WHY USE
STRATEGNOS FOR YOUR
VALIDATION & QUALIFICATION?

We manage the entire process from start to finish and provide an audit-ready validation/ qualification protocol and report with all supporting evidence, working with our Clients to show the desired parameters have been achieved.

 

FEELING RELIEVED ALREADY? IT GETS EVEN BETTER.
WE VALIDATE JUST ABOUT EVERYTHING
Validation of processes according to WHO, SAHPRA, MCC and PDA guidelines and requirements, GAMP, FDA, CFR 21 and company defined procedures

 

Equipment and facilities such as:
Processes and systems, including:
  • warehouses
  • fridges
  • cold rooms
  • freezer rooms
  • freezers

 

  • ultra-low freezers
  • vehicles
  • hot tunnels
  • stability chambers
  • incubators
  • autoclares
  • Insulated containers
  • vaccine carriers
  • PQS testing and PQ testing of containers and cold chain boxes

 

  • IT systems and temperature and humidity monitoring systems
  • ERP systems
  • BMS systems

REGULATORY OVERVIEW

SAHPRA

South African Health Products Regulatory Authority
Good Wholesale Practice for Wholesalers – 2016

SAPC

South African Pharmacy Council
Good Pharmacy Practice – 2017
Num-01

11.4.1. The following should be validated as a minimum: (a) Warehouse premises: ambient and cold-chain storage conditions including temperature mapping; (b) Lagged containers; (c) Cold-chain processes;  (d) Computerised systems; and (e) Transportation systems

2.3.5.4. (a) Packaging system of thermolabile pharmaceutical products, for purposes of distribution must be quality assured to ensure that it occurs within the cold room environment, fulfils the manufacturers’ specifications requirements, is thermally designed and validated, and is related to Temperature Profile(s)/Logistic history.

COMPLIANCE IS A JOURNEY.

Let us be your partner to ensure cost effective, consistent adherence to compliance requirements.