Technical Note: The Case for Supplier Qualification - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Technical Note: The Case for Supplier Qualification
This article demonstrates that test results support the position of FDA on the importance of an appropriate supplier-qualification program.


Pharmaceutical Technology
Volume 33, Issue 10, pp. 84-88

International Pharmaceutical Excipients Auditing (IPEA), the conformance services subsidiary of the International Pharmaceutical Excipients Council of the Americas (IPEC-Americas), sampled excipients available in the United-States market from two US Pharmacopeia (USP)-verified companies (referred to collectively as established manufacturers) and corresponding ingredients from Nanhang Industrial Co. (Hangzhou, Zhoupu Xihu, China) and Tianjin Boai NKY International (Caigongzhuang, Jinghai Tianjin, China), referred to in this article as Manufacturers A and B, respectively, to evaluate their conformance to monographs for Copovidone NF, Crospovidone NF, and Povidone USP. The goal was to compare the quality of the established manufacturer excipients with the ingredient quality offered by the two new excipient suppliers. IPEA coordinated the project and was responsible for ensuring that the excipients were properly sampled from sealed manufacturers' containers and tested in USP-verified laboratories to develop unbiased data, thus lending credibility to the findings.

Test results support the position of the US Food and Drug Administration as to the importance of having an appropriate supplier-qualification program (1). Such a program includes laboratory testing to confirm that components from a supplier meet compendial requirements and a site assessment to ensure that the component was produced under appropriate good manufacturing practices (GMPs). As described in this article, many of the tested excipient lots failed to conform to USP monograph requirements. However, IPEA did not conduct an evaluation to ensure conformance of the sites to appropriate GMPs because this was outside the project's scope. It should be noted that the established manufacturers were in conformance with USPNF <1078> Good Manufacturing Practices for Bulk Pharmaceutical Excipients.

Regulatory basis for supplier qualification

Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act requires that drugs (components and drug products) be manufactured in conformance with current GMP (CGMP), and 501(b) of the Act further requires that a drug whose name appears in an official compendium meet the standards set forth in the official compendium. The FDA Compliance Policy Guidance Manual (section 420.100) indicates that a drug, or drug component is considered adulterated if it fails to conform to compendial requirements. This section further states that "it should be kept in mind that the types of adulteration found under 501(b) and 501(c) may be indicative of a wider problem involving failure of the manufacturer to adhere to current good manufacturing practice that should be addressed."

The FDA expectation, under 21 CFR 211.84(d)(2) is implementation of an appropriate supplier-qualification program. Qualification should be completed before the pharmaceutical manufacturer reviews, and relies on, incoming approval of test results reported on the manufacturers' Certificate of Analysis (CoA) in addition to satisfactory results from at least one specific identity test. A supplier-qualification program should include an audit of the supplier's manufacturing facility (2).

Polymeric vinyl pyrrolidinone excipients

Povidone USP, polyvinyl pyrrolidinone, has been used in drug products for more than 50 years. Crospovidone NF, crosslinked polyvinyl pyrrolidinone, has been marketed as an excipient for more than 25 years and more recently, Copovidone NF, the copolymer of polyvinyl pyrrolidinone and vinyl acetate, was added to USPNF. Until recently, these three excipients were marketed by the established manufacturers but are now being offered by new manufacturers based in Asia. There were reasons to believe the new Asian manufacturers would have difficulties in meeting all monograph requirements for these excipients because some excipients from the Asian-based manufacturers failed to meet monograph requirements.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

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

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Source: Pharmaceutical Technology,
Click here