Study of Packaging Material for Pharmaceutical Product

Simple words!!!
The packaging decision of any product is effortless if you follow a particular rule. Otherwise, it will be a blunder pack design or failed product in the market.

The pharmaceutical is based on certain norms and SOP guidelines. Each and everything is documented if it happens at that time.

Basically, Pharma has two different categories – Generic and New molecule product
A. Generic drugs are replicas of brand-name drugs that have the equivalent dosage, intended use, effects, side effects, risks, safety, and strength precisely as the original drug.
B. In simple terms, patented drugs.

A. For Generic drugs:
Completed benchmarking of competitors, related to the packaging material – Primary, secondary, and tertiary content.
B. Brand/New Molecule Product

A complete study of new molecule behavior, to get to know the insight from the product R&D department.

Selection method points for every section:
1. Compatibility Study*: The temperature and humidity vary from product to product. This test shall be done by Packaging & Product R & D dept jointly. Before going to the selection, Many countries have their specific rule for the packaging like an only blister is applicable. So, the study shall perform as per prescribed norms. The study shall do to keep in mind all the machine feasibility and quality aspects with the financial limitation.

2. Stability study*: This study is jointly done with QA, QC, and the packaging team for getting the desired result. The study temperature/humidity data is with the product R&D team.
* Many companies do the testing in a single step. The above test is only for the primary packaging study.

3. Dimensional Studies: Whatever you select the packaging material, just have to ensure that it would be within the range of the packaging filling machine. And if required any changes, it required bracketing study or else with the new starting. On that behalf can change the size. (for the cost-saving, it will help the bracketing study). This study shall do with production and IPQA personnel (In-Process Quality Assurance) with the trial study.

4. Safety and Security Features: This feature depends on the marketing requirement, if marketing wants their product with particular enhanced functionality, then you have to combine it. For Example, Tamper-evident seal, Pilfer proof seal, a 3D barcode on closure/wad seal, registered mold, etc.

5. Functionality Parameters: After deciding all the above parameters, the function test must be performed for getting the best result in the market. This is a test performed to get to know the pre-feedback from the market. For example, how the closure of the bottle will open, the opening feature of a monocarton, etc.

6. Performance Test: The test is jointly done with the marketing & logistics team. They can give the exact idea of your product behavior in the market. This gives the whole concept of your transport worthiness test. For example, Vibration tests, stack load tests, etc.

7. Aesthetic features: Totally depends on RA and marketing personnel.

The document shall check with your QA and RA departments.

Secret code of packaging – its pack-aging