‘Game changer’: latest GDP rules spell full traceability for APIs

By Fiona BARRY

- Last updated on GMT

The Good Distribution Practices guidelines for active ingrdients were two years in the making. (Image: Nicholas Raymond/CC)
The Good Distribution Practices guidelines for active ingrdients were two years in the making. (Image: Nicholas Raymond/CC)

Related tags Active ingredient

Makers and distributors of APIs (active pharmaceutical ingredients) will have to track their products throughout the supply chain and meet rules on cold chain transport and outsourcing under revised guidance from the European Commission.

The guide aims for full traceability of APIs from beginning to end of their supply chain, “so that all the suppliers of, or those supplied with, an active substance can be identified.​”

The finalised GDP guidelines​ are “a superb step forward in securing a falsified free supply chain,​” and a “game changer,​” according to GDP consultancy PLS Pharma.

Companies must document each purchase and sale including the names of the supplier, original manufacturer, and/or shipping agent; manufacturer’s batch number; certificates of analysis; purchase orders; and retest or expiry date.

The guidance also requires documenting deviations and installing a CAPA (corrective and preventative action) system.

‘Industry will embrace’ standards

A PLS Pharma spokeswoman told in-Pharmatechnologist.com these latest rules improve on “the excellent standard​” set by GDP guidelines published in November 2013 (Guidelines for Medicinal products 2013/C 343/01)​ and tighten up safety expectations in the distribution part of the API business.

Many of the overall standards from the 2013/C 343/01 GDP medicinal products guideline are now ensuring the quality system starts at procurement, and states appropriate storage and transport conditions will be successfully managed in a secure supply chain.”

The document also sets out GDP training requirements for staff and written contracts with all outsourcing partners, including transport, to create a fully traceable supply chain.

PLS was hopeful the API industry will cooperate with the new requirements:

Not unlike the new GDP guidelines 2013/C 343/01 this is a game changer; and new standards and expectations – although they will initially pose opportunities to address – there is no doubt that the Pharmaceutical industry will embrace these new requirements and do everything possible to implement in a timely fashion.​”

Quality requirements

Under the rules, distributors of APIs must install a quality system, with a designated person holding responsibility for risk management at each location in the distribution chain.

The quality system should have suitable staff, premises and equipment and make sure APIs are delivered in a “satisfactory time period.​”

The guidelines stress the importance of maintaining correct temperature or humidity storage, and it is distributors’ responsibility to ensure outsourced transport companies know the appropriate cold-chain conditions.

Records of transactions should be made at the time they happen, and deviations from established procedures should be documented and investigated.

A CAPA (corrective and preventative action) should be in place to prevent and correct deviations.

Deliveries should be examined immediately to check containers and safety seals are not damaged, and that the certificate of analysis is included. APIs which arrive with broken seals or damaged packaging should be quarantined and investigated. If distributors suspect an active ingredient has been falsified,​ they should inform their national regulator.


The guidelines require distributors to turn over to authorities all data related to compliance when requested. Any alterations to documents must still allow the original information to be read, and the reason for the change should be recorded.

Firms should note the distribution activities which could affect the quality of the APIs, including  receiving and checking deliveries, storage, cleaning of facilities, including pest control, security on site and in transit, withdrawal from saleable stock, handling of returned products, and recalls.

Companies must retain records for at least one year after the expiry date of each batch, and for active substances with retest dates, records should be retained for three years after the batch is completely distributed.

Distributors should notify customers of any potential interruptions to supply. And reveal the original API manufacturer to authorities on request.

The rules apply to anyone who buys, imports, holds, supplies or exports APIs, including manufacturers who sell on their product. Brokers who do not physically handle the chemicals are not affected by the rules, and neither are intermediates of active substances.

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