EC Updates Guidance to Ensure Supplier Compliance

By Zachary Brennan

- Last updated on GMT

EC Updates Guidance to Ensure Supplier Compliance

Related tags: European union, European commission

The European Commission has updated its GMP guidance to notify manufacturing authorization holders (MAHs) of their legal obligation to ensure that active substances are produced in accordance with GMP.

Through audits of active substance manufacturers and distributors, MAHs are now required to ensure that their suppliers meet GMP and good distribution practice standards. Excipients “should be given similar attention to those for active substances​,” according to the updated guidance​ released last week.

The commission’s revisions are related to four different chapters on GMP guidance for drug production, quality control, equipment and premises, as well as complaints, quality defects and product recalls.

Under the guidance on production, MAHs are now required to ensure supply chain traceability and notify competent authorities at least two months before constraints in manufacturing operations will cause either a temporary or permanent shortage.

In addition, the revised guidance calls for manufacturers’ quality requirements to be discussed and agreed with suppliers. The agreement should incorporate aspects of the production and control processes, including handling, labelling, packaging and distribution requirements, complaints, recalls and rejection procedures, according to the commission.

Manufacturers can use partial or full test results from the approved starting material manufacturer ”but must, as a minimum, perform identification testing of each batch themselves​,” according to the new guidance.

The supply chain and traceability records for each active substance should be available and retained by the EEA-based manufacturer or importer of the drug, the guideline says. And if possible, the commission recommends that “starting materials should be purchased directly from the manufacturer of the starting material​.”

Other revisions include:

  • A new section in chapter six of the GMP guidance on the technical transfer of testing methods and other items such as out of specification results;
  • Additional emphasis in chapter eight on the need for the cause(s) of quality defects/complaints to be investigated, and so appropriate preventative actions are put in place; and
  • Further integrations with the new European Medicines Agency guidance on ways to prevent cross-contamination​ from multiple drugs produced at shared facilities.

 Comments on the revised GMP guidelines are due July 18 and they are expected to come into operation soon after the comments are received.

Meanwhile, the European Commission has set a Jan. 31 deadline for finalizing its amended first chapter on the GMP guidelines, which is part of plans to align quality system guidelines with the International Conference on Harmonisation’s Q10 guidance.

The US Food and Drug Administration is also expected to issue guidance sometime soon on what drugmakers are required to share with CMOs and other suppliers, officials said in September.

Related news

Related products

show more

Integrated Solutions for Accelerated Time to Market

Integrated Solutions for Accelerated Time to Market

Piramal Pharma Solutions | 08-Jun-2021 | Technical / White Paper

Facing capacity constraints? Lock in your program now! With 14 sites around the world providing diverse services ranging from discovery to drug substance...

Transforming Clinical Development

Transforming Clinical Development

PerkinElmer | 01-Jun-2021 | Technical / White Paper

The estimated cost of bringing a drug to market in the U.S. according to JAMA is $1 billion.1 The extreme cost of clinical trials urge biopharmaceutical,...

Vaccine Innovation in the Era of COVID19

Vaccine Innovation in the Era of COVID19

Covance Patient Safety | 01-Oct-2020 | Sponsored Link

During this time of worldwide crisis, there is an increasing demand for the acceleration of a vaccination for COVID19. Regardless of the great recent advancements...

Lactium, your ally to manage day to day stress

Lactium, your ally to manage day to day stress

Ingredia | 27-Aug-2020 | Product Presentation

Stress has been called the ‘health epidemic of the 21st century’ by the World Health Organization. Increasingly, consumers are looking for safe, reliable...

Related suppliers

Follow us


View more