GUIDELINES FOR THE PREPARATION OF PRODUCT DESIGN DOSSIER
Product Design Dossier Constitute a Chronological account of product design.
A typical product design dossiers will contain the following: -
- Design & Development Planning: - Planning will include-
- Stages in design and development.
- Design reviews i.e stages of development when a review would be carried out (to be pre decided).
- Verification activities.
- Validation activities.
- Design transfer activities.
- Responsibility- A matrix indicating the person / function responsible for design activities.
- Design & Development Inputs: - This may include the following –
- Functional, performance & safety requirements.
- Applicable statutory & regulatory requirements.
- Information derived from previous similar design where available.
- Any other input essential for the design.
- Risk analysis of product design.
- Design output: - This should be in a form that enables verification against – the design & development input. This includes –
- Product drawings – draft & final drawings
- Prototype or Module – where applicable.
- Details of material.
- Review of prototype test / performance results (FMEA may be applied).
- Product specification and formulation.
- Draft, product structure, such as a module outline, technical description etc.
- Quality specifications – test of method & equipments.
- Details of design reviews i.e initial, Intermediate.
- Clinical evaluation, if required.
- Pre production validation – This may include as appropriate:
a. Equipment and tooling validation.
b. Material validation
c. Toxicology / Biocompatibility test data.
d. Raw material & supplier validation.
e. Stability studies as applicable.
f. Final design review to be carried out when all design and validation is complete.
- Design verification data: - Evaluation of product against specification.
- Design validation data: - This is to ensure that the final product is capable of meeting the requirements for the intended use – This includes results of clinical evaluation / evaluation of performance of the product.