Efficacy of Corporate Quality Systems


The USFDA posted a warning letter for an inspection of 3-different Mylan laboratory sites.  This data is summarized below:

Facility Mylan Lab Limited  Agila Specialties Pvt Ltd (SFF) Agila Specialties Pvt Ltd (SPD)
Inspection Feb 6-13 2015 September 23-Oct 3 2014 August 1-8, 2014
Citation’s 211.113(b) 211.113(b) 211.113(b)
211.160(b)  211.68(b) 211.192
211.42(c)(10)(iv) 211.42(c)(10)(iv) 211.42(c)(10)(iv))

There were two common findings across all three facilities.

  • The first item, 21 CFR 211.113(b), addresses the facilities failure to follow appropriate written procedures designed to prevent microbial contamination of sterile drug products which includes the validation of all aseptic and sterilization processes.
  • The second item, 21 CFR 42(c)(10)(iv), addresses failure to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

Additionally, Mylan Laboratory Limited was cited for failure to establish laboratory controls in one-instance analytical results for two water drops were reported as being tested when in fact they had not been sampled.  In another instance the media plates used for environmental monitoring were potentially compromised based on being over incubated.

At Agila (SFF) the facility was cited for computer security related issues in that both BMS and MVPMS to not require password to access the network and servers.

At Agila (SPD) the facility was cited for failure to investigate unexplained discrepancy or failure of a batch.

The FDA summarized their concern in the warning letter thus:

These items found at three different sites, together with other deficiencies found by the USFDA investigators, raise questions about the ability of Mylan’s current corporate quality system to achieve overall compliance with CGMP.  Furthermore, several violations are recurrent and long-standing.  Although we acknowledge that the Agila facilities were acquired by Mylan recently, Mylan was on notice of the violations in Warning Letter 320-13-26, dated September 9, 2013.  Even without this Warning Letter, Mylan’s corporate quality system should have detected and corrected the forgoing violations without FDA intervention.

The FDA summary is a great learning point.  How do we ensure the corporate quality system is helping the subordinate organizations to achieve and maintain compliance?  Does the corporate quality system have the requisite authority to implement actions across the organization?  Alternatively, do you have competing quality systems either facility to facility, facility to corporate, or corporate to facility,  that are misaligned, and not congruent? In many organizations, politics can create organizational silos and fiefdoms that negate corporate initiatives in reducing redundancy and increasing organizational effectiveness.