The Competitive Advantage

The Competitive Advantage
The competitive advantage of non-compliance by Guy Villax, CEO, Hovione CPhI 2004 - Show Daily (8 Dec.2004)

2004.12.08
pdf - 26k

Enforcement of Compliance with GMPs in API manufacture
Presentation given on the 8th December 2004 to the press during CPHI Brussels. The slides with the “EU action items” summarise the position taken by the following industry associations: "APIC - the Active Pharmaceutical Ingredients Committee of CEFIC AFAQUIM - the Spanish Fine Chemical Association/ APIs producers" - "APEQ - The Portuguese Chemical Companies Association" - "CPA - The Chemical Pharmaceutical Generic Association, Italy. The other slides have been put together by Guy Villax of Hovione to explain the current situation based on available information.

2004.12.08
pdf - 425k

Managing the Cost of Compliance in Pharmaceutical Operations
by Frances Bruttin & Dr. Doug Dean / IBM Business Consulting Services, April 2004. Studies published in recent years confirm that the magnitude of the “costs of compliance” makes production costs of APIs manufactured in compliance with the regulations much higher than those for non-complying APIs. This puts a heavy responsibility upon the authorities, because it implies that the effectiveness of the EU inspection-, enforcement- and penalisation system should really provide waterproof protection against illicit APIs, because these can be offered at significantly lower prices. They will therefore easily win a competitive battle against legitimate API material.

2004.04.01

APIC Hot Topics
APIC expresses public support for mandatory enforcement of GMP compliance inspections

2004.10.20

CPA Position paper: Impurity profiling: brand products versus copies
chimica oggi • Chemistry Today • March/April 2005 (Marcello Fumagalli). An article that has recently appeared on a leading scientific journal (J. of Pharm. Biomed. Anal., 34 (2004) 341–348) has shown the results of a comparative study between drug CLOPIDROGEL by Sanofi-Synthélabo and the generic copies currently on the market. The article showed that the situation is much more serious than what we could have expected, with basically all of the generic drugs checked having significant discrepancies compared to the control drug as regards compliance with pharmacopoeia standards. In other words their quality was strongly questionable, if not unacceptable.

2005.06.03
pdf - 37k

Answer French Assemblée Nationale
Date: 02/06/2005 In response to question 63018 made by a French Député at the Assemblée Nationale (JO on 19/04/2005 page 4005), the Ministère de la Santé confirms (JO on 27/09/2005 page 9039) that compliance with GMPs can only be verified through an inspection performed by inspectors of the competent authorities. It states also that during 2005 French isnpectors will check for GMP compliance two plants located in India that supply API for French MA/AMM.

2005.09.30
pdf - 88k

APIC Audit Programme
The APIC Audit Programme (AAP) is a worldwide 3rd party auditing programme that follows a standardized procedure for the planning, conducting and evaluating GMP compliance audits of API manufacturers, contract manufacturers, contract laboratories and/or distributors. The audits are being conducted by experienced APIC certified auditors on the basis of the ICH Q7a Good Manufacturing Guide for APIs. The AAP that was initiated by APIC on the basis of its APIC Auditing Guide and is coordinated by the API Compliance Institute (www.api-compliance.org), where you can find detailed information.

2005.10.11
pdf - 538k

The APIC Audit Programme. Parallel Session
presented by Dr. Tom Buggy, DSM-Anti.Infectives B.V., The Netherlands; and Dr. Barbara Jentges, Concept GmbH, Germany

2005.10.14
ppt - 3,187k

EU GMP API compliance benchmark questionnaire for senior regulatory contacts in each EU Member State’s health authority inspectorate
EFCG is carrying out an EU wide benchmarking exercise for its members to assess the readiness of EU Regulators to enforce the new provisions contained in Directive 2004/27 that for the first time require that APIs used be made in compliance with GMP – as per Article 47.

2005.11.04
pdf - 41k

Europe Makes Manufacturing Compliance An Obligation
European Union legislation now requires that all active pharmaceutical ingredients (APIs) going into drugs sold in Europe meet Good Manufacturing Practices (GMPs). The directive went into effect on Oct. 30, almost 50 years after the U.S. enacted similar rules. But rather than chafing under another regulation, the European Fine Chemicals Group (EFCG), an organization launched a year ago to represent fine chemicals manufacturers, is embracing it.

