Design and Construction
of pharmaceutical facilities 

41 Duke Street, Edinburgh, EH6 8HH, United Kingdom

Spectrum can prepare various documents like:

Validation Protocol Preparation & Execution:
  • Validation Master Plan
  • IQ protocols for all types of Equipment
  • OQ Protocols
  • OQ Protocols
  • Conducting Process Validation at your site
  • Purified Water Validation Protocol & Validation

Qualification and Validation

Qualification and Validation are integral steps in building quality into any facility. Spectrum with an experience for over a decade and a half provides an efficient and effective documentation system that meets the requirements of International Regulatory authorities.

Qualification and Validation

In addition, Spectrum can also prepare the following documents and conduct training programs as detailed further.

Documentation as per ICH / Orange guide:

  • Quality Assurance Procedures
  • Quality Control Procedures
  • Raw Material Specifications
  • Finished Product specifications
  • Packaging Material specifications
  • Equipment Cleaning Procedures
  • Manufacturing batch records
  • In process Test specifications
  • Stability Protocols

Regulatory:

  • Drugs Master File in CTD format
  • Site Master file as per PIC/s & Local FDA requirement.
  • Liaison with FDA for drug License
  • Schedule ‘M’ Requirements & documentation for compliance to Indian FDA’s norms

Training Programs on:

  • Standard Operating Procedures –QA/QC/Manufacturing /Maintenance
  • On the job Training for QA/QC/Shop floor employees
  • Process Validation
  • Installation Qualification
  • Operational Qualification Method Validation
  • Facility Qualification
  • Facility Qualification
  • urrent Good Manufacturing Practices
  • Good laboratory Practices
  • How to prepare & FACE Regulatory audits
  • WHO guideline
  • OST Improvement Projects
  • Technology Transfer
  • Statistical Process Control