Production, Maintenance, Calibration, & Engineering Programs

and Equipment Commissioning and Qualification

  for Pharmaceutical, Biotech, and related industries

Pharmaceutical Technical Services (PTS) is a focused consulting organization, specializing in serving the GMP production and facilities' operations activities of the pharmaceutical, biopharmaceutical, diagnostic, and related regulated industries as per CFR 211, CFR 600 and CFR 820. We help organizations establish sustainable, compliant programs for managing their production and engineering-based activities supporting ongoing operations. In particular, we work with clients to develop programs for managing their production, project engineering, maintenance, calibration, contractor assessment, and GMP training activities to establish and maintain the validated state.

We have worked with many client locations that were under regulatory oversight, e.g. 483's, Consent Decree, Application Integrity Process (AIP), or  Warning Letter.  Programs developed at these sites have contributed to the organizations being able to put the additional regulatory burden behind them by demonstrating a program that is both effective and sustainable. 

The Principal of PTS, Joseph T. Busfield,  has worked with many companies, in the U.S., Europe, and other parts of the world to perform compliance audits and/or develop sustainable production and facility compliance programs.  PTS develops programs that can sustain regulatory scrutiny and, more importantly, produce products compliantly and engineer, maintain, and calibrate systems and equipment correctly.  Performing these production and operations-based engineering functions correctly is good business, good economics and compliant. The regulatory requirements should not be perceived as a burden, rather a guide to help an organization establish robust systems to ensure product is made consistently, meeting pre-determined quality requirements.

Often programs need to be implemented quickly to meet pre-inspection or licensing timetables. Our experience in developing these programs can reduce the timeline to compliance drastically.  PTS has also helped implement auxiliary programs to compliantly control facilities such as:

Documentation Systems

Contractor Qualification

Operations and Cleaning SOPs

Technical Training

Pest Control

HEPA Filter Testing

Spare Parts, etc.

PTS also draws upon extensive equipment and process experience to develop Commissioning and/or Qualification-Validation documents that are both compliant and pragmatic avoiding excess cost and expediting schedules.

Pharmaceutical Technical Services can help you with services that are technically excellent, timely, and cost-effective. Services that help overcome the resource shortages that are a part of modern day business life. If your organization is faced with the need for current, expert knowledge in a specific area of operations compliance, PTS can provide expertise in to help ensure compliant programs in production, calibration, maintenance, and engineering. PTS continues to add new clients to the base of satisfied customers. Clients who need resources to enhance compliance or complete the qualification portion of a project, but do not want to lose control of the quality or cost of the project. PTS programs and documentation have regularly and successfully undergone regulatory scrutiny.

Please check the particular area of interest given as links along the top of the web pages.  Some of these pages have additional resources to help you on the path to enhanced compliance. We are ready and willing to help your organization reach its compliance goals.  Please contact us for more information or to discuss your needs.

Brochure

Contact email

Good Manufacturing Practices for Pharmaceuticals, Sixth Edition, edited by Joseph D. Nally

Publication date: December 2006 / 424 pp.

ISBN-10: 0849339723 / ISBN-13: 9780849339721

(Includes a section on maintenance and calibration contributed by PTS Principal, Joe Busfield.)

 © Pharmaceutical Technical Services 2009