Breakdown: Knowing your product's disintegration curve is key to quality

01. Juni 2010

The next phase of dietary supplements Current Good Manufacturing Practices (CGMP) is now underway for manufacturers. Conscientious manufacturers and packagers are taking advantage of a vast host of consultants, industry experts, webinars, seminars, mock inspections, and CGMP-compliant programs to armor themselves for an anticiptaed visit from government inspectors. However, ensuring quality is not merely about satisfying CGMP audits.

It may sound like an obvious statement, but product efficacy - and very importantly, a tablet's disintegration time - significantly affects sales and customer satisfaction. A good example of a company that understands this is NBTY, whose Boca Raton, FL facility was the first to undergo a dietary supplements CGMP audit in August 2008. During the audit, the facility's quality assurance excellence was acknowledged when the lead FDA inspector announced, after completion of the audit, that the facility was in full compliance with the new CGMPs.

In particular, NBTY was lauded for its excellent Master Manufacturing Records. Part of NBTY's records contained, among other specifications, disintegration end-times for each and every tablet and capsule manufactured at the Boca Raton plant. All disintegration tests described in NBTY's records and standard operating  test procedures either met or exceeded relevant United States Pharmacopeia (USP; Rocjkland, MD) disintegration guidelines. Adhering to USP recommendations turned out to be an important FDA audit criteria.

Disintegration testing standards are modeled in accordance with USP-NF General Chapter <2040> for dietary supplements. NBTY often exceeds USP and FDA standards. An example of exceeding official standards is qualifying all incoming hard gel capsules, excipients, and ingredients for their disintegration times. According to NBTY's Boca Raton quality-assurance manager, Robert Feldman, it is not unusual for any given batch of empty hard gel caps or raw materials to fail NBTY's disintegration standards.

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