  3. Adequate records of repair, maintenance and calibration activities for key equipment should be made and the results should be retained. Key equipment would include for example cold stores, monitored intruder alarm and access control systems, refrigerators, thermo hygrometers, or other temperature and humidity recording devices, air handling units and any equipment used in conjunction with the onward supply chain.
  4. Specialist Quality Assurance Resume Samples and examples of curated bullet points for your resume to help you get an interview. (Qualified Person) and GDP guidelines 2013/C 343/01 chapter 2.2 (Responsible Person) Computer literacy Download Specialist Quality Assurance Resume Sample as Image file
  5. e where temperature controls are required. Equipment used for temperature monitoring during transport within vehicles and/or containers should be maintained and calibrated at regular intervals at least once a year.
  6. If requested, customers should be provided with information to demonstrate that products have complied with the temperature storage conditions.
  7. European Commission, 23 November 2013 ( 2013/C 343/01 EU Guidelines on good distribution practice (GDP) of medicinal products for human use 23 March 1994; European Commission ( Ref 94/C 63/03) ICH Q9 Quality Risk Managemen

monitoring and review of the performance of the contract acceptor, and the identification and implementation of any required improvements on a regular basis.Before a computerised system is brought into use, it should be demonstrated, through appropriate validation or verification studies, that the system is capable of achieving the desired results accurately, consistently and reproducibly.In addition, at least the following procedures and instructions, along with the corresponding records of execution, should be in place: 2013/C 343/01. INTRODUCTION. These Guidelines are based on Article 84 and Article 85b(3) of Directive 2001/83/EC (1). The Commission has published EU Guidelines on Good Distribution Practice (GDP) in 1994 (2) On 19 November 2013, the Commission decided not to oppose the above notified concentration and to declare it compatible with the common market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004. The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available:

EU Guidelines 2013/C 343/01 GDP Trainin

GDP is that part of quality assurance which ensures that the quality of medicinal products is maintained throughout all stages of the supply chain from the site of manufacturer to the pharmacy or person authorised or entitled to supply medicinal products to the public. human use [2013/C 343/01] (3), as it applies to medical gas products. 2. SCOPE This document applies to medical gas storage and distribution sites named on a company's WDA(H) (and WDA(V) as applicable), where medical gas products are supplied only to approved customers. These facilities could include: Company managed sites

All activities of providing, selling, donating medicinal products to wholesalers, pharmacists, or persons authorised or entitled to supply medicinal products to the publicin electronic form on the EUR-Lex website (http://eur-lex.europa.eu/en/index.htm) under document number 32013M6995. EUR-Lex is the online access to the European law.Wholesale distributors should identify what key equipment qualification and/or key process validation is necessary to ensure correct installation and operation. The scope and extent of such qualification and/or validation activities (such as storage, pick and pack processes) should be determined using a documented risk assessment approach. Its overall procedures and operation are in accordance with the new European Union guidelines concerning the wholesale's Good Distribution Practice (G.D.P.) of medicine for human use (directive 2013/C 343/01) and are applicable under the monitor of the National Organization of Medicine (NOM)

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Warehousing operations must ensure appropriate storage conditions are maintained and allow for appropriate security of stocks.Besluit om geen bezwaar aan te tekenen tegen een aangemelde concentratie (Zaak COMP/M.6922 — Triton/Logstor) (1)It is the responsibility of the supplying wholesale distributor to protect medicinal products against breakage, adulteration and theft, and to ensure that temperature conditions are maintained within acceptable limits during transport.

Update to the EU's Good Distribution Practice guidelines

On 23 August 2013, the Commission decided not to oppose the above notified concentration and to declare it compatible with the common market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004. The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available:All personnel involved in wholesale distribution activities should be trained on the requirements of GDP. They should have the appropriate competence and experience prior to commencing their tasks. Questions and answers. 1. How can I become a holder of authorisation of distribution of medicinal products? 2. I am a distributor with a distribution authorisation from another EU Member State where the company has also its registered office. Can I distribute medicinal products also within the territory of the Czech Republic?.

