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This phase includes the following activities:
> Pre-formulation development: component/s is/are selected in terms of physical, chemical characteristics in order to
identify the best ones for the defined purpose.
> Formulation design: APR is able to set up a range of hypothetical formulations to achieve the requested characteristics
in terms of release, stability and performance of the device. Generally, several possible formulations, showing different
features, are taken into account during this phase .
> Prototypes development: the APR background, together with the continuous research of innovation, permits to find out
the best formulations for the intended purpose. The preparation method is set up on the laboratory equipment, with an
eye to the future scale up: in this way, only minor modifications are generally necessary after the technological transfer.
All the phases are maintained under control also regarding the analytical aspect: in-process control are managed by the
GMP analytical laboratory which is at its complete service for a continuous analytical support.
> Preliminary stability study: a preliminary stability study in stressed and/or ICH storage conditions can be performed on
several prototypes, as additional information for the selection of the formulation/s able to achieve the big laboratory
batch/es production. Performances, aspect and degradation are simultaneously evaluated during the study. The
conditions to be satisfied to successful pass the preliminary evaluations are defined case by case, depending on product
type , formulation characteristics. and particular customers' requests. In this phase, the analytical methods are set up
and , in some case, validated according to our internal procedures.
> Microbiological analysis: Microbial contamination of topical medical device products is a matter of great importance.
Water and several ingreients of the device can promote the growing of microorganisms which often cause organoleptic
alterations (offensive odours, changes in viscosity and colour...) or, in some case, the formation of substances potentially
hazardous for the consumer. In order to detect this risk a pool of tests are carried out according to pharmacopoeias and
official specific guidelines during all the estimated shelf life taking into account also the consumer use as source of
contamination.
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This phase foreseen the following activities:
> Manufacturing of big-laboratory batch/es: the formulations selected for their performances are manufactured as big
laboratory batches
> Manufacturing of big-laboratory batch/es: the formulation/s selected for its/their performances is/are manufactured as
big laboratory batch/es
> Biological evaluation: a biological evaluation is performed on the big laboratory batch/es in order to exclude any
potential hazardous effect on the body; all the tests have to demonstrate that the benefits brought by the device exceed
the potential risks linked with components device.
> Production of industrial batch for a clinical purpose: on the base of the stability results , winner prototype/s, is/are
selected for the industrial production using a network of authorized partners or the one selected by the costumer. On the
industrial batch stored in the selected packaging material , a stability study according to the ICH conditions is usually
performed. This batch can be used for clinical studies
The manufacturer has to demonstrate that the intended purposes claimed for the medical device are achieved. The
efficacy of the product is tested and objectively demonstrated by suitable protocols designed by APR. The new Directive
2007/47/EC requests to provide clinical data to support the product conformity to the safety and performance
requirements by an evaluation (Clinical Evaluation) of the side effects and the acceptability of the risk benefit ratio
derived from the use of the device in normal conditions. This Clinical Evaluation for each developed product, based on
literature or on clinical investigations is provided by APR.
APR is able to prepare a complete Dossier for the submission to the Notify Body for obtaining the CE mark. This Dossier
has to be reviewed and implemented only regarding the chapters related to the Manufacturer [as defined by 93/42/EEC
Directive and relative amendments] in order to obtain the Technical Documentation as required by the Directive 93/42/
EEC and related amendments.
The dossier contains also the following documents:
> Conformity to the essential requirements: the manufacturer demonstrates the conformity of a medical device to the
essential requirements by affixing the CE marking to each device. The essential requirements explain the aim of the
Medical Devices Act where they represent a set of criteria that must be fulfilled by a medical device to be freely traded on
the European internal market. The essential requirements give particular consideration to:
> the safety
> the technical performance and
> the medical performance of a medical device
APR prepares an essential requirements compliance checklist, ready to be reviewed and approved by the manufacturer.
Risk analysis management: is a structured tool for the evaluation of potential problems which could be met in the use
of a medical device. Risk analysis is routinely used during the design phase of the medical devices. APR prepares the
Risk Management File as a description of the activities proposed in order to evaluate and manage the risks associated to
the Medical Device in accordance to Harmonize Standards where applicable.
Important note: Customer Reports describing all the activities performed and related results are monthly
delivered, in this way our customers have always the project under control to face the GO/NO GO decision with
all the necessary information
