Importance of Quality Packing Material in Third Party Pharmaceuticals Manufacturing

Medicine plays a crucial role in maintaining health, preventing disease and saving lives. However, ineffective medicines pose great risks to individuals and even threaten lives.

Ineffectiveness takes several forms, such as medicines containing less than the stated dose of the active ingredient or containing unstated or harmful substance(s). Similarly, fake or counterfeit medicines and medicines that have been degraded or adulterated due to improper storage and handling may also be ineffective.

These days as more and more companies are opting for THIRD PARTY MANUFACTURING, so it becomes all the more critical for marketing companies to keep a check on the quality of packaging material, like foil, carton used by the manufacturer. Small but very crucial precautions at the time of manufacturing can help in maintaining the quality of the finished product till its actual expiry date. Ultimately it helps in fighting the diseases.

Critical Example

Amoxicillin and clavulanic acid is a broad-spectrum antibiotic useful for the treatment of the number of bacterial infections. It is a combination antibiotic consisting of amoxicillin trihydrate, a β-lactam antibiotic, and potassium clavulanate, a β-lactamase inhibitor. This combination restored efficacy against amoxicillin-resistant bacteria that produce β-lactamase.

Clavulanic acid is volatile and unstable when exposed to high temperatures and high pH . In addition, clavulanic acid is hygroscopic; therefore, 30% RH or less is desirable for storage. The poor quality packaging material can cause deterioration of clavulanic acid in amoxicillin-clavulanic acid combination thus reducing its effectiveness.

 Importance of packaging

Packaging is referred to as the collection of different components which surround the pharmaceutical product from the time of production until its use.

 Packaging material

•  Protect against all adverse external influences that can change the characteristics of the product.
• Protect against microbial contamination.
• Protect against physical damage.
• Carry the correct information and identification of the product.
• Tamper evident / Child resistance/ Anti counterfeiting.

Selection of packaging material

• Moisture barrier requirements
• Light barrier requirements
• Gas barrier requirements
• Chemical properties

 Testing and stability

Critical parameters during the screening of PM.

It should not release chemicals

• It should not release visible and /or sub-visible particles
• It should not Adsorb or absorb pharmaceutical components
• It should not chemically reactive to the pharmaceutical product
• It should not degrade on coming in contact with pharmaceutical products

Use of quality of packing material may have a non-significant impact on the cost of third-party manufacturing pharma products, but the use of POOR QUALITY packaging material puts each and every stakeholder in the chain at RISK specifically the end user The Patients.

• Effects of packaging and storage conditions on the quality of amoxicillin-clavulanic acid – an analysis of Cambodian samples. http://www.biomedcentral.com/2050-6511/14/33
• http://apps.who.int/medicinedocs/documents/s19638en/s19638en.pdf