The Role and Responsibilities of the Responsible Pharmacist in Israel – The Israeli QP
Israeli legislation has been recently aligned with EU legislation with regards to GMP.
Thus it has become a legal requirement in Israel as within the European Union, that a Qualified Person (Responsible Pharmacist in Israel) is required to release every batch of medicinal products to the market, whether locally manufactured or imported.
In addition, the Responsible Pharmacist (QP) has responsibilities in other areas such as Clinical Trials (Phase III).
The purpose of this article is to provide an overview of the roles, responsibilities and activities of the QP over the product and its supply chain.
According to Israeli legislation, the Responsible Pharmacist (QP) has the ultimate power and responsibility to approve batch release of pharmaceuticals to the market. A personal liability is attached to this position. He may also reject and disqualify a batch. The position is defined as professionally independent.
In order to qualify as a Responsible Pharmacist, it is mandatory to be a licensed pharmacist with minimum of 2 years experience in a company that has been approved as importer/ manufacturer of pharmaceuticals. Responsible Pharmacist with MSc needs only 6 months of experience.
The nomination is granted by the Ministry of Health who may also demote him/ her from position should he/ she fail to comply or neglect his duties.
The nomination of a Responsible Pharmacist is contained in the Ministry of Health approavl of “Manufacturer/ Importer” license.
The leading governing laws are the Pharmacists Regulation (Good Manufacturing Practices) – 2008 and its updates and EU GMP guidelines – Eudralex volume 4 referenced and adopted by the Israeli Ministry of Health.
The Responsible Pharmacist’s main requirements and responsibilities:
- Be well acquainted with current Israeli Healthcare legislation, Ministry of Health regulations, guidelines, circulars and SOPs
- Be knowledgeable regarding Eudralex volume 4 – Good Manufacturing Practices guidelines
- Be knowledgeable regarding Quality Assurance, Batch release procedures, Batch records review, Annual product review, complaints and returns handling
- Must have access to registration dossier
- Approve / Reject a batch following review of batch records and transportation documents and assess for deviations or excursions implications
- Assure compliance of medicine with registration dossier and marketing authorization license terms
- Sign a Batch Certificate and advise of release to Ministry of Health
- Retain samples
- Establish communication and commitment to receive updates on manufacturing, specifications, analytical testing, limits etc. from the manufacturer, relevant QP or QA manager or officials or as the case may be
- Be informed of any change in the registration / marketing authorization license by the Appointed Pharmacist
Vaccines, blood products oror plasma derivatives, biologicals require approval of the Israeli Ministry.
The Israeli Ministry of Health emphasizes the importance of keeping public safety and allows only safe, efficacious and high quality drugs reach the market. The Responsible Pharmacist (QP) is a main gatekeeper.
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We also support establishing quality assurance system management, writing SOPs, audits, mock audits, quality and technical agreements.
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