CHAPTER 6 —   COMPLAINTS, RETURNS, SUSPECTED FALSIFIED MEDICINAL PRODUCTS AND MEDICINAL PRODUCT RECALLS On 18 November 2013, the Commission received a notification of a proposed concentration pursuant to Article 4 and following a referral pursuant to Article 4(5) of Council Regulation (EC) No 139/2004 (1) by which the undertakings TPG Slowhand, LP (‘TPG’, USA), an investment vehicle of TPG Growth II LP, which belongs to the TPG Group, and Servco Pacific Inc (‘Servco’, USA) acquire within the meaning of Article 3(1)(b) of the Merger Regulation joint control of the undertaking Fender Musical Instruments Corporation (‘Fender’, USA) by way of purchase of shares.Stock should be rotated according to the ‘first expiry, first out’ (FEFO) principle. Exceptions should be documented. The EU Good Distribution Practice (GDP) Guidelines (2013/C 343/01) revised in 2013 reflect the requirements and expectations of the authorities during the transport and distribution of medicinal products in a very detailed way

Analysis of Good Distribution Practice Inspection

Where premises are not directly operated by the wholesale distributor, a contract should be in place. The contracted premises should be covered by a separate wholesale distribution authorisation.A change control system should be in place. This system should incorporate quality risk management principles, and be proportionate and effective.Destruction of medicinal products should be in accordance with national or international requirements for handling, transport and disposal of such products.

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Good Distribution Practice (GDP) Guidelines - European GDP

FAQs on Good Distribution Practices (GDP) - European GDP

(International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Q9)Batches of medicinal products intended for the EU and EEA countries should not be transferred to saleable stock before assurance has been obtained in accordance with written procedures, that they are authorised for sale. For batches coming from another Member State, prior to their transfer to saleable stock, the control report referred to in Article 51(1) of Directive 2001/83/EC or another proof of release to the market in question based on an equivalent system should be carefully checked by appropriately trained personnel. EU Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01) FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic HPRA Guide to Good Distribution Practice of Medicinal Products for Human Use (9 MAY 2019

Presentation on the published EU GDP Guidelines (2013/C 68

The definition of wholesale distribution does not depend on whether that distributor is established or operating in specific customs areas, such as in free zones or in free warehouses. All obligations related to wholesale distribution activities (such as exporting, holding or supplying) also apply to these distributors. Relevant sections of these Guidelines should also be adhered to by other actors involved in the distribution of medicinal products.Possession of a manufacturing authorisation includes authorisation to distribute the medicinal products covered by the authorisation. Manufacturers performing any distribution activities with their own products must therefore comply with GDP.Receiving and dispatch bays should protect products from prevailing weather conditions. There should be adequate separation between the receipt and dispatch and storage areas. Procedures should be in place to maintain control of inbound/outbound goods. Reception areas where deliveries are examined following receipt should be designated and suitably equipped.Action of proving that any procedure, process, equipment, material, activity or system actually leads to the expected results (see also ‘qualification’)Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301), by email to COMP-MERGER-REGISTRY@ec.europa.eu or by post, under reference number COMP/M.6981 — TPG/Servco/Fender, to the following address:

Amy Flood - QA Specialist - MSD LinkedI

appropriate corrective and preventive actions (commonly known as ‘CAPA’) are taken to correct deviations and prevent them in line with the principles of quality risk management.Systematic and common information and education strategies on dog welfare are supported by the Commission cooperating with others to develop the ‘CARODOG’ website (http://www.carodog.eu), an informative platform on canine population management leading to responsible animal ownership as a basic principle for the promotion of companion animal welfare in the EU. For pharmaceutical manufacturers, our comprehensive report enables them to easily demonstrate to regulatory bodies, for example the MHRA (Medicines and Healthcare products Regulatory Agency), that the requirements of standards and guidelines such as European GDP guidelines 2013/C 343/01 and 2015/C 95/01, have been met

Client-Pharma is licensed by the UK MHRA and complies with the EU Guidelines for Good Distribution Practice (GDP) for Medicines for Human Use, 2013/C 343/01. We profoundly understand and recognize the risks associated with global procurement as well as worldwide storage and distribution of supplies for clinical trials The quality system of a broker should be defined in writing, approved and kept up-to-date. It should set out responsibilities, processes and risk management in relation to their activities.

