cGMP can be defined as a series of state regulations in the United States, relating to the minimum requirements in methods, facilities and controls used in the manufacturing, processing and packaging processes of drugs, in order to ensure that these products are safe and contain the properties that have been declared. Its provisions are documented in the Code of Federal Regulations (CFR) of the FDA, there being the CFR 21 Part 820 that defines the requirements of a quality system to meet the requirements of the FDA.
Innovamed is certified in the ISO 13485 standard, which defines the requirements of a quality system for companies involved in at least one phase of the life cycle of a medical device (therefore the requirements of all processes involved) in order to guarantee the operation, safety and applicable regulatory compliance of the medical device. In other words, Innovamed's quality system contemplates the provisions of the cGMPs that apply to them in accordance with their requirements, which, apart from those that are redundant with those of the regulations, are determined by the clients with whom it works. Examples of Innovamed's compliance with applicable cGMPs are the qualification of its critical equipment or the limit levels in the microbiological monitoring of rooms.
The previous license of operation of medical devices facilities, according to the requirements of the royal decree of commercialization and placing on the market of medical devices, is granted by the Spanish Agency of Medicines and Medical Devices (AEMPS) to manufacturers, groups, importers, companies that sterilize third parties as well as manufacturers of custome made devices in the communities of Ceuta and Melilla, of medical devices (including IA, IVD and accessories among others). In the case of Innovamed, as it is a company that manufactures (or some of its phases) these types of products but for third parties and therefore does not market them in its own name, it is not required to hold this licence. Even so, Innovamed allows all types of audits and inspections by the AEMPS in relation to its clients in which the possession of such a license does apply.
In order to guarantee the compliance with the clients' requirements, Innovamed monitors several parameters within the Rooms to guarantee the conformity of all the products manufactured as well as the processes themselves. In addition to the annual monitoring of the Rooms according to the frequency established by ISO14644-1:2015, Innovamed carries out additional controls of the total number of particles as well as the number of viable particles (both in the environment and on the surface) every 15 days. In this way, it is possible to monitor the levels in which the room is located, as well as to identify situations that could generate adverse trends that could compromise the room specifications and be able to anticipate them.
Innovamed is currently finalizing the installation qualification (IQ) of the injection molding equipment for medical device components. The objective is to provide the opportunity for our customers to have the qualified injection equipment and thus be able to perform the subsequent process validation for any of their molds (OQ/PQ). In addition, we are also performing the qualification of equipment for post-injection phases or sterile barrier packaging (welding, blistering, etc).
With this, Innovamed intends to facilitate its customers the compliance with the requirements based on the applicable standards and regulations. If you have any questions, please contact Carlos Real, Quality Director, email@example.com or Albert Amselem, Sales Director, firstname.lastname@example.org, who will be pleased to provide you with any further information you may require.
Frequently, in the early stages of the development of new projects, potential customers ask us if producing in ISO-7 cleanroom is significantly more expensive than producing in "clean" rooms that do not comply with the UNE-EN ISO 14644-1 standard.
In our answer we try to restate the question and formulate it in terms that we understand help to clarify this doubt:
What differentiates the price between the offers of different injectors is not so much that they have Clean Room facilities, according to regulations, but also that they are additionally required to have ISO-13485 Certification. It is this Certification that requires the maintenance of a fixed structure that incorporates:
And it is here where the price differences lie, in the human and technical structure capable of ensuring the production stability, technical requirements and traceability necessary for the manufacture of a medical device. The manufacturing, in ISO-7 clean room, is part of Innovamed's commitment to offer the best service and the highest quality to the products manufactured in our facilities.
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