In case of both construction from scratch and restoration of an existing pharmaceuticals manufacturer, an essential condition for further construction is the design documentation that has been checked by regulatory assessment authorities and provided with statement of conformity (affirmative statement) from the relevant authorities.
A pharmaceuticals company designing is a complex comprehensive effort, during which, in addition to compliance with safety and health. documents, etc., it is necessary to follow Good manufacturing practices requirements to ensure further successful design qualification.
Active interaction with a Customer at the conceptual design stage allows to choose best possible solutions, which are later specified more precisely and detailed during preparation of the design documentation.
The design documentation includes detailed information about various characteristics of the facility.
The degree of the design documentation detailing is determined individually in each case depending on the Customer's requirements, but it always strictly adheres to the requirements of the Resolution of the Government of the Russian Federation No"On the composition of design documentation sections and requirements to their content" both in terms of composition and appearance of design documents.
The design documentation is the main design document, consisting of text and graphic parts.
The documents should contain reliable data on engineering and technical equipment, architectural and process solutions, as well as design features of a production facility.
Safety of structures, as well as its other operational and technical characteristics directly depend on the quality of the design documentation preparation.
- Section 1 "Explanatory note".
- Section 2 "Site space planning".
- Section 3 "Architectural solutions".
- Section 4 "Design, space and layout solutions".
- Section 5 "Information on engineering equipment, on utilities systems, list of engineering and technical measures, content of process solutions"
- a) subsection "Power supply system";
- b) subsection "Water supply system";
- c) subsection "Water disposal system";
- d) subsection "HVAC, heat supply networks";
- e) subsection "Communication networks";
- f) subsection "Gas supply system";
- g) subsection "Process solutions".
- Section 6 "Construction arrangement project".
- Section 7 "Project for demolition or dismantling of capital construction facilities".
- Section 8 "List of environmental protection measures".
- Section 9 "Fire safety activities".
- Section 10 "Measures to ensure the disabled people access".
- Section 11 "Capital construction facilities estimate".
- Section 12 "Other documentation in cases provided for by federal laws".
The design documentation scope is, as a rule, insufficient for facility construction: it lacks necessary specifications and required degree of detailing.
The design documentation contains only main technical solutions allowing to assess their safety, as well as to prove technical feasibility (and in some cases - economic feasibility) of an investment project implementation.
Detailed documentation is developed to implement the technical solutions built in the design documentation during construction.
