#traceabilitysoftwareinchennai

To make it easier to track and trace items along the supply chain, the Indian government has made it mandatory for Active Pharmaceutical Ingredients (APIs) that are produced in India or imported & distributed to have QR codes. The new regulation will go into force on January 1st, 2023.

When teamed with the appropriate individuals who are specialists in barcoding technology and comprehend the pharmaceutical sector, QR codes on API container labels are an easy and cost-effective option that may be readily applied. The advantages are substantial, particularly the huge influence it will have on strengthening the security of the supply chain in the Indian pharmaceutical business.

This post will give a general overview of how to implement.

What are QR codes? What is the government Mandate?

QR codes or Quick Response codes are 2D barcodes that can contain information about the product and can be scanned at any point to retrieve the information for verification.

The Gazette notification issue by the MOHFW, dated 18th January 2022, mentions

“(5) Every active pharmaceutical ingredient (bulk drug) manufactured or imported in India shall bear Quick Response code on its label at each level packaging that store data or information readable with software application to facilitate tracking and tracing. The stored data or information shall include the following minimum particulars, namely: 

(i) Unique product identification code, (ii) Name of the API, (iii) Brand name (if any), (iv) Name and address of the manufacturer, (v) Batch no., (vi) Batch size, (vii) Date of manufacturing, (viii) Date of expiry or retesting, (ix) Serial shipping container code, (x) Manufacturing licence no. or import licence no. (xi) Special storage conditions required (if any).”

 Implementation of QR code in API Labels, what you need to know

 GS1 Company Prefix

 A GS1 Company prefix must be obtained by each Company from a GS1 Member Organization. The same is available in India via GS1 India. A business can develop distinctive identifying keys for each of its trade commodities, logistical units, locations, etc. using the GS1 Company Prefix.

Create your GLN and GTIN

 A distinct Global Trade Identification Number must be used to identify each trade item and its packing configuration (GTIN). This 14-digit number can be created by adding the GS1 business prefix and the product code, followed by a checksum and an indication digit at the beginning. This needs to be produced in accordance with GS1 standards.

 The Site Identifiers, also known as Global Location Numbers (GLNs), are particular to each location inside the organisation and can be generated for a production location or a sub-location within of each manufacturing unit, depending on the needs of the business.

Select your Barcode Printing Partner 

 The QR code installation procedure will go more smoothly if you choose a barcode partner (Company) with experience in AIDC Technology and functional knowledge of the Pharmaceutical Industry and its subtleties. The main OEMs offer a wide selection of barcode printers and scanners with different features, specifications, and pricing points. When it comes to selecting high-quality consumables like labels and carbon rolls that will match your company's demands, the ideal barcode partner should be able to assist.

 Choose the right hardware and consumables

 Select the appropriate printers for printing based on the label size, print volumes, connectivity requirements (USB/LAN/Bluetooth/Wifi), and the label-printing software application. Depending on factors including weight, physical characteristics, durability, estimated life, mobility, range, and usage circumstances, scanners may be selected. The market offers a large selection of printers and scanners from both top OEM brands and more affordable brands, allowing the customer to select according to their needs.

All information can be printed on plain white labels, or labels can be pre-printed with static data like the firm name, logo, manufacturing site address, licence number, etc. and only the variable data can be printed in real time. From the most affordable paper labels to the highest quality synthetic labels and a suitable carbon roll to print on, one can select from a wide range of label substrates.

Get the Right software tool that is regulatory compliant

This is essential for the mandate on QR codes to be implemented successfully. A QR code printing application created specifically for this function is essential for a hassle-free printing experience. More than merely printing QR codes on the Labels should be possible with the QR code print application. The most important characteristics to search for in a QR code printing application are

Dynamically design label template, save and manage the templates specific to APIs, grade, marketing regions, customers etc.

Create and manage API masters, user and role masters.

Approval workflow for supervisor, QA and admin approval

Meet the requirements for electronic data management and is compliant with requirements for electronic system (21 CFR Part 11, EU annex 11)

Validation in compliance with GS1 standards

Upgradable on par with the evolving regulations (as the requirements for API is not yet clearly define and is still evolving)

Pull standard and customised reports as required

Although it is not required by the present Indian Government rule for this mandate, it is better to have a software solution that is 21 CFR part 11 compliant because it will allow a hassle-free regulatory audit.

Establish Process and Procedures 

 To print QR codes on labels, establish the quality process and record the standard operating procedures (SOP). This procedure should cover handling the workflow, handling users and passwords, handling the approval process, storing and retrieving data, and other things.

 Plan a data backup in accordance with regulatory specifications for future reference, conduct necessary internal and regulatory audits, and administer the database effectively.

Are you Ready to go Live?

Ensure the tool is validated, all necessary process & procedures are in place and all relevant personnel are trained on the use of the hardware and the printing application. 

Implement the process well in advance before the deadline 1 Jan 2023, to sort out any teething issues that may arise during implementation.