Will the GMP Regulations Be Harmonised Worldwide?

GMP News No. 335

GMP News
6 August 2003

Willthe GMP Regulations Be Harmonised Worldwide?

For a long time, the worldwide harmonisation of the GMP requirementsseemed inconceivable. But now, this idea is not so unthinkable any more.

Many will find it astonishing that suchan initiative comes from the FDA. We have already reported several timesabout the FDA reform "cGMP for the 21st Century." Some peoplemay just have seen it as a normal improvement process of an authority.However, the actual consequences of this initiative will nowalso become clear to the last remaining sceptics.

The initiative, about which we reportedin our News of 4 September 2002,has been established in order to review and revise the now almost25-year-old GMP regulations fundamentally. TheRisk-based Approach, as it is called, is at the heart of this initiative. By means of this approach, the FDAintends to coordinate all of its activities, e.g. the creation ofguidelines, but also the conduct of inspections. In the interest ofpatient safety, special focus is now to be placed on those processes thatinvolve a high risk for the patient. This means that the regulations willcertainly place more emphasis e.g. on aseptic processing rather than onclassic solid dosage forms manufacture for a generic drug.

The FDA does not see this initiative asan isolated activity. The Agency also intends to introduce this approachinto international harmonisation. It aims at harmonising inspections andregulations and thus at increasing patient safety while reducing costs. Toreach this aim, the FDA intends to harmonise the GMP requirements inimportant areas via the InternationalConference on Harmonisation (ICH). With ICH Q7A, there are already GMPregulations (GMP for active pharmaceutical ingredients) that have beenharmonised worldwide. The other harmonised regulations in the triadconsisting of Europe, Japan, and the USA concern mainly the registrationof medicinal products. At the moment, the FDA is investigating whether itshould join the Pharmaceutical Inspection Convention Scheme (PIC/S). Onlyfew months ago, this would have been absolutely unthinkable. But the firststeps that have been taken leave no room for doubt.
The following paragraphs were taken from the minutes of the FDA meetingfor preparing the participation in ICH6 on 24 June 2003:

Ms Showalter, ICH Coordinator of FDA: "The way we are going to do the meeting today, we aregoing to go through some of the big topics for the Brussels meeting. Oneof the big items on the agenda is actually the ICH portion of the GMPProgram, the Drug Product Quality, or GMP, Program for the 21st Century."
"When we decided to take the GMP Initiative up in ICH, we had someconcerns about whether ICH would be an appropriate venue for this. As wewent, we reflected on some of the kinds of topics that we had taken in thepast to ICH and we realized that there were some similarities with othertopics in terms of the process that we might use for this one."
"One of the other venues that you will find repeatedly gets mentioned,and we had a discussion of this at our February meeting, is the PIC/s.That is something that we are currently investigating as a venue forfurther regulatory collaboration on this topic."

The FDA already presented its approach at the preparation meeting inBrussels for the coming ICH6 Conference, where it fell on sympathetic ears.In the minutes of the ICH Meeting from 15 to 18 July, it says:
The Steering Committee was pleased to hearthe positive outcome of a brainstorming workshop on initiatives related toa risk-based approach to Drug Product Quality. This session was attendedby more than 60 designated experts from the six ICH parties, observers andnon-ICH parties. The workshop discussion led to a general agreement on ahigh level vision: a harmonized pharmaceutical quality system applicableacross the lifecycle of the product emphasizing an integrated approach torisk management.

The Steering Committee agreed that the experts from the six partieswill work further on two areas:

  • on Pharmaceutical Development incorporating elements of Risk andQuality By Design, and covering the product lifecycle. 
  • on a better definition of the principles by which Risk Management isintegrated into decisions regarding Quality including GMP complianceboth by the regulators and industry. 

Industry will, in addition, produce a Quality Systems Scoping Documentincluding GMP as a subset, which should address areas of perceiveddifferences in the three regions.

It was also agreed to include a one-hour session of presentations onthese GMP-related discussions and initiatives in the programme of the ICH6Conference.

And what does the industry think about it? It is positivelysurprised! It considers the new FDA Initiative "cGMP for the 21stCentury" as an extraordinary chance to harmonise the requirements andto focus them on the risk for the patient. Within the shortest possible time, EFPIA, theEuropean Federation of Pharmaceutical Industries and Associations, has produced aseparate paper on this subject. Here just a brief excerpt that shows howpositive EFPIA's reaction to this FDA initiative was:

EFPIA welcomes the FDA's initiative to develop regulations and guidelines that would resultin advancing scientifically sound and integrated systems, applicable toensuring pharmaceutical product quality. EFPIA also appreciates the chanceto comment on the concept paper and to participate in further discussion atthe ICH meeting in Brussels in July 2003.

So this unique FDA initiative will not only influence the area regulatedand inspected by the FDA, but it will also have a direct impact on the requirements here inEurope.


Since its foundation, the EuropeanCompliance Academy (ECA) has been focusing its activities on impartingboth the EU GMP requirements and the FDA cGMP requirements. Now it turnsout that ECA's decision was, and still is, pointing the way ahead!


Oliver Schmidt


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