Quality testing is the backbone of the pharma industry, especially in API manufacturing. API quality testing is necessary for patient safety, regulatory compliance, and product success.
So, what does the QC in pharma indicate? In this blog, we have discussed the 6-step API development process for API QC testing that we use as a WHO-GMP certified API manufacturer in India. This process helps us meet diverse pharmacopeia standards and break into the international market.
Why Does API Quality Testing Matter?
API quality testing is an important step that makes sure APIs are safe, effective, consistent, and free of impurities. If you work with an API manufacturer that adheres to quality standards, your pharmaceutical products will meet market standards and gain customer trust.
Here are some more reasons why quality control (QC) is important in the pharmaceutical industry:
- Guarantee the health and safety of patients
- Improve the reputation of drug companies
- Get the approvals from regulatory bodies in all markets easily.
- Make sure your supply chain is reliable for a long time.
Chemox Pharma’s Step-by-Step Process of API Quality Testing
Chemox Pharma is one of the most trusted API and Intermediate manufacturers in India. We adhere to WHO-GMP standards to develop high-quality, stable pharmaceutical products.
Step 1: Raw Material Testing
The raw material used in API manufacturing affects its quality the most. Therefore, Chemox Pharma uses high-quality raw materials for developing our APIs and Intermediates.
All the products we use for API formulation are tested before use to reduce the variation and prevent contamination. We test the following factors to ensure error-free production and quality:
- Identity verification
- Purity level
- Moisture content
- Impurity profiling
We have predefined specifications for each factor to ensure batch consistency and regulatory compliance.
Step 2: In-Process Quality Control (IPQC)
The secret of consistent quality compliance in each batch lies in our In-Process Quality Control (IPQC) system. We don’t just check quality at the start and end of the production cycle; we also check it at various stages.
Multi-stage API quality testing focuses on impurity profiling, variable detection, and more. This test allows us to ensure the level of:
- Reaction completion
- Correct pH levels
- Temperature control
- Intermediate purity
With in-process quality control, we reduce batch failures, ensure consistent quality, and maintain strict adherence to regulatory standards.
Step 3: Final API Testing
The API undergoes strict QC tests to ensure that it meets the desired pharmacopeia standards. The data of the analytical testing of APIs is essential for regulatory approval.
As a WHO-GMP certified pharma company, our final QC test focuses on:
- Assay (Potency)
- Related Substances / Impurities
- Residual Solvents
- Loss on Drying / Water Content
- Particle Size (if applicable)
- Heavy Metals
Step 4: Stability Testing
Stability testing is performed to determine the storage conditions and the shelf life of the APIs. So, this is among the most significant tasks to do to ensure the safety and efficacy of pharma products.
The stability testing process checks how different environmental components, which include temperature, humidity, and light will affect the API. The test enables the manufacturer to select appropriate packaging solutions which will ensure safe product delivery to customers.
Step 5: Documentation & Certification
Quality testing is incomplete without transparent Documentation and API certification. We provide all the necessary documents to ensure quality compliance and gain customer trust.
Each batch of API developed by Chemox Pharma is supported with:
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Regulatory Documentation (as applicable)
Each batch is dispatched with the necessary documents and API certification for better traceability, regulatory compliance, and audit compliance for pharmaceutical partners.
Step 6: Regulatory Compliance Review
The main goal of our API QC testing process is to meet all regulatory standards. We use our testing process to collect data through various QC tests. This data helps us confirm our compliance with GMP guidelines and international regulatory requirements.
As a WHO-GMP certified API manufacturer, we ensure that we adhere to all the WHO guidelines at all stages for seamless market approval.
We are known for customizing API pharmacopeia standards. Therefore, we provide the documents required for compliance with USP / EP / IP / BP standards, as per the pharmaceutical partner’s needs.
Buy high-quality and compliant APIs and Intermediates for flawless pharma product development from Chemox Pharma. If you have any queries, feel free to connect with us.
Conclusion
API quality testing is a critical step in pharma production to ensure the purity, safety, efficacy, and regulatory compliance of the pharma product. Compliance with the regulatory standards makes it easier to penetrate global markets. Top API manufacturers like Chemox Pharma use multi-stage QC testing, stability testing, clear documentation, and API certification for regulatory compliance. If you have any questions about APIs and Intermediates, please get in touch with us.
FAQ
What are the steps in the API manufacturing process?
A reliable API manufacturer adheres to regulatory standards at every step to ensure seamless market approval. The following are the steps in API manufacturing process:
- Sourcing high-quality raw material
- Chemical synthesis
- In-progress quality control
- Final API testing
- Stability testing
- API certification
What is the importance of QC in pharma?
The QC tests in the pharma industry are critical to ensure:
- Patient safety after consumption
- Efficacy of the pharma product after packaging and shipping
- Consistency in the quality of the product
- Regulatory compliance to enter global markets
- Reduce batch failures
- Avoid a product recall due to quality failure
Chemox Pharma adheres to WHO-GMP standards to develop high-quality APIs and Intermediates. Contact us to know more.
What is impurity profiling in API manufacturing?
Impurity profiling requires the identification, measurement and control of all impurities that exist in the API. The impurities found in products trace back to the materials used in production, the manufacturing process, and degradation. Impurity profiling is essential to ensure patient safety and reduce batch failure. Additionally, it is necessary for regulatory compliance.
What are the GMP standards for API manufacturing?
GMP in API manufacturing stands for Good Manufacturing Practices. These GMP standards offer guidelines for facility design, Documentation, personnel training, equipment validation, and quality control. These guidelines ensure that APIs are safe and comply with regulatory requirements. Chemox Pharma is a WHO-GMP-certified API manufacturer known for regulatory adherence and transparent Documentation. Contact us to know more.
