The medicines/drugs are critical for the health of all species. Therefore, quality control is necessary to ensure that all the drugs are safe and have the same therapeutic impact. That is where GMP manufacturing regulations play a vital role in API production. In this blog, we will understand the GMP good manufacturing practices that reliable API manufacturers must follow.
What is GMP manufacturing in pharma?
An authoritative organization issues GMP manufacturing regulations and guidelines to ensure that all the pharma products have consistent quality. These regulations focus on the products and the premises on which they are manufactured.
APIs are responsible for the therapeutic effect of the drug. Therefore, adhering to the GMP standards is critical for API manufacturers. By following the GMP good manufacturing practice, the manufacturers ensure that all their APIs:
- Have the right purity and potency
- Aren’t contaminated
- Are safe to consume
- Meet the necessary quality standards
Each country has its specific GMP standards. Therefore, if an API manufacturer wants to enter a country, they must meet the GMP regulations to export. WHO-GMP is a good manufacturing guideline issued by the World Health Organization (WHO). These regulations concern the raw materials, procedure, and packaging of the drugs and APIs. Those who follow the WHO-GMP guidelines can easily trade with the WHO member countries. Let’s understand more about the GMP regulations.
What are the GMP good manufacturing practices?
The following are the key GMP good manufacturing guidelines that an API/drug manufacturer must follow to make their pharma products acceptable in the desired market.
Consistency in the materials used in the product
The API manufacturer must document all the materials used in the production of their pharmaceutical products. The manufacturer must create a master formula for a particular product with details of the material quantity and procedures used to develop the API. This ensures that each batch has the same quality and potency.
Optimum facility and equipment layout
The environment affects the quality of the drugs. Therefore, GMP standards pay close attention to the facility and equipment layout of the API manufacturers.
The facility must be cleaned, have proper ventilation, and have a controlled manufacturing unit separate from other utility areas used by the team. It reduces the chances of contamination and variation in the drug quality.
The equipment in the API manufacturing unit must follow SOPs (Standard Operating Procedures) to minimize deviation and ensure consistent APIs quality. The manufacturer must invest in the best tools to reduce the production time and cost while meeting the quality standards.
Trained personnel
Even the best manufacturing unit can fail if they don’t have trained personnel. Therefore, GMP authorities pay close attention to the teamwork in the API manufacturing. All the personnel involved in the API production must undergo GMP training outlining the rules and guidelines for operating the machines and maintaining the quality standards. The team must know how to follow the safety measures of the manufacturing procedure, understand deviation management, and comply with the hygiene standards in the production facility.
Updated procedure
Technology and the resistance mechanism of the antigens are evolving rapidly. Therefore, the manufacturing procedure must also be updated to maintain and upgrade the quality of the drug. By following GMP manufacturing guidelines, API manufacturers ensure that they follow the latest trends and tools to create effective pharma products.
Documentation of each production cycle
The most crucial GMP good manufacturing practice is to record each step, from the raw material to the final packaging. It ensures that the API is made with the necessary quantity of raw material and meets the quality standards in each step. Therefore, deviations are minimized and the drug’s potency is maintained in all batches.
How did Chemox Pharma become one of the best API drug manufacturers in India?
Chemox Pharma is among the top API manufacturers in India, known for its quality and a WHO-GMP-approved manufacturing unit in Dahej, Gujarat. We have been focused on thorough R&D to create innovative and affordable intermediates and APIs. Our goal is to make medications more accessible to everyone across the globe.
By following the WHO-GMP guidelines, we have been able to create 18 APIs and export them to 20+ countries. We employ the best pharma professionals and adhere to the global standards to produce intermediates and APIs based on custom pharmacopoeia needs. We can also customize the packaging for you. Contact us with your queries or secure a consultation call!
Conclusion
GMP manufacturing is essential in the pharma industry to ensure the quality and efficacy of the drugs and APIs. Authoritative bodies like the WHO provide the GMP good manufacturing guidelines. These guidelines concern the raw materials, master formulas, production premises, personnel training, and documentation of each production cycle to maintain the quality and minimize the deviation of the drugs and APIs. Chemox Pharma is one of the best API drug manufacturers in India, and it has a WHO-GMP-approved facility and APIs. Contact us for custom-quality intermediates and APIs.
FAQ
Why is GMP important in the pharmaceutical manufacturing process?
GMP guidelines ensure that each batch of pharmaceutical products maintain consistent quality and efficacy. These guidelines are critical for the quality assurance of the drugs, reducing quality deviation, and ensuring they are safe to consume. Chemox Pharma adheres to the GMP standards to create effective and safe intermediates and APIs.
What are WHO-GMP regulations?
WHO-GMP regulations are the GMP guidelines issued by WHO. These regulations cover all aspects of API or pharmaceutical product manufacturing including raw material usage, production facility, hygiene standards, personnel training, documentation of the production steps, and quality control. Many pharma manufacturers, including Chemox Pharma, follow the global regulations outlined by WHO.
What are the 5 Ps of GMP good manufacturing?
The 5Ps of GMP are Products, Procedures, People, Processes, and Premises. All these Ps affect the quality of the pharma products. All reliable API manufacturers, like Chemox Pharma, follow GMP guidelines.
What are the common challenges of adhering to GMP regulations?
The most common challenges pharma manufacturers face are the cost of establishing a manufacturing unit adhering to the GMP standards, keeping up with the evolving GMP standards, and tracking and documenting each production cycle. At Chemox Pharma, we take extra measures to ensure we follow the WHO-GMP guidelines to create the best quality intermediates and APIs.
