Our Services

Computer System Validation

Tamprature mapping

Automation

Quality Policy
Validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality attributes.
Computer System Validation / PLC Validation is becoming Very Essential / Mandatory for the Life Science Companies as Current GAMP 5 Regulation are becoming very Stringent.
It is now a big challenge for Pharmaceutical Companies to Install & Maintain fully Automatic Systems for different stages of Production in a Fully Compliant Manner. Here we can support you with our Vast
Experience in this field. We validate your Systems in Cost Effective Manner to ensure all Predicate Rules are satisfied with Proper Documentation of Complete Activity.
Temperature mapping is the process of mapping the differences and changes in temperature that occur within a single temperature controlled system due to influences like opening doors, proximity to cooling fans, personnel movement, and the quantity of products being stored at any given time.
An initial temperature mapping exercise should be carried out on the storage area before use, under representative conditions. Temperature monitoring equipment should be located according to the results of the mapping exercise, ensuring that monitoring devices are positioned in the areas that experience the extremes of fluctuations.
The mapping exercise should be repeated according to the results of a risk assessment exercise or whenever significant modifications are made to the facility or the temperature controlling equipment.
For small premises of a few square meters which are at room temperature, an assessment of potential risks (e.g. heaters) should be conducted and temperature monitors placed accordingly”.
It has become apparent during inspections that some companies are unclear as to what is expected of them to comply with this requirement in the GDP Guidelines.
This seems particularly apparent with new applicants and those companies with small storage areas, possibly a few shelves or small refrigerators, to which this blog is particularly aimed.
Some larger storage areas may employ the expertise of a third party company specialising in this area. Guidelines say that mapping should take place, but it does not state how this should be done.
When to map:
If possible, before stock is stored.
This might not be possible where a storage area is being reconfigured.
In smaller empty storage areas, dummy products could be used to simulate normal operational storage without compromising genuine product, including cold stores and fridges/freezers.
In an empty storage area, a mapping exercise should be repeated when fully stocked.
Data arising from the exercise should be documented and a risk assessment documented with any hot or cold spots identified. This exercise should then be repeated to take into account seasonal variations.
Precision Technologies has been started with enthusiastic, dynamic and innovative team to serve world class solution in the field of industrial automation, which consist of design, installation & commissioning of automation projects like PLC/SCADA.
We are the Service provider for PLC Programming Allen Bradley, Mitsubishi, Siemens, Delta. We are undertaking the project of Automation for Installation & Commissioning including all pneumatic assembly, Field wiring, Design & trials at customer end.
We are also manufacturer of PLC panels, MCC panels, PDB panels etc.
We at PRECISION TECHNOLOGIES are committed to provide full satisfaction to our customers with respect to Quality, Reliability and Delivery and attain Quality Leadership for all the services and products offered by us.
Establishing a Quality management system conforming to International standards.
Institutionalising a culture of “Getting it Right, first Attempt”, Service with commitment, dedication and team work
Continuous up gradation of technology, knowledge and skills of our employees to meet expectations of customers.
Planned and structured Training and Development Programmes for all employees.
Creating an environment which encourages team effort and where each individual’s contribution is recognized and valued.