Submit a Sample - Life Sciences

It is the client’s responsibility to specify the intended use of the testing data. The Quality Management System (QMS) at Pace® is designed to be compliant with current Good Manufacturing Practices (cGMP), but also provides exceptions for services intended to support Research & Development (R&D) and other early-phase development services. The Analysis Request Form (ARF), to be accompanied with all sample submissions, includes options to designate testing for either cGMP or non-GMP purposes. Failure to properly identify the intended use of the data may result in testing delays.

Pace^® provides research and development, analytical laboratory testing, and related support services from several laboratory locations. Four (4) of these laboratory sites are currently registered with the United States Food and Drug Administration (US FDA) as Drug Establishments (https://www.fda.gov/drugs/drug-approvals-and-databases/drug-establishments-current-registration-site-decrs)

The Quality Management System (QMS) in place in these four locations provides the governing framework for all services to be compliant with current Good Manufacturing Practices (cGMP). The standard deliverable services are generally commensurate to expectations appropriate to support materials and products filed with the US FDA and intended for human administration in a clinical phase of development or marketed as commercially available therapeutics.

The QMS provides an exception for services from Oakdale, MN, laboratory site intended to support Research & Development (R&D) and other early-phase development and/or investigational services via a series of Development Standard Operating Procedures (D-series SOPs). Materials and/or products in early development phase, not yet intended for human administration and not yet filed with the US FDA as an Investigational New Drug (pre-IND) may be handled in a modified manner, as described in this series of procedures. The D-series SOPs modify the standard QMS obligations, for example: 1) quality assurance review of all activity records and reports may be replaced by technical peer review, 2) reduced documentation requirements, 3) compulsory investigations of suspect results when a formal specification or other documentation of an expectation result is not available, and 4) increased flexibility to handle Deviations (DEV) and Investigations (LIR).

Good documentation practices are applicable to all quality and technical records at Pace^® Life Sciences (Pace^®). Good documentation practices are key to ensuring data integrity and are a fundamental part of the Pace^® Quality Management System. This SOP addresses the key concepts of GDocP, including, but not limited to, assuring that data is attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, available, and traceable (ALCOA++).

Pace^® recognizes that the level of GMP compliance required early in a project’s life cycle (e.g., development and feasibility, preclinical, phase I/II, and non-commercial testing) is not as stringent as the requirements for late-phase and commercial product testing, allowing for a degree of flexibility in documentation and controls. This understanding is referred to as phase-appropriate GMP and is a risk-based approach, meaning that the level of GMP controls and documentation should be proportionate to the potential risks associated with the product and its manufacturing or laboratory testing at each phase.

The R&D classification includes basic research, method development and redevelopment, method feasibility testing, and similar activities. Activities performed under R&D are streamlined to avoid overburdening technical and quality resources in a relatively low-risk environment.

The Early-Phase (EP) classification includes testing and validation activities for pre-clinical, phase I/II, and non-commercial materials using test methods that may be in various states of validation.

The decision to classify laboratory activities as R&D or EP should be made in conjunction with the client to ensure that the services provided meet client expectations and the phase-appropriate regulatory requirements. Client projects in phase IIb and III should only be classified as EP in certain situations and with careful consideration since these phases typically involve data that will be submitted to regulatory agencies.

If a client provides confirmation that a scope of services is intended to support pre-IND materials/products and application of the D-series SOPs is appropriate this may be designated within the written work instruction.