The pharmaceutical supply chain has gotten more international. Today, the drug industry prefers to purchase Active Pharmaceutical Ingredients (APIs) from other countries for the purpose of cost reduction, increased sourcing and guaranteed supply.
Global sourcing offers many opportunities, but also compliance challenges arise. The regulatory control of imported pharmaceutical ingredients has been tightened by domestic regulators in the USA, the E.U., Canada, Japan, Australia and other countries. One instance of non-compliance may result in delays, rejection of import, warning letters, product recalls, and/or damage to a company's reputation.
Compliance risk mitigation is no longer a quality function, it is also a priority for procurement teams and regulatory professionals along with pharmaceutical manufacturers.
In this article, you'll learn about the most common compliance issues and what businesses can do to create a more secure and compliant API sourcing strategy.
Why API Import Compliance Matters More Than Ever
Imported APIs need to be regulated to the same standards as domestic APIs in regulated pharmaceutical markets. The regulatory agencies not only test the product, they test the entire supply chain that brought the product to them.
If an API that's imported doesn't conform to regulatory standards, the repercussions can be serious:
- Delayed product approvals
- Supply chain disruptions
- Increased procurement costs
- The inspections and observations related to the regulation.
- Product shortages
- There is a risk of loss of trust of the customer.
In today's global marketplace, pharmaceutical supply chains are more dynamic with suppliers located all over the world; the Procurement team has to ensure that all suppliers are quality, regulatory and document compliant at all times.
Compliance will not occur before an audit. It needs to be considered as part of the supplier selection, qualification, procurement and supplier management processes.
Common Compliance Risks When Importing APIs
The very first step towards avoiding common compliance issues is to identify them.
Supplier GMP Non-Compliance
Good Manufacturing Practice (GMP) is one of the most crucial standards for API manufacturers.
As long as you are an experienced supplier, you can get regulatory observations on:
- Lack of quality control in procedures.
- Poor documentation practices
- Insufficient process validation
- Data integrity issues
- Incomplete corrective actions
If the supplier's issues are not resolved and are not addressed by the regulatory authority, pharmaceutical manufacturers may encounter a serious dilemma with their suppliers.
Incomplete Regulatory Documentation
The need for documentation on the quality, safety and traceability of products in regulated markets is very great.
Typical documentation problems are:
- Old Drug Master Files (DMFs)
- No certificates of analysis (CoAs) are available (Maintenance problems).
- Incomplete validation reports
- Inconsistent batch records
- Missing quality agreements
Documentation may be incomplete, resulting in a delay in the approval process or problems with compliance when it is looked at during inspection.
Poor Supply Chain Traceability
Many procurement teams in the world use a number of intermediaries when sourcing APIs from around the world. When it is not possible to trace, businesses may encounter problems when it comes to proving:
- Manufacturing locations
- The raw materials' origin.Find and obtain raw materials.
- Supply chain ownership
- Transportation conditions
- Product authenticity
The absence of transparency will increase compliance risks and will make investigations more difficult in case of a quality problem.
Data Integrity Concerns
Data integrity is increasingly gaining importance in regulatory environments.
The documentation can be inaccurate or compromised, records may be missing, or poor documentation practices with electronic records can result in substantial regulatory action.
Even if the product quality is good, the customer may not believe in the supplier's business due to poor data quality.
How to Qualify API Suppliers Before Importing
One of the best strategies for minimizing compliance risks is to qualify suppliers.
Procurement teams shouldn't only focus on price when selecting a supplier – they need to also consider quality, regulatory compliance and reliability.
Assess Manufacturing Capabilities
Quality of the product is always directly related to the manufacturing infrastructure of a supplier.
Here are some factors to keep in mind:
- Production capacity
- Manufacturing technology
- Quality control laboratories
- Process validation programs
- Change control procedures
Suppliers need to prove their capacity to consistently supply APIs as per regulatory expectations.
Verify Regulatory History
Experience is a good indicator of future performance when it comes to suppliers and their regulatory as well as operational experience.
To be reviewed by procurement teams:
- Regulatory inspection outcomes
- GMP certifications
- Previous warning letters
- Import restrictions
- Customer audit results
Having a good compliance history is a good indication of a more well-developed quality system.
Analyse Quality Management Systems
Good quality systems assist to minimise deviations turning into regulatory issues.
Important elements include:
- Standard operating procedures
- CAPA programs
- Risk management frameworks
- Internal audit programs
- Training systems
A strong quality culture can often be used as a method to differentiate between reliable suppliers and high risk suppliers.
Conduct Supplier Audits
Supplier audits provide firsthand insight into manufacturing processes.
Audits help procurement and quality staff to assess:
- Facility conditions
- Documentation practices
- Employee training
- Process controls
- Regulatory readiness
Audits should continue to be a part of any supplier management plan.
Essential Documentation Every Importer Should Verify
One's adherence to the rules is based on documentation.
Procurement and quality teams need to check a number of important documents before importing APIs.
