GDP Standards for API Suppliers

GDP standards

Good distribution practice (GDP) standards are a set of guidelines that wholesale distributors of pharmaceuticals must meet to ensure that medicine quality and integrity are maintained throughout the supply chain. 

Compliance with GDP standards ensures that medicines are authorized according to European Union (EU) legislation, pharmaceuticals are stored in the right conditions, contamination is avoided, adequate turnover takes place, and that delivery times are within a satisfactory time period.

Active pharmaceutical ingredients (API) are pharmaceutical components that can either be used alone or as part of a combination drug therapy to treat different conditions and/or symptoms. The safe use of APIs depends greatly on Good Manufacturing Practices (GMP) in addition to GDP guidelines.

What are GDP standards?

Distribution is an essential component of pharmaceutical supply chain management. Various organizations and people are responsible for the storage, handling, and distribution of pharmaceutical products, and each part of the distribution process can benefit from a set of standards that ensure efficient distribution. 

Risks of improper pharmaceutical distribution are similar to those in the manufacturing sector, including mislabelling, contamination, cross-contamination, and mixups. GMP standards should be applied in these circumstances to ensure efficient distribution, storage, packaging, transportation, documentation, labeling, and recordkeeping practices.

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Types of GDP Standards

Sufficient control over the various activities that occur during the distribution process is necessary to ensure pharmaceutical products meet high standards. GDP standards ensure the adequate establishment, maintenance, development, and control over all aspects of pharmaceutical supply chain activities. 

The purpose of GDP guidelines is to assist in making sure that the quality and integrity of pharmaceutical products is consistent across the distribution process. The European Commission and World Health Organization are two governing bodies that have outlined GDP practices for the appropriate distribution and storage of medicinal products under the following summarized categories:

Please note this is a summary and does not include all details according to the European Commission and World Health Organization. Please refer to these organizations for a complete list of standards. 


Practices concerning organization and management include guidelines for distributors and organizations, their standing under applicable legislation, liability, and organizational structure. GDP guidelines also stipulate that arrangements should be in place to ensure that no employees are subjected to commercial, financial, political, or conflicts of interest.


Guidelines concerning personal include: 

  • Training requirements
  • Ability and experience to carry out duties
  • Number of personnel
  • National regulations with regard to qualifications
  • Procedures concerning hazardous pharmaceutical products
  • Records
  • Protective garments
  • Hygiene procedures


Quality management guidelines include:

  • Using quality assurance as a management tool
  • Documented quality policies
  • Appropriate infrastructure or a “quality system”
  • Traceability for electronic commerce (e-commerce) procedures
  • Authorized procurement and release procedures to ensure pharmaceutical products are sourced from approved suppliers
  • Traceable entities in the supply chain 
  • Inspection and certification of compliance with relevant quality system


Premising, warehousing, and storage guidelines include guidelines on good storage practices, storage areas, precautions be taken to prevent unauthorized persons, capacity, storage conditions, and cleanliness procedures. 


Vehicles and equipment used to handle, store, or distribute pharmaceutical products should be adequate and safe to use. The design and usage of these vehicles must aim to reduce errors and permit effective cleaning and maintenance to avoid contamination.


Pharmaceutical products should be sold and/or distributed under applicable national, regional, and international legislation to appropriate entities with written proof. Other guidelines include:

  • Awareness of rules by contract acceptor for transportation of the pharmaceutical products
  • Dispatch and transport of products commenced only after receipt of delivery order or material replenishment plan
  • Established written procedures
  • Records for dispatch of pharmaceutical products
  • Full description of the products

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Pharmaceutical transportation guidelines include:

  • Adherence to requirements throughout transportation and at storage stages.
  • Procedures that make sure the ID of the product is not lost, the product does not contaminate and is not contaminated by other pharmaceuticals, adequate precautions are taken against breakage, spillage, theft, and misappropriation
  • Appropriate temperature and humidity conditions


GDP guidelines stipulate that all written instructions and records should be available that document the following:

  • Applicable receipts
  • Preparation, approval, and review of the use of and control of changes to all distribution documents
  • Procedures enforced for both internally generated and externally generated documents
  • Documents relating to any activity that could impact the quality of pharmaceutical products
  • Title, nature, and purpose of each document
  • Compliance with national legislative requirements 


Repackaging and relabelling of pharmaceutical products should only be conducted by authorized entities in accordance with GMP principles. Where these functions are performed, they should be compliant with relevant national, regional, and international guidelines that relate to pharmaceutical products.


GDP guidelines concerning complaints include:

  • Written procedures in place for handling complaints
  • Review process describing the action to be taken, including the need to consider a recall
  • Consideration should be given as to whether other batches of the product should also be checked.
  • Appropriate follow-up action


GDP guidelines concerning recalls include a system that includes a written procedure to recall pharmaceutical products known or suspected to have defects. In the event of a recall, the original manufacturer should be informed. Other guidelines include:

  • Evaluation at regular intervals
  • Stored of recalled pharmaceuticals in a secure, separate area
  • Informing all customers and competent authorities of a recall
  • Issuance of a final report that includes a reconciliation between delivered and recovered quantities of products

Other GDP standards to be considered include:

  • Rejected and returned products
  • Counterfeit pharmaceutical products
  • Importation
  • Contract activities
  • Self-inspection

API Sourcing with GDP Standards

Sourcing quality APIs produced according to GMP and distributed in compliance with GDP standards ensures quality and reliability across batches. MedicaPharma operates across an extensive network of over 400 GMP manufacturers with API supply agreements to hospitals, universities, and pharmacies. Our product lines include hormones, vitamins, amino acids, excipients, plant extracts, phospholipids, photosensitizers, and Active Pharmaceutical Ingredients (APIs).

FAQ: GDP Standards for API Suppliers

API manufacturing is the production of Active Pharmaceutical Ingredients (APIs) for use in pharmaceutical products.

No. MedicaPharma operates with a comprehensive network of over 400 manufacturers that apply GDP and GMP standards.

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