If you are reading this blog you may also be familiar with Medical Device and Life Sciences specific acronyms for example IQ, OQ, and PQ. For those who are new to the very specific world of Life Sciences, we’ll try to debunk the myths around some of the terminology.

So what is meant by IQ, OQ, and PQ? They are terms that fall under the category of validation and verification.

IQ stands for “Installation Qualification”. The IQ records the installation of the software, and ensures that the installation follows the correct steps.

OQ stands for “Operational Qualification”. The OQ tests or qualifies that the solution is working using test data in general. This maps across to the requirements stated in the Functional Specification, and ensures the product or application meets all the predetermined requirements as stated.

PQ stands for “Performance Qualification” which means that the application, under real life conditions, consistently produces products which meet all predetermined requirements. The PQ is the final test before production (potentially the most important test document you will ever run), testing that the solution works fully in the live environment using live data, and should be based back on a workflow model from your User Requirements Specification.

On top of the IQ/OQ/PQ, you should ensure that you have other key documents including The Validation Master. This will form the detail and coverage of the documentation that you need.

Last thought for the day is that validation requires documented evidence, if the validation process is not documented then it cannot be proven to have occurred. Put another way, your regulatory body will view your validation process as solely a ‘rumour’.

Go online: http://www.pharmaserialisation.com/Prisym
Call: +44 (0)207 368 9300
Email: enquire@iqpc.co.uk

Why is it Important?

The HDMA aims to protect patient safety and access to medicines through the safe and efficient distribution of healthcare products and services. It creates and exchanges industry knowledge and best practices to enhance the value of the healthcare supply chain. The HDMA is an advocate for standards, public policies and business processes that produce safe, innovative and cost-effective healthcare solutions.

Who is it Relevant to?

The HDMA is relevant to any organization working in or supplying products to the US for health and human services. Where can I find out more about the FDA?

Visit http://www.healthcaredistribution.org/ for more information.

How can PRISYM ID Help?

PRISYM Enterprise labeling software is purpose design labeling solution for industrial organizations developed to meet various labeling compliance requirements, helping aid the distribution process. PRISYM Enterprise is supplied with auditable security protocols and lifecycle documentation based on the GAMP V Model.

Available both as a thin or thick client, PRISYM Enterprise is a secure labeling solution which allows you to design, review, approve, print, reprint and reconcile your labels. It can also simply link to ERP and MRP systems to ensure that information from production can be delivered to the label at time of print.

HIBC (Health Industry Bar Code) was created in 1983 as a way to track data via bar codes and has been the method of choice for creating barcodes and tracking medical and pharmaceutical products for many years. Healthcare products need to be treated differently than consumer products since human safety requirements apply and they are monitored by the government. Labels for patient use must be error-free, and must contain specific, required information. HIBC meets the unique needs of the healthcare and medical manufacturing industries.

GS1 is an international, non-profit association that develops and implements global standards and solutions to improve supply chain management for all sectors. GS1 developed GTIN, or Global Trade Item Number, as the unique identification number on a product. GTIN ensures that every variation of a product is allocated a single reference number that is globally unique. Another GS1 identification number, GLN or Global Location Number, identifies physical locations, such as place of departure, place of delivery, and point of storage, adding security and sustainability which is so important when dealing with pharmaceuticals and medical devices.

While HIBC focuses on the healthcare industry, the GS1 standards are used across many different industries, including retail, healthcare, transport and logistics, consumer electronics, defense and collaboration.

Most in the healthcare industry agree that having two different barcoding systems is not efficient, but the more difficult task is selecting one option as the standard. The Association for Healthcare Resource and Materials Management supports GS1 and is asking for the industry to implement its Global Location Number standards by December 31, 2010 and the Global Trade Item Number by December 31, 2012. The FDA has not backed either option, but has concentrated more on the concept of developing a Unique Device Identification (UDI) system for pharmaceuticals and medical devices.

Do you support HIBC or the GS1 standards? What are your thoughts?

Essentially, ECHA have interpreted ‘already placed on the market’ within Article 61 (4) as it having been supplied by the organization to the next company in the supply chain. If your product is still in your warehouse or similar, it has not already been placed on the market. If it has not already been placed on the market then the product does not benefit from the 2 year extension.

The CHCS published the following ECHA draft

‘Further, regarding the transitional provision of Article 61 (4) of CLP the concept “already placed on the market” should not be interpreted restrictively: substances/mixtures should benefit from the transitional arrangements regarding the re-labelling and re-packaging obligation independently of the fact that they may have been placed either on the shelves or in a store or in a warehouse. However, substances or mixtures manufactured before 1/12/2010 and stored in the manufacturer’s or formulator’s warehouse after 1/12/2010 should not benefit from the transitional arrangements provided for in Article 61 (4) (this does not amount to placing on the market within the meaning of Articles 2 (18) and 61 (4) of CLP)’

This is a change to the way the CHCS, HSE and most instructors/consultants have been approaching this Article. If you are planning on using this derogation, you must read 61 (4) with this interpretation in mind.

It aims to ensure that the information on physical hazards and toxicity from chemicals is available in order to enhance the protection of human health and the environment during the handling, transportation and use of these chemicals. The GHS also provides a basis for harmonization of rules and regulations on chemicals at national, regional and worldwide level, an important factor also for trade facilitation.

Why is it Important?

All over the world there are different laws on how to identify the hazardous properties of chemicals (called ‘classification’) and how information about these hazards is then passed to users (through labeling and safety data sheets for workers).

This can be confusing because the same chemical can have different hazard descriptions in different countries. For example, a chemical could be labelled as ‘toxic’ in one country, but not in another. Therefore UN has brought together experts from different countries to create the Globally Harmonized System of Classification and Labeling of Chemicals (GHS).

The aim of the GHS is to have one worldwide standard for:

• The criteria for classifying chemicals according to their health, environmental and physical hazards
• Hazard communication requirements for labelling and safety data sheets.

Who is it Relevant to?

GHS is relevant to any organization supplying products or working in chemical manufacturing and distribution.

Where can I find out more about the GHS?  Visit www.unece.org/trans for more information.

How can PRISYM ID Help?

PRISYM Chemica Labeling Software offers manufacturers and distributors a single solution to meet their packaging and chemical labeling requirements. PRISYM Chemica is a simple to use, label design application which allows you to place the required symbols/ pictograms, text, branding and codes onto your labels in compliance with chemical industry regulations including CHIP4 and CLP.

It enables the management of chemical classifications and automates the production of labels and transit cards in multiple languages.