Recognizing Excellence in the U.S. Supply Chain
HDA recently launched its Good Distribution Practices (GDP) Accreditation Program, a first of its kind in the United States, through the Pharmaceutical Cargo Security Coalition (PCSC). ASC Associates Ltd, a European-based firm with extensive experience developing and implementing GDP training programs consistent with European standards worldwide, will help administer the program.
GDP is an important standard of processes that ensure the quality and integrity of medical products within the pharmaceutical supply chain. The GDP Accreditation Program seeks to provide pharmaceutical supply chain trading partners, primarily those providing vendor services — such as transportation, warehousing, freight-forwarding, customs brokerage, 3PL and cargo insurance — the ability to demonstrate familiarization and adherence to recognized GDP operational and training criteria. Complying with these standards can help mitigate distribution deviations.
Process for Earning GDP Accreditation
Reviews and Assessment
Companies may apply to the program, and if accepted, applicants will undergo an assessment process using a set of standards, including those of the European Medicines Agency.
A review of a company’s existing supply chain security criteria and those developed and endorsed through PCSC will also be offered. The process will go through current protocols, on-site assessments and several different levels of training.
There are three phases to the required training for a business entity to obtain accreditation. They are:
- GDP Introductory Training (1 hour, conducted virtually)
- GDP Awareness Training (6 hours, conducted virtually over a one- or two-day period)
- GDP Responsible Person Training (12 hours, conducted in person over two days)
At least two individuals from each business entity that has applied for accreditation must be trained in all three program phases. It is recommended that more than two individuals receive GDP Introductory Training.
Introductory and Awareness Training are conducted virtually, while Responsible Person Training, due to its intensity level, is conducted in person over two days in groups (preferably no larger than 12 individuals per group).
Responsible Person training will be offered quarterly at a site of the HDA’s choosing.
Due to the generic nature of this training, multiple companies can be trained in the same session.
Certification
Upon successful completion of the assessment and training process, an accreditation standing will be awarded by HDA and valid for two years, with an option for renewal. A reference library will also be made available to participants in the program to allow them to remain current in GDP initiatives.