2005.11.25
pdf - 18k

GMP Compliance In Europe
It’s no longer business as usual for suppliers of active pharmaceutical ingredients in Europe. New Good Manufacturing Practices will impact API manufacturers who want to conduct business in the European Union.

2005.12.21

GMP Compliance in Europe
Pharma & Bio Ingredients, November/December 2005, p. 35-36. It’s no longer business as usual for suppliers of active pharmaceutical ingredients in Europe. New Good Manufacturing Practices will impact API manufacturers who want to conduct business in the European Union.

2006.01.26
pdf - 300k

Fine Chemicals Group Offers Commonsense Steps
Chemical & Engineering News, February 13, 2006, Volume 84, Number 7, p. 31.

2006.02.14

At last – a more level playing field
Manufacturing Chemist, 01 February 2006 . A new EU directive should help to establish a more level playing field where APIs are concerned.

2006.02.21
pdf - 40k

EU To Begin ICH Q7A Enforcement
“The Gold Sheet”, Vol. 40, No. 1, January 2006. NEW EU REQUIREMENTS FOR API GMP OVERSIGHT are now in force calling for finished product manufacturers to audit their bulk suppliers and attest to their GMP compliance. With global implications, European regulators and industry have been debating how to create an effective implementation approach, and a flurry of guidances and position papers is emerging. The EU industry views authority inspections as a critical enforcement lever in the effort to achieve fairer competition with Asia and more control over API quality. [A detailed explanation by a European regulatory official of the new API GMP legislation and implementing measures and the impact on the obligations of application holders, API manufacturers, and regulatory authorities is provided on pp. 19-23. A recent release from the EMEA focusing specifically on the expectations for API auditing by dosage manufacturers is included on pp.3-4.]

2006.04.07
pdf - 1,617k

GMP compliance of APIs - Finally!
Chimica Oggi / Chemistry Today, March/April 2006, vol. 24 (2). What is the EFCG and why was it created? The EFCG groups together, the companies and associations of fine chemical manufacturers in the European Chemical Industry Council (CEFIC), and the committee of which I am the Chairman represents over 200 European producers of APIs (active pharmaceutical ingredients and their precursors) located in the EU. We decided to create this group as we felt we had no representative voice in Brussels and we could not keep a passive position when facing an avalanche of legislation that strongly penalizes those who produce in Europe, and favours those who manufacture outside Europe and...

2006.04.17
pdf - 193k

EFCG and SOCMA Urge More Inspection of Foreign API Makers
Date: 2006.10.12 Pharmaceutical Technology. CPhI Worldwide, Paris (Oct. 3, 2006)—The Synthetic Organic Chemical Manufacturers Association (SOCMA, Washington, DC, www.socma.org) and the European Fine Chemicals Group (EFCG, Brussels, www.efcg.cefic.org) have teamed to urge US and European regulatory authorities to increase inspections of foreign manufacturing facilities of active pharmaceutical ingredients (APIs) to reduce patient risk from sub-par drugs, to increase national security, and to level the economic playing field

2006.10.23
pdf - 25k

US and EU pharma trade bodies slam poor regulation of foreign APIs
Date: 2006.10.20 in-PharmaTechnologist.com, 20 Oct 2006. Two trade associations of the world’s two largest pharma economies – Europe and the US - took the unusual step of banding together at the CPhI in Paris to condemn their regulatory authorities for poor regulation of foreign active pharmaceutical ingredient (API) manufacturers. The Synthetic Organic Chemical Manufacturers Association (SOCMA) and the European Fine Chemicals Group (EFCG) are demanding that regulators increase their inspections of such foreign facilities.

2006.11.27

SOCMA and EFCG call for more inspections of foreign API facilities.
Date: 2006.10.20 Manufacturing Chemist, October 2006. Even though 75-80% of all APIs used by EU and US medicine manufacturers are imported, most of the facilities where they were manufactured have never been inspected to ensure they conform to GMP standards.

2006.11.27
pdf - 46k