Nualter Herbovet

Why Quality Assurance is the Backbone of Third-Party Pharma Manufacturing?

In the pharmaceutical industry's fast-changing landscape, many companies that want to increase operational scalability, reduce costs, or diversify their product ranges use third-party manufacturers. Maintaining product quality is a main concern regardless of the industry and in the case of pharmaceutical outsourcing, this quickly becomes a significant challenge. Whether dealing with human or animal medicines, there are no margins for error when it comes to quality; patient and brand safety hang in the balance.

In this blog, we look at why quality assurance stands as the primary pillar of third-party pharma manufacturing.

What is Quality Assurance in Pharma Manufacturing?

In pharmaceutical manufacturing, quality assurance involves developing a complete system that makes sure all products entering the market are of high quality, safe and effective. Unlike the relatively straightforward quality control which focuses on the end product, QA incorporates processes like raw material purchasing, equipment calibration, personnel training, documentation, packaging and even post-market surveillance of sold items.

For external pharmaceutical providers, quality assurance serves as a trust link for the brand owner and the contract manufacturer. It guarantees transparency, accountability, etc. regardless of the geographic location or the precise timing of the batch being produced.

Quality Assurance in Third-Party Manufacturing

Guarantees Product Safety and Efficacy: Each pharmaceutical product, be it human or animal, has to be safe and therapeutically effective. Quality assurance guarantees that:

The raw materials are of pharmaceutical-grade quality.
Every stage of formulation, filling and packaging is performed under verified conditions.
There is no contamination, dosage deviation, or stability concerns.

This is important for veterinary medicine where specific formulations for different species impose rigid compliance to detailed standards.

Builds Trust and Brand Reputation: Once companies decide to outsource their manufacturing, they depends their brand to a business’s practices. Strong quality assurance systems:

Encourages brand loyalty.
Eliminates possibilities of defective batches from reaching the market.
Improves consumer confidence due to reliability in products.

Ensures Regulatory Compliance: Pharmaceuticals in particular have intense national and international requirements such as WHO-GMP, ISO and FSSAI, etc. The QA department ensures that:

All batch documentation is done accurately.
All production processes are legally compliant and can pass audits.
All products intended for trade and export in controlled economical areas are registered and compliant.

The absence of QA could lead to undue regulatory fines, trade sanctions, or corporate insolvency – consequences no pharma company wants to face.

Reduces Wastage and Financial Risk: Failed quality checks lead to:

Batches being rejected.
Significantly increased costs of reworking procedures.
A loss of value in professional or business relationships with customers or other healthcare stakeholders.

With effective preventive QA frameworks designed to address these issues – which include in-process checks, clearly defined standard operating procedures and comprehensive validation – manufacturers can enhance delivery rigidities, minimize expenditures and risk exposure.

Supports Product Innovation and Scalability: In new formulation developments, penetration of niche markets, or expansion of production volumes, QA makes sure that:

Developed products are scientifically and structurally safe.
There is unformulated variability for scale-up.
There is assurance for new launches to meet realistic expectations in the market.

Conclusion

If you are looking for third-party pharma manufacturer that follows proper quality control processes, Nualter Herbovet has established manufacturing facilities equipped with ISO, GMP and WHO GMP compliance certifications. Our company is the renowned Pharma Third Party Manufacturer in India and has multiple fully automatic manufacturing plants and prides itself on offering a range of healthcare products.