Drug Master Files (DMFs)
DMFs contain detailed information related to the manufacturing process, facilities, process controls, and quality systems for the manufacture of APIs.
A clean and maintained DMF ensures successful regulatory submissions and transparency of a supplier.
GMP Certificates
Good Manufacturing Practice certificates are valid as the manufacturing plant has been visited by the regulatory authorities or third party inspection bodies.
All GMP certifications should be checked for authenticity and validity by procurement teams.
Certificates of Analysis (COAs)
CoAs that provide details about the batch of product along with displaying the compliance of the product quality and specification.
All shipments should include analytical documentation and it should be done well.
Quality Agreements
There is a clear understanding of responsibilities in quality agreements between supplier and buyer.
These contracts can include:
- Change notifications
- Investigation procedures
- Documentation requirements
- Product complaints
- Audit rights
Good quality agreements minimise misunderstandings and enhance the level of supervision of compliance.
Evaluation of API Suppliers in Regulated Markets in India
India is a critical link in the worldwide supply chain of medicines and one of the world's big API suppliers.
However, not every API supplier in India is equally knowledgeable when it comes to regulatory issues. Not all suppliers are created equal, and it's important to do your due diligence when selecting your supplier.
What to look for in a trustworthy API provider?
Good suppliers will normally provide:
- Consistent GMP compliance
- Strong regulatory history
- Transparent documentation
- Stable manufacturing operations
- Proven export experience
They are prepared to share pertinent good information and work with the customer audit if necessary.
These are some of the important questions to ask, where your Procurement Teams are not involved.
Key Questions Procurement Teams Should Ask
Prior to making a sourcing agreement, buyers must ask:
- Which markets are there today that are regulated?
- What are some of the regulatory inspections that you have faced?
- Do you have an up-to-date, maintained DMF?
- How do you control changes?
- What are some data quality integrity systems?
The responses frequently indicate the supplier's willingness to be compliant.
Common Red Flags to Avoid
The following are standardized red flag rules to avoid:
When suppliers demonstrate:
- Inconsistent documentation
- Limited regulatory experience
- Lagged responses to answers to compliance questions
- There is insufficient transparency in auditing. Inadequate auditing transparency.
- The lease will be owned, manufactured, and then owned once again, since it is a contract.
These warning signs can indicate a greater possibility of compliance.
How a Bulk API Sourcing Platform Helps Reduce Compliance Risks
A Bulk API Sourcing Platform can help reduce compliance risk by making it easier. A bulk API sourcing platform can help reduce compliance risks by simplifying the process.
A lot of traditional supplier discovery methods are dependent on uncoordinated information, word of mouth and manual qualification procedures.
This can cause slashed procurement times and increased risk.
The bulk API sourcing platform provides a more systematic and clear-cut supplier identification and qualification process.
Improved Supplier Verification
This is because verified supplier profiles enable buyers to assess manufacturers' more efficient.
The procurement team is able to see details about:
- Manufacturing capabilities
- Product portfolios
- Certifications
- Export experience
- Regulatory credentials
This helps to make better decisions in the selection of suppliers.
Faster Documentation Access
Having information about suppliers in one place can minimize the qualification process delay.
Pro procurement teams will be able to compare documentation more efficiently, rather than having to get information from multiple suppliers.
Streamlined RFQ Processes
The procurement platforms are digital and help the management of RFQs and connect buyers with qualified suppliers.
This improves communication, speeds up the sourcing process and improves sourcing decisions.
Greater Procurement Visibility
The 1-to-1 sourcing model allows procurement departments to evaluate suppliers based on the same criteria.
This improves supplier governance and enables quicker detection of compliance risks during the sourcing process.
Building a Compliance-Focused API Sourcing Strategy
Compliance in successful pharmaceutical companies is not considered a regulatory process, rather part of procurement strategy.
The following are examples of the elements of a good sourcing framework:
- Risk-based supplier qualification
- Regular supplier audits
- Continuous regulatory monitoring
- Documentation verification
- Multi-supplier sourcing strategies
- Ongoing performance reviews
By capturing the compliance value during procurement, it can provide the supply chain with resiliency and reduce disruptions.
Conclusion
APIs are allowed to be imported to regulated markets, offering pharmaceutical companies greater sourcing flexibility and superior supplier options. The benefits are accompanied, however, with many compliance requirements.
Companies with a focus on supplier qualification, documentation verification, GMP compliance and transparency in the supply chain are more likely to avoid more expensive issues related to regulatory compliance.
Global Sourcing is increasingly becoming more complex and difficult, and procurement teams need tools and processes to support the decision making process. This can help to reduce compliance risks and improve the long term performance of the supply chain through cooperation with qualified API suppliers in India, effective supplier monitoring, and by leveraging a credible bulk API sourcing platform.
Compliance is no longer just a regulatory matter but it also constitutes a competitive advantage to ensure quality of product, continuity of business and access to the market in the pharmaceutical industry.
