info@pharmaproject.in     +(91)-22-25002610 / 11

India’s leading Pharma Project Consultants

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ABOUT US


Quality policy :-

Pro-pack Technologies Pvt. Ltd. perceives that the disciplines of Quality, wellbeing and security ecological management are an integral part of its management work. The Company sees these as an essential duty and to be the way to great business in adopting proper quality Standards. Pharma Project company Quality policy calls for continuous improvement in its Quality administration activities and business will be conducted according to the principle.


Standard :-

The Company follows International standards, codes and norms for sterile liquid processing system as a primary requirement of cGMP practice.

  • GMP standard :- USFDA, WHO, cGMP, EHEDG, FDA, ASME, A3, ISPE Baseline ISO-14159
  • Mechanical Standards

Vessels: ASME Sec. VIII Div. 1, AD-Merkblatt, ASME BPE Heat exchanger: TEMA.

  • European Nations standards for CE Making :-

Safety standards:- DS/EN 1050
Hygienic Design:-B3 EN 1672-2

  • Qualification document and execution standards :- ISPE Baseline Vol 5
  • Equipment layout standards :- ISPE Baseline Vol 3
  • Piping standards :-

(BPE)/ SA 270
Utility: ANSI B 31.3

  • Automation standards :- GAMP 5 & 21CFR Part 11

Documentation :-

Pro-pack highly works on the bases on documentation stage for the managing Quality standards system we provide product through various stages of qualification like

  • Design Qualification (DQ)
  • Operation Qualification(OQ)
  • Installation Qualification(IQ)
  • Performance Qualification (PQ)
  • Testing
  • Quality control
  • Certification
  • Working safety
  • Maintenance plan

Pharmaceuticals:-

Pro-Pack PVT. Ltd. as aCertificate Company

  • Material Test Certificates
  • Food Grade Certificate for all Elastomers
  • Organ Purity Certificate
  • Orbital Welding parameters
  • P&ID
  • Welder qualification Certificate
  • Borescoping photographs
  • Radiographic Test Documents
  • Calibration certificates For all industries
  • GA drawing

OUR PRODUCT

 

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