How Important is WHO-GMP for Patient Safety?
It is the fundamental quality testing.
It is used globally by the pharmaceutical manufacturers to ensure patient safety and quality.
It’s the global health standard. It is accepted worldwide.
What is WHO-GMP certification?
It is the World Health Organization – Good Manufacturing Practices
WHO –GMP certification of the pharmaceutical manufacturing company, ensures its reliability.
It assures that the drugs manufactured are of-
- Standard quality
- Safe to use
- Effective and accurate dose
It confirms that the manufacturing unit follows strict quality and safety protocols.
How is WHO-GMP different from normal quality testing?
WHO -GMP qualifies and tests the entire manufacturing process.
It ensures the quality from the raw material to the final product.
It is a good manufacturing practice to be followed by the drug manufacturers.
It assures patient safety, quality, and reliability.
The normal testing assures the final product quality.
WHO- GMP adherence ensures the product manufactured is safe.
It follows a stringent process of formation.
Even without testing it ensure safe and effective preparations.
How WHO- GMP ensure medicine quality and safety?
WHO guidelines indicate a proactive strategy to mitigate potential risk and errors.
Strict Hygiene Protocols-
WHO –GMP lays strict guidelines to ensure sterile and safe products.
It lays out cleaning processes of the equipment and the manufacturing areas.
It implements the use of a controlled environment with particulate control. It prevents microbial contamination.
- Using air filters (HEPA)
- Positive air pressures
- Unidirectional air flow
- using sanitizable surfaces
Batch to Batch Consistency –
WHO recommends a standard procedure for manufacturing different batches.
It ensures consistent quality and dose accuracy between the two batches.
Purity and stability of the medicines –
It suggests raw material testing, stability studies to ensure shelf–life.
Traceability and Accountability-
WHO recommends maintaining comprehensive documentation from the procurement of the raw material to the launch of the product in the market.
It includes –
- Manufacturing protocols
- Packaging protocols
- Equipment logs
- Calibration records
- Batch distribution records
- Transportation logs
- Storage records
Aprazer Healthcare’s Commitment to WHO–GMP Standards
Aprazer Healthcare is the top pharmaceutical manufacturing company.
We are focused on manufacturing global quality products.
We have WHO-GMP certified manufacturing facilities.
With strict adherence to the quality standards, we are focused on manufacturing safe and effective medicines.
Using high-quality API and robust quality controls, Aprazer Healthcare is a global name in manufacturing top-quality pharmaceutical products.
Our group of trained professionals ensures precision and care at every step of the manufacturing process.
