Ensuring Compliance: The Crucial Role of Pharma Traceability in our Packaging Unit

Whether it’s packaging for a brand new pharmaceutical product or the packaging of one that has an established presence in the market, the layout, printing and production procedure is critical. 

In Pakistan's pharmaceutical landscape, compliance with regulatory standards in packaging is not just a matter of best practice; it's a legal requirement enforced by the Drug Regulatory Authority of Pakistan (DRAP). At Pakistan International Printers, we recognize the gravity of complying with these regulations to ensure the safety and efficacy of medications set for market. 

From the outset, our operations are underpinned by DRAP's guidelines for pharmaceutical packaging. We meticulously adhere to requirements regarding labeling, tamper-evident features, and product traceability. Each step of our packaging process is conducted with unassailable focus and care. Regulatory compliance genuinely requires quality assessments at the level of every individual; this is how we ensure that the final packaging leaving our facility meets the regulatory standards set forth by DRAP. 

We maintain a purist approach to labeling requirements; essential information such as dosage, administration instructions, expiration dates, and warnings is accurately displayed on the outer packaging.Moreover, Track and trace systems are essential for fighting counterfeiting and keeping products safe. 

This system involves assigning a unique identifier, such as a serial number or barcode, to each unit or batch of products at the secondary packaging level. In the context of secondary packaging, track and trace systems typically involve printing or applying these unique identifiers onto folding cartons, blister packs, or other forms of packaging. Our offset printing faculties also offer the option to use specialty inks that change color or reveal hidden messages when tampered with. 

Our state-of-the-art Cast and Cure (C2) specialized printing is primed for anti-counterfeit packaging, as it includes elements such as holographic images, special inks, or adhesive patterns that make it difficult to tamper with or remove the label without leaving visible signs of damage.

At the heart, our commitment to compliance extends beyond mere obligation, it is our dedication to the well-being of patients across Pakistan and the Healthcare institution at large. By embracing transparency and proactively aligning our practices with DRAP's regulations, we strive to play our part in safeguarding public health and fostering trust in the pharmaceutical industry.

A Note from our Regulation and Compliance Officer, Ammar: 

 As a best practice, it is important to ensure that product conformity is maintained during the production cycle in both print and pack. Manufacturing processes are always advancing so we always need to maintain inspection checks on our end. At this stage, I am appointed to conduct a formal risk assessment to minimize risk to the end patient.  

In addition, the inspection shall ensure that the predefined Critical to Quality checks are completed accurately in real time.