Contractual Agreement to meet Requirements EMA Chapter 7
On 19th April 2018, the European Medicines Agency issued a revised copy of their "Questions and answers on implementation of risk-based prevention of cross-contamination in production and ‘Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’ (EMA/CHMP/CVMP/SWP/169430/2012)" hereafter, known as "the guidance." Of particular interest in the guidance is Q4.
Q4 of the guidance indicates the following:
In response to this section of the guidance, Affygility Solutions provides the following:
While this statement, appears to be targeting "technical experts" that are contractors; unfortunately, there is a lot of context surrounding this statement that is missing from the EMA Q&A document. This includes that there must be appropriate documentation to support the qualifications of the person performing the HBEL assessment, no matter if they are internal to the pharmaceutical company or an external contractor.
Can Affygility Solutions provide a template assessment to the client to demonstrate that Affygility Solutions is a qualified contractors?
Affygility Solutions personnel are experts in the field of occupational toxicology and industrial hygiene. All personnel involved in the authoring of OEL Fastrac monographs have advanced degrees, and have been extensively trained in the determination of health-based exposure limits. All supervising staff have decades of direct pharmaceutical industry experience. Affygility Solutions can provide your company with a template contractor qualification assessment form, along with the appropriate documentation (CVs)
Can Affygility Solutions enter into a contractual agreement as a "qualified contractor" as required by EMA's Chapter 7 requirements?
Answer: Yes. Affygility Solutions can provide either a template technical agreement for your use or you can send us your standard contractor qualification agreement. Please contact pburke@affygility.com for additional information.
Periodical review.
In addition to providing expert personnel in the field of occupational toxicology and industrial hygiene to author the original monograph, Affygility Solutions has developed technology to scan publicly available scientific databases for relevant changes and alerts. If Affygility Solutions receives an alert, either from these databases or from customers, that the underlying data for an existing monograph has changed, and such, that it will materially impact the OEL or ADE, Affygility Solutions will update the monograph.