If temperature-controlled vehicles are used, the temperature monitoring equipment used during transport should be maintained and calibrated at regular intervals. Temperature mapping under representative conditions should be carried out and should take into account seasonal variations.Where medicinal products are obtained from another wholesale distributor, the receiving wholesale distributor, must verify that the supplier complies with the principles and guidelines of good distribution practices and that they hold an authorisation for example by using the Union database. If the medicinal product is obtained through brokering, the wholesale distributor must verify that the broker is registered and complies with the requirements in Chapter 10 (15). (2013/C 343/01) ÚVOD Tyto pokyny jsou založeny na článku 84 a čl. 85b odst. 3 směrnice 2001/83/ES (1). Komise zveřejnila pokyny EU pro správnou distribuční praxi v roce 1994 (2). Revidované pokyny byly zve řejněny v březnu 2013 (3) s cílem zohlednit poslední vývoj postup ů pro řádn The wholesale distributor must designate a person as responsible person. The responsible person should meet the qualifications and all conditions provided for by the legislation of the Member State concerned (6). A degree in pharmacy is desirable. The responsible person should have appropriate competence and experience as well as knowledge of and training in GDP.Any member of personnel involved in the brokering activities should be trained in the applicable EU and national legislation and in the issues concerning falsified medicinal products.

Quality - GP Nor

  1. Medicinal Products for Human Use (2013/C 68/01). These guidelines, published by the European Commission, became effective on 8 September 2013. Due to some typographical errors in the guidelines, an updated version was published, Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01.
  2. for Servco: automotive retailing, parts and service, home products retailing and commercial insurance brokerage,
  3. guidelines 2013/C 343/01 and the Law on medicines in human health (2007) with the related r egulation - Regu- lation 39/13.09.2007 on the principles an d requirement

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All equipment impacting on storage and distribution of medicinal products should be designed, located and maintained to a standard which suits its intended purpose. Planned maintenance should be in place for key equipment vital to the functionality of the operation.Wholesale distributors must ensure they supply medicinal products only to persons who are themselves in possession of a wholesale distribution authorisation or who are authorised or entitled to supply medicinal products to the public.Pompac Group: active throughout France as a wholesaler for products in the areas of sanitary fittings, heating, tiling and electrical equipment. The undertaking also trades in building materials in eastern France.Medicinal products which have left the premises of the distributor should only be returned to saleable stock if all of the following are confirmed:in the merger section of the Competition website of the Commission (http://ec.europa.eu/competition/mergers/cases/). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes,

Objective In today's context of globalisation of pharmaceutical production and distribution, international and national procurement agencies play a de facto key role in defining the quality of medicines available in sub-Saharan Africa. We evaluated the compliance of a sample of pharmaceutical distributors active in sub-Saharan Africa with the standards of the WHO guideline 'Model Quality. Any recall operation should be recorded at the time it is carried out. Records should be made readily available to the competent authorities.The outcome of each management review of the quality system should be documented in a timely manner and effectively communicated internally.ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place;In relation to deliveries containing medicinal products requiring special conditions such as narcotics or psychotropic substances, the wholesale distributor should maintain a safe and secure supply chain for these products in accordance with requirements laid down by the Member States concerned. There should be additional control systems in place for delivery of these products. There should be a protocol to address the occurrence of any theft.

Radioactive materials and other hazardous products, as well as products presenting special safety risks of fire or explosion (e.g. medicinal gases, combustibles, flammable liquids and solids), should be stored in one or more dedicated areas subject to local legislation and appropriate safety and security measures.Quality risk management should ensure that the evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the patient. The level of effort, formality and documentation of the process should be commensurate with the level of risk. Examples of the processes and applications of quality risk management can be found in guideline Q9 of the International Conference on Harmonisation (‘ICH’). (2013/C 343/01) UVOD Ove se Smjernice temelje na članku 84. i članku 85.b stavku 3. Direktive 2001/83/EZ (1). Komisija je 1994. izdala Smjernice dobre prakse u prometu lijekova EU-a (2). U ožujku 2013. izdane su revidirane smjerni ­ ce (3) kako bi se uzelo u obzir nedavni napredak u praksam Validation and qualification reports should be prepared summarising the results obtained and commenting on any observed deviations. Deviations from established procedures should be documented and further actions decided to correct deviations and avoid their reoccurrence (corrective and preventive actions). The principles of CAPA should be applied where necessary. Evidence of satisfactory validation and acceptance of a process or piece of equipment should be produced and approved by appropriate personnel.

