Product Annual/Quality Review: US–EU Comparative Analysis and Interpretations - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Product Annual/Quality Review: US–EU Comparative Analysis and Interpretations
There are significant differences between the United States and European Union requirements for the annual review of records related to the manufacturing and control for pharmaceutical products and active pharmaceutical ingredients.


Pharmaceutical Technology
Volume 3, Issue 32

Conclusion and recommendations

The EU product quality review (PQR) requires a greater number of items and areas for review compared with either the US product annual review (PAR) or Q7A PQR, and expands the review to include quality systems and registration commitments. Despite this expanded review, it does not incorporate two of the three major FDA objectives for the review. The Q7A PQR is very similar to the EU PQR, although it does not include nearly as many areas and items for review as the EU PQR. The Q7A also does not include any of the three objectives of the FDA PAR.

The expanded review required by the EU PQR may not necessarily require additional time and resources, compared with the FDA PAR review, because the EU PQR allows for the grouping of products together in one review whereas the FDA does not. If a company decides to perform one PAR/PQR to satisfy both FDA and the EU, then, they would need additional resources to perform an expanded review, for each product. Companies that supply the US and EU markets should, therefore, decide on the approach that is the most effective, efficient, and economical before rushing to develop or redevelop their PAR/PQR program.

As with all GMP guidance information, it is always valuable to try to understand the underlying principles to respond in a way that both meets the GMP requirement or expectation and strengthens the quality system with ultimate benefit to the patient. This is a shared goal of both regulators and industry. By presenting some of the background information relevant to the PAR/PQR, comparing it with other well-established reviews and outlining one possible approach (i.e., a modular approach) to meeting the EU PQR requirements, compliance can be achieved from a stronger foundation.

John G. Grazal is senior director of the Global Compliance Management Group at AstraZeneca (Wilmington, DE). John Y. Lee* is executive director at Pharmaceutical Compliance Associates, and a former FDA investigator at New Jersey District, 523 No. Bay Avenue, No. Massapequa, NY 11758, tel: 516.752.0998, fax: 516.752.8931, e-mail:
.

*To whom all correspondence should be addressed.

Submitted: May 10, 2007. Accepted:Aug. 23, 2007

References

1. FDA, "Human and Veterinary Drugs, Good Manufacturing Practices and Proposed Exemptions for Certain OTC Products," Fed. Regist. 43 (190), 45013–45089 (Sept. 29, 1978).

2. FDA, Guidance for Industry: Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (Rockville, MD, Aug. 2001).

3. European Commission, "Medicinal Products for Human and Veterinary Use," in EU Guidelines for GMP, Chapters 1–9, Dec. 2005.

4. European Commission, Enterprise and Industry, Pharmaceuticals, Documents, "New GMP Provisions For Product Quality Review," website announcement, Nov. 8, 2005.

5. FDA, Guideline on General Principles of Process Validation (Rockville, MD, May 1987).

6. European Commission, Final Version of Annex 15 to the EU Guide to Good Manufacturing Practice, "Qualification and Validation," July 2001.

7. FDA, Guidance to Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations (Rockville, MD, Sept. 2006).

8. FDA, "Current Good Manufacturing Practice in Manufacturing, Processing, Packaging, or Holding of Drugs; Amendment of Certain Requirements for Finished Pharmaceuticals," Fed. Regist. 60 (13), 4087–4091 (Jan. 20, 1995).

9. FDA, "Human Drug CGMP Notes," HFD-320, 6 (1) (Mar. 1998).

10. FDA, "Human Drug CGMP Notes," HFD-320, 8 (2) (June 2000).

11. Health Products and Food Branch Inspectorate, Health Canada, Good Manufacturing Practices Guideline 2007 Edition (for comment), Dec. 2006.

12. FDA, "Human Drug CGMP Notes," HFD-320, 6 (4) (Dec. 1998).

13. PDA Comments on Addition to Chapter 1 of the EU GMP Guide "Product Quality Review," June 2004.

14. EFPIA Comments on Addition to Chapter 1 of the EU GMP Guide "Product Quality Review," June 2004.

15. FDA, Guide To Inspections Of Dosage Form Drug Manufacturer's —CGMPs (Rockville, MD, Oct. 1993).

16. FDA, "Guide To Inspection Of Computerized Systems In Drug Processing," HFN-320 (Feb. 1983).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
25%
Oversee medical treatment of patients in the US.
13%
Provide treatment for patients globally.
10%
All of the above.
43%
No government involvement in patient treatment or drug development.
10%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Source: Pharmaceutical Technology,
Click here