<img height="1" width="1" style="display:none;" alt="" src="https://px.ads.linkedin.com/collect/?pid=489233&amp;fmt=gif">

GDP:
Good Distribution Practice
Good Documentation Practice

Glossary

The abbreviation GDP is known with two different meanings.

 

1. Good Distribution Practice (GDP)

According to the EMA, Good Distribution Practice (GDP) comprises minimum standards that a wholesale distributor should meet to ensure that the quality and integrity of medicines are maintained over the supply chain.

Compliance with Good distribution practice ensures that:

  • medicines in the supply chain are authorized in line with European Union (EU) legislation;

  • medicines are maintained in the right conditions at all times, including during transportation; contamination by or of other products is avoided;

  • an adequate turnover of stored medicines takes place;

  • the right products reach the right recipient within a satisfactory time period.

 

The GDP term is included in World Health Organization WHO’s Technical Report Series Annex 5 - Good distribution practices for pharmaceutical products. Good Distribution Practice (GDP) is defined in this guideline, as follows;

 

Quality assurance should ensure the quality of a pharmaceutical product is maintained by means of acceptable controls of the multiple activities which happen during the distribution process as well as providing a tool to guarantee the distribution system from counterfeits, unapproved, illegally imported, stolen, substandard, adulterated, and/or misbranded pharmaceutical products. The guideline consists of the subtitles below.

    1.  General principles
    2.  Regulation of the distribution of pharmaceutical products
    3.  Organization and management
    4.  Personnel
    5.  Quality system
    6.  Premises, warehousing, and storage
    7.  Vehicles and equipment
    8.  Shipment containers and container labeling
    9.  Dispatch and receipt
    10.  Transportation and products in transit
    11.  Documentation
    12.  Repackaging and relabelling
    13.  Complaints
    14. Recalls
    15.  Returned products
    16. Counterfeit pharmaceutical products
    17. Importation
    18. Contract activities
    19.  Self-inspection

 

2. Good Documentation Practice (GDP)

Good documentation practices are also known as GDocP. Alternatively, the abbreviation GRK (Good Record-Keeping) can be used for documentation studies.

This GDP term is comprised of World Health Organization’s (WHO’s) Guidance on good data and record management practices. Organizations should follow good documentation practices (GDocP) in order to assure the accuracy, completeness, consistency, and reliability of the records and data throughout their entire period of use along with the data life cycle. The guidelines mandate that documentation should have the characteristics of being attributable, legible, contemporaneously recorded, original and accurate (sometimes referred to as ALCOA).

 

Alcoa-V2

  • Attributable means information is captured in the record so that it is uniquely identified as having been executed by the originator of the data (e.g. a person or computer system).

  • Legible, traceable, and permanent refer to the requirements that data are readable, understandable and allow a clear picture of the sequencing of steps or events in the record so that all GXP activities conducted can be fully reconstructed by people reviewing these records at any point during the records retention period set by the applicable GXP.

  • Contemporaneous data are data recorded at the time they are generated or observed.

  • Original data include the first or source capture of data or information and all subsequent data required to fully reconstruct the conduct of the GXP activity.

  • Accurate means data are correct, truthful, complete, valid, and reliable.

PIC/S Guide to Good Manufacturing Practice for Medicinal Products - Part 1 defines the Good documentation practices as follows.

  • If there are handwritten entries, they should be made in a clear, legible, indelible way.
  • Records should be made or completed when the action is taken and in such a way that all significant activities associated with the manufacture of medicinal products are traceable.
  • If An alteration is needed to the entry on a document, it should be signed and dated; the alteration should allow reading the original information. Where appropriate, the reason for the alteration should be recorded.
If you found useful this description maybe you'll like to see:

We can make better science, together

Contact us to learn how we can help you make life-changing solutions.

Scilife-boosts-life-sciences-2