on principles of Good Distribution Practice of active substances for medicinal products for human use (Text with EEA relevance) (2015/C 95/01) Introduction. These guidelines are based on the fourth paragraph of . Article 47. of . Directive 2001/83/EC (1). They follow the same principles that underlie the guidelines of EudraLex Volume 4, Part II The required storage conditions for medicinal products should be maintained during transportation within the defined limits as described by the manufacturers or on the outer packaging.

The system for managing quality should encompass the organisational structure, procedures, processes and resources, as well as activities necessary to ensure confidence that the product delivered maintains its quality and integrity and remains within the legal supply chain during storage and/or transportation. viglya.co Brokers are subject to a registration requirement. They must have a permanent address and contact details in the Member State where they are registered (22). They must notify the competent authority of any changes to those details without unnecessary delay.Records should be made available to the competent authorities, for inspection purposes, for the period stated in national legislation but at least five years.the distributor has reasonable evidence that the product was supplied to that customer (via copies of the original delivery note or by referencing invoice numbers, etc.) and the batch number for products bearing the safety features is known, and that there is no reason to believe that the product has been falsified.

The new version 2013/C 343/01 corrects factual mistakes identified in subchapters 5.5 and 6.3 of the revised guidelines. It also gives more explanations on the rationale for the revision as well as a date of coming into operation. (1) Medizone happily acknowledged, that many of the additional translations errors were corrected by. GxP compliance, including EU good distribution practice (GDP) guidelines (2013/C 343/01) Continent-wide standards of practice (SOP) Real-time satellite tracking and temperature display; Assistance with border and customs issues; In-market knowledge and business conducted in local languag

It is a requirement stated in the EU GDP Guidelines 2013/C 343/01 that Good Distribution Practice training is carried out on an annual basis to keep up to date with industry and regulatory changes. At the end of this course you will achieve a certificate of successful completion and evidence of your training for you records Vorherige Anmeldung eines Zusammenschlusses (Sache COMP/M.7079 — Bulgaria Airways Group/Swissport International/Swissport Bulgaria) — Für das vereinfachte Verfahren in Frage kommender Fall (1) Chapter 1 of the Good Distribution Practice guidelines (EU 2013/C 343/01) states: Wholesale distributors must maintain a quality system setting out responsibilities, processes and risk management principles in relation to their activities in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/en/index.htm) under document number 32013M6922. EUR-Lex is the online access to the European law. EU guidelines on Good Distribution Practice (GDP) of medicinal products for human use (2013/C 343/01). The imported products should be tested to demonstrate that they comply with the German Pharmacopoeia (Deutsches Arzneibuch, 2019, DAB 2019 ) for standardised cannabis extract or cannabis flower

European Commission: Guidelines on Good Distribution Practice of medicinal products for human use, 2013/C 343/01, November 2013. World Health Organization, Technical Report Series 961, Annex 9, Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products, WHO, 2011 2013/C 343/01. Leitlinien vom 5. November 2013 für die gute Vertriebspraxis von Humanarzneimitteln 1. 2013/C 343/02. Keine Einwände gegen einen angemeldeten Zusammenschluss (Sache COMP/M.6922 — Triton/Logstor) 15. 2013/C 343/03. Keine Einwände gegen einen angemeldeten Zusammenschluss (Sache COMP/M.6995 — Reggeborgh/Boskalis/VSMC) 1 on Good Distribution Practice of medicinal products for human use (Text with EEA relevance) (2013/C 343/01) INTRODUCTION These Guidelines are based on Article 84 and Article 85b(3) of Directive 2001/83/EC (1). The Commission has published EU Guidelines on Good Distribution Practice (GDP) in 1994 (2). Revised guideline

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