10 points on how the FDA's CDER monitors the Quality of Medicinal Products

The FDA's Centre for Drug Evaluation and Research (CDER) has compiled a 10-point overview of how it fulfils its task of ensuring the quality of medicinal products. What are these 10 points?

Pharmaceutical Quality

The process of ensuring the quality of a medicinal product begins with the CDER checking, when it receives an application for marketing authorisation of a prescription-only medicinal product, whether the medicinal product can be manufactured in such a way that it consistently meets the quality standards. According to the CDRH, the concept of pharmaceutical quality is about more than just the quality of the medicine itself. It also includes the production facilities and the processes used to manufacture the medicine. The CDER also monitors the medicinal products on the market and the facilities in which they are manufactured to ensure the quality of the medicinal products. But now to the 10 points:

1) Prior to approval by the FDA, manufacturers of prescription drugs must prove that their drugs are safe and effective and meet quality standards. This applies to US companies, but of course also to companies outside the USA.

2) CDER is working to develop national and international guidelines that set quality standards for drug manufacturers. These include guidance documents to help drug manufacturers understand regulatory requirements and best practices so that they can produce high quality drugs. The FDA also works with industry organisations and international regulatory authorities to advance pharmaceutical quality policy.

3) As part of the review of a marketing authorisation application, CDER reviews how the manufacturer will ensure the identity, strength, consistency and purity of the medicinal product. This includes the assessment of premises and equipment and the manufacturing process in accordance with regulatory requirements. 

4) During the marketing authorisation process for a medicinal product, CDER uses a risk-based approach to determine which drug manufacturing facilities must be inspected before the medicinal product is authorised (e.g. an inspection is normally carried out if the medicinal product is the first product to be manufactured in a newly built facility). A positive inspection result is a prerequisite for the granting of a marketing authorisation.

5) The CDER maintains the "CDER Site Catalogue", an overview of facilities involved in the commercial manufacture of pharmaceuticals marketed in the USA. Most inspections of these manufacturing sites are surveillance inspections to assess whether quality assurance procedures are being followed on site in accordance with regulatory requirements.

6) The FDA also inspects manufacturers of medicinal products that are marketed without an FDA-approved use (e.g., over-the-counter - OTC drugs) for quality and safety.

7) The CDER can also conduct remote audits to verify compliance with manufacturing practices and request documents from companies. It is also possible to co-operate with regulatory authorities in other countries regarding inspection results. All this allows the CDER to obtain information about production facilities without having to be present on site.

8) In the event of a safety or quality problem, the CDER becomes active and can recommend that a company recalls its medicinal product from the market or include a company in an "import warning" to prevent potentially unsafe products from entering the USA. It is also possible to issue a "Warning Letter".

9) On a risk-based basis, the FDA regularly takes drug samples and tests them to monitor quality problems.

10) It is also possible to report concerns about the quality of medicines themselves via the FDA's "Medwatch" programme.


The CDER describes very nicely in 10 points which measures it uses to ensure the quality of medicines.

You can find the entire 10-point document on the FDA website.

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