Technical Services for Manufacturers of Pharmaceuticals and B​iologics

GMP Contracting, Inc.

 

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Matt Bestercy     (631) 838-9083        mbestercy@bestgmp.net
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Mid-Size Rx Drug Product Manufacturer, New Jersey (2011-2013)

  • Warning Letter Remediation - Warning Letter lifted.
  • Cleaning Validation: Preparation of Master Plan, including Matrix Scheme. Drafted sampling plans, including MAC acceptance criteria.
  • Process Validation: PV program Gap Assessment and remediation
  • Packaging Validation: Drafted Master Plan, Gap Assessment and remediation.


Large Generic Drug Manufacturer, New Jersey (2009-2010)

  • Qualification of Equipment, Facilities and Utilities related to two major manufacturing area additions. Qualifications included Water Systems, Fluid Bed Dryers, High Shear Mixer, V-Blenders, Mills, USP Purified Water Systems, HVAC Systems and Production Suites. Produced Protocols, execution, reports.


Large Topical Rx Drug Product Manufacturer, Canada (2009)

  • Remediation project for FDA Warning Letter - Warning Letter lifted.
  • Restructured the Process Validation Program. Drafted Master Plans, PV SOP's and Protocols.
  • Performed Gap Assessment and Remediation Plan for the Cleaning Validation of equipment across a variety of creams, ointments and lotions, totaling over 90 products.
  • ​Optimized Filing Process and Operational Parameters through the use of HACCP. Established formal Filler setup sheets. Initiated revalidation of filling process.


Mid-Size Rx Drug Product Manufacturer, Florida (2009)

  • ​Remediation project for FDA Warning Latter and Consent Decree - Consent Decree lifted.
  • Developed Validation Policies and Procedures for the corporation, including Equipment and Utilities Qualification, Process and Cleaning Validation.
  • Implemented and oversaw the validation of assets and processes.


Sterile Injectable Manufacturer, Ohio (2010)

  • Performed training of Aseptic Operators in aseptic practices.
  • Monitored and enforced aseptic practices in the sterile core of a three-shift operation in the three different manufacturing facilities manufacturing critical, life-saving products on drug shortage lists.

Recent Projects

Large Pharmaceutical OTC Manufacturer, Pennsylvania (2010-ongoing)

  • Remediation project for FDA Consent Decree
  • Third party oversight of $200MM rebuild of a pharmaceutical liquids manufacturing facility.
  • Consulted on the development and subsequently approved Critical Aspect Risk Assessments, VMP's (Site, Cleaning, Process, Equipment/Facility/Utilities, Computer Systems, Lab), Protocols and Reports.
  • Provided guidance and review on the complete rewrite of all site engineering maintenance, calibration and operating procedures and policies.

Large Rx Pharmaceutical Manufacturer, New Jersey (2010-2011)

  • Commissioning and Qualification of Equipment, Facilities and Utilities related to the move of an entire Stability Facility and Labs from one location to another (within state).


Mid-Size OTC Drug Product Manufacturer, New York (2010-2011)

  • Produced Cleaning Validation Master Plan, Cleaning Validation Protocol Master Design.
  • Produced Process Validation Procedure Design and Implementation, drafted Process Validation Protocols/Reports.​​​​