When the time comes to have your drug developed, it can be difficult to navigate through the different existing statuses. It is therefore good to know the pharmaceutical responsibilities meanings of each in order to choose.
Pharmaceutical responsibility is a key point to clarify with your contract manufacturer especially that batch recall, major deviation are situations where the Responsible Pharmacist faces its responsibility. Between the marketing authorization holder, the owner and the manufacturer, it is often difficult to find out what is the pharmaceutical responsibility of each entity. The information below will guide you in the roles and responsibilities of each when activities are outsourced.
The outsourced activities must first be well defined and controlled so that the pharmaceutical responsibilities of each are clearly established. A contract between the client and the subcontractor clearly establishes the obligations of each party.
In the case where the subcontractor is considered as manufacturer then the company must have one or more qualified persons with Pharmaceutical Responsibility to ensure that each individual batch has been manufactured and tested in compliance with the in force regulation. The manufacturing activity includes the purchase of raw materials and packaging items to the release of batches as well as storage operations.
The owner engages itself in the exploitation of the drugs by having the pharmaceutical responsibility of the whole seller sales or of free cession, of publicity, information, pharmacovigilance, follow-up of batches and recall, corresponding storage operations where appropriate.
The owner is usually the marketing authorization holder. It can also operate on behalf of a holder in this case it is 2 different companies or organizations. The owner and the holder may also co-operate a marketing authorization, but in this case the responsibilities, including the pharmaceutical responsibilities of each, must be clearly identified and each entity is responsible for one or more categories of operations.
Regarding batch tracking, as discussed above, the owner has the pharmaceutical responsibility to set up internal procedures and a strong organization to ensure batch tracking rules compliance, traceability, batch recall and quality claims management. The contractor is very aware of these procedures! It already applies them on behalf of other owners and includes a service of experts specialized in the management of these high pharmaceutical responsibility subjects. If the holder and owner are two different entities, the pharmaceutical liability of the owner’s RP must be expressed in a specification binding the owner and the holder. However in all cases the owner’s RP remains the sole final decision-maker in the batch recall process.
The owner is also required to report all suspected serious or non-serious adverse reactions. In the event of a breach to this declaration, the owner is liable to heavy penalties such as jailing and penalties.
The owner periodically asks his subcontractor for feedback of PV cases that have been directly addressed to him. The subcontractor having the structure for this type of registration easily finds the information to be provided. Once the information has been transmitted to the owner, it is compiled into a Periodic Safety Update Report (PSUR) for transmission to the EMA.