USFDA

ISPE

MHRA

WHO

PIC/S

QC

USFDA

ISPE

MHRA

WHO

PIC/S

QC

USFDA

ISPE

MHRA

WHO

PIC/S

QC

USFDA

ISPE

MHRA

WHO

PIC/S

QC

USFDA

ISPE

MHRA

WHO

PIC/S

QC

USFDA

ISPE

MHRA

WHO

PIC/S

QC

  • From Idea to Conceptualization

Engineering Consultancy

Engineering is one of the key services of Pharma Access where we design the greenfield Pharmaceutical plant considering relevant guidelines and local regulations of the country. Our expertise ranges from designing various facilities over past two decades with a holistic approach for future readiness and expansion.

The three steps that we undertake under our consultancy services are:

  • Feasibility studies – Identification of growth drug segments, business plan and sales forecast
  • Conceptualizing the idea of producing required number of medicines from a given stretch of land
  • Basic and detailed engineering studies resulting in good for construction drawings (including 3D drawings) with required BoQ for tendering

The facility is designed to support Manufacturing process with respect to sustainability, output, compliance, regulations, and market ready supply chain facility. Our subject matter experts and pharmaceutical process consultant focus on efficient and functional layouts that provides least Operational expense per square foot of plant operation. Risk factors like contamination, intermixing of products, machine breakdown services, waste disposal, gas exhaustion etc. are all considered carefully as per relevant cGMP standards.

A detailed plan of action including Project execution schedule and Validation Master Plan is put in place prior to execution so to have right visibility in supply chain as well as site preparedness. All these activities are performed inhouse and hence a better control is ensured. We consider ourselves as stakeholders of the project and hence our team puts all the effort in designing it right having considered following factors:

  • Pharmaceutical Process engineering knowledge by Pharmaceutical Process consultant and experts
  • Capital expenditure in the initial phase of the plant
  • Operational expenditure during day to day plant running
  • Energy efficient systems
  • GMP compliance
  • Lean and agile operations feasibility
  • Faster implementation
  • Geographical considerations of Environment and surroundings
  • Sustainability and Environmental conservation
  • Future expansion

The engineering deliverables shall include P&ID, 3D drawings, good for construction drawings, BoQs with detailed specifications, GAP assessment, Site planning, execution strategy, storage plan, and validation plan.

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