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Operational pharmacovigilance
ICSR management, EudraVigilance, RMP, CCSI, PSUR, DSUR, Signal management, XEVMPD, and many more.
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Pharmacovigilance System
QPPV/deputy QPPV, SOPs, Quality Management Systems, (electronic) PSMF
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Clinical trial safety
Management of SUSARs and SARs, safety narrative writing, medical assessments and DSUR
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Medical Device Vigilance
Full range of medical device safety services for all different types of medical equipment
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Quality Management System
Web-based quality management system software including training and document management
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Audits & other support
Includes among others: ad hoc assistance, audits, training, assessment of risk-benefit, medical and scientific writing services
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Pharmacovigilance related IT
PQ validations, data migrating and mapping, safety database software, EMA gateway testing
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Cosmetovigilance
Full range of cosmetic product safety services for all different types of cosmetic products
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Good Distribution Practice (GDP)
Lindeq provides GDP active substances quality system including web based QMS software (ItQMS)



Good Distribution Practice (GDP)

The Good Distribution Practice (GDP) guideline for active substances (in force since September 2015) represents standards towards which regulators will reference during upcoming inspections. It mandates distributors to develop and maintain a quality system setting out responsibilities, processes and risk management principles.

 

The quality system should ensure that:

  • active substances and medicinal products are procured, imported, held, supplied or exported in a way that is compliant with the requirements of GDP

  • management responsibilities are clearly specified

  • active substances or medicinal products are delivered to the right recipients within a satisfactory time period

  • records and traceability

  • deviations from established procedures are documented and investigated

  • appropriate corrective and preventive actions

  • changes that may affect the storage and distribution are evaluated

  • a responsible is at each location where distribution activities are performed

  • written procedures are on place describing the distribution activities

 

To meet all requirements, Lindeq provides the following tasks:

 

  • Develop, implement and operate GDP quality system including written procedures, nonconformity system, CAPA,  and related services

  • Local responsible person

  • Coordinate and improve performance during GDP audits and inspections

  • Process and evaluate product complaints

  • Trend analysis of product complaints

  • A web based quality management system software (ItQMS) handling workflows for document management

 

For more detailed information see below. 

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The new GDP guideline for active substances has been in force since 21 September 2015 and follow the same principles as for the GDP of medicinal products for human use since 05 November 2013.

 

 

The distribution of active substances or finished medicinal products are highly regulated to ensure safe products for the patients. An active substance is any substance or mixture of substances intended to be used in the manufacture of a medicinal product. Distribution of both the active substances and finished medicinal products comprises all activities consisting of procuring, importing, holding, supplying or exporting substances or products.

 

 

The guidelines represent the standards towards which regulators will reference during upcoming inspections. It mandates distributors to develop and maintain a quality system setting out responsibilities, processes and risk management principles.

 

The quality system should ensure that:

  • active substances and medicinal products are procured, imported, held, supplied or exported in a way that is compliant with the requirements of GDP

  • management responsibilities are clearly specified

  • active substances or medicinal products are delivered to the right recipients within a satisfactory time period

  • records and traceability

  • deviations from established procedures are documented and investigated

  • appropriate corrective and preventive actions

  • changes that may affect the storage and distribution are evaluated

Also, the distributor shall have a responsible person at each location where distribution activities are performed. This person must have defined authority and responsibility to ensure a QMS is implemented and maintained.

 

 

Written procedures should describe the distribution activities which affect the quality of the active substances and medicinal products. This could include receipt and checking of deliveries, storage, cleaning and maintenance of the premises, recording of the storage conditions, security of stocks on site and of consignments in transit, withdrawal from saleable stock, handling of returned products, recall plans, etc. Each employee should have ready access to all necessary documentation (written procedures, contracts etc.) for the tasks executed.

 

 

All documentation related to compliance of the distributor with these guidelines should be made available on request of competent authorities.

 

Lindeq has developed a web-based quality management system that includes workflows for document storing, updating and handling, monitoring and responding to non-conformities, documented training and CAPA-all controlled within the system.

 

 Lindeq can provide the following tasks:

  • Develop, implement and operate GDP quality system including written procedures, nonconformity system, CAPA,  and related services

  • Local responsible person

  • Coordinate and improve performance during GDP audits and inspections

  • Process and evaluate product complaints

  • Trend analysis of product complaints

  • A web based quality management system software (ItQMS) 

 

Lindeq works with quality systems for several clients on a daily basis. Lindeq has extensive experience in creating and maintaining quality systems in addition to auditing and updating existing quality systems.

Your Lindeq contact person has experience in training employees both internal and external, at various levels, in order to adapt the respective quality system in a smooth and orderly fashion for integrating into daily routines.

 

Not found what you were looking for? Do not hesitate to contact us for further information at

Lindeq@lindeq.com, or call us at +47 2223 8880

 

References:

Good Distribution Practice of medicinal products for human use (2013/C 343/01)

Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01)

Directive 2003/94/EC (Laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use.)

EudraLex Volume 4, Part II (Volume 4 of "The rules governing medicinal products in the European Union" contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively)

Commission Delegated Regulation (EU) No 1252/2014 (Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use)