Have Questions? Contact Us Today
 

Validation Services

Pharmatech has established a history of excellence in terms of validation services. We assist clients with the design, development, implementation and administration of validation programs within their own organization. We help clients develop systems, which are appropriate for each stage of development and establish a validation structure that will grow with our clients’ organization, prevent bad decision-making, and ensure that quality is designed into all product development activities.

METHODOLOGY
Of greater value than the expertise of a single individual, Pharmatech Associates offers the advantage of services that are methodology driven, based on a documented, structured and analytical procedural map that evolves over time in response to regulatory, scientific and business conditions. Constantly tested and upgraded, Pharmatech’s methodology ensures a common defined practice, specific vocabulary and consistent results.

Pharmatech’s validation services encompass all aspects of product, process, packaging, facility, equipment and personnel validation required in the regulated life-science industries. Our approach to developing, implementing and administrating a validation program begins by setting out a clear hierarchy between policies, procedures and protocols, to design a program that is effective, supportable and manageable.

Areas of expertise include biotechnology and cellular-based processing, biopharmaceutical manufacturing, bulk and aseptic fill/finish, active pharmaceutical ingredient (API) production, oral, liquid and semi-solid drug manufacturing, pulmonary and transdermal drug-delivery systems, human medical diagnostics and medical device operations. Pharmatech retains industry-recognized experts in the field of computer validation and Part 11 compliance and sterile biologics manufacturing.

Validation services include:

Protocol and Master Plan Development

  • Validation Master Plans - Cleaning, Process, Equipment, Facility
  • Facility Basis of Design
  • Control System/Computerized System Validation Protocols
  • User Requirement Specifications
  • Functional Requirements Specifications
  • Design Qualification Protocols
  • Construction Qualification Protocols
  • Turn-Over-Package Preparation
  • Equipment/System Commissioning Protocols
  • Equipment FAT and SAT Protocols
  • Equipment Qualification (IQ, OQ and PQ) Protocols
  • Facility Qualification Protocols
  • Process Characterization Protocols
  • Process Validation Protocols
BACK TO TOP

Laboratory Systems Validation

Pharmatech personnel have significant experience with establishing GLP systems and the validation of analytical and quality control systems.

Services include:

  • Analytical Equipment Qualification - Systems experience includes, small molecule and macro-molecule appropriate analytical systems, e.g. PCR stations, spectrophotometers, thermocyclers, HPLC’s, etc.
  • Laboratory Information Systems
  • Stability Database Systems
BACK TO TOP

Risk Assessment and FMEA

Pharmatech can lead your organization through a risk assessment as it is defined in GAMP4 to identify issues which could compromise the success of your project or pose a risk to your business or financial goals. The same methodology can be applied to technical issues via a Failure Mode and Effects Analysis which can be used to identify technical risks that could jeopardize your projects success.

BACK TO TOP

Computerized System Validation

Pharmatech’s broad background in the validation of computerized and database management systems allows us to offer the following specific areas of service:

  • The application of GAMP4 guidelines to automated systems
  • Application of CFR 211, Part 11 and Electronic Records and Signatures Validation

Validation of the following systems:

  • MRP II, ERP and Training Management Systems
  • PLC’s-Allen-Bradley, Siemens, GE
  • Motion Controllers
  • Vision Systems-Acuity, Cognex
  • SCADA Systems-RS Batch, WonderWare, FIX DMACS
  • SQL and Oracle Databases
  • Ethernet Networks
  • Industrial PC’s

BACK TO TOP

Raw Material Qualification

Pharmatech provides clients with a program to qualify primary and secondary API and raw material suppliers including the generation of stability testing protocols.

BACK TO TOP

Packaging Validation

Pharmatech assists clients in the design and qualification of shippers for domestic and international shipping. Qualification activities can be applied to both clinical and commercial supplies. Specific services include:

  • API and finished goods shipper design and pricing
  • Shock and vibration testing
  • Temperature testing
  • Validation protocol generation and final report
BACK TO TOP

Construction Management and Facility Validation
Pharmatech provides project coordination and management assistance for pharmaceutical and biopharmaceutical construction programs. We work with our clients to deliver a facility that is both on time and on budget. This service can be combined with our facility validation capabilities and provide our clients with the confidence they need that their project will meet their strategic and business objectives.

BACK TO TOP